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Completed

NCT Number: NCT01901861

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

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).

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Key information

Conditions

Type 2 Diabetes Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

20 year–75 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Department of Clinical Science Lund,Lund University

Lund, Sweden

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Sitagliptin

Drug

Sitagliptin 100mg is given before meal ingestion

Other names: Mixed meal test with sitagliptin

Placebo

Drug

Placebo is given before meal ingestion

Other names: Mixed meal test with placebo

Primary outcomes

  1. Release of incretins hormones

    Time frame: 300 min

Sponsors and collaborators

Lead sponsor

Lund University

Other

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
Jul 17, 2013
Registry last updated
Dec 15, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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