Type 2 diabetes mellitus.
Conditions
Interventions
Trade Name: Januvia 100mg
Product Name: Sitagliptin
Product Code: Sitagliptin
Pharmaceutical Form: Tablet
Sponsors
Lund University
Eligibility
Sex/Gender
Male
Inclusion criteria
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 • Written informed consent has been given • Capability and willingness to participate in the whole study Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 12 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 12
Exclusion criteria
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 |
|---|---|
| Main Objective: To examine the acute effect of sitagliptin as a single dose on insulin and glucose levels after ingestion of a standardized mixed meal in men with type 2 diabetes.;Secondary Objective: To examine the acute effect of sitagliptin as a single dose on glucagon, activa and total GIP, activa and total GLP-1 levels and insulin secretory rate after ingestion of a standardized mixed meal in men with type 2 diabetes.;Primary end point(s): • The area under the 180 min curves for plasma insulin concentrations • The area under the 180 min curves for plasma glucose ;Timepoint(s) of evaluation of this end point: 0-180 min after meal ingestion | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - The area under the 180 min curves for glucagon, total and intact GIP and total and intact GLP-1 concentrations - The area under the 30 min curves for insulin, glucagon, total and intact GIP and total and intact GLP-1 concentrations - Ratio of area under the curves (180 min) for intact to total GIP and GLP-1 - Insulin secretion rate and glucose sensitivity of the ß-cells as determined by C-peptide convolution of the data. ;Timepoint(s) of evaluation of this end point: 0-180 min after meal ingestion | — |
Countries
Sweden
Contacts
Public ContactBo Ahrén
Lund University
Outcome results
None listed