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

Primary Purpose

Type 2 Diabetes Mellitus

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
300 mg LX4211 (150 mg tablets)
300 mg LX4211 (50 mg tablets)
300 mg LX4211 (liquid)
Sponsored by
Lexicon Pharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Type 2 Diabetes Mellitus

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Lexicon Investigational Site

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Solid Oral Dose - 150 mg tablets

Solid Oral Dose - 50 mg tablets

Liquid Oral Dose

Arm Description

Outcomes

Primary Outcome Measures

Maximum observed plasma concentration
Time at which maximum observed plasma concentration occurs
Half-life of the drug in plasma

Secondary Outcome Measures

Plasma glucose
Urinary glucose excretion
Insulin
Peptide YY
Glucagon-like Peptide 1

Full Information

First Posted
August 24, 2010
Last Updated
March 29, 2011
Sponsor
Lexicon Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT01188863
Brief Title
Study of Two Oral Formulations of LX4211 in Patients With Type 2 Diabetes Mellitus
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
Study Type
Interventional

2. Study Status

Record Verification Date
March 2011
Overall Recruitment Status
Completed
Study Start Date
September 2010 (undefined)
Primary Completion Date
October 2010 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Lexicon Pharmaceuticals

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes Mellitus

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
15 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Solid Oral Dose - 150 mg tablets
Arm Type
Experimental
Arm Title
Solid Oral Dose - 50 mg tablets
Arm Type
Experimental
Arm Title
Liquid Oral Dose
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
300 mg LX4211 (150 mg tablets)
Intervention Description
Single oral dose of two 150 mg tablets LX4211
Intervention Type
Drug
Intervention Name(s)
300 mg LX4211 (50 mg tablets)
Intervention Description
Single oral dose of six 50 mg tablets LX4211
Intervention Type
Drug
Intervention Name(s)
300 mg LX4211 (liquid)
Intervention Description
Single 30 mL dose of liquid oral solution LX4211 (10 mg/mL)
Primary Outcome Measure Information:
Title
Maximum observed plasma concentration
Time Frame
Pharmacokinetics samples collected on day of dosing and 24 and 48 hours post-dose (Follow-up).
Title
Time at which maximum observed plasma concentration occurs
Time Frame
Pharmacokinetics samples collected on day of dosing and 24 and 48 hours post-dose (Follow-up).
Title
Half-life of the drug in plasma
Time Frame
Pharmacokinetics samples collected on day of dosing and 24 and 48 hours post-dose (Follow-up).
Secondary Outcome Measure Information:
Title
Plasma glucose
Time Frame
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.
Title
Urinary glucose excretion
Time Frame
Samples collected on Day -1 (Washout), day of dosing, and 24 and 48 hours post-dose (Follow-up).
Title
Insulin
Time Frame
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.
Title
Peptide YY
Time Frame
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.
Title
Glucagon-like Peptide 1
Time Frame
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.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joel P. Freiman, MD, MPH
Organizational Affiliation
Lexicon Pharmaceuticals, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Lexicon Investigational Site
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78209
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
22739142
Citation
Zambrowicz B, Freiman J, Brown PM, Frazier KS, Turnage A, Bronner J, Ruff D, Shadoan M, Banks P, Mseeh F, Rawlins DB, Goodwin NC, Mabon R, Harrison BA, Wilson A, Sands A, Powell DR. LX4211, a dual SGLT1/SGLT2 inhibitor, improved glycemic control in patients with type 2 diabetes in a randomized, placebo-controlled trial. Clin Pharmacol Ther. 2012 Aug;92(2):158-69. doi: 10.1038/clpt.2012.58. Epub 2012 Jul 4.
Results Reference
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Study of Two Oral Formulations of LX4211 in Patients With Type 2 Diabetes Mellitus

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