A Study to Evaluate the Interaction of LX4211 and Metformin in Healthy Subjects

Phase 1

Completed

• Conditions: Type 2 Diabetes Mellitus
• Interventions: Drug: 1000 mg metformin; Drug: 400 mg LX4211

• Registration Number: NCT01292993
• Lead Sponsor: Lexicon Pharmaceuticals

Brief Summary

The purpose of this study is to determine the effects of LX4211 and metformin on each other when given at the same time as single doses to healthy human subjects.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-02
• Study First Submitted: 2011-02-08
• Study First Submitted QC: 2011-02-09
• Study First Posted: 2011-02-10
• Status Verified: 2011-03
• Primary Completion: 2011-03
• Last Update Submitted: 2011-03-29
• Last Update Posted: 2011-03-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 18

Inclusion Criteria

• Adults ≥18 to ≤55 years of age. Females must be of non-childbearing potential.
• Body mass index (BMI)≥18 to ≤35 kg/sq m
• Able to provide written consent
• Vital signs within sponsor-defined ranges

Exclusion Criteria

• Use of any medication, including any prescription, over-the-counter, herbal tea, or other supplements within 5 days of dosing
• No investigational agent or study treatment within 30 days prior to Day 1.
• No protein or antibody-based therapeutic agents within 3 months prior to screening
• Use of any tobacco product
• History of bariatric surgery or any gastrointestinal surgery that may induce malabsorption
• History of any major surgery within 6 months prior to screening
• History of any serious adverse reaction or hypersensitivity to metformin or LX4211.
• History of renal disease or significantly abnormal kidney function test
• History of hepatic disease or significantly abnormal liver function test
• History of any active infection within 30 days prior to Day 1
• History of any surgical or medical condition or clinically significant laboratory or physical finding
• Positive urine glucose at Screening
• Use of drugs or alcohol

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Treatment B	1000 mg metformin	1000 mg metformin
Treatment C	1000 mg metformin	400 mg LX4211 + 1000 mg metformin
Treatment A	400 mg LX4211	400 mg LX4211
Treatment C	400 mg LX4211	400 mg LX4211 + 1000 mg metformin

Primary Outcome Measures

Name	Time	Method
Plasma concentration of LX4211 and metformin after concurrent single-dose administration	Up to 43 days, including screening

Secondary Outcome Measures

Name	Time	Method
Glucagon-like peptide (GLP-1)	Up to 43 days, including screening
Glucose-dependent insulinotropic peptide	Up to 43 days, including screening
Urinary glucose excretion	Up to 43 days, including screening
Fasting plasma glucose	Up to 43 days, including screening
Postprandial glucose	Up to 43 days, including screening
Insulin	Up to 43 days, including screening
Peptide YY	Up to 43 days, including screening

Trial Locations

Locations (1)

Lexicon Investigational Site; 🇺🇸 San Antonio, Texas, United States