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Meal-time Administration of Exenatide for Glycaemic Control in Type 1 Diabetic Cases (MAG1C)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03017352
Recruitment Status : Completed
First Posted : January 11, 2017
Last Update Posted : July 10, 2019
Sponsor:
Collaborator:
Steno Diabetes Center Copenhagen
Information provided by (Responsible Party):
Filip Krag Knop, University Hospital, Gentofte, Copenhagen

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.


Condition or disease Intervention/treatment Phase
Diabetes Mellitus, Type 1 Drug: Exenatide Drug: Placebos Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 108 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diabetes Type 1
Drug Information available for: Exenatide

Arm Intervention/treatment
Experimental: Intervention
Exenatide 10 mikrogram, thrice daily, subcutaneous injection prior to main meals, 6 months.
Drug: Exenatide
Other Name: Byetta

Placebo Comparator: Placebo
Placebo, thrice daily, subcutaneous injection prior to main meals, 6 months.
Drug: Placebos



Primary Outcome Measures :
  1. Change in HbA1c [ Time Frame: 6 months ]
    Change in HbA1c from baseline to end of study (time 6 months)


Secondary Outcome Measures :
  1. adverse events (including hypoglycaemic episodes) [ Time Frame: 6 months ]
  2. changes in insulin dosage [ Time Frame: 6 months ]
  3. changes in body weight [ Time Frame: 6 months ]
  4. changes in BMI [ Time Frame: 6 months ]
  5. changes in body composition [ Time Frame: 6 months ]
    DXA scan measuring bonemineral density

  6. changes in body composition [ Time Frame: 6 months ]
    DXA scan measuring lean mass

  7. changes in body composition [ Time Frame: 6 months ]
    DXA scan measuring fat mass

  8. changes in fasting plasma glucose [ Time Frame: 6 months ]
  9. changes in post prandial plasma glucose [ Time Frame: 6 months ]
  10. changes in fasting plasma levels of C-peptide [ Time Frame: 6 months ]
  11. Quality of life self reported [ Time Frame: 6 months ]
    Quality of Life Questionaire

  12. Treatment satisfaction [ Time Frame: 6 months ]
    Diabetes treatment satisfactory questionnaire status version

  13. Treatment satisfaction [ Time Frame: 6 months ]
    Diabetes treatment satisfactory questionnaire change version

  14. dietary patterns [ Time Frame: 6 months ]
    Food frequency questionaire three times during the intervention

  15. HDL (High Density Lipoprotein) [ Time Frame: 6 months ]
  16. LDL (Low Density Lipoprotein) [ Time Frame: 6 months ]
  17. VLDL (Very Low Density Lipoprotein) [ Time Frame: 6 months ]
  18. total cholesterol [ Time Frame: 6 months ]
  19. triglycerides [ Time Frame: 6 months ]
  20. proBNP (Pro-Brain Natriuretic Peptide) [ Time Frame: 6 months ]
  21. hsCRP (High-Sensitivity C-Reactive Protein) [ Time Frame: 6 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

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


Locations
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Denmark
Steno Diabetes Center Copenhagen
Gentofte, Capital Region, Denmark, 2820
Sponsors and Collaborators
Filip Krag Knop
Steno Diabetes Center Copenhagen
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Filip Krag Knop, Professor, MD, PhD, University Hospital, Gentofte, Copenhagen
ClinicalTrials.gov Identifier: NCT03017352    
Other Study ID Numbers: Eudract-nr.: 2016-001365-92
First Posted: January 11, 2017    Key Record Dates
Last Update Posted: July 10, 2019
Last Verified: July 2019
Keywords provided by Filip Krag Knop, University Hospital, Gentofte, Copenhagen:
Diabetes Mellitus, Type 1
Exenatide
Incretins
GLP-1
Insulin
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Exenatide
Hypoglycemic Agents
Physiological Effects of Drugs
Anti-Obesity Agents
Incretins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists