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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-02-28

Study Completion Date

2014-01-31

Brief Summary

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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).

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Detailed Description

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Conditions

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Type 1 Diabetes Mellitus

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Sotagliflozin 400 mg - Pioneer Group

Sotagliflozin 400 milligram (mg) (two 200 mg tablets), once daily, orally, before breakfast for 29 days; open label administration.

Group Type EXPERIMENTAL

Sotagliflozin

Intervention Type DRUG

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.

Placebo - Expansion Group

Two placebo-matching sotagliflozin tablets, once daily, orally, before breakfast for 29 days; double-blind administration.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

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

Sotagliflozin 400 mg - Expansion Group

Sotagliflozin 400 mg (two 200 mg tablets), once daily, orally, before breakfast for 29 days; double-blind administration.

Group Type EXPERIMENTAL

Sotagliflozin

Intervention Type DRUG

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

Interventions

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Sotagliflozin

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.

Intervention Type DRUG

Placebo

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

Intervention Type DRUG

Sotagliflozin

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

Intervention Type DRUG

Other Intervention Names

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LX4211 LX4211

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No