Safety and Efficacy of Sotagliflozin (LX4211) in Patients With Inadequately Controlled Type 1 Diabetes Mellitus

Lexicon Pharmaceuticals36 enrolled

Overview

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).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Type 1 Diabetes Mellitus

Interventions

SotagliflozinDRUG

Participants received sotagliflozin once daily for 29 days. Pioneer Group participants were to have completed dosing prior to any study drug administration in Expansion Groups.

PlaceboDRUG

Participants received placebo-matching sotagliflozin tablets once daily for 29 days.

SotagliflozinDRUG

Participants received sotagliflozin once daily for 29 days; pioneer participants completed dosing prior to dosing any other study participants.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 55 Years

Medical Language ↔ Plain English

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.

Locations (7)

Lexicon Investigational Site

Aurora, Colorado, United States

Lexicon Investigational Site

Atlanta, Georgia, United States

Lexicon Investigational Site

Baton Rouge, Louisiana, United States

Lexicon Investigational Site

Omaha, Nebraska, United States

Outcomes

Primary Outcomes

Percent Change From Baseline in Total Daily Bolus Amount of Exogenous Insulin Required Calculated Over Days 3 to 27 (Treatment Outpatient Period)

Baseline was calculated as the mean value from Day -6 to -2 for Expansion groups and from Day -6 to Day -3 for Pioneer Group. Percent mean change from baseline was calculated as 100\*(sum \[each daily value - baseline\]/number of assessments)/baseline over Days 3 to 27. Least squares (LS) Means and confidence interval (CI) for the Expansion groups were based on an analysis of covariance (ANCOVA) model with covariates of baseline mean total bolus insulin, treatment group, factor used to stratify the randomization (screening A1C \<= 8%, \> 8%), and random effect of participant\*treatment group. LS Means and CI for the Pioneer Group were based on the arithmetic treatment mean.

Time frame: Baseline, Day 3 to Day 27

Secondary Outcomes

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)

Baseline was calculated as the mean value from Day -6 to -2 for Expansion groups and from Day -6 to Day -3 for Pioneer Group. Percent mean change from baseline was calculated as 100\*(sum \[each daily value - baseline\] / number of assessments)/baseline over Days 3 to 27. Percent change was calculated and is presented separately for each meal: i.e., breakfast, lunch and dinner. LS Means and CI for the Expansion groups were based on an ANCOVA model . LS Means and CI for the Pioneer Group were based on the arithmetic treatment mean.

Time frame: Baseline, Day 3 to Day 27

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)

Data from ClinicalTrials.gov

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