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Study of LX4211 in Subjects With Type 2 Diabetes Mellitus

Primary Purpose

Type 2 Diabetes Mellitus

Status

Completed

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

LX4211 Low Dose

LX4211 High Dose

Placebo

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:

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

Exclusion Criteria:

History of Type 1 diabetes mellitus, diabetic ketoacidosis, hyperosmolar nonketotic syndrome, incontinence, or nocturia
Use of any blood glucose lowering agent other than metformin
Prior exposure to insulin, thiazide, or loop diuretics within 4 weeks prior to screening
Laboratory or electrocardiogram abnormalities deemed significant by the Sponsor or the Investigator
Positive test result for glutamic acid decarboxylase (GAD) antibody
Surgery within 6 months of screening
Exposure to any investigational agent or participation in any investigational trial within 30 days prior to Day 1
Hypersensitivity to an SGLT2 inhibitor
History of drug or alcohol abuse within the last 12 months

Sites / Locations

Lexicon Investigational Site

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Placebo Comparator

Arm Label

Low Dose

High Dose

Placebo

Arm Description

A low dose of LX4211; daily oral intake for 28 days

A high dose of LX4211; daily oral intake for 28 days

Matching placebo dosing with daily oral intake for 28 days

Outcomes

Primary Outcome Measures

Change From Baseline at Day 28 in 24-hour Urinary Glucose Excretion

To assess 24-hour urinary glucose excretion, urine was collected over a 24-hour period and evaluated for glucose concentration.

Secondary Outcome Measures

Change From Baseline at Day 29 in Fasting Plasma Glucose

Change From Baseline at Day 28 in Plasma HbA1c

Change From Baseline at Day 28 in Plasma Fructosamine Level

Change From Baseline at Day 28 in Mean Arterial Pressure

Change From Baseline at Day 28 in Triglycerides

Full Information

NCT ID

NCT00962065

First Posted

August 10, 2009

Last Updated

February 4, 2011

Sponsor

Lexicon Pharmaceuticals

1. Study Identification

Unique Protocol Identification Number

NCT00962065

Brief Title

Study of LX4211 in Subjects With Type 2 Diabetes Mellitus

Official Title

A Phase 2, Single-Center, Randomized, Double-Blind, Placebo-Controlled, Multiple-Dose Study to Determine the Safety and Efficacy of Orally Administered LX4211 in Subjects With Type 2 Diabetes Mellitus

Study Type

Interventional

2. Study Status

Record Verification Date

February 2011

Overall Recruitment Status

Completed

Study Start Date

August 2009 (undefined)

Primary Completion Date

December 2009 (Actual)

Study Completion Date

undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor

Lexicon Pharmaceuticals

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

The purpose of this study is to evaluate the safety, tolerability, and efficacy of LX4211 versus a placebo control 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 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

36 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Low Dose

Arm Type

Experimental

Arm Description

A low dose of LX4211; daily oral intake for 28 days

Arm Title

High Dose

Arm Type

Experimental

Arm Description

A high dose of LX4211; daily oral intake for 28 days

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Matching placebo dosing with daily oral intake for 28 days

Intervention Type

Drug

Intervention Name(s)

LX4211 Low Dose

Intervention Description

A low dose of LX4211; daily oral intake for 28 days

Intervention Type

Drug

Intervention Name(s)

LX4211 High Dose

Intervention Description

A high dose of LX4211; daily oral intake for 28 days

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Matching placebo dosing with daily oral intake for 28 days

Primary Outcome Measure Information:

Title

Change From Baseline at Day 28 in 24-hour Urinary Glucose Excretion

Description

To assess 24-hour urinary glucose excretion, urine was collected over a 24-hour period and evaluated for glucose concentration.

Time Frame

Baseline to Day 28

Secondary Outcome Measure Information:

Title

Change From Baseline at Day 29 in Fasting Plasma Glucose

Time Frame

Baseline to Day 29

Title

Change From Baseline at Day 28 in Plasma HbA1c

Time Frame

Baseline to Day 28

Title

Change From Baseline at Day 28 in Plasma Fructosamine Level

Time Frame

Baseline to Day 28

Title

Change From Baseline at Day 28 in Mean Arterial Pressure

Time Frame

Baseline to Day 28

Title

Change From Baseline at Day 28 in Triglycerides

Time Frame

Baseline to Day 28

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Males and females (non-childbearing potential), aged 18-65 years Diagnosis of Type 2 diabetes mellitus for at least 6 months prior to screening Fasting plasma glucose ≤ 240 mg/dL prior to metformin washout Body mass index < 42 kg/m^2 HbA1c value of 7 to 11% C-peptide ≥ 1.0 ng/mL Ability to provide written informed consent Exclusion Criteria: History of Type 1 diabetes mellitus, diabetic ketoacidosis, hyperosmolar nonketotic syndrome, incontinence, or nocturia Use of any blood glucose lowering agent other than metformin Prior exposure to insulin, thiazide, or loop diuretics within 4 weeks prior to screening Laboratory or electrocardiogram abnormalities deemed significant by the Sponsor or the Investigator Positive test result for glutamic acid decarboxylase (GAD) antibody Surgery within 6 months of screening Exposure to any investigational agent or participation in any investigational trial within 30 days prior to Day 1 Hypersensitivity to an SGLT2 inhibitor History of drug or alcohol abuse within the last 12 months

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

derived

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Study of LX4211 in Subjects With Type 2 Diabetes Mellitus

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