South Danish Diabetes Study: Evaluation of the Antidiabetic Treatment of Type 2 Diabetes Mellitus (SDDS)
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.
Type 2 Diabetes Mellitus
Drug: Insulin Aspart
Drug: Insulin NPH
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Factorial Assignment
Primary Purpose: Treatment
|Official Title:||South Danish Diabetes Study: A Prospective Randomised Multi-Centre Study for the Evaluation of the Optimal Pharmacological Antidiabetic Treatment of Type 2 Diabetes Mellitus|
- HbA1c following two years of treatment
- body weight
- blood pressure
- fasting blood glucose
- diurnal blood glucose profiles (self monitored and continuously monitored)
- fasting cholesterol (including HDL, LDL, and triglyceride)
- free fatty acids
- fasting insulin, proinsulin-C-peptide
- urine glucose
- urine albumin/creatinine ratio
|Study Start Date:||January 2003|
|Study Completion Date:||July 2007|
|Primary Completion Date:||July 2007 (Final data collection date for primary outcome measure)|
Please refer to this study by its ClinicalTrials.gov identifier: NCT00121966
|Diabetes Research Center|
|Odense, Denmark, 5000|
|Principal Investigator:||Jeppe Gram, MD, PhD||Esbjerg Hospital|