Meal-time Administration of Exenatide for Glycaemic Control in Type 1 Diabetic Cases (MAG1C)
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|ClinicalTrials.gov Identifier: NCT03017352|
Recruitment Status : Completed
First Posted : January 11, 2017
Last Update Posted : July 10, 2019
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.
|Condition or disease||Intervention/treatment||Phase|
|Diabetes Mellitus, Type 1||Drug: Exenatide Drug: Placebos||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||108 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Meal-time Administration of Exenatide for Glycaemic Control in Type 1 Diabetic Cases: A Randomised, Placebo-controlled Trial|
|Study Start Date :||December 2016|
|Actual Primary Completion Date :||June 2019|
|Actual Study Completion Date :||June 2019|
Exenatide 10 mikrogram, thrice daily, subcutaneous injection prior to main meals, 6 months.
Other Name: Byetta
Placebo Comparator: Placebo
Placebo, thrice daily, subcutaneous injection prior to main meals, 6 months.
- Change in HbA1c [ Time Frame: 6 months ]Change in HbA1c from baseline to end of study (time 6 months)
- adverse events (including hypoglycaemic episodes) [ Time Frame: 6 months ]
- changes in insulin dosage [ Time Frame: 6 months ]
- changes in body weight [ Time Frame: 6 months ]
- changes in BMI [ Time Frame: 6 months ]
- changes in body composition [ Time Frame: 6 months ]DXA scan measuring bonemineral density
- changes in body composition [ Time Frame: 6 months ]DXA scan measuring lean mass
- changes in body composition [ Time Frame: 6 months ]DXA scan measuring fat mass
- changes in fasting plasma glucose [ Time Frame: 6 months ]
- changes in post prandial plasma glucose [ Time Frame: 6 months ]
- changes in fasting plasma levels of C-peptide [ Time Frame: 6 months ]
- Quality of life self reported [ Time Frame: 6 months ]Quality of Life Questionaire
- Treatment satisfaction [ Time Frame: 6 months ]Diabetes treatment satisfactory questionnaire status version
- Treatment satisfaction [ Time Frame: 6 months ]Diabetes treatment satisfactory questionnaire change version
- dietary patterns [ Time Frame: 6 months ]Food frequency questionaire three times during the intervention
- HDL (High Density Lipoprotein) [ Time Frame: 6 months ]
- LDL (Low Density Lipoprotein) [ Time Frame: 6 months ]
- VLDL (Very Low Density Lipoprotein) [ Time Frame: 6 months ]
- total cholesterol [ Time Frame: 6 months ]
- triglycerides [ Time Frame: 6 months ]
- proBNP (Pro-Brain Natriuretic Peptide) [ Time Frame: 6 months ]
- hsCRP (High-Sensitivity C-Reactive Protein) [ Time Frame: 6 months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03017352
|Steno Diabetes Center Copenhagen|
|Gentofte, Capital Region, Denmark, 2820|