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

Type 2 Diabetes Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01901861
• Other study ID #: 2012-005660-98
• Status: Completed
• Phase: N/A
• First received: July 14, 2013
• Last updated: December 14, 2015
• Start date: July 2013
• Est. completion date: December 2015

Study information

• Verified date: March 2015
• Source: Lund University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: Medical Products Agency
• Study type: Interventional

Clinical Trial 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).

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 20 Years to 75 Years

Eligibility

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

Allocation: Non-Randomized, Intervention Model: Factorial Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Type 2 Diabetes

Intervention

Drug:
• Sitagliptin
Sitagliptin 100mg is given before meal ingestion
• Placebo
Placebo is given before meal ingestion

Locations

Country	Name	City	State
Sweden	Department of Clinical Science Lund,Lund University	Lund

Sponsors (1)

Lead Sponsor	Collaborator
Lund University

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Release of incretins hormones		300 min	No