Efficacy and Safety of Sotagliflozin Versus Placebo in Participants With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control While Taking Insulin Alone or With Other Oral Antidiabetic Agents

Conditions

• Type 2 Diabetes Mellitus

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Sotagliflozin — DRUG
  Pharmaceutical form: Tablet Route of administration: Oral
• Insulin glargine (HOE901) — DRUG
  Pharmaceutical form: Solution Route of administration: Subcutaneous
• Placebo — DRUG
  Pharmaceutical form: Tablet Route of administration: Oral
• Oral Antidiabetes Drugs (OADs) — DRUG
  OADs (including metformin) as prescribed by the investigator as per local labeling.

Study Details

Primary Objective: To demonstrate the superiority of sotagliflozin 400 milligrams (mg) versus placebo with respect to hemoglobin A1C (HbA1c) reduction in participants with type 2 diabetes mellitus (T2D) who have inadequate glycemic control on basal insulin alone or with oral antidiabetes drugs (OADs). Secondary Objectives: * To assess the effects of sotagliflozin 400 mg versus placebo on fasting plasma glucose (FPG), body weight, systolic blood pressure (SBP), and HbA1c. * To assess the effects of sotagliflozin 200 mg versus placebo on HbA1c, body weight, FPG, and SBP. * To evaluate the safety of sotagliflozin 400 and 200 mg versus placebo.

Key Dates

Start date

Sep 15, 2017

Status verified

Apr 2021

Primary completion

Sep 17, 2019

Completion

Sep 27, 2019

Study Design

Enrollment

571 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Placebo Comparator: Placebo
  Following a 4-week run-in period, participants were randomized to matching placebo to sotagliflozin 200 milligrams (mg) administered as 2 tablets, once daily, before the first meal of the day in the double-blind treatment period for up to 52 weeks. Background therapy with insulin glargine (with or without OADs) continued throughout the study.
• Experimental: Sotagliflozin 200 mg
  Following a 4-week run-in period, participants were randomized to sotagliflozin 200 mg administered as 1 tablet and matching placebo as 1 tablet, once daily, before the first meal of the day in the double-blind treatment period for up to 52 weeks. Background therapy with insulin glargine (with or without OADs) continued throughout the study.
• Experimental: Sotagliflozin 400 mg
  Following a 4-week run-in period, participants were randomized to sotagliflozin 400 mg administered as 2 tablets, once daily, before the first meal of the day in the double-blind treatment period for up to 52 weeks. Background therapy with insulin glargine (with or without OADs) continued throughout the study.

Primary Outcome Measure

Change From Baseline in Hemoglobin A1c (HbA1c) at Week 18 [ Time Frame: Baseline and Week 18 ]

Locations (50)

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