A Study to Evaluate Safety and Effects of Sotagliflozin 400 and 200 mg on Glucose Control in Participants With Type 2 Diabetes, Severe Impairment of Kidney Function and Inadequate Blood Sugar Control

Conditions

• Chronic Kidney Disease Stage 4
• Type 2 Diabetes Mellitus

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Placebo — DRUG
  Placebo tablet (identical to sotagliflozin 200 mg in appearance) orally, once daily.
• Sotagliflozin — DRUG
  Sotagliflozin 200 mg, tablet, orally, once daily.

Study Details

Primary Objective: To demonstrate the superiority of sotagliflozin 400 milligrams (mg) versus placebo with respect to hemoglobin A1c (HbA1c) reduction at Week 26 in participants with Type 2 diabetes who have inadequate glycemic control and severe renal impairment Secondary Objectives: * To assess the effects of sotagliflozin 200 mg versus placebo based on change from baseline in HbA1c * To assess the effects of sotagloflozin 400 mg and 200 mg versus placebo * To evaluate the safety of sotagliflozin 400 mg and 200 mg versus placebo

Key Dates

Start date

Aug 16, 2017

Status verified

Jun 2021

Primary completion

May 16, 2019

Completion

Dec 11, 2019

Study Design

Enrollment

277 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Placebo Comparator: Placebo
  Following a 2-week run-in phase, participants received two placebo tablets (identical to sotagliflozin 200 milligrams \[mg\] in appearance) orally once daily for up to 56 weeks.
• Experimental: Sotagliflozin 200 mg
  Following a 2-week run-in phase, participants received two tablets, one sotagliflozin 200 mg tablet and one placebo tablet (identical to sotagliflozin 200 mg in appearance), orally once daily for up to 56 weeks.
• Experimental: Sotagliflozin 400 mg
  Following a 2-week run-in phase, participants received sotagliflozin 400 mg, administered as 2 sotagliflozin 200 mg tablets, orally once daily for up to 56 weeks.

Primary Outcome Measure

Change From Baseline in HbA1c at Week 26 Comparing Sotagliflozin 400 mg Versus Placebo [ Time Frame: Baseline to Week 26 ]

Locations (34)

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