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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 (inTandem3)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02531035
Recruitment Status : Completed
First Posted : August 21, 2015
Results First Posted : November 19, 2019
Last Update Posted : February 12, 2020
Sponsor:
Collaborator:
Sanofi
Information provided by (Responsible Party):
Lexicon Pharmaceuticals

Tracking Information
First Submitted Date  ICMJE August 20, 2015
First Posted Date  ICMJE August 21, 2015
Results First Submitted Date  ICMJE October 8, 2019
Results First Posted Date  ICMJE November 19, 2019
Last Update Posted Date February 12, 2020
Actual Study Start Date  ICMJE September 2015
Actual Primary Completion Date April 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 15, 2019)
Percentage of Participants With A1C <7.0% at Week 24 and No Episode of Severe Hypoglycemia and No Episode of Diabetic Ketoacidosis (DKA) After Randomization [ Time Frame: Week 24 ]
The primary composite endpoint included blood samples for the assessment of Hemoglobin A1C to determine the participants with a value <7.0%. A central blinded adjudication process determined whether participants experienced either DKA or Severe Hypoglycemia.
Original Primary Outcome Measures  ICMJE
 (submitted: August 20, 2015)
Proportion of patients with A1C <7.0% at Week 24 [ Time Frame: Week 24 ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 15, 2019)
  • Change From Baseline in A1C [ Time Frame: Baseline to Week 24 ]
    Baseline value was defined as the last value collected prior to the first dose of double-blind study medication. Least Squares (LS) means were obtained from a mixed-effects model for repeated measures (MMRM) model including all available post baseline data. A negative change from Baseline (a lower AIC value at Week 24) indicates an improvement.
  • Absolute Change From Baseline in Body Weight [ Time Frame: Baseline to Week 24 ]
    Baseline value was defined as the last value collected prior to the first dose of double-blind study medication. LS means were obtained from MMRM model. A negative change from Baseline indicates a loss in body weight from Baseline to Week 24.
  • Change From Baseline in Systolic Blood Pressure (SBP) in the Subset of Participants With Baseline SBP >=130 Millimeter of Mercury (mmHg) [ Time Frame: Baseline to Week 16 ]
    An automatic sphygmomanometer was used with instructions on blood pressure measurements to allow for standardization. Week 16 was used because the protocol required Investigators to keep participant's hypertensive medications stable between Baseline and Week 16, unless a change was required for safety reasons. Baseline was defined as the last value collected prior to the first does of double-blind study medication. LS means were obtained from MMRM model including all available post baseline values. A negative change indicates a decrease in SBP between Baseline and Week 16.
  • Percent Change From Baseline in Mean Daily Bolus Insulin Dose [ Time Frame: Baseline to Week 24 ]
    The mean bolus insulin dose in international units/day (IU/day) for Week 24 was the average over the 3 to 5 days prior to the Week 24 visit. The Baseline value was defined as the last value collected prior to the first dose of double-blind study medication. LS means were obtained from MMRM model including all available post Baseline values. A negative percent change from Baseline indicated a reduction in the amount of bolus insulin used and a positive percent change from Baseline indicated an increase in the amount of bolus insulin used between Baseline and Week 24.
Original Secondary Outcome Measures  ICMJE
 (submitted: August 20, 2015)
  • Change from Baseline to Week 24 in A1C [ Time Frame: Week 24 ]
  • Change from Baseline in body weight [ Time Frame: Week 24 ]
  • Change from Baseline in systolic blood pressure (SBP) [ Time Frame: Week 16 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE 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
Official Title  ICMJE 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
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 Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Type 1 Diabetes Mellitus (T1DM)
  • High Level of Sugar (Glucose) in the Blood
Intervention  ICMJE
  • Drug: Sotagliflozin
    Sotagliflozin, once daily, before the first meal of the day
    Other Name: LX4211
  • Drug: Placebo
    Placebo, once daily, before the first meal of the day
Study Arms  ICMJE
  • Placebo Comparator: Placebo
    Two placebo-matching to sotagliflozin tablets daily, orally, before the first meal of the day for 24 weeks.
    Intervention: Drug: Placebo
  • Experimental: Sotagliflozin 400 mg
    Sotagliflozin 400 milligram (mg) (two 200 mg tablets) once daily, orally, before the first meal of the day for 24 weeks.
    Intervention: Drug: Sotagliflozin
Publications * Garg SK, Henry RR, Banks P, Buse JB, Davies MJ, Fulcher GR, Pozzilli P, Gesty-Palmer D, Lapuerta P, Simó R, Danne T, McGuire DK, Kushner JA, Peters A, Strumph P. Effects of Sotagliflozin Added to Insulin in Patients with Type 1 Diabetes. N Engl J Med. 2017 Dec 14;377(24):2337-2348. doi: 10.1056/NEJMoa1708337. Epub 2017 Sep 13.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 16, 2017)
1405
Original Estimated Enrollment  ICMJE
 (submitted: August 20, 2015)
1400
Actual Study Completion Date  ICMJE April 2017
Actual Primary Completion Date April 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Participants 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 T1DM made at least 1 year prior to informed consent
  • Participants were being treated with insulin or insulin analog
  • Willing and able to perform self-monitoring of blood glucose (SMBG) and complete the study diary as required per protocol
  • At the Screening Visit, A1C was between 7.0% to 11.0%
  • Females of childbearing potential used an adequate method of contraception and had 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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Argentina,   Australia,   Belgium,   Bulgaria,   Canada,   Colombia,   Czechia,   France,   Germany,   Hungary,   Israel,   Italy,   New Zealand,   Poland,   Slovakia,   South Africa,   Spain,   United Kingdom,   United States
Removed Location Countries Czech Republic
 
Administrative Information
NCT Number  ICMJE NCT02531035
Other Study ID Numbers  ICMJE LX4211.1-312-T1DM
LX4211.312 ( Other Identifier: Lexicon Pharmaceuticals, Inc. )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Lexicon Pharmaceuticals
Study Sponsor  ICMJE Lexicon Pharmaceuticals
Collaborators  ICMJE Sanofi
Investigators  ICMJE
Study Director: Sangeeta Sawhney, MD Lexicon Pharmaceuticals, Inc.
PRS Account Lexicon Pharmaceuticals
Verification Date February 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP