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
Conditions
Interventions
Trade Name: Byetta 5 Mikrogramm Injektionslösung in Fertigpen
Pharmaceutical Form: Injection*
INN or Proposed INN: exendin-4
Other descriptive name: byetta, exenatide
Concentration unit: mg/ml milligr
Sponsors
Institute of Diabetes “Gerhardt Katsch”
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: type 2 diabetes, age = 30 =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
Germany
Outcome results
None listed