Recruitment

Recruitment Status
Completed

Inclusion Criteria

Age 40-75 years
Capability and willingness to participate in the whole study
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
Capability and willingness to participate in the whole study
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
HbA1c 52-80 mmol/mol (inclusive)
BMI: 20-40 kg/m2
Written informed consent has been given

Exclusion Criteria

Paracetamol intolerance
Symptomatic heart failure (NYHA class II-III)
Diabetic nephropathy (GFR < 30 mL/min/1.73 m2 or albuminuria) or other causes of renal disease
...
Paracetamol intolerance
Symptomatic heart failure (NYHA class II-III)
Diabetic nephropathy (GFR < 30 mL/min/1.73 m2 or albuminuria) or other causes of renal disease
Proliferative diabetic retinopathy
Larger surgical intervention during the last 12 weeks
Previous myocardial infarction, coronary heart disease or instable angina pectoris in the last 6 months.
Hypersensitivity to the active substances of to any of the excipients
Women of child bearing potential not using a highly effective method of birth control
Previous surgery on the gastrointestinal tract
Treatment with any glucose-lowering medication except metformin
Participation in another study the last 4 weeks
Smoker
Female subject who are pregnant or breast feeding
Treatment with oral steroids, thiazide diuretics, digoxin or growth hormone

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

Age 40-75 years
Capability and willingness to participate in the whole study
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
Capability and willingness to participate in the whole study
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
HbA1c 52-80 mmol/mol (inclusive)
BMI: 20-40 kg/m2
Written informed consent has been given

Exclusion Criteria

Paracetamol intolerance
Symptomatic heart failure (NYHA class II-III)
Diabetic nephropathy (GFR < 30 mL/min/1.73 m2 or albuminuria) or other causes of renal disease
...
Paracetamol intolerance
Symptomatic heart failure (NYHA class II-III)
Diabetic nephropathy (GFR < 30 mL/min/1.73 m2 or albuminuria) or other causes of renal disease
Proliferative diabetic retinopathy
Larger surgical intervention during the last 12 weeks
Previous myocardial infarction, coronary heart disease or instable angina pectoris in the last 6 months.
Hypersensitivity to the active substances of to any of the excipients
Women of child bearing potential not using a highly effective method of birth control
Previous surgery on the gastrointestinal tract
Treatment with any glucose-lowering medication except metformin
Participation in another study the last 4 weeks
Smoker
Female subject who are pregnant or breast feeding
Treatment with oral steroids, thiazide diuretics, digoxin or growth hormone

Tracking Information

NCT #
NCT02089438
Collaborators
Not Provided
Investigators
  • Principal Investigator: Bo Ahrén, MD, PhD Lund University
  • Bo Ahrén, MD, PhD Lund University