Meal-time Administration of Exenatide for Glycaemic Control in Type 1 Diabetic Cases
Status:
Completed
Trial end date:
2019-06-01
Target enrollment:
Participant gender:
Summary
Patients with type 1 diabetes (T1D) depend on insulin therapy as substitution for the lack of
endocrine insulin production due to an autoimmune destruction of beta-cells in the pancreatic
inslets. Insulin therapy is based on long lasting basal insulin for controlling fasting
plasma glucose, and short lasting mealtime insulin for the postprandial plasma glucose. The
long term efficacy of this treatment is measured in glycated haemoglobin A1c (HbA1c) of <7.0%
as the treatment goal.
Intensive insulin therapy is associated with side effects such as hypoglycaemia, weight gain,
and unwanted exaggerated excursions in PPG. This may ultimately affect treatment compliance.
The abovementioned problems associated with insulin treatment in T1D can also be seen in
insulin-treated patients with type 2 diabetes (T2D). However, in T2D the combination of
insulin with glucagon-like peptide-1 (GLP-1) receptor agonist (RA) has proven effective in
reducing the weight gain and insulin dose in insulin-treated patients with T2D without
exacerbating the risk of hypoglycaemia.
Exenatid is a short lasting GLP-1RA approved for treatment in T2D, and the investigators
intend to evaluate it in a randomized, controlled trial as add-on therapy to standard insulin
therapy for patients with T1D.
The investigators hypothesise that the add-on of exenatide to insulin therapy in patients
with T1D will reduce insulin requirements, glycaemic excursions and body weight and improve
glycaemic control without increasing the risk of hypoglycaemia.
Phase:
Phase 2
Details
Lead Sponsor:
Filip Krag Knop
Collaborators:
Steno Diabetes Center Steno Diabetes Center Copenhagen