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NCT Number: NCT03017352

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

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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Key information

Conditions

Diabetes Mellitus, Type 1 Autoimmune Diseases Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Hyperinsulinism Immune System Diseases Insulin Resistance Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Steno Diabetes Center Copenhagen

Gentofte Municipality, Capital Region, 2820, Denmark

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

exenatide

Drug

Other names: Byetta

Placebos

Drug

Primary outcomes

  1. Change in HbA1c

    Time frame: 6 months

    Change in HbA1c from baseline to end of study (time 6 months)

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Filip Krag Knop

Other

Collaborators

  • Steno Diabetes Center Copenhagen

Registry information

Official study title

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

Acronym: MAG1C

Important dates

Study start
2016
Primary completion
2019
Study completion
2019
First posted
Jan 11, 2017
Registry last updated
Jul 10, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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