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Diabetes Mellitus, Type 1Phase 2MAG1CNCT03017352

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

A Phase 2 study testing Exenatide in people with Diabetes Mellitus, Type 1, run by Filip Krag Knop at 1 site in Denmark.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Diabetes Mellitus, Type 1
What is being tested?
Exenatide
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
108 participants
Where
1 siteDenmark
Study dates
Dec 2016to Jun 2019
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 17Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

Denmark1 site

  • Steno Diabetes Center Copenhagen

    Gentofte Municipality, Capital Region, 2820

Other trials in Denmark

About this study

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

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.

Read more

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.

Being tested
Exenatide, Placebos
Keywords
Diabetes Mellitus, Type 1, Exenatide, Incretins, GLP-1, Insulin
Medical subject headings
Diabetes Mellitus, Type 1, Insulin Resistance

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ExenatideDrug

    Also called Byetta

  • PlacebosDrug

Study groups in NCT03017352
Study groupRoleWhat they receive
InterventionExperimentalExenatide 10 mikrogram, thrice daily, subcutaneous injection prior to main meals, 6 months.
Receives: Drug: Exenatide
PlaceboPlacebo comparatorPlacebo, thrice daily, subcutaneous injection prior to main meals, 6 months.
Receives: Drug: Placebos

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in HbA1c

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

    Measured: 6 months

Secondary outcomes (21)

  1. adverse events (including hypoglycaemic episodes)

    Measured: 6 months

  2. changes in insulin dosage

    Measured: 6 months

  3. changes in body weight

    Measured: 6 months

  4. changes in BMI

    Measured: 6 months

  5. changes in body composition

    DXA scan measuring bonemineral density

    Measured: 6 months

  6. changes in body composition

    DXA scan measuring lean mass

    Measured: 6 months

  7. changes in body composition

    DXA scan measuring fat mass

    Measured: 6 months

  8. changes in fasting plasma glucose

    Measured: 6 months

  9. changes in post prandial plasma glucose

    Measured: 6 months

  10. changes in fasting plasma levels of C-peptide

    Measured: 6 months

  11. Quality of life self reported

    Quality of Life Questionaire

    Measured: 6 months

  12. Treatment satisfaction

    Diabetes treatment satisfactory questionnaire status version

    Measured: 6 months

  13. Treatment satisfaction

    Diabetes treatment satisfactory questionnaire change version

    Measured: 6 months

  14. dietary patterns

    Food frequency questionaire three times during the intervention

    Measured: 6 months

  15. HDL (High Density Lipoprotein)

    Measured: 6 months

  16. LDL (Low Density Lipoprotein)

    Measured: 6 months

  17. VLDL (Very Low Density Lipoprotein)

    Measured: 6 months

  18. total cholesterol

    Measured: 6 months

  19. triglycerides

    Measured: 6 months

  20. proBNP (Pro-Brain Natriuretic Peptide)

    Measured: 6 months

  21. hsCRP (High-Sensitivity C-Reactive Protein)

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Jan 2017 (estimated)
  2. Study startDec 2016
  3. Primary completionJun 2019
  4. Study completionJun 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
108 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03017352
Sponsor's protocol ID
Eudract-nr.: 2016-001365-92
Acronym
MAG1C
Status last verified
Jul 2019
First submitted
2 Jan 2017
Last updated
10 Jul 2019
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 29950475

  • 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.

    PubMed 32135138

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Exenatide in people with Diabetes Mellitus, Type 1, run by Filip Krag Knop at 1 site in Denmark.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 10 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in HbA1c (time frame: 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03017352, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jul 2019.

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