Prediction of the efficacy of exenatide treatment in suboptimally controlled type 2 diabetic patients by Metabolic Fingerprint” and evidence-based KADIS® decision support: a clinical pilot trial - KADIS-Byetta
- Conditions
- the trial will be performed in a total of 58 male and female patients with type 2 diabetes who will be assigned to two groups, receiving either exenatide or insulin glargine
- Registration Number
- EUCTR2008-006251-46-DE
- Lead Sponsor
- Institute of Diabetes Gerhardt Katsch”
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Not Recruiting
- Sex
- All
- Target Recruitment
- 72
type 2 diabetes, age = 30 < 70 y, diabetes duration = 1 and = 12 y, A1c = 7.0 and = 8.5%
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
preceding ketoacidosis or lactic acidosis, severe hypoglycaemic episodes, existing cardiac or haematological diseases, severe hypertension, hepatic and renal disease (macroalbuminuria or diabetic nephropathy, severe diabetic neuropathy, existing gastrointestinal disease, acute or chronic inflammatory disease, established foot ulceration, drug taking to promote weight reduction, treatment with insulin, thiazolidinediones or meglitinides prior to inclusion examination, therapy with corticosteroids, drugs known to have gastrointestinal effects, psychological disorder, lactation and pregnancy, subjects who are not able to understand written and verbal instructions, unwillingness of blood taking, participation in a clinical trial during the last 2 months prior to the study, hypersensitivity reactions against medicinal product
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: to assess the predictive power of in-silico evaluation of glycemic control with exenatide and insulin glargine;Secondary Objective: to compare risk of hypoglycaemia, glucose variability, oxidative stress, low grade inflammation, and A1c-values;Primary end point(s): KADIS®-based prediction for the two treatments by measuring the predicted and observed incremental area under the CGM sensor glucose curve
- Secondary Outcome Measures
Name Time Method