Phase 2
N=141
Dose-ranging Study in Patients With Type 1 Diabetes Mellitus
Type 1 Diabetes Mellitus
Bottom Line
View on ClinicalTrials.gov: NCT02459899 ↗Enrolled (actual)
141
Serious AEs
2.8%
Results posted
Oct 2019
Primary outcome: Primary: Change From Baseline in Hemoglobin A1C (A1C) at Week 12 — -0.35; -0.60; -0.84; -0.73 percentage of A1C — p=0.07
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Placebo (Drug); Sotagliflozin (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Lexicon Pharmaceuticals
- Primary completion
- Aug 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Hemoglobin A1C (A1C) at Week 12 |
-0.35; -0.60; -0.84; -0.73 | 0.07 |
| SECONDARY Change From Baseline to Week 12 in 2-Hour Postprandial Glucose (PPG) Following the Standardized Mixed Meal |
-0.2; -20.5; -27.6; -49.7 | — |
| SECONDARY Absolute Change From Baseline in Body Weight to Week 12 |
1.13; -0.16; -1.24; -1.48 | — |
| SECONDARY Percent Change From Baseline in Body Weight to Week 12 |
1.26; 0.11; -1.47; -1.61 | — |
| SECONDARY Change From Baseline to Week 12 in 24-Hour Urinary Glucose Excretion |
0.2555; 42.0185; 57.9850; 70.7058 | — |
| SECONDARY Change From Baseline to Week 12 in Fasting Plasma Glucose |
-10.8; -19.4; -19.8; -32.2 | — |
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.
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT02459899). 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.