Meal-time Administration of Exenatide for Glycaemic Control in Type 1 Diabetic Cases (MAG1C)
Primary Purpose
Diabetes Mellitus, Type 1
Status
Completed
Phase
Phase 2
Locations
Denmark
Study Type
Interventional
Intervention
Exenatide
Placebos
Sponsored by
About this trial
This is an interventional treatment trial for Diabetes Mellitus, Type 1 focused on measuring Diabetes Mellitus, Type 1, Exenatide, Incretins, GLP-1, Insulin
Eligibility Criteria
Inclusion Criteria:
- T1D according to WHO criteria with duration of ≥1 year
- Age ≥18 years
- BMI >22.0 kg/m2
- HbA1c >7.5% and <10.0% at visit 0 (screening)
- Able to count carbohydrates
Exclusion Criteria:
- Insulin pump treatment
- Hypoglycaemia unawareness (inability to register low blood glucose)
- Diabetic gastroparesis
- Compromised kidney function (eGFR <60 ml/min/1.73m2, dialysis or kidney transplantation)
- Liver disease with elevated plasma alanine aminotransferase (ALT) > three times the upper limit of normal (measured at visit 0 with the possibility of one repeat analysis within a week, and the last measured value as being conclusive)
- History of acute and/or chronic pancreatitis
- Subjects with personal or family history of medullary carcinoma or MEN syndrome
- Inflammatory bowel disease
- Cancer unless in complete remission for >5 years
- Proliferative retinopathy
- Other concomitant disease or treatment that according to the investigator's assessment makes the patient unsuitable for study participation
- Alcohol/drug abuse
- Fertile women not using chemical (tablet/pill, depot injection of progesterone, subdermal gestagen implantation, hormonal vaginal ring or transdermal hormonal patch) or mechanical (spirals) contraceptives
- Pregnant or nursing women
- Known or suspected hypersensitivity to trial product or related products
- Receipt of an investigational drug within 30 days prior to visit 0
- Simultaneous participation in any other clinical intervention trial
Sites / Locations
- Steno Diabetes Center Copenhagen
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Intervention
Placebo
Arm Description
Exenatide 10 mikrogram, thrice daily, subcutaneous injection prior to main meals, 6 months.
Placebo, thrice daily, subcutaneous injection prior to main meals, 6 months.
Outcomes
Primary Outcome Measures
Change in HbA1c
Change in HbA1c from baseline to end of study (time 6 months)
Secondary Outcome Measures
adverse events (including hypoglycaemic episodes)
changes in insulin dosage
changes in body weight
changes in BMI
changes in body composition
DXA scan measuring bonemineral density
changes in body composition
DXA scan measuring lean mass
changes in body composition
DXA scan measuring fat mass
changes in fasting plasma glucose
changes in post prandial plasma glucose
changes in fasting plasma levels of C-peptide
Quality of life self reported
Quality of Life Questionaire
Treatment satisfaction
Diabetes treatment satisfactory questionnaire status version
Treatment satisfaction
Diabetes treatment satisfactory questionnaire change version
dietary patterns
Food frequency questionaire three times during the intervention
HDL (High Density Lipoprotein)
LDL (Low Density Lipoprotein)
VLDL (Very Low Density Lipoprotein)
total cholesterol
triglycerides
proBNP (Pro-Brain Natriuretic Peptide)
hsCRP (High-Sensitivity C-Reactive Protein)
Full Information
NCT ID
NCT03017352
First Posted
January 2, 2017
Last Updated
July 9, 2019
Sponsor
Filip Krag Knop
Collaborators
Steno Diabetes Center Copenhagen
1. Study Identification
Unique Protocol Identification Number
NCT03017352
Brief Title
Meal-time Administration of Exenatide for Glycaemic Control in Type 1 Diabetic Cases
Acronym
MAG1C
Official Title
Meal-time Administration of Exenatide for Glycaemic Control in Type 1 Diabetic Cases: A Randomised, Placebo-controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
July 2019
Overall Recruitment Status
Completed
Study Start Date
December 2016 (undefined)
Primary Completion Date
June 2019 (Actual)
Study Completion Date
June 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Filip Krag Knop
Collaborators
Steno Diabetes Center Copenhagen
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type 1
Keywords
Diabetes Mellitus, Type 1, Exenatide, Incretins, GLP-1, Insulin
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
108 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Intervention
Arm Type
Experimental
Arm Description
Exenatide 10 mikrogram, thrice daily, subcutaneous injection prior to main meals, 6 months.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo, thrice daily, subcutaneous injection prior to main meals, 6 months.
