Recruitment

Recruitment Status
Completed

Inclusion Criteria

BMI: 20-40 kg/m2
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
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)
Capability and willingness to participate in the whole study
Written informed consent has been given
Age 40-75 years

Exclusion Criteria

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

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

BMI: 20-40 kg/m2
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
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)
Capability and willingness to participate in the whole study
Written informed consent has been given
Age 40-75 years

Exclusion Criteria

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

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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