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

Not Applicable

Completed

• Conditions: Type 2 Diabetes
• Interventions: Drug: Placebo; Drug: Sitagliptin

• Registration Number: NCT01901861
• Lead Sponsor: Lund University

Brief Summary

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

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).

Study Timeline

• Study Start: 2013-07
• Study First Submitted: 2013-07-14
• Study First Submitted QC: 2013-07-14
• Study First Posted: 2013-07-17
• Status Verified: 2015-03
• Primary Completion: 2015-12
• Study Completion: 2015-12
• Last Update Submitted: 2015-12-14
• Last Update Posted: 2015-12-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 12

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Placebo is given before meal ingestion
Sitagliptin	Sitagliptin	Sitagliptin 100mg is given before meal ingestion

Primary Outcome Measures

Name	Time	Method
Release of incretins hormones	300 min

Trial Locations

Locations (1)

Department of Clinical Science Lund,Lund University; 🇸🇪 Lund, Sweden