Medtronic teams up with Tidepool to develop interoperable insulin pump

Medtronic (NYSE:MDT) will collaborate with nonprofit Tidepool to develop an interoperable automated insulin pump system. Specifically, MDT will develop a Bluetooth-enabled MiniMed pump that will be compatible Tidepool Loop, an open source insulin delivery app for Apple’s iPhone and Apple Watch.

MDT will continue its financial support to Tidepool for its integration and software development activities to enable iPhone-to-pump communications. Both organizations will work with the FDA through the registration process.

Additional details remain confidential.

https://seekingalpha.com/news/3469969-medtronic-teams-tidepool-develop-interoperable-insulin-pump

Novo’s oral semaglutide successful in two late-stage T2D studies

Novo Nordisk (NYSE:NVO) announces positive results from two Phase 3 clinical trials evaluating its oral semaglutide in adults with type 2 diabetes (T2D). The data were presented at the American Diabetes Association Scientific Sessions in San Francisco.

In PIONEER 2, once-daily 14 mg doses of oral semaglutide demonstrated statistically significantly better HbA1C reduction compared to once-daily 25 mg doses Eli Lilly’s (NYSE:LLY) oral Jardiance (empagliflozin) at week 26 (1.3% vs. 0.9%; p<0.0001). Weight loss at weeks 26 and 52 (3.8 kg at both time points) slightly favored oral semaglutide versus Jardiance (3.7 kg, 3.6 kg) but the separation was not statistically valid.

In PIONEER 4,  once-daily doses of 14 mg of oral semaglutide demonstrated a non-inferior (no worse than) reduction in HbA1C compared to once-daily injections of Victoza (liraglutide) at week 26 (1.2% vs. 1.1%) while demonstrating superiority versus placebo (1.2% vs. 0.2%).

At week 52, the HbA1C-lowering effect in the oral semaglutide cohort was statistically significantly better than Victoza and control (1.2% vs. 0.9% and 0.2%, respectively) as was weight loss at weeks 26 (4.4 kg vs. 3.1 kg and 0.5 kg, respectively) and 52 (4.3 kg vs. 3.0 kg and 1.0 kg, respectively).

Previously reported results from another Phase 3, PIONEER 3, showed the superiority of oral semaglutide compared to Merck’s (NYSE:MRK) oral Januvia (sitagliptin).

The company filed its U.S. marketing application in late March with a Priority Review Voucher that cuts the action date to six months after the agency formally accepts it for review.

https://seekingalpha.com/news/3469971-novos-oral-semaglutide-successful-two-late-stage-t2d-studies

For high stakes employer-based coverage, Senate eyes hospital contract reform

Some healthcare experts view the Senate health committee’s proposed reformsto hospital and insurer contracts as essential to try to sustain the employer-based insurance system in the face of bloating costs.

Yet even as the healthcare industry seems bent on defending the commercial market against calls for a single-payer system, hospitals are poised to fight at least some of these policies.

Comments on the draft legislation from Senate health committee Chair Lamar Alexander (R-Tenn.) and his Democratic counterpart, Sen. Patty Murray of Washington, are due Wednesday, and hospitals have already framed the potential restrictions to some of their contracting practices as another threat to rural healthcare.

The discussion draft includes a ban on “all-or-nothing” clauses, which force insurers to contract with all of a health system’s facilities or none of them. American Hospital Association Executive Vice President Tom Nickels said this “could lead to even more narrow networks with fewer provider choices for patients, while adversely affecting access to care at rural and community hospitals.”

The AHA declined to share all the group’s comments on all the contract provisions before they send full feedback to the Senate health committee this week.

But in an October letter to Senate Finance Committee Chair Chuck Grassley (R-Iowa) about transparency measures, Nickels argued that insurers usually have the upper hand with most hospitals and health systems. He also contended that hospitals typically use their contract provisions for “pro-competitive and pro-consumer purposes” such as “value-based care alternatives or protecting the hospital and its patients from unwarranted denials.”

