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

Type 2 Diabetes Mellitus Clinical Trial

Official title:

A Phase 1, Randomized, Open-Label, Three-Way Crossover Study of Two Oral Formulations of LX4211 in Subjects With Type 2 Diabetes Mellitus

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01188863
• Other study ID #: LX4211.1-102-DM
• Secondary ID: LX4211.102
• Status: Completed
• Phase: Phase 1
• First received: August 24, 2010
• Last updated: March 29, 2011
• Start date: September 2010

Study information

• Verified date: March 2011
• Source: Lexicon Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. primary completion date: October 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Bio-availability Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type 2 Diabetes Mellitus

Intervention

Drug:
• 300 mg LX4211 (150 mg tablets)
Single oral dose of two 150 mg tablets LX4211
• 300 mg LX4211 (50 mg tablets)
Single oral dose of six 50 mg tablets LX4211
• 300 mg LX4211 (liquid)
Single 30 mL dose of liquid oral solution LX4211 (10 mg/mL)

Locations

Country	Name	City	State
United States	Lexicon Investigational Site	San Antonio	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Lexicon Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximum observed plasma concentration		Pharmacokinetics samples collected on day of dosing and 24 and 48 hours post-dose (Follow-up).	No
Primary	Time at which maximum observed plasma concentration occurs		Pharmacokinetics samples collected on day of dosing and 24 and 48 hours post-dose (Follow-up).	No
Primary	Half-life of the drug in plasma		Pharmacokinetics samples collected on day of dosing and 24 and 48 hours post-dose (Follow-up).	No
Secondary	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.	No
Secondary	Urinary glucose excretion		Samples collected on Day -1 (Washout), day of dosing, and 24 and 48 hours post-dose (Follow-up).	No
Secondary	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.	No
Secondary	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.	No
Secondary	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.	No