NCT03241303

Brief 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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2017

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2017

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

August 2, 2017

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 7, 2017

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2018

Completed
Last Updated

March 26, 2020

Status Verified

March 1, 2020

Enrollment Period

5 months

First QC Date

August 2, 2017

Last Update Submit

March 25, 2020

Conditions

Glucose Metabolism Disorders

Keywords

Glp-1alpha-glucosidase inhibitoracarbose

Outcome Measures

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).

    240 min

Study Arms (4)

Acarbose

EXPERIMENTAL

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

Drug: Acarbose

Placebo Oral tablets

PLACEBO COMPARATOR

180 mg. 2 weeks.

Drug: Placebo Oral Tablet

Exendin (9-39)

EXPERIMENTAL

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

Drug: Exendin (9-39)

Placbo Saline

PLACEBO COMPARATOR

9 mg/ml placebo saline infusion on experimental day.

Drug: Placebo Saline

Interventions

AcarboseDRUG

Glucobay tablets on experimental day.

Also known as: Glucobay, Precose
Acarbose
Placebo Oral TabletDRUG

Placebo tablets on experimental day.

Placebo Oral tablets
Exendin (9-39)DRUG

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

Also known as: Ex(9-39)
Exendin (9-39)
Placebo SalineDRUG

9 mg/ml placebo saline infusion on experimental day.

Placbo Saline

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Center for Diabetesresearch

Hellerup, 2900, Denmark

Location

MeSH Terms

Conditions

Glucose Metabolism Disorders

Interventions

Acarboseexendin (9-39)

Condition Hierarchy (Ancestors)

Metabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

TrisaccharidesOligosaccharidesPolysaccharidesCarbohydrates

Study Officials

  • Filip K Knop, MD, PhD

    University Hospital, Gentofte, Copenhagen

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Bachelor of Science

Study Record Dates

First Submitted

August 2, 2017

First Posted

August 7, 2017

Study Start

August 1, 2017

Primary Completion

January 1, 2018

Study Completion

January 1, 2018

Last Updated

March 26, 2020

Record last verified: 2020-03

Data Sharing

IPD Sharing
Will not share

Locations

DK(1)