Phase 3
Completed N=1,405
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
Type 1 Diabetes Mellitus (T1DM) · High Level of Sugar (Glucose) in the Blood
Source: ClinicalTrials.gov NCT02531035 ↗
Enrolled (actual)
1,405
Serious AEs
5.1%
Results posted
Nov 2019
Primary outcomePrimary: 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 — 15.2; 28.6 percentage of participants — p=< 0.001
◆ Published Evidence
Highly cited
415citations · ~46 / year
Effects of Sotagliflozin Added to Insulin in Patients with Type 1 Diabetes.
Summary
This Phase 3 study was designed to demonstrate the net benefit of sotagliflozin versus placebo in patients with Type 1 Diabetes (T1D).
Linked Publications
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Effects of Sotagliflozin Added to Insulin in Patients with Type 1 Diabetes.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY 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 |
15.2; 28.6 | < 0.001 sig |
| SECONDARY Change From Baseline in A1C |
-0.33; -0.79 | < 0.001 sig |
| SECONDARY Absolute Change From Baseline in Body Weight |
0.77; -2.21 | < 0.001 sig |
| SECONDARY Change From Baseline in Systolic Blood Pressure (SBP) in the Subset of Participants With Baseline SBP >=130 Millimeter of Mercury (mmHg) |
-5.7; -9.2 | = 0.002 sig |
| SECONDARY Percent Change From Baseline in Mean Daily Bolus Insulin Dose |
6.62; -5.71 | < 0.001 sig |
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 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
Data sourced from ClinicalTrials.gov (NCT02531035) 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.