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Dose-Ranging Study In Subjects With Type 2 Diabetes Mellitus Who Are Treatment-Naive | Clinical Trials | Clareo Health

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Dose-Ranging Study In Subjects With Type 2 Diabetes Mellitus Who Are Treatment-Naive

A Once-Daily Dose-Ranging Study of GSK189075 Versus Placebo In The Treatment of Type 2 Diabetes Mellitus in Treatment-Naïve Subjects

NCT00495469•GlaxoSmithKline

View on ClinicalTrials.gov

Summary

This is a dose-ranging study to evaluate the efficacy, safety and tolerability of a range of doses of GSK189075 (an SGLT2 inhibitor) compared to placebo, administered over 12 weeks in treatment-naive subjects with type 2 diabetes mellitus

Eligibility

Age

18 - 70 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Subjects with a documented diagnosis of T2DM and HbA1c ≥7.0% and ≤9.5% measured by the central laboratory at Visit 1.
•* Note: Subjects with HbA1c \<7.5% must have a fasting fingerstick glucose ≥7 mmol/L (126 mg/dL) at Week 0, prior to randomization.
•* Note: The proportion of subjects who are randomized with an HbA1c \<7.5% will be limited to be no more than 20% (approximately 51 subjects)
•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 childbearing and non-childbearing and 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 who have a current documented tubal ligation, or who are surgically sterile (i.e. documented total hysterectomy or bilateral oophorectomy), or females who are post-menopausal.
•All females must have a negative urine pregnancy test on the day of, and prior to randomization.
•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 \<0.4 MIU/L (\<0.4 MCIU/mL) or \>5.5 mIU/L (\>5.5 MCIU/mL) at Screening
•* BMI of \<22 kg/m2 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 within 3 months of screening
•* Has taken insulin or any oral or injectable anti-diabetic medication ≥4 weeks at any time in the past
+53 more criteria

Locations (157)

GSK Investigational Site

Mesa, Arizona, United States

GSK Investigational Site

Artesia, California, United States

GSK Investigational Site

Buena Park, California, United States

GSK Investigational Site

Fresno, California, United States

GSK Investigational Site

Greenbrae, California, United States

GSK Investigational Site

La Jolla, California, United States

GSK Investigational Site

Norwalk, California, United States

GSK Investigational Site

Petaluma, California, United States

GSK Investigational Site

Sacramento, California, United States

GSK Investigational Site

San Mateo, California, United States

Key Dates

Start Date

August 17, 2007

Primary Completion Date

June 5, 2008

Completion Date

June 5, 2008

Last Updated

October 30, 2017

Enrollment

250

ACTUAL participants

Conditions

Diabetes Mellitus, Type 2

Interventions

GSK189075

DRUG

Placebo

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: October 30, 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 Subjects With Type 2 Diabetes Mellitus Who Are Treatment-Naive

Inclusion Criteria

Exclusion Criteria

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