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CompletedNCT03241303AlfaExUpdated Mar 26, 2020

Delineation of the Role of Glucagon-like Peptide-1 Signalling in Relation to Increased Carbohydrate Content in the Distal Small Intestines

An interventional study of Acarbose and Placebo Oral Tablet in Glucose Metabolism Disorders, sponsored by University Hospital, Gentofte, Copenhagen. Completed at 1 site in Denmark. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-03-26.

Sponsored by University Hospital, Gentofte, Copenhagen · Not applicable, Interventional, and Basic science

Phase
Not applicable
Study type
Interventional
Enrollment
15
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

Investigation of GLP-1 signalling in the glucose-lowering effect of increased carbohydrate content in the distal small intestines induced by alpha-glucosidase inhibition during meal ingestion in patients with type 2 diabetes

Read the detailed description

The primary aim of the study is to investigate whether GLP-1 released as a result of increased carbohydrate content in the distal and L cell-rich part of the small intestine after a meal affects postprandial plasma glucose levels in patients with type 2 diabetes. This will be done by applying an alpha-glucosidase inhibitor (to increase the postprandial carbohydrate content in the distal small intestine) and the specific GLP-1 receptor antagonist exendin(9-39) (to isolate any GLP-1-mediated effects) during meal tests in patients with type 2 diabetes.

02

Conditions studied

  • Glucose Metabolism Disorders

Keywords

  • Glp-1
  • alpha-glucosidase inhibitor
  • acarbose
03

In context

Glucose Metabolism Disorders

264 studies on the registry are indexed under Glucose Metabolism Disorders; 37 are open to participants now.

This study's enrollment of 15 is below the median of 50 across 214 interventional studies indexed under Glucose Metabolism Disorders.

Browse Glucose Metabolism Disorders studies →

Lead sponsor

University Hospital, Gentofte, Copenhagen is the lead sponsor of 160 studies on the registry; 9 are open to participants now.

Browse University Hospital, Gentofte, Copenhagen studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Type 2 diabetes for at least three months (diagnosed according to the criteria of the World Health Organization (WHO)) treated with metformin monotherapy
  • Caucasian ethnicity
  • Normal haemoglobin
  • Age >18 years
  • BMI >23 kg/m2 and \<35 kg/m2
  • Informed and written consent

Exclusion criteria

Exclusion Criteria:

  • Liver disease (alanine aminotransferase (ALAT) and/or serum aspartate aminotransferase (ASAT) >2 times normal values) or history of hepatobiliary disorder
  • Gastrointestinal disease, previous intestinal resection, cholecystectomy or any major intra-abdominal surgery
  • Reduced kidney function or nephropathy (estimated glomerular filtration rate (eGFR) \<60 ml/min/1.73 m2 (based on serum creatinine) and/or albuminuria
  • Treatment with medicine that cannot be paused for 12 hours
  • Intake of antibiotics two months prior to study
  • Treatment with glucose-lowering drugs other than metformin
  • Hypo- and hyperthyroidism
  • Treatment with oral anticoagulants
  • Active or recent malignant disease
  • Any treatment or condition requiring acute or sub-acute medical or surgical intervention
  • Lack of effective birth control in premenopausal women
  • Positive pregnancy test on study days in premenopausal women
  • Pregnancy
  • Women who are breastfeeding
  • Any condition considered incompatible with participation by the investigators
  • If the subjects receive any antibiotic treatment while included in the study they will be excluded
05

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Triple (Participant, Investigator, Outcomes assessor)
Enrollment
15 participants (actual)

Study arms

  • Experimental
    Acarbose

    50 mg and 100 mg glucobay tablets. 2 weeks. Other name: Precose

    Drug: Acarbose

  • Placebo comparator
    Placebo Oral tablets

    180 mg. 2 weeks.

    Drug: Placebo Oral Tablet

  • Experimental
    Exendin (9-39)

    Infusion of GLP-1 receptor antagonist as a study tool to block GLP-1 activity on experimental day.

    Drug: Exendin (9-39)

  • Placebo comparator
    Placbo Saline

    9 mg/ml placebo saline infusion on experimental day.

    Drug: Placebo Saline

Interventions

  • DrugAcarbose

    Glucobay tablets on experimental day.

    Also known as: Glucobay, Precose

  • DrugPlacebo Oral Tablet

    Placebo tablets on experimental day.

  • DrugExendin (9-39)

    Infusion of GLP-1 receptor antagonist as a study tool to block GLP-1 activity on experimental day.

    Also known as: Ex(9-39)

  • DrugPlacebo Saline

    9 mg/ml placebo saline infusion on experimental day.

06

What researchers measure

Primary outcomes

  1. Plasma glucose

    The primary outcome is the difference between the effect of increased carbohydrate content in the distal part of the small intestine (obtained by inhibiting alpha-glucosidase with acarbose) on postprandial glucose tolerance (as assessed by area under curve (AUC) for plasma glucose during a standardised liquid mixed meal test) with and without blockade of GLP-1 signalling by exendin(9-39).

    Time frame: 240 min

07

Study locations

1 site
  • Center for Diabetesresearch
    Hellerup, 2900, Denmark
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Aug 2017 to primary completion in Jan 2018, 5 months.

Of 100 non-industry interventional studies with no phase under Glucose Metabolism Disorders, half reached primary completion within 18 months of starting (the median), counting those still running; a quarter within 7 and three quarters within 41. This study's 5 months is below that.

Counting every sponsor, half of 110 studies reached it within 19 months; a quarter within 8 and three quarters within 41.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 2, 2017
First posted
Aug 7, 2017
StartActual
Aug 1, 2017
Primary completionActual
Jan 1, 2018
CompletionActual
Jan 1, 2018
Last update
Mar 26, 2020
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Mar 26, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03241303
Lead sponsor
University Hospital, Gentofte, Copenhagen
Collaborators
University of Copenhagen
Responsible party
Niels Bjørn Dalsgaard (Bachelor of Science, University Hospital, Gentofte, Copenhagen) — Principal investigator
First posted
Aug 7, 2017
Start date
Aug 1, 2017
Primary completion
Jan 1, 2018
Completion
Jan 1, 2018
Last update
Mar 26, 2020

Study contacts

Filip K Knop, MD, PhD
study director · University Hospital, Gentofte, Copenhagen

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Mar 2020. You cannot join it, but the record below documents what was studied.

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Studies of the drugs tested here: Acarbose · Avexitide

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