Type 2 Diabetes
Conditions
Brief summary
Hypothesis is that DPP-4 inhibition affects glucose levels through changes in incretin and islet hormones. The study examines this in relation to breakfast, lunch and dinner over an entire 24h study period by the use of three different DPP-4 inhibitors and placebo.
Detailed description
The study is a single-center study with a cross-over design to examine glycemia, incretin hormones and islet hormones over a 24h study period with standardized breakfast, lunch and dinner after administration of placebo, saxagliptin, vildagliptin or sitagliptin.
Interventions
DRUGSaxagliptin
Saxagliptin (5 mg) is given before breakfast
DRUGVildagliptin
Vildagliptin (50mg) is given before breakfast and dinner
DRUGSitagliptin
Sitagliptin (100 mg) is given before breakfast
Sponsors
Lund University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
40 Years to 75 Years
Healthy volunteers
No
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
Exclusion criteria
* • Liver disease (K70-77 in ICD10) or liver enzymes 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 | Description |
|---|---|---|
| Postprandial glucose | 180 min | The area under the 180 min curves for plasma glucose after each meal |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Postprandial insulin and glucagon | 180 min | The area under the 180 min curves for plasma insulin and glucagon after each meal |
| Postprandial glucagon-like peptide-1 (GLP-1) and glucose-dependent insulinotropic polypeptide (GIP) | 180 min | The area under the 180 min curves for plasma GLP-1 and GIP after each meal |
Countries
Sweden
Outcome results
None listed