South Danish Diabetes Study: Evaluation of the Antidiabetic Treatment of Type 2 Diabetes Mellitus
Status:
Completed
Trial end date:
2007-07-01
Target enrollment:
Participant gender:
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 objectives of this study are:
- To study if a combination treatment with metformin and/or rosiglitazone and insulin
aspart with meals is better than a standard treatment with insulin NPH combined with one
or more of the above oral antidiabetic drugs. According to the hypothesis, special focus
will be given to the treatment group with insulin aspart combined with metformin and
rosiglitazone. The treatment effect will be evaluated by HbA1c.
- To examine the effects of the treatments on glucose metabolism and beta cell function,
evaluated by diurnal blood glucose, fasting plasma glucose, insulin, C-peptide, and
lactate.
- To examine the effects of the treatments on cardiovascular risk factors evaluated by
serum lipid profiles, serum free fatty acids, urine albumin/creatinine ratio, and
electrocardiogram (ECG).
- To quantify and describe the patients' subjective experiences of the two different
insulin treatments (quality of life assessment)
- To examine patients with type 2 diabetes for the presence of variability in a series of
genes, which are known to or are assumed to:
- affect the long term outcome;
- determine the responsiveness to treatment with diet, exercise and drugs targeting
the known risk markers for late diabetic complications; and
- after intervention, to analyse the complex interrelationships between genotypes and
clinical endpoints and the responsiveness to actual treatment modalities.