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NCT03285594 · ClinicalTrials.gov registry record · Phase 3
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
A Phase 3 study of Type 2 Diabetes Mellitus, sponsored by Lexicon Pharmaceuticals.
- Completed
- Registry status
- Phase 3
- Development phase
- 571
- Enrollment target
- 20
- Study locations
NCT03285594: Completed Phase 3 study of Type 2 Diabetes Mellitus, sponsored by Lexicon Pharmaceuticals.
NCT03285594 is a Phase 3 study of Type 2 Diabetes Mellitus that has completed, run by Lexicon Pharmaceuticals. The registered enrollment target is 571 participants, below the 2,955-participant average among 130 other Type 2 Diabetes Mellitus trials with a reported enrollment target (81% lower). The trial reports 20 study locations across 6 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03285594, a Phase 3 study of Type 2 Diabetes Mellitus, has completed, sponsored by Lexicon Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 571 participants
- Enrollment target
- 20
- Study locations
Study Summary
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.
Primary Outcome
An analysis of covariance (ANCOVA) model was used for the analysis.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Sotagliflozin
- DRUG Insulin glargine (HOE901)
- DRUG Oral Antidiabetes Drugs (OADs)
Study Locations (20)
Florida
- Investigational Site Number 8406043 - Coral Gables
- Investigational Site Number 8406008 - DeLand
- Investigational Site Number 8406030 - Maitland
- Investigational Site Number 8406003 - New Port Richey
- Investigational Site Number 8406029 - North Miami Beach
- Investigational Site Number 8406052 - Ocoee
- Investigational Site Number 8406001 - Port Charlotte
- Investigational Site Number 8406022 - St. Petersburg
- Investigational Site Number 8406025 - Tampa
- Investigational Site Number 8406002 - West Palm Beach
Arizona
- Investigational Site Number 8406028 - Mesa
- Investigational Site Number 8406013 - Phoenix
- Investigational Site Number 8406020 - Phoenix
California
- Investigational Site Number 8406006 - Huntington Park
- Investigational Site Number 8406053 - Lincoln
- Investigational Site Number 8406040 - Los Angeles
Illinois
- Investigational Site Number 8406054 - Chicago
- Investigational Site Number 8406027 - Chicago
Indiana
- Investigational Site Number 8406042 - Evansville
Louisiana
- Investigational Site Number 8406044 - New Orleans
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 571 participants |
| Start Date | 2017-09-15 |
| Est. Completion | 2019-09-27 |
| Phase | Phase 3 |
What the finished NCT03285594 record still lists
NCT03285594 is an interventional study that assigns participants to a tested intervention. The registered 571 participants enrollment target is mid-sized for trials with a published cap, below the 2,955-participant average among 130 other Type 2 Diabetes Mellitus trials with a reported enrollment target (81% lower).
The record links to 1 condition, with Type 2 Diabetes Mellitus appearing as the primary indexed condition, and to 4 interventions - of which Placebo is the first listed.
NCT03285594 names 20 study sites across 6 states, led by Florida, Arizona, California.
Frequently Asked Questions
What is clinical trial NCT03285594 about?
NCT03285594 is a clinical study titled "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". 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 (OAD...
What is the current status of trial NCT03285594?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 571 participants. The study started on 2017-09-15. Estimated completion is 2019-09-27.
What conditions does trial NCT03285594 study?
This clinical trial studies the following conditions: Type 2 Diabetes Mellitus.
What interventions are being tested in trial NCT03285594?
The interventions under investigation include: Placebo (DRUG), Sotagliflozin (DRUG), Insulin glargine (HOE901) (DRUG), Oral Antidiabetes Drugs (OADs) (DRUG).
Who is sponsoring clinical trial NCT03285594?
This trial is sponsored by Lexicon Pharmaceuticals, which has 56 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03285594 being conducted?
This trial has 20 study locations across Arizona, California, Florida, Illinois, Indiana. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Type 2 Diabetes Mellitus
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT03285594's enrollment target sits among peer trials
571 19th of 130 higher than 112 of 130 other Type 2 Diabetes Mellitus trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Type 2 Diabetes Mellitus trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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