Recruitment

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
About Us
Innovation
Privacy
Terms
Copyright
Get Well Soon © Copyright 2024