Dose-ranging Study in Patients With Type 1 Diabetes Mellitus

Type 1 Diabetes Mellitus Clinical Trial

— inTandem4  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02459899
• Other study ID #: LX4211.1-206-T1DM
• Secondary ID: LX4211.206
• Status: Completed
• Phase: Phase 2
• Start date: July 2015
• Est. completion date: August 2016

Study information

• Verified date: February 2020
• Source: Lexicon Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 141
• Est. completion date: August 2016
• Est. primary completion date: August 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 1
• Type 1 Diabetes Mellitus

Intervention

Drug:
• Placebo
Placebo, once daily, before the first meal of the day
• Sotagliflozin
Sotagliflozin,once daily, before the first meal of the day

Locations

Country	Name	City	State
United States	Lexicon Investigational Site	Auburn	Maine
United States	Lexicon Investigational Site	Chesapeake	Virginia
United States	Lexicon Investigational Site	Columbus	Ohio
United States	Lexicon Investigational Site	Concord	California
United States	Lexicon Investigational Site	Denver	Colorado
United States	Lexicon Investigational Site	Great Falls	Montana
United States	Lexicon Investigational Site	High Point	North Carolina
United States	Lexicon Investigational Site	Jacksonville	Florida
United States	Lexicon Investigational Site	Manassas	Virginia
United States	Lexicon Investigational Site	Metairie	Louisiana
United States	Lexicon Investigational Site	Miami	Florida
United States	Lexicon Investigational Site	Omaha	Nebraska
United States	Lexicon Investigational Site	Rockville	Maryland
United States	Lexicon Investigational Site	Salt Lake City	Utah
United States	Lexicon Investigational Site	San Antonio	Texas
United States	Lexicon Investigational Site	Springfield	Illinois
United States	Lexicon Investigational Site	Ventura	California

Sponsors (2)

Lead Sponsor	Collaborator
Lexicon Pharmaceuticals	Sanofi

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change From Baseline in Hemoglobin A1C (A1C) at Week 12	Baseline was defined as the last value collected prior to the first dose of double-blind study medication. Post-baseline Least Square (LS) mean values were obtained from mixed-effects model repeated measures (MMRM) model with treatment, randomization strata of insulin delivery method (continuous subcutaneous insulin infusion [CSII] or multiple daily injection [MDI]), time (study week), and a treatment-by-time interaction as fixed categorical effects, and baseline A1C-by-time interaction as a covariate.	Baseline to Week 12
Secondary	Change From Baseline to Week 12 in 2-Hour Postprandial Glucose (PPG) Following the Standardized Mixed Meal	A 2-hour PPG sample (plasma) was obtained 2-hours after a standardized Mixed Meal at Baseline (Day 1) and at the visit at Week 12. Post-Baseline LS mean was obtained from analysis of covariance (ANCOVA) model with treatment, randomization strata of insulin delivery method (CSII, MDI) as fixed categorical effects, and baseline postprandial glucose as a covariate.	Baseline, Week 12
Secondary	Absolute Change From Baseline in Body Weight to Week 12	Baseline was defined as the last value collected prior to the first dose of double-blind study medication. Post-Baseline LS mean was obtained from MMRM model with treatment, randomization strata of insulin delivery method (CSII, MDI), time (study week), and a treatment-by-time interaction as fixed categorical effects, and baseline weight-by-time interaction as a covariate.	Baseline to Week 12
Secondary	Percent Change From Baseline in Body Weight to Week 12	Baseline was defined as the last value collected prior to the first dose of double-blind study medication. Post-Baseline LS mean was obtained from MMRM model with treatment, randomization strata of insulin delivery method (CSII, MDI), time (study week), and a treatment-by-time interaction as fixed categorical effects, and baseline weight-by-time interaction as a covariate.	Baseline to Week 12
Secondary	Change From Baseline to Week 12 in 24-Hour Urinary Glucose Excretion	Urine was collected over 24 hours to measure Urinary Glucose Excretion at baseline, and at the end of the 12-week treatment. Post-Baseline LS mean was obtained from ANCOVA model with treatment, randomization strata of insulin delivery method (CSII, MDI) as fixed categorical effects, and Baseline urinary glucose excretion as a covariate.	Baseline, Week 12
Secondary	Change From Baseline to Week 12 in Fasting Plasma Glucose	Baseline was defined as the last value collected prior to the first dose of double-blind study medication. Post-Baseline LS mean was obtained from MMRM model with treatment, randomization strata of insulin delivery method (CSII, MDI), time (study week), and a treatment-by-time interaction as fixed categorical effects, and baseline fasting plasma glucose-by-time interaction as a covariate.	Baseline to Week 12