Comparison of Three DPP-4 Inhibitors on 24 Hour Blood Glucose, Incretin Hormones and Islet Function in Patients With Type 2 Diabetes
Overview
- Phase
- Phase 4
- Intervention
- Saxagliptin
- Conditions
- Type 2 Diabetes
- Sponsor
- Lund University
- Enrollment
- 24
- Locations
- 1
- Primary Endpoint
- Postprandial glucose
- Status
- Completed
- Last Updated
- 8 years ago
Overview
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.
Investigators
Bo Ahren
Professor
Lund University
Eligibility 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
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
Arms & Interventions
Saxagliptin
Ssaxagliptin is given before breakfast
Intervention: Saxagliptin
´Sitagliptin
Sitagliptin is given before breakfast
Intervention: Sitagliptin
Vildagliptin
Vildagliptin is given before breakfast
Intervention: Vildagliptin
Outcomes
Primary Outcomes
Postprandial glucose
Time Frame: 180 min
The area under the 180 min curves for plasma glucose after each meal
Secondary Outcomes
- Postprandial insulin and glucagon(180 min)
- Postprandial glucagon-like peptide-1 (GLP-1) and glucose-dependent insulinotropic polypeptide (GIP)(180 min)