Phase 3
Completed N=793
Efficacy, Safety, and Tolerability Study of Sotagliflozin as Adjunct Therapy in Adult Patients With Type 1 Diabetes Mellitus Who Have Inadequate Glycemic Control With Insulin Therapy
Source: ClinicalTrials.gov NCT02384941 ↗Enrolled (actual)
793
Serious AEs
9.6%
Results posted
Nov 2019
Primary outcomePrimary: Change From Baseline in A1C at Week 24 — -0.07; -0.43; -0.48 percentage of A1C — p=<0.001
◆ Published Evidence
Highly cited
227citations · ~28 / year
Sotagliflozin in Combination With Optimized Insulin Therapy in Adults With Type 1 Diabetes: The North American inTandem1 Study.
Summary
This Phase 3 study was intended to demonstrate superiority of either sotagliflozin high dose or low dose versus placebo on glycosylated hemoglobin A1C (A1C) reduction at Week 24 when used as an adjunct in adult participants with type 1 diabetes mellitus (T1D) who have inadequate glycemic control with insulin therapy.
Linked Publications (5)
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Sotagliflozin in Combination With Optimized Insulin Therapy in Adults With Type 1 Diabetes: The North American inTandem1 Study.
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Improved Time in Range and Glycemic Variability With Sotagliflozin in Combination With Insulin in Adults With Type 1 Diabetes: A Pooled Analysis of 24-Week Continuous Glucose Monitoring Data From the inTandem Program.
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Diabetic Ketoacidosis and Related Events With Sotagliflozin Added to Insulin in Adults With Type 1 Diabetes: A Pooled Analysis of the inTandem 1 and 2 Studies.
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Improvement in Patient-Reported Outcomes in Adults with Type 1 Diabetes Treated with Sotagliflozin plus Insulin Versus Insulin Alone.
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Insights Into Patients' Experience With Type 1 Diabetes: Exit Interviews From Phase III Studies of Sotagliflozin.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in A1C at Week 24 |
-0.07; -0.43; -0.48 | <0.001 sig |
| SECONDARY Percentage of Participants With A1C <7.0% (at Week 24) and No Episode of Severe Hypoglycemia and No Episode of Diabetic Ketoacidosis (DKA) Upto Week 24 |
21.6; 33.5; 43.5 | 0.002 sig |
| SECONDARY Absolute Change From Baseline in Body Weight at Week 24 |
0.78; -1.57; -2.67 | < 0.001 sig |
| SECONDARY Change From Baseline in Mean Daily Bolus Insulin Dose at Week 24 |
-0.84; -2.33; -4.13 | 0.10 |
| SECONDARY Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24 |
0.21; -0.34; -0.78 | < 0.001 sig |
| SECONDARY Change From Baseline in Diabetes Total Treatment Satisfaction Scores as Measured by Total Diabetes Treatment Satisfaction Questionnaire Status (DTSQs) Scores at Week 24 |
-0.4; 2.1; 2.1 | < 0.001 sig |
| SECONDARY Change From Baseline in Diabetes Distress Scores as Measured by 2-item Diabetes Distress Screening Scale (DDS2) Scores at Week 24 |
0.3; -0.4; -0.5 | < 0.001 sig |
| SECONDARY Percent Change From Baseline in Body Weight at Week 24 |
0.92; -1.87; -3.10 | — |
Eligibility Criteria
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 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 injections (MDI).
- Willing and able to perform self-monitored blood glucose (SMBG) and complete the study diary as required per protocol.
- At the Screening Visit, A1C must be between 7.0% to 11.0%.
- Females of childbearing potential must 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 randomization.
- Chronic systemic corticosteroid use.
- Type 2 diabetes mellitus (T2D), or severely uncontrolled T1D as determined by the Investigator.
Data sourced from ClinicalTrials.gov (NCT02384941) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.