The association echoed those criticisms in its comments on the Office of the National Coordinator for Health Information Technology’s proposals to force hospital and insurer negotiations into the public eye.

Disclosing “price information actually would inhibit competition because it would create a platform for price-fixing,” the AHA said. “Health plans would know what every other health plan was paying and could use that information indirectly to collude and drive prices below competitive levels, thereby reducing the incentives for actual competition in the marketplace, and threatening the viability of some of the nation’s most vulnerable hospitals.”

On rural healthcare specifically, an AHA representative pointed to the March Government Accountability Office report about insurance market consolidation — since states like Alabama, Alaska, Mississippi and Montana are dominated by a single company holding at least 80% of the market.

The rural healthcare argument draws strong skepticism from others.

“They do it because it’s effective,” Dr. Farzad Mostashari, co-founder and CEO of the primary-care company Aledade, said of the approach. “The Senate being what it is, and rurals and rural healthcare being a real concern, it really has political potency to talk about this. But in reality (fixing) the rural hospital closure problem would take a fraction of what they’re proposing, which is to hold all hospitals harmless from any reform.”

Mostashari also argued that the mere fact of bipartisan agreement in the Senate shows “how far beyond the pale hospitals and certain provider groups” have gone to get Congress to act.

“This is the thing: Congress hates to get involved in private contracts—hates it,” he said.

Meanwhile, advocates for the employer system say hospitals have to give up something on costs.

And for many on the employers’ side, the case to back the Senate proposals has been building in the courts.

North Carolina’s Atrium Health only recently settled with the U.S. Justice Department over its anticompetitive steering clauses. Alexander’s draft legislation would prohibit hospitals and insurers from entering into anti-steering agreements to keep patients from cheaper hospitals or clinics.

And California Attorney General Xavier Becerra’s antitrust lawsuit against Sutter Health almost presents the Senate-proposed reforms point by point.

Becerra’s case, filed in March 2018 and headed for oral arguments in August, described contracting strategies that allegedly caused regional healthcare costs to skyrocket in Northern California. One report from the University of California at Berkeley, detailed that average hospital inpatient procedures cost $90,000 per patient more in Northern California than Southern California.

The contracting tactics outlined in the Sutter Health lawsuit would get axed in the legislation from Alexander and Murray, who have proposed a ban on the “all-or-nothing” clauses deployed by Sutter, insurer-hospital collusion to keep patients from knowing the prices ahead of their treatments, and more.

Becerra blamed the “punitively high out-of-network hospital pricing in combination with the anticompetitive provisions in its agreements with network vendors” for making low-cost employer coverage “economically unfeasible.”

With about half of Californians covered through an employer plan, “the economic damage to the state is quite substantial,” the lawsuit said.

The panel’s draft legislation coincided with the fallout of a recent RAND Health study, which sampled 25 states and found that on average hospitals get 241% of Medicare rates from employer insurance.

Some hospitals and hospital groups have questioned the study’s accuracy, but the RAND researchers specifically highlighted hospital contractual clauses that inflate and obfuscate pricing—including “all-or-nothing” clauses and other gag clauses.

The White House has not commented specifically on the Senate health committee’s proposal, but an official said that legislation addressing high healthcare costs “is exactly what the American people want Congress to do.”

Mostashari predicted that the committee proposals will ultimately win out over any hospital objections.

“They’ve just gone too far,” Mostashari said. “And the issue is, like drug pricing, people can see it in their own lives. You just have to go on any local news or Twitter or constituent letters to see thousands of examples of these abuses. They’re going to try to do their usual lobbying tricks, but they don’t have much to stand on. Maybe they should save their bullets.”

Suzanne Delbanco, the executive director of the not-for-profit Catalyst for Payment Reform which helps employers try to find savings, said they have few options left now that they have come to rely on high-deductible plans that are proving too expensive for their workers.

