Safety and Efficacy Study of Sotagliflozin on Glucose Control in Participants With Type 2 Diabetes, Moderate Impairment of Kidney Function, and Inadequate Blood Sugar Control

Conditions

• Chronic Kidney Disease Stage 3
• 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. Route of administration: Oral
• Sotagliflozin — DRUG
  Sotagliflozin 200 mg, tablet, orally once daily. Route of administration: Oral

Study Details

Primary Objective: To demonstrate the superiority of Sotagliflozin 200 milligrams (mg) and Sotagliflozin 400 mg versus placebo on HbA1c reduction at 26 Weeks in participants with Type 2 diabetes who have inadequate glycemic control and moderate renal impairment. Secondary Objectives: * To assess the effects of Sotagliflozin 200 mg and 400 mg versus placebo with respect to additional measures of glycemic control, blood pressure, and body weight. * To evaluate the safety of Sotagliflozin 200 mg and 400 mg versus placebo.

Key Dates

Start date

Aug 16, 2017

Status verified

May 2021

Primary completion

Mar 25, 2019

Completion

Oct 25, 2019

Study Design

Enrollment

787 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Placebo Comparator: Placebo
  Following a 2-week run-in period, participants received two placebo tablets (identical to sotagliflozin 200 mg in appearance), orally once daily, before the first meal of the day for up to 54 weeks.
• Experimental: Sotagliflozin 200 mg
  Following a 2-week run-in period, participants received two tablets, 1 sotagliflozin 200 mg tablet and 1 placebo tablet (identical to sotagliflozin 200 mg in appearance), orally once daily, before the first meal of the day for up to 58 weeks.
• Experimental: Sotagliflozin 400 mg
  Following a 2-week run-in period, participants received sotagliflozin 400 mg, administered as two 200 mg sotagliflozin tablets, orally once daily, before the first meal of the day for up to 60 weeks.

Primary Outcome Measure

Change From Baseline in HbA1c at Week 26 [ Time Frame: Baseline to Week 26 ]

Locations (51)

Find similar trials in Birmingham, AL

Related Studies

• Puberty, Diabetes, and the Kidneys, When Eustress Becomes Distress (PANTHER Study)
  Recruiting · Petter Bjornstad · Aurora, Colorado
• Proact: A Study of REACT in Subjects With Type 2 Diabetes Mellitus and Chronic Kidney Disease
  PHASE3 · Recruiting · Prokidney · Huntsville, Alabama
• Safety and Effectiveness of Endoscopic Intestinal Re-Cellularization Therapy in Individuals With Type II Diabetes
  Recruiting · Endogenex, Inc. · Birmingham, Alabama
• An Observational Study Called FINEROD to Learn More About the Use of the Treatment Finerenone Including How Safe it is and How Well it Works Under Real-world Conditions
  Recruiting · Bayer · Multiple Locations, New Jersey