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Dose-Ranging Study in Treatment Naive Type 2 Diabetes Mellitus(T2DM) | Clinical Trials | Clareo Health

COMPLETEDPHASE2

Dose-Ranging Study in Treatment Naive Type 2 Diabetes Mellitus(T2DM)

A Double-blind, Randomized 12-week Study to Evaluate the Safety and Efficacy of GSK189075 Tablets vs Pioglitazone in Treatment Naive Subjects With Type 2 Diabetes Mellitus

NCT00500331•GlaxoSmithKline

View on ClinicalTrials.gov

Summary

This is a dose-ranging study that will evaluate the efficacy, safety and tolerability of a range of doses of investigational product and pioglitazone, compared to placebo, administered as monotherapy over 12 weeks in treatment naive patients with T2DM

Eligibility

Age

18 - 70 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Subjects with a documented diagnosis of T2DM and have an HbA1c level at Visit 1 of ≥7.0% and ≤9.5% as measured by a central laboratory. Subjects with HbA1c \<7.5% must have a fasting fingerstick glucose ≥7 mmol/L (126 mg/dL) at Week 0 prior to randomization.
•Subjects who are treatment-naïve and have not taken insulin, or any oral or injectable anti-diabetic medication in the past 3 months and have not taken a glucose lowering agent for ≥4 weeks at any time in the past, or Subjects who are newly diagnosed and treated with diet and exercise for a minimum of 6 weeks
•Subjects who are 18 to 70 years of age inclusive at the time of Screening.
•Females of non-childbearing and childbearing potential are eligible to participate as follows:
•* Women of childbearing potential must be willing to use one of the following contraception methods: intrauterine device, condom or occlusive cap (diaphragm or cervical/vault caps) plus spermicidal agent for at least 30 days prior to the start of study medication, throughout the study and the follow-up visit. Note: use of oral contraceptives is not permitted.
•* Women of non-child bearing potential are defined as follows: females regardless of age, with functioning ovaries and who have a current documented tubal ligation \[Hatcher, 2004\] bilateral oophorectomy or total hysterectomy, or females who are post-menopausal).
•(Post-menopausal is defined as after one year without menses with an appropriate clinical profile, e.g. age appropriate, \>45 years, in the absence of hormone replacement therapy. In addition to the above criteria, if the post-menopausal status is still questionable, a blood sample should be drawn for simultaneous measurement of follicle stimulating hormone and estradiol; values considered to confirm the post-menopausal state are respectively: FSH \>40 MIU/mL and estradiol \<40pg/mL (\<140 pmol/L)).
•Informed Consent: a signed and dated written consent must be obtained from the subject before any procedures are performed.

Exclusion Criteria

•Metabolic Disease
•* Diagnosis of Type 1 diabetes mellitus.
•* History of ketoacidosis which has required hospitalization.
•* Thyroid disorder \[TSH below the lower limit of the reference range (LLRR) of 0.4mIU/L or above the upper limit of the reference range (ULRR) of \>5.5 mIU/L at Screening\]. Hypothyroidism treated with the same dose and regimen of thyroid hormone replacement for at least 3 months prior to Screening is allowed.
•* BMI of \<22 or \>43 kg/m2.
•* Significant weight gain or loss (as defined as \>5% of total body weight) in the 3 months prior to Screening.
•Diabetic Medication
•* Has taken insulin or any oral or injectable anti-diabetic medication ≥4 weeks at any time prior to screening.
•* Has taken insulin or any oral or injectable anti-diabetic medication within 3 months of screening.
•Cardiovascular Disease
+52 more criteria

Locations (136)

GSK Investigational Site

Mesa, Arizona, United States

GSK Investigational Site

Hollywood, Florida, United States

GSK Investigational Site

Miami, Florida, United States

GSK Investigational Site

Saint Cloud, Florida, United States

GSK Investigational Site

Sunset, Louisiana, United States

GSK Investigational Site

Oxon Hill, Maryland, United States

GSK Investigational Site

Las Vegas, Nevada, United States

GSK Investigational Site

Las Vegas, Nevada, United States

GSK Investigational Site

Las Vegas, Nevada, United States

GSK Investigational Site

Albuquerque, New Mexico, United States

Key Dates

Start Date

January 23, 2007

Primary Completion Date

February 14, 2008

Completion Date

February 14, 2008

Last Updated

December 6, 2017

Enrollment

334

ACTUAL participants

Conditions

Diabetes Mellitus, Type 2

Interventions

GSK189075

DRUG

pioglitazone

DRUG

Placebo

OTHER

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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: December 6, 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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Dose-Ranging Study in Treatment Naive Type 2 Diabetes Mellitus(T2DM)

Inclusion Criteria

Exclusion Criteria

PATHS-UP Health Behavior Self-monitoring Mobile App for Adolescents

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