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