“There are many parties who want to make sure employers can continue offering benefits, and employers want to,” Delbanco said. “But it is a really challenging job when there is so much money in healthcare, and so many entities are holding that money close that it can feel like people forget that healthcare is ultimately about the patient.”

https://www.modernhealthcare.com/politics-policy/high-stakes-employer-based-insurance-senate-seeks-hospital-contract-reform

CMS plans to release list of 400 troubled nursing homes following Senate report

The Centers for Medicare & Medicaid Services said Wednesday it would release a list of nearly 400 poorly performing nursing homes that qualified for but have not received heightened federal scrutiny through what the agency calls the Special Focus Facility program.

The move comes after a Senate report this week revealed the federal government had identified far more troubled nursing homes that qualified for the program than it previously disclosed to the public, the Associated Press reported.

During a call with reporters, Kate Goodrich, M.D., director of CMS Center for Clinical Standards and Quality and chief medical officer, said the agency will be posting the Special Focus Facility candidate list after receiving numerous calls to release it.

“The recent heightened attention to and dialogue around the agency’s Special Focus Facilities program is welcome because it has amplified a very important national dialogue on national nursing home quality,” Goodrich said.

She declined to confirm when it would be posted, saying the agency was working to ensure it was in a format that was “understandable,” but she said it would be updated monthly once it is posted. She said the agency previously did not release the list because it already made a more comprehensive quality reporting tool available to the public, including star ratings, through its website Nursing Home Compare.

CMS contracts with state agencies, known as survey agencies, to investigate abuse allegations. That information is used for its oversight and is made available on the Nursing Home Compare website. Out of the 16,000 nursing homes around the country, about 3,000 have a one-star rating on their health inspection, Goodrich said.

There are 88 Special Focus Facility program slots for about 400 candidates for that program, Goodrich said. States help CMS narrow down which nursing homes are most in need of the available slots, she said.

Of those nursing homes that have entered the program, 90% have graduated from it after passing consecutive inspections and 10% have been terminated from qualifying to receive Medicare funds, she said.

“Certainly we think this is an important program that can lead to improved quality for nursing homes that are poor performers. But we are limited in the number of slots that we have available for the Special Focus Facilities program due to budgetary constraints,” she said.

President Donald Trump’s fiscal year 2020 budget also requests a $45 million increase for survey and certification—for an overall request of $442 million—to enable CMS to meet the statutory survey requirements while dealing with the increase in volume and severity of complaints as well as rising survey costs.

Officials said they’ve already made changes in nursing home oversight.

In April, CMS announced it was undertaking a comprehensive review of its regulations and processes when it came to ensuring safety and quality in nursing homes. The announcement came the same day the Government Accountability Office released a report saying CMS needs to do more to address gaps in federal oversight of nursing home investigations in Oregon.

At the time, CMS Administrator Seema Verma said her team has begun executing a five-point plan, including strengthening its oversight of nursing homes and improving enforcement of quality and safety policies by nursing homes.

Goodrich said the agency also began requiring a more “robust, standardized survey process, strengthened the staffing requirements for nursing homes, updated the way nursing homes report their staffing to CMS, then targeting nursing homes with staffing problems for off-hours and weekend surveys; and began to post all of the agency’s surveyor training online.”

https://www.fiercehealthcare.com/hospitals-health-systems/cms-plans-release-list-400-troubled-nursing-homes

Scientists Spot Unexpected Player in Fibromyalgia

Fibromyalgia is a mysterious and misunderstood illness, but researchers may have uncovered at least one key to the disease’s origin: insulin resistance.

The new research compared a small group of people with fibromyalgia to two groups of healthy people and noted that a long-term measure of blood sugar levels was higher in the people with fibromyalgia. Insulin resistance develops when the body starts to struggle with breaking down sugar.

