Status:
COMPLETED
South Danish Diabetes Study: Evaluation of the Antidiabetic Treatment of Type 2 Diabetes Mellitus
Lead Sponsor:
Odense University Hospital
Conditions:
Type 2 Diabetes Mellitus
Eligibility:
All Genders
30-70 years
Phase:
PHASE4
Brief Summary
The primary objective of this study is: * To investigate whether insulin aspart with meals is better than a standard treatment with insulin NPH at bedtime, evaluated by HbA1c. The secondary objectiv...
Eligibility Criteria
Inclusion
- Ages between 30 and 70 years
- Fasting C-peptide \>300 pmol/l
- Body mass index (BMI) \> 25 kg/m2
- Diabetes for more than 2 years
- Pharmacological antidiabetic treatment for more than 3 months
- 0%\<HbA1c\<12.0% at randomisation
- Patient willing to sign informed consent
- Fertile women: negative pregnancy test and use of oral or intra-uterine contraception or depot gestagen.
Exclusion
- S-creatinine \> 120 μmol/l
- History of intolerance to metformin or glitazones
- S-ALAT/S-ASAT \> 2.5 x upper normal limit
- Total cholesterol \> 10 mmol/l
- Total triglyceride \> 8 mmol/l
- Hemoglobin (Hb) \< normal range
- Treatment with glitazone preceding 30 days New York Heart Association (NYHA) functional class III or IV
- Night work
- Present or planned pregnancy
- Poor vision impeding insulin administration
- Unawareness of hypoglycaemia (complete or partly)
- Mental illness or alcohol abuse
- Clinically relevant major organ or systemic illness
- Uncontrolled hypertension \>180/110 mmHg, systolic or diastolic
- Steroid treatment
- Severe lung disease
- A history of malign disease
- An expectation that the patient will not be collaborative or will not be able to understand the character of this trial
Key Trial Info
Start Date :
January 1 2003
Trial Type :
INTERVENTIONAL
End Date :
July 1 2007
Estimated Enrollment :
400 Patients enrolled
Trial Details
Trial ID
NCT00121966
Start Date
January 1 2003
End Date
July 1 2007
Last Update
June 19 2008
Active Locations (1)
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1
Diabetes Research Center
Odense, Denmark, 5000