Author Interviews, Diabetes, Pediatrics / 13.06.2017
Oral Sotagliflozin On Top of Optimized Insulin Significantly Reduced A1C
MedicalResearch.com Interview with:
Prof. Dr. Thomas Danne
Chief Physician Diabetology, Endocrinology and General Pediatrics and Clinical Researc
Kinder und Junden Krankenhaus
MedicalResearch.com: What is the background for this study? What are the main findings?
Response: The double-blind, placebo controlled, Phase 3 study known as inTandem2 randomized 782 adult patients from 99 sites in the EU and Israel with type 1 diabetes on insulin pump or multiple daily injection therapy who had an A1C level entering the study between 7.0% and 11.0%. The three-arm study evaluated two doses of sotagliflozin, 200mg and 400mg, each taken once daily before the first meal of the day, against placebo. Prior to randomization, insulin was optimized for all patients over a six-week period, with the objective of improving glycemic control using insulin alone. After completion of this optimization period, patients were maintained on optimized insulin and randomized to one of two doses of sotagliflozin or placebo, and their baseline, post-optimization A1C was measured.
The mean baseline A1C levels after the six-week optimization period were 7.8%, 7.7% and 7.7% for patients randomized to the placebo, 200mg and 400mg arms, respectively (A1C was 8.4% across all dose arms prior to insulin optimization).
The primary endpoint of the study was change in A1C from baseline after a 24-week period of treatment. The trial has a double-blind long term extension of 28 weeks, with a total treatment duration of 52 weeks. There were 258 patients in the placebo arm, 261 patients in the 200mg dose arm and 263 patients in the 400mg dose arm. The overall mean placebo-adjusted A1C reduction at week 24 was 0.36% in the 200mg dose arm (p<0.001) and 0.35% in the 400mg dose arm (p<0.001). In response to regulatory input, a secondary endpoint to measure “net clinical benefit” was defined for this study as the proportion of patients at week 24 who achieved the standard of care A1C goal of less than 7.0% without any episode of severe hypoglycemia or DKA. 15% of patients in the placebo arm, 32% in the 200 mg dose arm and 32% in the 400mg dose arm achieved this endpoint (p<0.001 for both treatment arms).
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