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SGLT2 Inhibitor
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 (SOTA-CKD3 Trial)
Phase 3
Waitlist Available
Research Sponsored by Lexicon Pharmaceuticals
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 60 weeks
Awards & highlights
Pivotal Trial
All Individual Drugs Already Approved
Summary
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.
Eligible Conditions
- Diabetes
- Chronic Kidney Disease
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 60 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 60 weeks
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Change From Baseline in HbA1c at Week 26
Secondary study objectives
Change From Baseline in Body Weight at Week 26
Change From Baseline in Fasting Plasma Glucose (FPG) at Week 26
Change From Baseline in SBP at Week 12 for All Participants
+2 moreOther study objectives
Hypoglycemia
Awards & Highlights
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Trial Design
3Treatment groups
Experimental Treatment
Placebo Group
Group I: Sotagliflozin 400 mgExperimental Treatment1 Intervention
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.
Group II: Sotagliflozin 200 mgExperimental Treatment2 Interventions
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.
Group III: PlaceboPlacebo Group1 Intervention
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Placebo
1995
Completed Phase 3
~2670
Sotagliflozin
FDA approved
Find a Location
Who is running the clinical trial?
Lexicon PharmaceuticalsLead Sponsor
66 Previous Clinical Trials
23,647 Total Patients Enrolled
SanofiIndustry Sponsor
2,215 Previous Clinical Trials
4,046,331 Total Patients Enrolled
Suman Wason, MDStudy DirectorLexicon Pharmaceuticals, Inc.
25 Previous Clinical Trials
16,045 Total Patients Enrolled