A Dose-Ranging Study of GSK189075 Versus Placebo In The Treatment of Type 2 Diabetes Mellitus in Treatment Naive Subjects.
- Conditions
- Type 2 diabetes mellitusMedDRA version: 8.1Level: LLTClassification code 10045242Term: Type II diabetes mellitus
- Registration Number
- EUCTR2006-004694-97-CZ
- Lead Sponsor
- GlaxoSmithKline Research & Development
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 336
Specific information regarding warnings, precautions, contraindications, adverse events, and other pertinent information on the investigational product that may impact subject eligibility is provided in the Investigator’s Brochure.
Subjects eligible for enrollment in the study must meet all of the following criteria:
1. Subjects with a documented diagnosis of T2DM and have an HbA1c level at Visits 1
and 2 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.
2. Subjects who are treatment naïve, and have not taken insulin or any oral or injectable antidiabetic medications in the past 3 months and have not taken a glocose lowering agent for =4 weeks in the past or subjects who are newly diagnosed and treated with diet and exercise for a minimum of 6 weeks.
3. Subjects who are 18 to 70 years of age inclusive at the time of Screening.
4. 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).
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
Subjects meeting any of the following criteria must not be enrolled in the study:
1. 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.
2. 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.
3. Cardiovascular Disease
• Recent history or presence of clinically significant acute cardiovascular disease
including:
- Documented myocardial infarction in the 6 months prior to Screening.
- Coronary revascularization including percutaneous transluminal coronary
angioplasty (PTCA) or coronary artery bypass graft (CABG) surgery either
planned and/or occurred in the 6 months prior to Screening.
- Unstable angina in the 6 months prior to Screening.
- Clinically significant supraventricular arrhythmias requiring medical therapy,
or history of nonsustained or sustained ventricular tachycardia. Symptomatic
valvular heart disease or valvular heart disease requiring therapy other than
endocarditis prophylaxis.
- Congestive heart failure (CHF, New York Heart Association (NYHA) Class II
to IV) requiring pharmacologic treatment. NYHA Class I may be included in
accordance with the local prescribing information for pioglitazone.
- Blood pressure (BP) >150/100mmHg. If a subject is receiving permitted
antihypertensive therapy, then they must be on stable dose(s) of therapy for at
least 4 weeks prior to Screening.
- Has a QTc interval (Bazett’s) =450msec at Screening on a single ECG or an
average value from 3 ECGs taken 5 minutes apart (on local reading of ECG).
- Other clinically significant ECG abnormalities which, in the opinion of the
investigator, may affect the interpretation of efficacy and safety data, or which
otherwise contraindicates participation in a clinical trial with a new chemical
entity.
• Fasting plasma triglycerides =400mg/dL (4.56mmol/L) at Screening. If a
subject is receiving permitted lipid-lowering therapy, then they must be on a
stable dose(s) of therapy for at least 6 weeks prior to Screening. Niacin and
bile acid sequestrants are prohibited.
4. Hepatic Disease
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.
- alanine transaminase (ALT).
- aspartate transaminase (AST).
- 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.
5. Pancreatic Disease
• Secondary causes of diabetes:
- history of chronic or acute pancreatitis
6. Renal Disease
• Significant renal disease at Screening as manifested by:
- Glomerular filtration rate (GFR) <60mL/min (as estimated from serum creatinine at Visit 1 and demographic data using the MDRD equati
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method