Recruitment

Recruitment Status
Completed

Inclusion Criteria

Written informed consent has been given
HbA1c 52-80 mmol/mol (inclusive)
BMI: 20-40 kg/m2
...
Written informed consent has been given
HbA1c 52-80 mmol/mol (inclusive)
BMI: 20-40 kg/m2
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

Exclusion Criteria

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

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

Written informed consent has been given
HbA1c 52-80 mmol/mol (inclusive)
BMI: 20-40 kg/m2
...
Written informed consent has been given
HbA1c 52-80 mmol/mol (inclusive)
BMI: 20-40 kg/m2
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

Exclusion Criteria

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

Tracking Information

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