To see if treating those higher blood sugar levels might help, the researchers gave people who had blood sugar levels in the pre-diabetic range or higher a diabetes medication called metformin. People taking metformin reported significantly lower pain scores, according to the study.

“We combined metformin with standard drugs used for fibromyalgia and saw a much greater degree of pain relief,” said study author Dr. Miguel Pappolla. He is a professor of neurology at the University of Texas Medical Branch at Galveston.

In fact, Pappolla said, the additional pain relief was so significant that the researchers actually called patients on different days to re-check their pain scores.

Because this is a preliminary finding, the researchers aren’t sure how insulin resistance might contribute to fibromyalgia or how metformin might reduce pain. “Metformin may have some analgesic [pain-relieving] activity on its own,” Pappolla said.

Fibromyalgia is a condition that causes widespread pain, fatigue, sleep problems and distress, according to the U.S. Centers for Disease Control and Prevention. Even celebrities aren’t spared from this painful condition — Lady Gaga reportedly had to cancel concerts on her tour due to pain from fibromyalgia.

Though the cause of the disorder isn’t clear, it appears that people with fibromyalgia may be more sensitive to pain than other people — what the CDC calls abnormal pain processing.

Pappolla said that studies have shown differences in the brain between people with fibromyalgia and those without, such as areas with a lower blood flow than expected. The researchers noted that similar problems have been seen in people with diabetes.

The study included 23 people with fibromyalgia. The researchers compared their hemoglobin A1c levels to large groups of healthy people from two other studies. Hemoglobin A1c is a simple blood test that measures what someone’s blood sugar levels were during the past two or three months. A level of 5.7% to 6.4% is considered pre-diabetes, according to the American Diabetes Association. A level of 6.5% or higher means a person has diabetes.

Only six of those with fibromyalgia had normal blood sugar levels. Sixteen had levels considered pre-diabetes and one met the criteria for diabetes.

When the researchers compared the average blood sugar levels of the fibromyalgia group to healthy age-matched people in the other studies, they saw that the blood sugar levels were higher in the people with fibromyalgia, suggesting insulin resistance.

The findings were published online recently in the journal PLOS ONE.

Dr. Edward Rubin, an anesthesiologist and pain management specialist at Long Island Jewish Medical Center, said, “It’s interesting that there’s a possible connection between fibromyalgia and blood sugar. We’ve been attacking the symptoms of fibromyalgia, but we don’t have a good understanding of the root cause of fibromyalgia.”

Rubin, who wasn’t involved in the study, said there may be enough evidence here to try metformin along with other medications used for fibromyalgia for people whose blood sugar levels fall outside of the normal range, to see if they have a positive response.

Dr. Bharat Kumar, from the University of Iowa Hospitals and Clinics, said this study shows people with the disease that there is hope.

“People with fibromyalgia are often told [falsely] that they have a disease that simply cannot be managed. This article shows that it’s not true. Although it’s unclear if metformin will work for every person suffering from fibromyalgia, there is active research into finding solutions for this frustrating and overlooked condition,” he said.

Kumar said it’s biologically plausible that insulin could have an effect on pain. “We know that other hormone abnormalities can cause fibromyalgia-like symptoms, so [this finding] is not too surprising,” he added.

Still, he said, he didn’t expect that metformin would be a “silver bullet” for all fibromyalgia pain. He said there are likely a number of causes of the disease.

More information

Learn more about fibromyalgia from the American College of Rheumatology.

https://www.usnews.com/news/health-news/articles/2019-05-16/scientists-spot-unexpected-player-in-fibromyalgia

ADA Standards Updated With Renal Guidance Based on CREDENCE

The American Diabetes Association (ADA) has updated its “living” Standards of Medical Care in Diabetes to incorporate findings from the Canagliflozin and Renal Outcomes in Type 2 Diabetes and Nephropathy (CREDENCE) trial, including revised renal management guidelines.

