Efficacy and Safety of Sotagliflozin Versus Placebo and Empagliflozin in Participants With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control While Taking a DPP4 Inhibitor Alone or With Metformin

Conditions

• Type 2 Diabetes Mellitus

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Sotagliflozin — DRUG
  Sotagliflozin 400 mg was administered as two tablets, once daily before the first meal of the day.
• Empagliflozin — DRUG
  Empagliflozin 25 mg capsule was administered, once daily before the first meal of the day.
• Placebo — DRUG
  Placebo was administered as two tablets (identical to sotagliflozin in appearance), once daily before the first meal of the day.
• Placebo — DRUG
  Placebo was administered as one capsule (identical to the empagliflozin capsule in appearance), once daily before the first meal of the day.

Study Details

The purpose of the study is to demonstrate the superiority of sotagliflozin versus placebo on hemoglobin A1c (HbA1c) reduction in participants with type 2 diabetes (T2D) who have inadequate glycemic control on a DPP4(i) with or without metformin.

Key Dates

Start date

Nov 27, 2017

Status verified

Apr 2021

Primary completion

May 16, 2019

Completion

May 16, 2019

Study Design

Enrollment

770 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Sotagliflozin 400 mg
  Following a 2-week run-in period, sotagliflozin 400 mg (milligrams) administered as two 200 mg tablets and one placebo capsule (identical to the empagliflozin capsule in appearance), once daily before the first meal of the day for up to 26 weeks.
• Active Comparator: Empagliflozin 25 mg
  Following a 2-week run-in period, placebo matching sotagliflozin administered as two tablets (identical to sotagliflozin in appearance) and one capsule of empagliflozin 25 mg, once daily before the first meal of the day for up to 26 weeks.
• Placebo Comparator: Placebo
  Following a 2-week run-in period, placebo was given as two placebo tablets (identical to sotagliflozin) and one placebo capsule (identical to empagliflozin) once daily before the first meal of the day for up to 26 weeks.

Primary Outcome Measure

Change From Baseline in Hemoglobin A1c (HbA1c) % at Week 26 [ Time Frame: Baseline, Week 26 ]

Locations (53)

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