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| Name | Class |
|---|---|
| Steno Diabetes Center Copenhagen | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention | Experimental | Exenatide 10 mikrogram, thrice daily, subcutaneous injection prior to main meals, 6 months. |
|
| Placebo | Placebo Comparator | Placebo, thrice daily, subcutaneous injection prior to main meals, 6 months. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Exenatide | Drug |
|
| |
| Placebos |
| Measure | Description | Time Frame |
|---|---|---|
| Change in HbA1c | Change in HbA1c from baseline to end of study (time 6 months) | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| adverse events (including hypoglycaemic episodes) | 6 months | |
| changes in insulin dosage | 6 months | |
| changes in body weight |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Steno Diabetes Center Copenhagen | Gentofte Municipality | Capital Region | 2820 | Denmark |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29950475 | Background | Johansen NJ, Dejgaard TF, Lund A, Vilsboll T, Andersen HU, Knop FK. Protocol for Meal-time Administration of Exenatide for Glycaemic Control in Type 1 Diabetes Cases (The MAG1C trial): a randomised, double-blinded, placebo-controlled trial. BMJ Open. 2018 Jun 27;8(6):e021861. doi: 10.1136/bmjopen-2018-021861. | |
| 32135138 | Derived |
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| ID | Term |
|---|---|
| D003922 | Diabetes Mellitus, Type 1 |
| D007333 | Insulin Resistance |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D000077270 | Exenatide |
| ID | Term |
|---|---|
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D014688 | Venoms |
| D045424 | Complex Mixtures |
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| Drug |
|
| 6 months |
| changes in BMI | 6 months |
| changes in body composition | DXA scan measuring bonemineral density | 6 months |
| changes in body composition | DXA scan measuring lean mass | 6 months |
| changes in body composition | DXA scan measuring fat mass | 6 months |
| changes in fasting plasma glucose | 6 months |
| changes in post prandial plasma glucose | 6 months |
| changes in fasting plasma levels of C-peptide | 6 months |
| Quality of life self reported | Quality of Life Questionaire | 6 months |
| Treatment satisfaction | Diabetes treatment satisfactory questionnaire status version | 6 months |
| Treatment satisfaction | Diabetes treatment satisfactory questionnaire change version | 6 months |
| dietary patterns | Food frequency questionaire three times during the intervention | 6 months |
| HDL (High Density Lipoprotein) | 6 months |
| LDL (Low Density Lipoprotein) | 6 months |
| VLDL (Very Low Density Lipoprotein) | 6 months |
| total cholesterol | 6 months |
| triglycerides | 6 months |
| proBNP (Pro-Brain Natriuretic Peptide) | 6 months |
| hsCRP (High-Sensitivity C-Reactive Protein) | 6 months |
| Johansen NJ, Dejgaard TF, Lund A, Schluntz C, Frandsen CS, Forman JL, Wewer Albrechtsen NJ, Holst JJ, Pedersen-Bjergaard U, Madsbad S, Vilsboll T, Andersen HU, Knop FK. Efficacy and safety of meal-time administration of short-acting exenatide for glycaemic control in type 1 diabetes (MAG1C): a randomised, double-blind, placebo-controlled trial. Lancet Diabetes Endocrinol. 2020 Apr;8(4):313-324. doi: 10.1016/S2213-8587(20)30030-9. Epub 2020 Mar 2. |
| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D006946 | Hyperinsulinism |
| D014118 |
| Toxins, Biological |
| D001685 | Biological Factors |