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Type 1 DiabetesPhase 2/3ALFA-1NCT02584582

The Effect of GLP-1 on Postprandial Glucagon Secretion Independent of The Gastric Emptying Rate

A Phase 2/3 study testing Liraglutide, Exenatide and Liquid meal test in people with Type 1 Diabetes, run by Hvidovre University Hospital.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

Aim: To investigate the glucagonostatic effect of glucagon-like peptide-1 (GLP-1) independent of the gastric emptying rate. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Type 1 Diabetes
What is being tested?
Liraglutide, Exenatide and Liquid meal test
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
10 participants
Where
No sites listed yet
Study dates
Jul 2015to Nov 2015
Phase
Phase 2/3
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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Type 1 Diabetes
  • >18 years
  • No residual beta-cell function (stimulated C-peptide < 60 pmol)

Who cannot join

  • Pancreatitis
  • gastroparesis
  • history of alcohol and/or drug abuse
  • pregnancy and lactation
  • other medical or psychological condition that made the patient unsuitable for study participation according to the investigators´ assessment
  • contraindications to gastroscopy
  • cancer (unless in complete remission > five years)

About this study

Official title: The Effect of GLP-1 on Postprandial Glucagon Secretion During Prolonged and Intermittent Stimulation of the GLP-1 Receptor Independent of The Gastric Emptying Rate. A Randomized, Open-label Study in People With Type 1 Diabetes

Aim: To investigate the glucagonostatic effect of glucagon-like peptide-1 (GLP-1) independent of the gastric emptying rate.

Read the detailed description

Aim: To investigate the glucagonostatic effects of glucagon-like peptide-1 (GLP-1) during prolonged and intermittent stimulation of the GLP-1 receptor independent of the gastric emptying rate. Glucagon concentrations will be measured following a liquid meal administered in duodenum at baseline and after exenatide, and liraglutide treatment.

Conditions
Type 1 Diabetes
Being tested
Liraglutide, Exenatide, Liquid meal test, No drug (Baseline day)
Keywords
Glucagon, Glukagon-like peptide-1 (GLP-1), GLP-1 receptor agonist (GLP-1RA), Incretins
Medical subject headings
Diabetes Mellitus, Type 1

What participants receive

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

  • LiraglutideDrug

  • ExenatideDrug

  • Liquid meal testProcedure or surgery

  • No drug (Baseline day)Other

Study groups in NCT02584582
Study groupRoleWhat they receive
Liraglutide + Liquid meal testExperimentalLiraglutide 1.2 mg once daily for 14 days (0.6 mg/day for one week, escalated to 1.2 mg/day after one week)
Receives: Drug: Liraglutide; Procedure: Liquid meal test
Exenatide + Liquid meal testExperimentalExenatide 10 mcg twice daily for 14 days (5 mcg twice daily for one week, escalated to 10 mcg twice daily after one week)
Receives: Drug: Exenatide; Procedure: Liquid meal test
Baseline + Liquid meal testOtherBaseline day with no additional medication
Receives: Procedure: Liquid meal test; Other: No drug (Baseline day)

What is being measured

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

  1. Glucagon concentration (postprandial)

    glucagon area under the curve (AUC) (0-240 minutes) and baseline to peak increments will be calculated

    Measured: 4 hours

Secondary outcomes (11)

  1. Postprandial glucose concentrations

    glucose AUC (0-240 minutes) and baseline to peak increments will be calculated

    Measured: 4 hours

  2. glucagon-like peptide-1 (GLP-1)

    GLP-1 AUC (0-240 minutes) and baseline to peak increments will be calculated

    Measured: 4 hours

  3. glucagon-like peptide-2 (GLP-2)

    GLP-2 AUC (0-240 minutes) and baseline to peak increments will be calculated

    Measured: 4 hours

  4. glucose-dependent insulinotropic polypeptide (GIP)

    GIP AUC (0-240 minutes) and baseline to peak increments will be calculated

    Measured: 4 hours

  5. Cholecystokinin (CCK)

    CCKAUC (0-240 minutes) and baseline to peak increments will be calculated

    Measured: 4 hours

  6. Peptide YY (PYY)

    PYY AUC (0-240 minutes) and baseline to peak increments will be calculated

    Measured: 4 hours

  7. Ghrelin

    Ghrelin AUC (0-240 minutes) and baseline to peak increments will be calculated

    Measured: 4 hours

  8. Gastrin

    Gastrin AUC (0-240 minutes) and baseline to peak increments will be calculated

    Measured: 4 hours

  9. Oxyntomodulin

    Oxyntomodulin AUC (0-240 minutes) and baseline to peak increments will be calculated

    Measured: 4 hours

  10. Free fatty acids (FFA)

    FFA AUC (0-240 minutes) and baseline to peak increments will be calculated

    Measured: 4 hours

  11. triacylglycerol (TAG)

    TAG AUC (0-240 minutes) and baseline to peak increments will be calculated

    Measured: 4 hours

Timeline

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

  1. First posted22 Oct 2015 (estimated)
  2. Study startJul 2015
  3. Primary completionNov 2015 (estimated)

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 2/3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Crossover
Masking
None (open label)
Enrolment
10 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02584582
Sponsor's protocol ID
H-3-2014-128
Acronym
ALFA-1
Status last verified
Oct 2015
First submitted
6 Aug 2015
Last updated
22 Oct 2015
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing Liraglutide, Exenatide and Liquid meal test in people with Type 1 Diabetes, run by Hvidovre University Hospital.

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 3 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 22 Oct 2015. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

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

What does this combined 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.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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

Are results available for this study?

Results are not available in the source record.

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?

Glucagon concentration (postprandial) (time frame: 4 hours). 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 NCT02584582.

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 22 Oct 2015.

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