The updates, from the ADA’s Professional Practice Committee, are published in sections 10 (Cardiovascular Disease and Risk Management) and 11 (Microvascular Complications and Foot Care) of the association’s online Standards.

The specific changes are detailed on a separate page.

In CREDENCE, which enrolled 4401 patients with type 2 diabetes and chronic kidney disease (CKD), canagliflozin (Invokana, Janssen), a sodium-glucose cotransporter type 2 (SGLT2) inhibitor, lowered the risk for progression to end-stage renal disease (ESRD) by 30%, and was also associated with significantly lower rates of major cardiovascular events, including death and hospitalization for heart failure. In addition, risk of the renal-specific composite outcome of ESRD, doubling of serum creatinine, and death from renal causes was lowered by 34% in the canagliflozin group compared with placebo.

The main CREDENCE results, hailed as ground-breaking, were reported in April at the International Society of Nephrology 2019 World Congress and simultaneously published in the New England Journal of Medicine.

The trial, which was launched in 2014, was stopped nearly a year earlier than planned because it met its prespecified efficacy endpoints.

Importantly, notes ADA, “the renal and cardiovascular risk reduction observed in CREDENCE was present in patients with an eGFR in the 30-45 mL/min/1.73m² range.”

And “although the adverse event profiles of these agents must be considered, the risk-benefit balance of SGLT2 inhibitor treatment appears to be favorable for most patients with type 2 diabetes and CKD,” it adds.

“No increased risk of lower-limb amputations, fractures, acute kidney injury, or hyperkalemia were noted for canagliflozin relative to placebo in CREDENCE. An increased risk for diabetic ketoacidosis was noted, however, with 2.2 and 0.2 events per 1000 patient-years noted in the canagliflozin and placebo groups, respectively.”

Updated Renal Management Guidelines

Based on the CREDENCE results, ADA now recommends as part of section 11 (Microvascular Complications and Foot Care):

• 11.1 At least once a year, assess urinary albumin (eg, spot urinary albumin-to-creatine ratio) and estimated glomerular filtration (eGFR) rate in patients with type 1 diabetes with duration of ≥ 5 years; in all patients with type 2 diabetes, regardless of treatment; and in all patients with comorbid hypertension. Grade of evidence: B
• 11.3 For patients with type 2 diabetes and diabetic kidney disease, consider use of an SGLT2 inhibitor in patients with an eGFR ≥ 30 mL/min/1.73m² and particularly in those with > 300 mg/g albuminuria to reduce risk of CKD progression, cardiovascular events, or both. Grade of evidence: A
• In patients with CKD who are at increased risk for cardiovascular events, use of a glucagon-like peptide 1 (GLP-1) receptor agonist may reduce risk of progression of albuminuria, cardiovascular events, or both. Grade of evidence: C

Section 11.8 (continued monitoring of urinary albumin-to-creatinine ratio in patients with albuminuria treated with an ACE inhibitor or an angiotensin receptor blocker is reasonable to assess the response to treatment and progression of CKD) has been removed.

CREDENCE Information Added to CVD Section

In section 10 (Cardiovascular Disease and Risk Management), information about CREDENCE has been added to the third paragraph of the subsection “Antihyperglycemic Therapies and Cardiovascular Outcomes.”

The updated section also summarizes data from the Canagliflozin Cardiovascular Assessment Study (CANVAS) and CANVAS renal endpoints trial (CANVAS-R), which were presented together at the American Diabetes Association (ADA) 2017 Scientific Sessions and simultaneously published in the New England Journal of Medicine (2017;377:644-657).

In CANVAS, canagliflozin reduced cardiovascular events by 14% and cut the rate of renal function decline by 40% but also doubled the risk for lower-limb amputation (6.3 vs 3.4 cases/1000 patient-years; hazard ratio, 1.97).

