Study of Two Oral Formulations of LX4211 in Patients With Type 2 Diabetes Mellitus

Phase 1

Completed

• Conditions: Type 2 Diabetes Mellitus
• Interventions: Drug: 300 mg LX4211 (150 mg tablets); Drug: 300 mg LX4211 (50 mg tablets); Drug: 300 mg LX4211 (liquid)

• Registration Number: NCT01188863
• Lead Sponsor: Lexicon Pharmaceuticals

Brief Summary

This protocol is intended to compare the effects of both a solid (tablet) and liquid oral dosage form of LX4211 in subjects with type 2 diabetes mellitus.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2010-08-24
• Study First Submitted QC: 2010-08-24
• Study First Posted: 2010-08-26
• Study Start: 2010-09
• Primary Completion: 2010-10
• Status Verified: 2011-03
• Last Update Submitted: 2011-03-29
• Last Update Posted: 2011-03-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 15

Inclusion Criteria

• Adults aged 18 to 65 years of age
• Males and females of non-childbearing potential
• Diagnosis of type 2 diabetes mellitus for at least 6 months prior to screening
• Fasting plasma glucose ≤240 mg/dL
• Body mass index <42 kg/sq m
• HbA1c of 7-11%
• C-peptide of ≥1.0 ng/mL
• Ability to provide written informed consent

Exclusion Criteria

• History of type 1 diabetes mellitus, diabetic ketoacidosis, hyperosmolar nonketonic syndrome, incontinence, or nocturia
• Current use of any blood glucose-lowering agent other than metformin
• Exposure to insulin, thiazide, or loop diuretics within 4 weeks prior to screening
• History of HIV, Hepatitis B, or Hepatitis C
• Surgery within 6 months of screening
• Donation or loss of >400 mL of blood or blood product within 8 weeks prior to start of study
• Use of proteins or antibodies within 12 weeks prior to screening. (Flu shots are allowed.)
• Exposure to any investigational agent or participation in an investigational trial within 30 days of the start of the study
• History of drug or alcohol abuse within 12 months prior to screening.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Solid Oral Dose - 150 mg tablets	300 mg LX4211 (150 mg tablets)	-
Solid Oral Dose - 50 mg tablets	300 mg LX4211 (50 mg tablets)	-
Liquid Oral Dose	300 mg LX4211 (liquid)	-

Primary Outcome Measures

Name	Time	Method
Maximum observed plasma concentration	Pharmacokinetics samples collected on day of dosing and 24 and 48 hours post-dose (Follow-up).
Time at which maximum observed plasma concentration occurs	Pharmacokinetics samples collected on day of dosing and 24 and 48 hours post-dose (Follow-up).
Half-life of the drug in plasma	Pharmacokinetics samples collected on day of dosing and 24 and 48 hours post-dose (Follow-up).

Secondary Outcome Measures

Name	Time	Method
Plasma glucose	Samples collected on initial visit; Day -15 and Day -5 (Washout); numerous timepoints on Day -1 (Washout) and day of dosing; 24 hours post-dose (Follow-up); and upon discharge.
Urinary glucose excretion	Samples collected on Day -1 (Washout), day of dosing, and 24 and 48 hours post-dose (Follow-up).
Insulin	Samples collected on initial visit; Day -15 and Day -5 (Washout); numerous timepoints on Day -1 (Washout) and day of dosing; 24 hours post-dose (Follow-up); and upon discharge.
Peptide YY	Samples collected on initial visit; Day -15 and Day -5 (Washout); numerous timepoints on Day -1 (Washout) and day of dosing; 24 hours post-dose (Follow-up); and upon discharge.
Glucagon-like Peptide 1	Samples collected on initial visit; Day -15 and Day -5 (Washout); numerous timepoints on Day -1 (Washout) and day of dosing; 24 hours post-dose (Follow-up); and upon discharge.

Trial Locations

Locations (1)

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