Ignite Creation Date:
2024-05-05 @ 11:45 AM
Last Modification Date:
2024-10-26 @ 9:12 AM
Study NCT ID:
NCT00121966
Status:
COMPLETED
Last Update Posted:
2008-06-19
First Post:
2005-07-08
Brief Title:
South Danish Diabetes Study Evaluation of the Antidiabetic Treatment of Type 2 Diabetes Mellitus
Sponsor:
Odense University Hospital
Organization:
Odense University Hospital
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 andor 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 albumincreatinine 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 andor 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 albumincreatinine 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:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None