Type 2 diabetes mellitus
Conditions
Interventions
Trade Name: Januvia
Product Name: Sitagliptin
Product Code: A10BH01
Pharmaceutical Form: Tablet
Trade Name: Galvus
Product Name: Vildagliptin
Product Code: EU/1/07/414/001-010
Pharmaceutical Form: Ta
Sponsors
Lund University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Caucasian men or women with type 2 diabetes diagnosed according to ICD10 at time of inclusion • Ongoing treatment with life style adjustment including diet and exercise regimen together with metformin as oral antidiabetic . Metformin therapy should be stable the last three months • Age 40-75 years • HbA1c 52-80 mmol/mol (inclusive) • 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 (K70-77 in ICD10) or ALAT three times above upper reference range • Diabetic nephropathy (GFR < 30 mL/min/1.73 m2 or albuminuria) or other causes of renal disease • Proliferative diabetic retinopathy • Treatment with any glucose-lowering medication except metformin • Previous myocardial infarction, coronary heart disease or instable angina pectoris in the last 6 months. • Symptomatic heart failure (NYHA class II-III) • Previous surgery on the gastrointestinal tract • Larger surgical intervention during the last 12 weeks • Female subject who are pregnant or breast feeding • Women of child bearing potential not using a highly effective method of birth control • Treatment with oral steroids, thiazide diuretics, digoxin or growth hormone • Hypersensitivity to the active substances of to any of the excipients • Participation in another study the last 4 weeks • Smoker • Paracetamol intolerance
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To compare the 24hr effects on glycemia of three different DPP-4 inhibitors in subjects with type 2 diabetes. ;Secondary Objective: To compare the 24hr effects on islet and incretin hormone levels of three different DPP-4 inhibitors in subjects with type 2 diabetes. ;Primary end point(s): • The area under the 180 min curves for plasma glucose after each meal ;Timepoint(s) of evaluation of this end point: 0-180 min efter each meal ingestion | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Difference between fasting glucose before and after 24hr - The area under the 180 min curves for plasma insulin concentrations after each meal - The area under the 180 min curves for glucagon, total and intact GIP and total and intact GLP-1 concentrations after each meal - The area under the 30 min curves for insulin, glucagon, total and intact GIP and total and intact GLP-1 concentrations after each meal - Ratio of area under the curves (180 min) for intact to total GIP and GLP-1 after each meal - Insulin secretion rate and glucose sensitivity of the ß-cells as determined by C-peptide convolution of the data after each meal.;Timepoint(s) of evaluation of this end point: 0-180 minafter meal ingestions or 24 hours after tablet intake | — |
Countries
Sweden
Contacts
Public ContactBo Ahrén
Lund University
Outcome results
None listed