Comparison of insulin detemir and insulin glargine in patients with Type 2 diabetes - Detemir vs Glargine
- Conditions
- Type 2 DiabetesMedDRA version: 8.1 Level: LLT Classification code 10045242 Term: Type II diabetes mellitus
- Registration Number
- EUCTR2005-004754-27-GB
- Lead Sponsor
- Cardiff University
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 12
• Type 2 diabetes (GAD negative) not currently treated with insulin
• Male or female
• Age 18-75 years inclusive
• HbA1c =7.0 = 11.0 % inclusive
• BMI =35 kg/m2
• Written, signed, informed consent.
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
• Diabetes other than type 2 diabetes mellitus
• Type 2 diabetic patients requiring insulin treatment
• Patients with severe complication of diabetes e.g. pre-proliferative or proliferative retinopathy; diabetic nephropathy (serum creatinine > 160 micromol/L); ischemic heart disease with clinically significant angina pectoris
• Evidence of hepatic disease as determined by AST and/or ALT values of greater than 2 X upper level of normal
• History of drug or alcohol abuse within the last 5 years
• History of multiple drug allergies
• Participation in any investigational drug trial within 3 months prior to Visit 1
• History of non-compliance to medical regimens or those patients who are unwilling or unable to comply with the trial protocol
• Pregnancy or planning to become pregnant during the trial
• Patients who are taking corticosteroids, thyroxine or growth hormones.
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