Ignite Creation Date:
2025-12-24 @ 4:21 PM
Ignite Modification Date:
2026-01-02 @ 3:46 AM
Study NCT ID:
NCT00121966
Status:
COMPLETED
Last Update Posted:
2008-06-19
First Post:
2005-07-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
South Danish Diabetes Study: Evaluation of the Antidiabetic Treatment of Type 2 Diabetes Mellitus
Sponsor:
Odense University Hospital
Organization:
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2008-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SDDS
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 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.
* 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.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?: