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)
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|ClinicalTrials.gov Identifier: NCT02531035|
Recruitment Status : Completed
First Posted : August 21, 2015
Results First Posted : November 19, 2019
Last Update Posted : February 12, 2020
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|Condition or disease||Intervention/treatment||Phase|
|Type 1 Diabetes Mellitus (T1DM) High Level of Sugar (Glucose) in the Blood||Drug: Sotagliflozin Drug: Placebo||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||1405 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|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|
|Actual Study Start Date :||September 2015|
|Actual Primary Completion Date :||April 2017|
|Actual Study Completion Date :||April 2017|
Placebo Comparator: Placebo
Two placebo-matching to sotagliflozin tablets daily, orally, before the first meal of the day for 24 weeks.
Placebo, once daily, before the first meal of the day
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.
Sotagliflozin, once daily, before the first meal of the day
Other Name: LX4211
- 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.
- 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.
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|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- 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
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02531035
|Study Director:||Sangeeta Sawhney, MD||Lexicon Pharmaceuticals, Inc.|
Documents provided by Lexicon Pharmaceuticals:
|Responsible Party:||Lexicon Pharmaceuticals|
|Other Study ID Numbers:||
LX4211.312 ( Other Identifier: Lexicon Pharmaceuticals, Inc. )
|First Posted:||August 21, 2015 Key Record Dates|
|Results First Posted:||November 19, 2019|
|Last Update Posted:||February 12, 2020|
|Last Verified:||February 2020|
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Endocrine System Diseases
Immune System Diseases
Sodium-Glucose Transporter 2 Inhibitors
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs