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

Diabetes Mellitus, Type 1 Clinical Trial

— MAG1C  

Official title:

Meal-time Administration of Exenatide for Glycaemic Control in Type 1 Diabetic Cases: A Randomised, Placebo-controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03017352
• Other study ID #: Eudract-nr.: 2016-001365-92
• Status: Completed
• Phase: Phase 2
• Start date: December 2016
• Est. completion date: June 2019

Study information

• Verified date: July 2019
• Source: University Hospital, Gentofte, Copenhagen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 108
• Est. completion date: June 2019
• Est. primary completion date: June 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 1

Intervention

Drug:
• Exenatide

• Placebos

Locations

Country	Name	City	State
Denmark	Steno Diabetes Center Copenhagen	Gentofte	Capital Region

Sponsors (2)

Lead Sponsor	Collaborator
Filip Krag Knop	Steno Diabetes Center Copenhagen

Country where clinical trial is conducted

Denmark, 

References & Publications (1)

Johansen NJ, Dejgaard TF, Lund A, Vilsbøll 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in HbA1c	Change in HbA1c from baseline to end of study (time 6 months)	6 months
Secondary	adverse events (including hypoglycaemic episodes)		6 months
Secondary	changes in insulin dosage		6 months
Secondary	changes in body weight		6 months
Secondary	changes in BMI		6 months
Secondary	changes in body composition	DXA scan measuring bonemineral density	6 months
Secondary	changes in body composition	DXA scan measuring lean mass	6 months
Secondary	changes in body composition	DXA scan measuring fat mass	6 months
Secondary	changes in fasting plasma glucose		6 months
Secondary	changes in post prandial plasma glucose		6 months
Secondary	changes in fasting plasma levels of C-peptide		6 months
Secondary	Quality of life self reported	Quality of Life Questionaire	6 months
Secondary	Treatment satisfaction	Diabetes treatment satisfactory questionnaire status version	6 months
Secondary	Treatment satisfaction	Diabetes treatment satisfactory questionnaire change version	6 months
Secondary	dietary patterns	Food frequency questionaire three times during the intervention	6 months
Secondary	HDL (High Density Lipoprotein)		6 months
Secondary	LDL (Low Density Lipoprotein)		6 months
Secondary	VLDL (Very Low Density Lipoprotein)		6 months
Secondary	total cholesterol		6 months
Secondary	triglycerides		6 months
Secondary	proBNP (Pro-Brain Natriuretic Peptide)		6 months
Secondary	hsCRP (High-Sensitivity C-Reactive Protein)		6 months