A Phase IIb, 12-week, multicenter, randomized, double-blind, placebo-controlled,pioglitazone-controlled, parallel-group dose-ranging study in approximately 336 maleand female subjects, aged 18 to 70 years with type 2 diabetes mellitus who are treatmentnaïve.
- Conditions
- Type 2 diabetes mellitusMedDRA version: 8.1Level: LLTClassification code 10045242Term: Type II diabetes mellitus
- Registration Number
- EUCTR2006-004694-97-HU
- 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 =7.5% and =9.5% as measured by a central laboratory.
2. Subjects who are treatment naïve, or who may have taken insulin or any oral
antidiabetic medications for a total of no more than 2 and 4 weeks respectively
within the previous 12 months, but not at all within the 3 months prior to screening,
or subjects who are newly diagnosed and treated with diet and exercise for a minimum of 8 weeks.
3. Subjects who are 18 to 70 years of age inclusive at the time of Screening.
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 <25 or >40 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 for more than 2 weeks in the 12 months prior to screening or
at any time within the 3 months prior to screening.
• Has taken any oral anti-diabetic medication for more than 4 weeks in the 12
months prior to screening or at anytime within the 3 months prior to 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 3 month 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 3 months 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 estima
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