Intervention Type
Drug
Intervention Name(s)
Exenatide
Other Intervention Name(s)
Byetta
Intervention Type
Drug
Intervention Name(s)
Placebos
Primary Outcome Measure Information:
Title
Change in HbA1c
Description
Change in HbA1c from baseline to end of study (time 6 months)
Time Frame
6 months
Secondary Outcome Measure Information:
Title
adverse events (including hypoglycaemic episodes)
Time Frame
6 months
Title
changes in insulin dosage
Time Frame
6 months
Title
changes in body weight
Time Frame
6 months
Title
changes in BMI
Time Frame
6 months
Title
changes in body composition
Description
DXA scan measuring bonemineral density
Time Frame
6 months
Title
changes in body composition
Description
DXA scan measuring lean mass
Time Frame
6 months
Title
changes in body composition
Description
DXA scan measuring fat mass
Time Frame
6 months
Title
changes in fasting plasma glucose
Time Frame
6 months
Title
changes in post prandial plasma glucose
Time Frame
6 months
Title
changes in fasting plasma levels of C-peptide
Time Frame
6 months
Title
Quality of life self reported
Description
Quality of Life Questionaire
Time Frame
6 months
Title
Treatment satisfaction
Description
Diabetes treatment satisfactory questionnaire status version
Time Frame
6 months
Title
Treatment satisfaction
Description
Diabetes treatment satisfactory questionnaire change version
Time Frame
6 months
Title
dietary patterns
Description
Food frequency questionaire three times during the intervention
Time Frame
6 months
Title
HDL (High Density Lipoprotein)
Time Frame
6 months
Title
LDL (Low Density Lipoprotein)
Time Frame
6 months
Title
VLDL (Very Low Density Lipoprotein)
Time Frame
6 months
Title
total cholesterol
Time Frame
6 months
Title
triglycerides
Time Frame
6 months
Title
proBNP (Pro-Brain Natriuretic Peptide)
Time Frame
6 months
Title
hsCRP (High-Sensitivity C-Reactive Protein)
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
T1D according to WHO criteria with duration of ≥1 year
Age ≥18 years
BMI >22.0 kg/m2
HbA1c >7.5% and <10.0% at visit 0 (screening)
Able to count carbohydrates
Exclusion Criteria:
Insulin pump treatment
Hypoglycaemia unawareness (inability to register low blood glucose)
Diabetic gastroparesis
Compromised kidney function (eGFR <60 ml/min/1.73m2, dialysis or kidney transplantation)
Liver disease with elevated plasma alanine aminotransferase (ALT) > three times the upper limit of normal (measured at visit 0 with the possibility of one repeat analysis within a week, and the last measured value as being conclusive)
History of acute and/or chronic pancreatitis
Subjects with personal or family history of medullary carcinoma or MEN syndrome
Inflammatory bowel disease
Cancer unless in complete remission for >5 years
Proliferative retinopathy
Other concomitant disease or treatment that according to the investigator's assessment makes the patient unsuitable for study participation
Alcohol/drug abuse
Fertile women not using chemical (tablet/pill, depot injection of progesterone, subdermal gestagen implantation, hormonal vaginal ring or transdermal hormonal patch) or mechanical (spirals) contraceptives
Pregnant or nursing women
Known or suspected hypersensitivity to trial product or related products
Receipt of an investigational drug within 30 days prior to visit 0
Simultaneous participation in any other clinical intervention trial
Facility Information:
Facility Name
Steno Diabetes Center Copenhagen
City
Gentofte
State/Province
Capital Region
ZIP/Postal Code
2820
Country
Denmark
12. IPD Sharing Statement
Citations:
PubMed Identifier
29950475
Citation
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.
Results Reference
background
PubMed Identifier
32135138
Citation
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.
Results Reference
derived
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Meal-time Administration of Exenatide for Glycaemic Control in Type 1 Diabetic Cases
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