Comparison between three different DPP-4 inhibitors on blood sugar and islet and gut hormones
- Conditions
- Type 2 diabetes mellitusTherapeutic area: Diseases [C] - Hormonal diseases [C19]
- Registration Number
- EUCTR2013-005570-22-SE
- Lead Sponsor
- und University
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- Not specified
•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
•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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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<br>;Timepoint(s) of evaluation of this end point: 0-180 min efter each meal ingestion
- Secondary Outcome Measures
Name Time Method Secondary end point(s): -Difference between fasting glucose before and after 24hr <br>-The area under the 180 min curves for plasma insulin concentrations after each meal<br>-The area under the 180 min curves for glucagon, total and intact GIP and total and intact GLP-1 concentrations after each meal<br>-The area under the 30 min curves for insulin, glucagon, total and intact GIP and total and intact GLP-1 concentrations after each meal <br>-Ratio of area under the curves (180 min) for intact to total GIP and GLP-1 after each meal<br>-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