Ignite Creation Date:
2025-12-24 @ 10:45 PM
Ignite Modification Date:
2026-01-02 @ 2:10 AM
Study NCT ID:
NCT02531035
Status:
COMPLETED
Last Update Posted:
2020-02-12
First Post:
2015-08-20
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Phase 3 Study to Evaluate the Safety of Sotagliflozin in Patients With Type 1 Diabetes Who Have Inadequate Glycemic Control With Insulin Therapy Alone
Sponsor:
Lexicon Pharmaceuticals
Organization:
Study Overview
Official Title:
A Phase 3, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study to Evaluate the Net Clinical Benefit of Sotagliflozin as Adjunct to Insulin Therapy in Type 1 Diabetes
Status:
COMPLETED
Status Verified Date:
2020-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
inTandem3
Brief Summary:
This Phase 3 study was designed to demonstrate the net benefit of sotagliflozin versus placebo in patients with Type 1 Diabetes (T1D).
Detailed Description:
None
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| LX4211.312 | OTHER | Lexicon Pharmaceuticals, Inc. | View |