Meal-time Administration of Exenatide for Glycaemic Control in Type 1 Diabetic Cases

Status

Completed

Phase

Phase 2

Enrollment

108 participants (actual)

Sponsor

Filip Krag Knop · Other

Design

Randomized · Quadruple masking

Countries

1 country

Denmark

Start

Dec 2016

Primary completion

Jun 2019

Completion

Jun 2019

First posted

11 Jan 2017 (estimated)

Last update posted

10 Jul 2019

Conditions

Diabetes Mellitus, Type 1

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.

• Experimental

  Intervention

  Exenatide 10 mikrogram, thrice daily, subcutaneous injection prior to main meals, 6 months.

• Placebo comparator

  Placebo

  Placebo, thrice daily, subcutaneous injection prior to main meals, 6 months.

1. Change in HbA1c

   Time frame · 6 months

   Registry description

   Change in HbA1c from baseline to end of study (time 6 months)