Information about CREDENCE is now also incorporated into the fourth paragraph of the subsection “Antihyperglycemic Therapies and Heart Failure” in section 10, noting that the risks for heart failure hospitalizations were reduced by 39% and the composite of cardiovascular death or heart failure hospitalization by 31% with canagliflozin.

The changes to section 10 have also been endorsed by the American College of Cardiology.

https://www.medscape.com/viewarticle/913868

D2d: Vitamin D Doesn’t Stop Diabetes in Those With Prediabetes

Vitamin D3 supplementation in people at high risk of developing diabetes but who did not have vitamin D insufficiency does not reduce the chances of developing the disease compared with placebo, the new results of a randomized, placebo-controlled trial show.

The findings from the Vitamin D and Type 2 Diabetes (D2d) trial were presented here at the American Diabetes Association 2019 Scientific Sessions by Anastassios Pittas, MD, from Tufts Medical Center, Boston, Massachusetts.

“Our study results did not show a statistically significant benefit for vitamin D in decreasing progression to type 2 diabetes in people who have sufficient levels,” he said.

However, he added that “in a post-hoc analysis we did see that vitamin D supplementation potentially had a benefit in those with very low vitamin D levels (20% of the study population was deemed at least vitamin D ‘insufficient’ as opposed to the remainder who were vitamin D sufficient).”

After 2.5 years of follow-up of over 99% of the participants, no significant difference was found in the development of diabetes between those taking vitamin D supplementation and those on placebo (P = .12).

The study was simultaneously published in the New England Journal of Medicine, along with an editorial by Deborah J. Wexler, MD, from Massachusetts General Hospital Diabetes Center and Harvard Medical School, Boston.

Wexler notes that D2d “is the largest” of a number of randomized controlled trials looking at vitamin D supplementation to prevent progression to type 2 diabetes and, as such, these results are “long-awaited.”

But she points out that the findings show that “Any benefit of vitamin D for diabetes prevention, if present, is modest and clearly does not pertain to a vitamin D-sufficient population.”

“Whether targeting populations with vitamin D levels below 12 ng/mL, many of whom have additional risk factors for diabetes, would have an effect on beta-cell function and progression to type 2 diabetes remains unresolved.”

Trial Participants Had Prediabetes but Most Were Not Vitamin D Insufficient

The D2d multicenter trial aimed to test whether vitamin D supplementation reduces the risk of the development of type 2 diabetes among adults at high risk for the disease, ie, those with prediabetes.

The authors note the biological plausibility of vitamin D status influencing risk for type 2 diabetes, highlighting that “both impaired pancreatic beta-cell function and insulin resistance have been reported with low blood [levels] of 25-hydroxyvitamin D.”

They add that observational studies suggest a low blood vitamin D level is associated with diabetes risk, and this is further supported by mechanistic studies showing that vitamin D supplementation improved pancreatic beta-cell function by 40%.

In the study, a total of 2423 participants across 22 US cities were randomized (1211 to the vitamin D group and 1212 to the placebo group) to receive 4000 IU/day of vitamin D or placebo, regardless of baseline serum 25-hydroxyvitamin D level.

The 4000 IU/day dose was selected to balance safety and efficacy and resulted in a large difference in the serum 25-hydroxyvitamin D level between the trial groups in the first 2 years of follow-up.

Participants were required to meet at least two of three glycemic criteria for prediabetes (fasting plasma glucose level, 100-125 mg/dL; plasma glucose level 2 hours after a 75-g oral glucose load, 140-199 mg/dL; and HbA_1c, 5.7%-6.4%) with no diagnostic criteria for diabetes.

Researchers specifically designed D2d to include participants at high risk for type 2 diabetes regardless of their vitamin D level.

When the study began, just under 80% of participants had vitamin D levels considered sufficient by US nutritional standards (≥ 20 ng/mL).

A further 17.4% had levels between 12 and 19 ng/mL, so they were not deficient but did not have sufficient levels, while 4.3% of the overall trial participants were vitamin D “deficient” (< 12 ng/mL).

