Clinical trial NCT02459899: Dose-ranging Study in Patients With Type 1 Diabetes Mellitus
Official title: A Phase 2b, Dose-ranging, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study in Patients With Type 1 Diabetes Mellitus Who Have Inadequate Glycemic Control With Insulin Therapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Type 1 Diabetes Mellitus
Lead sponsor: Lexicon Pharmaceuticals
Sponsor class: INDUSTRY
Collaborators: name: Sanofi
First posted: 2015-06-02
Enrollment: 141
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The primary objective of this study was to define the dose leading to desirable efficacy, as measured by the change in hemoglobin A1C (A1C) between Baseline and Week 12.


Eligibility criteria: Inclusion Criteria:

* Participant had given written informed consent to participate in the study in accordance with local regulations.
* Adult participants 18 years and older with a diagnosis of type 1 diabetes mellitus (T1D) made at least 1 year prior to informed consent.
* Participants were being treated with insulin or insulin analog delivered via continuous subcutaneous insulin infusion (CSII) or multiple daily injection (MDI).
* At the Screening Visit, A1C had to be between 7.0% and 10.0%.
* Females of childbearing potential had to use an adequate method of contraception and have a negative pregnancy test.

Exclusion Criteria:

* Use of antidiabetic agent other than insulin or insulin analog at the time of screening.
* Use of sodium-glucose cotransporter (SGLT) inhibitors within 8 weeks prior to screening.
* Chronic systemic corticosteroid use.
* Type 2 diabetes mellitus (T2DM), or severely uncontrolled T1D as determined by the Investigator.

Primary outcomes:
measure: Change From Baseline in Hemoglobin A1C (A1C) at Week 12
timeFrame: Baseline to Week 12
Secondary outcomes:
measure: Change From Baseline to Week 12 in 2-Hour Postprandial Glucose (PPG) Following the Standardized Mixed Meal
timeFrame: Baseline, Week 12
measure: Absolute Change From Baseline in Body Weight to Week 12
timeFrame: Baseline to Week 12
measure: Percent Change From Baseline in Body Weight to Week 12
timeFrame: Baseline to Week 12
measure: Change From Baseline to Week 12 in 24-Hour Urinary Glucose Excretion
timeFrame: Baseline, Week 12
measure: Change From Baseline to Week 12 in Fasting Plasma Glucose
timeFrame: Baseline to Week 12
Other outcomes:
Locations:
city: Concord
country: United States
facility: Lexicon Investigational Site
state: California
city: Ventura
country: United States
facility: Lexicon Investigational Site
state: California
city: Denver
country: United States
facility: Lexicon Investigational Site
state: Colorado
city: Jacksonville
country: United States
facility: Lexicon Investigational Site
state: Florida
city: Miami
country: United States
facility: Lexicon Investigational Site
state: Florida
city: Springfield
country: United States
facility: Lexicon Investigational Site
state: Illinois
city: Metairie
country: United States
facility: Lexicon Investigational Site
state: Louisiana
city: Auburn
country: United States
facility: Lexicon Investigational Site
state: Maine
city: Rockville
country: United States
facility: Lexicon Investigational Site
state: Maryland
city: Great Falls
country: United States
facility: Lexicon Investigational Site
state: Montana
city: Omaha
country: United States
facility: Lexicon Investigational Site
state: Nebraska
city: High Point
country: United States
facility: Lexicon Investigational Site
state: North Carolina
city: Columbus
country: United States
facility: Lexicon Investigational Site
state: Ohio
city: San Antonio
country: United States
facility: Lexicon Investigational Site
state: Texas
city: Salt Lake City
country: United States
facility: Lexicon Investigational Site
state: Utah
city: Chesapeake
country: United States
facility: Lexicon Investigational Site
state: Virginia
city: Manassas
country: United States
facility: Lexicon Investigational Site
state: Virginia
Study officials:
affiliation: Lexicon Pharmaceuticals, Inc.
name: Suman Wason, MD
role: STUDY_DIRECTOR
References:
citation: Baker C, Wason S, Banks P, Sawhney S, Chang A, Danne T, Gesty-Palmer D, Kushner JA, McGuire DK, Mikell F, O'Neill M, Peters AL, Strumph P. Dose-dependent glycometabolic effects of sotagliflozin on type 1 diabetes over 12 weeks: The inTandem4 trial. Diabetes Obes Metab. 2019 Nov;21(11):2440-2449. doi: 10.1111/dom.13825. Epub 2019 Aug 1.