Type 2 Diabetes MedDRA version: 8.1 Level: LLT Classification code 10045242 Term: Type II diabetes mellitus
Conditions
Interventions
Trade Name: Lantus 100 IU/ml
Product Name: insulin glargine
Pharmaceutical Form: Injection*
Other descriptive name: insulin glargine
Con
Sponsors
Cardiff University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • 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
Exclusion criteria
Exclusion criteria: • 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To compare the glucose infusion rate (GIR) over 24 hours of insulin detemir and insulin glargine in patients with type 2 diabetes. ;Secondary Objective: To compare the pharmacokinetics of insulin detemir and insulin glargine in patients with Type 2 diabetes.; Primary end point(s): The primary efficacy variable will be maximum concentration (Cmax) of the glucose infusion rate (GIR) over the 24 hour period - CmaxGIR0-24h Secondary efficacy variables will be AUC0-24h, Tmax and Cmax for insulin and C-peptide | — |
Countries
United Kingdom
Outcome results
None listed