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Study In People With Type 2 Diabetes | Clinical Trials | Clareo Health

COMPLETEDPHASE2

Study In People With Type 2 Diabetes

A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Dose-Ranging Study of Oral GW677954 as a Monotherapy for 12 Weeks Duration in Patients With Type 2 Diabetes Mellitus

NCT00196989•GlaxoSmithKline

View on ClinicalTrials.gov

Summary

This Phase 2 dose-ranging study will evaluate the efficacy, safety and tolerability of a range of doses of GW677954 compared with placebo over sixteen weeks of treatment in subjects with T2DM (Type 2 Diabetes Mellitus).

Detailed Description

A Multicenter, Randomized, Double-Blind, Double-Dummy, Parallel-Group, Placebo-Controlled, Study To Evaluate Efficacy, Safety And Tolerability Of Oral GW677954 Capsules (2.5, 5, 10, 15 And 20 Mg Once A Day) As A Monotherapy (Diet and/or exercise treated) Or As An Add-On To Metformin For 16 Weeks Duration In Subjects With Type 2 Diabetes Mellitus

Eligibility

Age

18 - 70 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Subjects with T2DM as defined by the criteria of the ADA and/or recognized by WHO Expert Committee on the Diagnosis and Classification of Diabetes Mellitus \[American Diabetes Association, 2004\], for at least 3 months preceding screening (see Section 15.3, Appendix 3:, "Diagnosis and Classification of Diabetes Mellitus").
•To be eligible for Randomization into the trial, a subject must satisfy all of the following glycemic criteria:
•* HbA1c level via central laboratory at the pre-screening visit
•* If HbA1c ≥ 8.0% but ≤ 10.0%: subject may proceed to Randomization;

Exclusion Criteria

•* FPG level via central laboratory at the pre-screening visit must be \< 270 mg/dL (15.0 mmol/L). FPG may be retested within a week to confirm eligibility (or lack thereof).
•Concurrent T2DM therapy:
•* Diet and/or exercise treated: Must not have taken antidiabetic medication for at least 2 months prior to the pre-screening visit, OR
•* Metformin monotherapy: Subjects entering the study on metformin must be on the same dose, formulation and regimen of metformin for at least 2 months prior to the pre-screening visit, AND
•* TZDs and insulin are excluded in the 3 months prior to the Screening visit for all subjects.
•Males and females who are 18 to 70 years of age inclusive at the time of Screening.
•If female, eligible to enter and participate in this study:
•* If of non-childbearing potential (i.e., physiologically incapable of becoming pregnant (tubal ligation), including any female who is post-menopausal \[\>1 year without menstrual period\]); or,
•* If of child-bearing potential, has a negative pregnancy test at Screening (serum), at Randomization (urine) and:
•* Has a male partner who is sterile prior to the female subject's entry into the study and is the sole sexual partner for that female subject, or
+62 more criteria

Locations (143)

GSK Investigational Site

Birmingham, Alabama, United States

GSK Investigational Site

Northport, Alabama, United States

GSK Investigational Site

Chandler, Arizona, United States

GSK Investigational Site

Phoenix, Arizona, United States

GSK Investigational Site

Phoenix, Arizona, United States

GSK Investigational Site

Alhambra, California, United States

GSK Investigational Site

Artesia, California, United States

GSK Investigational Site

Huntington Beach, California, United States

GSK Investigational Site

Inglewood, California, United States

GSK Investigational Site

Irvine, California, United States

Key Dates

Start Date

September 1, 2005

Primary Completion Date

April 1, 2007

Completion Date

April 1, 2007

Last Updated

March 23, 2017

Enrollment

448

ACTUAL participants

Conditions

Diabetes Mellitus, Type 2

Interventions

Pioglitazone

DRUG

GW677954

DRUG

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 23, 2017Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Study In People With Type 2 Diabetes

Inclusion Criteria

Exclusion Criteria

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