DPP-4 Inhibition, Incretins and Islet Function
Last updated on April 2022Recruitment
- Recruitment Status
- Completed
Inclusion Criteria
- HbA1c 52-80 mmol/mol (inclusive)
- Written informed consent has been given
- Age 40-75 years
- ...
- HbA1c 52-80 mmol/mol (inclusive)
- Written informed consent has been given
- Age 40-75 years
- 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
- Capability and willingness to participate in the whole study
- BMI: 20-40 kg/m2
Exclusion Criteria
- Women of child bearing potential not using a highly effective method of birth control
- Hypersensitivity to the active substances of to any of the excipients
- Smoker
- ...
- Women of child bearing potential not using a highly effective method of birth control
- Hypersensitivity to the active substances of to any of the excipients
- Smoker
- Larger surgical intervention during the last 12 weeks
- Treatment with any glucose-lowering medication except metformin
- Participation in another study the last 4 weeks
- Previous myocardial infarction, coronary heart disease or instable angina pectoris in the last 6 months.
- Previous surgery on the gastrointestinal tract
- Proliferative diabetic retinopathy
- Diabetic nephropathy (GFR < 30 mL/min/1.73 m2 or albuminuria) or other causes of renal disease
- Female subject who are pregnant or breast feeding
- Treatment with oral steroids, thiazide diuretics, digoxin or growth hormone
- Symptomatic heart failure (NYHA class II-III)
- Paracetamol intolerance
Summary
- Conditions
- Type 2 Diabetes
- Type
- Interventional
- Phase
- Phase 4
- Design
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Basic Science
Participation Requirements
- Age
- Between 40 years and 75 years
- Gender
- Both males and females
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.
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.
Inclusion Criteria
- HbA1c 52-80 mmol/mol (inclusive)
- Written informed consent has been given
- Age 40-75 years
- ...
- HbA1c 52-80 mmol/mol (inclusive)
- Written informed consent has been given
- Age 40-75 years
- 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
- Capability and willingness to participate in the whole study
- BMI: 20-40 kg/m2
Exclusion Criteria
- Women of child bearing potential not using a highly effective method of birth control
- Hypersensitivity to the active substances of to any of the excipients
- Smoker
- ...
- Women of child bearing potential not using a highly effective method of birth control
- Hypersensitivity to the active substances of to any of the excipients
- Smoker
- Larger surgical intervention during the last 12 weeks
- Treatment with any glucose-lowering medication except metformin
- Participation in another study the last 4 weeks
- Previous myocardial infarction, coronary heart disease or instable angina pectoris in the last 6 months.
- Previous surgery on the gastrointestinal tract
- Proliferative diabetic retinopathy
- Diabetic nephropathy (GFR < 30 mL/min/1.73 m2 or albuminuria) or other causes of renal disease
- Female subject who are pregnant or breast feeding
- Treatment with oral steroids, thiazide diuretics, digoxin or growth hormone
- Symptomatic heart failure (NYHA class II-III)
- Paracetamol intolerance
Tracking Information
- NCT #
- NCT02089438
- Collaborators
- Not Provided
- Investigators
- Principal Investigator: Bo Ahrén, MD, PhD Lund University
- Bo Ahrén, MD, PhD Lund University