Phase 2
Completed N=36
Safety and Efficacy of Sotagliflozin (LX4211) in Patients With Inadequately Controlled Type 1 Diabetes Mellitus
Source: ClinicalTrials.gov NCT01742208 ↗Enrolled (actual)
36
Serious AEs
5.6%
Results posted
Oct 2019
Primary outcomePrimary: Percent Change From Baseline in Total Daily Bolus Amount of Exogenous Insulin Required Calculated Over Days 3 to 27 (Treatment Outpatient Period) — -46.32; -7.00; -32.14 percent change — p=0.007
Summary
This Phase 2 study was intended to assess the pharmacodynamics (PD), pharmacokinetics (PK), safety and efficacy of sotagliflozin following daily oral administration for 29 days in participants with type 1 diabetes mellitus (T1DM).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percent Change From Baseline in Total Daily Bolus Amount of Exogenous Insulin Required Calculated Over Days 3 to 27 (Treatment Outpatient Period) |
-46.32; -7.00; -32.14 | 0.007 sig |
| SECONDARY Percent Mean Change From Baseline in Daily Bolus Amount of Exogenous Insulin Required at Each Meal Calculated Over Days 3 to 27 (Treatment Outpatient Period) |
-42.19; 10.79; -25.16; -59.02; 3.94; -25.85 | — |
| SECONDARY Percent Change From Baseline in Total Daily Amount of Exogenous Insulin (Total Daily Bolus + Total Daily Basal) Required Calculated Over Days 3 to 27 (Treatment Outpatient Period) |
-27.00; -1.20; -15.52 | — |
| SECONDARY Change From Baseline in Fasting Plasma Glucose (FPG) at Day 29 |
-54.2; 10.0; -12.5 | — |
| SECONDARY Change From Day 1 in 3-hour Plasma Glucose AUC (AUC0-3 h) Following a Mixed Meal Tolerance Test (MMTT) at Day 29: Expansion Groups |
-140.83; -308.51 | — |
| SECONDARY Change From Baseline in Percent Time Per Day Spent in Euglycemic Range (>=70 and <=180 mg/dL) Over Days 3 to 27 (Treatment Outpatient Period) Based on Continuous Glucose Monitoring |
6.6; -1.2; 11.1 | — |
| SECONDARY Change From Day 1 in 3-hour Urinary Glucose Excretion Following a Mixed Meal Tolerance Test (MMTT) to Day 29: Expansion Groups |
-6.34; 8.30 | — |
Eligibility Criteria
Inclusion Criteria
- Adults >=18 to <=55 years of age
- Confirmed diagnosis of T1DM, diagnosed prior to age 40 years, and for at least 6 months prior to Screening
- Willing to refrain from using carbohydrate counting to adjust insulin during the study
- Willing and able to wear and operate a continuous glucose monitor
- Willing and able to self-assess blood glucose
- Willing and able to provide written informed consent.
Exclusion Criteria
- History of type 2 diabetes mellitus or diabetes resulting from acromegaly, Cushing's disease, chronic pancreatitis, or pancreatectomy
- Two or more severe episodes of hypoglycemia that required emergency treatment within 3 months prior to Screening
- Use of premixed insulin
- History of diabetic ketoacidosis within 1 year of screening
- Presence of active hepatic disease or clinically significant abnormal liver function tests
- History of chronic pancreatitis
- Participants with a history of heart attack, severe/unstable angina, or coronary revascularization procedure
- History of clinically significant cardiac arrhythmias within 1 year prior to screening
- Participants with congestive heart failure
- Participants with uncontrolled Stage III hypertension
- History of human immunodeficiency virus (HIV) or hepatitis C
- History of illicit drug or alcohol abuse within 12 months prior to Screening
- Use of any investigational agent or device within 30 days prior to Screening or any therapeutic protein or antibody within 90 days prior to Screening
- Use of medication or herbal supplements taken for weight loss within 2 weeks of screening
- Chronic use of any antidiabetic therapy other than insulin within 2 months prior to Screening
- Use of systemic or inhaled corticosteroids within 2 weeks prior to Screening
- Participants who underwent major surgery within 6 months prior to Screening
- Inability or difficulty swallowing whole tablets or capsules
- Women who were pregnant or breastfeeding.
Data sourced from ClinicalTrials.gov (NCT01742208). 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.