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

Study Overview
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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).

Official Title
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Effect of a Single Dose of the DPP-4 Inhibitor on Islet Function After Igestion of a Standardized Mixed Meal in Subjects With Type 2 Diabetes

Conditions
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Type 2 Diabetes

Intervention / Treatment
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* Drug: Sitagliptin
* Drug: Placebo


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Allocation: Non-Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Sitagliptin<br>Sitagliptin 100mg is given before meal ingestion | Drug: Sitagliptin<br>* Sitagliptin 100mg is given before meal ingestion<br>* Other names: Mixed meal test with sitagliptin;|
| Placebo Comparator: Placebo<br>Placebo is given before meal ingestion | Drug: Placebo<br>* Placebo is given before meal ingestion<br>* Other names: Mixed meal test with placebo;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Release of incretins hormones |  | 300 min | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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GLP-1, GIP, DPP-4 inhibition, iset function