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Sponsored by: |
GlaxoSmithKline |
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Information provided by: | GlaxoSmithKline |
ClinicalTrials.gov Identifier: | NCT00500331 |
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
Condition | Intervention | Phase |
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Type 2 Diabetes Mellitus |
Drug: GSK189075 |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Dose-Ranging Study of GSK189075 Versus Placebo In The Treatment of Type 2 Diabetes Mellitus in Treatment Naïve Subjects. |
Estimated Enrollment: | 336 |
Study Start Date: | January 2007 |
Study Completion Date: | February 2008 |
Primary Completion Date: | February 2008 (Final data collection date for primary outcome measure) |
Ages Eligible for Study: | 18 Years to 70 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion criteria:
Females of non-childbearing and childbearing potential are eligible to participate as follows:
(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)).
Exclusion Criteria:
Metabolic Disease
Diabetic Medication
Cardiovascular Disease
Recent history or presence of clinically significant acute cardiovascular disease including:
Has a diagnosis of active hepatitis (hepatitis B surface antigen or hepatitis C antibody), or clinically significant hepatic enzyme elevation including:
Any one of the following enzymes greater than 2 times the upper limit of the reference range (ULRR) value at Screening.
alkaline phosphatase (AP). Has a total bilirubin level that is >1.5 times the ULRR at Screening with the exception of suspected or confirmed Gilbert's disease.
history of chronic or acute pancreatitis
Glomerular filtration rate (GFR) <60mL/min (as estimated from serum creatinine at Visit 1 and demographic data using the MDRD equation).For the MDRD equation, please refer to the study procedures manual.
Proteinuria of ≥1+ by urinary dipstick
A positive qualitative urinary dipstick for leukocytes, red blood cells (RBC) or nitrites at Screening.
Has a history of malignancy within the past five years [other than superficial squamous cell carcinoma which is non-invasive on pathology or basal cell carcinoma which is successfully treated with local excision] and cervical cancer in situ treated definitively at least 6 months prior to Screening
Is currently taking or has taken any of the following medications in the 8 weeks prior to Screening:
Oral chromium
Is currently lactating or pregnant
Study Director: | GSK Clinical Trials, MD, FRCPC | GlaxoSmithKline |
Responsible Party: | GSK ( Study Director ) |
Study ID Numbers: | KG2105255 |
Study First Received: | January 24, 2007 |
Last Updated: | December 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00500331 |
Health Authority: | United States: Food and Drug Administration; Latvia: State Agency of Medicines |
Diabetes mellitus Pioglitazone HbA1c |
Metabolic Diseases Pioglitazone Diabetes Mellitus, Type 2 Diabetes Mellitus |
Endocrine System Diseases Endocrinopathy Metabolic disorder Glucose Metabolism Disorders |