Status:
COMPLETED
Long Term Effects of DPP-IV Inhibitor Treatment in Patients With Type 2 Diabetes
Lead Sponsor:
University Hospital, Gentofte, Copenhagen
Collaborating Sponsors:
Merck Sharp & Dohme LLC
Conditions:
Type 2 Diabetes
Eligibility:
All Genders
18-80 years
Phase:
PHASE3
Brief Summary
We wish to evaluate the effect of long term treatment with a DPP-IV inhibitor on the function of the incretin hormones Hypothesis We hypothesize that that a gradual improvement in metabolic control i...
Detailed Description
Background The incretin effect, primarily mediated by the peptide hormones GIP and GLP-1, is known to be impaired in patients with type 2 diabetes, and characterised by reduced GLP-1 secretion and pot...
Eligibility Criteria
Inclusion
- Inclusion criteria
- Type 2 diabetes diagnosed according to and in accordance with the WHO criteria
- Metformin treatment of ≥ 1 gram
- 7,5 % ≤ HbA1c ≤ 10%
- Age \> 18
- BMI ≥ 25 kg/m2
- Informed consent
- Contraception, if appropriate
- Exclusion criteria
- Proliferating retinopathy
- Uremia, end stage renal disease, diabetic nephropathy or any other cause of impaired renal function with s-creatinine \> 130 µM and/or albuminuria (\>300 mg/day)
- Liver disease with ALAT and/or ASAT \> 2 x normal value
- Complicated coronary artery disease, NYHA group III and IV
- Positive screening for islet cell auto antibodies and/or GAD-65 auto antibodies
- Occurrence of type 1 diabetes in first degree relatives
- Anaemia
- Pregnancy and/or breast feeding
- Treatment with medication affecting insulin secretion
- non-compliance
- Withdrawal criteria
- The subject may withdraw at will at any time
- Pregnancy discovered during the trial
- Severe illness
- Unacceptable side effects
- If self-measured fasting plasma glucose on three consecutive days exceeds 15 mM, the result is repeated in an immediately scheduled visit, and no treatable intercurrent cause for the hyperglycaemia can be found.
Exclusion
Key Trial Info
Start Date :
February 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2009
Estimated Enrollment :
49 Patients enrolled
Trial Details
Trial ID
NCT00411411
Start Date
February 1 2007
End Date
March 1 2009
Last Update
August 13 2014
Active Locations (1)
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1
Gentofte Hospital
Hellerup, Denmark, 2900