Dataset Information

Dose-dependent glycometabolic effects of sotagliflozin on type 1 diabetes over 12?weeks: The inTandem4 trial.

ABSTRACT:

Aims

To assess the dose-related effects of sotagliflozin, a novel dual inhibitor of sodium-glucose co-transporters-1 and -2, in type 1 diabetes (T1D).

Materials and methods

In this 12-week, multicentre, randomized, double-blind, placebo-controlled dose-ranging trial, adults with T1D were randomized to once-daily placebo (n = 36) or sotagliflozin 75?mg (n = 35), 200?mg (n = 35) or 400?mg (n = 35). Insulin was maintained at baseline doses. The primary endpoint was least squares mean (LSM) change in glycated haemoglobin (HbA1c) from baseline. Other endpoints included proportion of participants with ?0.5% HbA1c reduction and assessments of 2-hour postprandial glucose (PPG), weight, and urinary glucose excretion (UGE).

Results

From a mean baseline of 8.0%?±?0.8% (full study population), placebo-adjusted LSM HbA1c decreased by 0.3% (P = .07), 0.5% (P?ConclusionsCombined with stable insulin doses, sotagliflozin 200?mg and 400?mg improved glycaemic control and weight in adults with T1D. Sotagliflozin 400?mg reduced PPG levels. UGE increased with all sotagliflozin doses. Rates of severe hypoglycaemia and DKA were low (NCT02459899).

SUBMITTER: Baker C

PROVIDER: S-EPMC6851757 | biostudies-literature | 2019 Nov

REPOSITORIES: biostudies-literature

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Publications

Dose-dependent glycometabolic effects of sotagliflozin on type 1 diabetes over 12 weeks: The inTandem4 trial.

Baker Claire C Wason Suman S Banks Phillip P Sawhney Sangeeta S Chang Anna A Danne Thomas T Gesty-Palmer Diane D Kushner Jake A JA McGuire Darren K DK Mikell Frank F O'Neill Mark M Peters Anne L AL Strumph Paul P

Diabetes, obesity & metabolism 20190801 11

<h4>Aims</h4>To assess the dose-related effects of sotagliflozin, a novel dual inhibitor of sodium-glucose co-transporters-1 and -2, in type 1 diabetes (T1D).<h4>Materials and methods</h4>In this 12-week, multicentre, randomized, double-blind, placebo-controlled dose-ranging trial, adults with T1D were randomized to once-daily placebo (n = 36) or sotagliflozin 75 mg (n = 35), 200 mg (n = 35) or 400 mg (n = 35). Insulin was maintained at baseline doses. The primary endpoint was least squares mean ...[more]

PMID: 31264767

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