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

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01901861

Enrollment

Registered

2013-07-17

Start date

2013-07-31

Completion date

2015-12-31

Last updated

2015-12-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 2 Diabetes

Keywords

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

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).

Interventions

DRUGSitagliptin

Sitagliptin 100mg is given before meal ingestion

DRUGPlacebo

Placebo is given before meal ingestion

Study design

Allocation

NON_RANDOMIZED

Intervention model

FACTORIAL

Masking

NONE

Eligibility

Sex/Gender

MALE

Age

20 Years to 75 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Release of incretins hormones	300 min

Countries

Sweden

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026