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Effect of the DPP-4 Inhibitor Sitagliptin on Islet Function After Mixed Meal in Patients With Type 2 Diabetes

NCT ID: NCT01901861

Last Updated: 2015-12-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-07-31

Study Completion Date

2015-12-31

Brief Summary

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study hypothesis to examine the acute effects on glycaemia and islet hormone secretion of increased levels of endogenous GLP-1 and GIP on islet cell function in men with type 2 diabetes. To this purpose, a standardized mixed meal test will be ingested with or without concomitant administration of sitagliptin (100mg).

Detailed Description

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In men subjects with type 2 diabetes treated with diet and exercise with or without metformin treatment as an antidiabetic agent, a standardized mixed meal test will be served with or without administration of sitagliptin (100mg).

Conditions

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Type 2 Diabetes

Keywords

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GLP-1, GIP, DPP-4 inhibition, iset function

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

FACTORIAL

Blinding Strategy

NONE

Study Groups

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Sitagliptin

Sitagliptin 100mg is given before meal ingestion

Group Type ACTIVE_COMPARATOR

Sitagliptin

Intervention Type DRUG

Sitagliptin 100mg is given before meal ingestion

Placebo

Placebo is given before meal ingestion

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo is given before meal ingestion

Interventions

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Sitagliptin

Sitagliptin 100mg is given before meal ingestion

Intervention Type DRUG

Placebo

Placebo is given before meal ingestion

Intervention Type DRUG

Other Intervention Names

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Mixed meal test with sitagliptin Mixed meal test with placebo

Eligibility Criteria

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Inclusion Criteria

* Caucasian men with type 2 diabetes diagnosed according to ICD10
* Ongoing treatment with life style adjustment or life style adjustment together with metformin as oral antidiabetic. Metformin therapy should not exceed 2 grams daily
* Age 20-75 years
* HbA1c ≤80 mmol/mol
* BMI: 20-40 kg/m2

Exclusion Criteria

* Liver disease or ALAT three times above upper reference range
* Diabetic nephropathy (GFR \< 50 mL/min/1.73 m2 or albuminuria)
* Proliferative diabetic retinopathy
* Treatment with any glucose-lowering medication except metformin
* Previous myocardial infarction, coronary heart disease or insatiable angina pectoris in the last 6 months.
* Previous surgery on the gastrointestinal tract
* Larger surgical intervention during the last 12 weeks
* Treatment with oral steroids or thiazide diuretics
* Treatment with digoxin
* Smokers
* Participation in another study the last 4 weeks
* Paracetamol intolerance
Minimum Eligible Age

20 Years

Maximum Eligible Age

75 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Lund University

OTHER

Sponsor Role lead

Responsible Party

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Bo Ahren

professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Bo Ahren, Professor

Role: PRINCIPAL_INVESTIGATOR

Lund University

Locations

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Department of Clinical Science Lund,Lund University

Lund, , Sweden

Site Status

Countries

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Sweden

Other Identifiers

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2012-005660-98

Identifier Type: -

Identifier Source: org_study_id