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IDegLira combination injection improves glycemic control without hypoglycemia, weight gain

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NEW ORLEANS — Adults with poorly controlled type 2 diabetes assigned a fixed combination injection of insulin degludec and liraglutide were more likely to reach a target HbA1c without hypoglycemia or weight gain vs. patients continuing insulin glargine therapy, according to a post-hoc analysis of the DUAL V study presented at the American Diabetes Association Scientific Sessions.

Insulin degludec and liraglutide (IDegLira) is a fixed-ratio combination of a glucagon-like peptide-1 receptor agonist and a basal insulin. Insulin degludec (Tresiba) and liraglutide (Victoza) are both approved agents; the drug combination is developed by Novo Nordisk.

“For patients uncontrolled on 20 to 50 units of glargine insulin, switching to IDegLira versus up-titration of glargine insulin has meaningful clinical advantages,” Ildiko Lingvay, MD, MPH, MSCS, associate professor of internal medicine at University of Texas Southwestern Medical Center, told Endocrine Today. “They are more likely to achieve glycemic goals (whether HbA1c or FPG) without hypoglycemia or weight gain. Furthermore, these advantages stand true regardless of the patient's starting HbA1c, even if the starting HbA1c is over 8.5%. Lastly, the improvement in glycemic control (as measured either by HbA1c or FPG) occurs faster if the patients is switched to IDegLira as opposed to up-titrated on Glargine insulin — despite an initial reduction in the insulin dose of about 50%.”

Ildiko Lingay

In a post-hoc analysis of the DUAL V study, researchers explored whether patients achieving an HbA1c of 7% or less or a fasting plasma glucose of 130 mg/dL or less also achieved composite endpoints relevant to diabetes management. DUAL V included patients with poorly controlled type 2 diabetes (HbA1c between 7% and 10%) on insulin glargine and metformin therapy (n = 557; mean age, 58 years, mean BMI, 31 kg/m²; mean diabetes duration, 11 years; mean insulin use, 30 units daily). Researchers randomly assigned patients to IDegLira plus metformin (mean baseline HbA1c, 8.4%; 16 dose steps initially) or to continue with insulin glargine plus metformin therapy up-titrated as needed (mean baseline HbA1c, 8.2%).

Lingvay noted that, across stratified baseline HbA1c groups, patients switched to IDegLira were more likely to reach the target HbA1c goal of 7% or less vs. patients who continued with insulin glargine.

Across the three baseline HbA1c groups (7.5%, or less; between 7.5% and 8.5%, and 8.5% or greater) more patients in the IDegLira group achieved an HbA1c of 7% or less vs. those assigned insulin glargine (87% vs. 66%; 76% vs. 50%; 59% vs. 31%, respectively). Across the same baseline HbA1c groups, more patients also achieved the target HbA1c without hypoglycemia (67% vs. 45%; 55% vs. 30%; 47% vs. 19%, respectively) and without hypoglycemia or weight gain (51% vs. 25%; 39% vs. 11%; 32% vs. 5%, respectively; P < .005 for all).

For patients switched to IDegLira, there was a faster drop in fasting plasma glucose levels vs. those continuing with insulin glargine therapy, despite patients in the IDegLira group decreasing their insulin glargine dose at randomization, Lingvay said.

“They were dropping much more rapidly with IDegLira vs. insulin glargine,” Lingvay said while presenting her findings, who added that, ultimately, the two groups’ fasting plasma glucose numbers merged because of the intent-to-treat design of the trial. Results were similar for a drop in HbA1c, Lingvay said.

“This is important from two sides,” Lingvay said. “For the patients, unless they see quick results when we change therapies, compliance with the therapy decreases, and we’re not able to get them to goal. From my standpoint, I was a worried in the beginning, if we cut back on the insulin dose on randomization, will they lose control or will they take longer to get to the same goal?”

The researchers wrote that the analysis suggests that the clinical advantages of IDegLira over insulin glargine in DUAL V would also be observed in clinical practice, allowing patients to experience improvements in glycemic control without the detrimental effects of hypoglycemia or weight gain.

“What this tells me is that there are clinical advantages of IDegLira over insulin glargine titration, and those extend beyond just glycemic control to patient-centric outcomes that include weight and hypoglycemia,” she said.

An FDA advisory panel unanimously recommended approval of IDegLira in May. – by Regina Schaffer

Reference:

Lingvay I. 239-OR. Presented at: American Diabetes Association 76th Scientific Sessions; June 10-14, 2016; New Orleans.

Disclosure: Lingvay reports receiving research support or serving on advisory boards for GI Dynamics, Jannsen, Merck and Novo Nordisk and Sanofi.