Women comprised 44.8% of participants, mean age was 60 years, and mean BMI was 32.1 kg/m²; 33.3% were nonwhite and 9.3% were Hispanic. Participants had a mean HbA_1c of 5.9% (48 mmol/mol).

Participants were followed for new-onset diabetes, with blood tests performed every 6 months for a median of 2.5 years.

The primary outcome was a diagnosis of new-onset diabetes, based on annual glycemic testing of fasting plasma glucose, HbA_1c, and 2-hour postload plasma glucose, and semi-annual testing of fasting plasma glucose and HbA_1c.

After 2.5 years of follow-up, new-onset diabetes had developed in 293 participants in the vitamin D group and 323 patients in the placebo group (9.4 events and 10.7 events/100 person-years, respectively), Pittas reported.

So no significant difference was found in the development of diabetes between those taking vitamin D supplementation and those taking placebo (hazard ratio [HR], 0.88; 95% CI, 0.75 – 1.04; P = .12).

By month 24, the mean serum 25-hydroxyvitamin D level in the vitamin D group was 54.3 ng/mL (from 27.7 ng/mL at baseline) compared with 28.8 ng/mL in the placebo group (from 28.2 ng/mL at baseline).

The incidence of adverse events did not differ significantly between the two groups, including hypercalcemia, a fasting urine calcium–creatinine ratio of more than 0.375, a low estimated glomerular filtration (eGFR) rate, and nephrolithiasis.

In the vitamin D supplementation group, 135 participants discontinued their pills, 15 started a diabetes medication, and seven started a weight-loss medication. compared with 107, 19 and 10 participants, respectively, in the placebo group.

“We did a per-protocol exploratory analysis to see if, by excluding patients who started medications or took out-of-trial vitamin D supplements above the trial limit of 1000 IU/day, made a difference.”

“We found that the primary outcome occurred in 22.0% in the vitamin D group and 25.1% in the placebo group with an HR of 0.84 [95% CI, 0.71 – 1.00],” Pittas explained.

Finally, Pittas noted that in the US population “the proportion of people with vitamin D insufficiency has improved over recent years; however, the proportion with vitamin D deficiency has remained stable, paving the way for further research with existing data.”

Effect of Vitamin D Supplementation in Those With Deficiency Unknown

In her editorial, Wexler remarks that the observed HR of 0.88 for the primary endpoint of the trial does not rule out a modest benefit of vitamin D. A larger and longer trial might be necessary to show a significant benefit in a vitamin D-sufficient population, she explains.

Wexler goes on to say that the effect might be greater if vitamin D supplementation was given to people who truly have a vitamin D deficiency, in comparison to participants in the D2d trial who largely did not.

In the US, “correlates of vitamin D insufficiency include older age, black, Asian or Hispanic race, and obesity,” among other factors.

“Indeed, in the D2d trial, a post hoc analysis of data from the 103 participants with vitamin D deficiency (< 12 ng/mL) showed an HR for [new-onset] diabetes with vitamin D supplementation of 0.38 (95% CI, 0.18 – 0.80),” compared with placebo, she stresses.

But Wexler adds that, overall, in a prespecified subgroup analysis of those who did not have sufficient levels, “the HR in participants with a level [of vitamin D] < 20 ng/mL was essentially the same as that in participants with a ‘sufficient’ level of ≥ 20 ng/mL or higher (0.87 and 0.89, respectively).”

Pittas noted that other large trials from Japan, the United States, and Norway have shown similar HRs to the D2d trial with a range of 0.87 to 0.9.

ADA 2019 Scientific Sessions. Presented June 7, 2019. N Engl J Med. Published online June 7, 2019. Abstract

Pittas has disclosed no relevant financial relationships. Wexler has sat on the data monitoring committee for oral semaglutide, Novo Nordisk. 

https://www.medscape.com/viewarticle/914136#vp_1