Status:
COMPLETED
LANN-study: Lantus, Amaryl, Novorapid, Novomix Study
Lead Sponsor:
Rijnstate Hospital
Conditions:
Diabetes Mellitus Type II
Eligibility:
All Genders
30-75 years
Phase:
PHASE3
Brief Summary
Many diabetics gain weight while on insulin therapy. In this study, we evaluate the efficacy of the combination of glimepiride and short-acting insulin on weight control and glucose control. In this s...
Detailed Description
Diabetic patients failing on maximal oral treatment usually switch to twice daily administration of a mixture of short- and longacting insulin. Although this improves glycemic control, it is generally...
Eligibility Criteria
Inclusion
- failing maximal oral treatment, defined as mean fasting blood glucose over 8 mmol/l and HbA1C over 7.5% for three months or more
- BMI 25 - 35 kg/m2
- fasting plasma C-peptide level over 0.3 nmol/l
- stable metformin and sulfonylurea dose for at least three months
- stable weight for at least three months (change maximal 2 kg)
Exclusion
- fasting glucose over 25 mmol/l
- use of alpha-glucosidase inhibitors or thiazolidinediones in the two months preceding the study
- renal or liver failure defined as serum creatinine over 150 micromol/l, liver enzymes over 1.5 upper normal limit
- heart failure
- pregnancy
- alcohol more than two units per day
- inflammatory or infectious diseases
- unstable chronic disease
- discontinuation of smoking within three months of randomisation date
- allergy for or intolerance of glimepiride or novorapid.
Key Trial Info
Start Date :
May 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT00151697
Start Date
May 1 2005
Last Update
August 9 2011
Active Locations (1)
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1
Rijnstate Hospital
Arnhem, Netherlands, 6800 TA