South Danish Diabetes Study: Evaluation of the Antidiabetic Treatment of Type 2 Diabetes Mellitus - Tabular View

This Tabular View shows the required WHO registration data elements as marked by ^†

Tracking Information

First Received Date ^†

July 8, 2005

Last Updated Date

June 18, 2008

Start Date ^†

January 2003

Current Primary Outcome Measures ^†

HbA1c following two years of treatment

Original Primary Outcome Measures ^†

Same as current

Change History

Complete list of historical versions of study NCT00121966 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^†

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
lactate
fasting insulin, proinsulin-C-peptide
urine glucose
urine albumin/creatinine ratio

Original Secondary Outcome Measures ^†

body weight
blood pressure
free fatty acids,
Fasting blood glucose,
lactate,
fasting insulin, pro-insulin-C-peptide,
urine albumin/creatinine ratio.
diurnal blood glucose profiles (self monitored and continuously monitored),
fasting cholesterol (including HDL, LDL, and triglyceride),
urine glucose,

Descriptive Information

Brief Title ^†

South Danish Diabetes Study: Evaluation of the Antidiabetic Treatment of Type 2 Diabetes Mellitus

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

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.

Detailed Description

Study Phase

Phase IV

Study Type ^†

Interventional

Study Design ^†

Treatment, Randomized, Double-Blind, Uncontrolled, Factorial Assignment, Safety/Efficacy Study

Condition ^†

Type 2 Diabetes Mellitus

Intervention ^†

Drug: Insulin Aspart
Drug: Insulin NPH
Drug: Metformin
Drug: Rosiglitazone

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^†

Completed

Enrollment ^†

400

Completion Date

July 2007

Primary Completion Date

July 2007 (final data collection date for primary outcome measure)

Eligibility Criteria ^†

Inclusion Criteria:

Ages between 30 and 70 years
Fasting C-peptide >300 pmol/l
Body mass index (BMI) > 25 kg/m2
Diabetes for more than 2 years
Pharmacological antidiabetic treatment for more than 3 months
7.0%<HbA1c<12.0% at randomisation
Patient willing to sign informed consent
Fertile women: negative pregnancy test and use of oral or intra-uterine contraception or depot gestagen.

Exclusion Criteria:

S-creatinine > 120 μmol/l
History of intolerance to metformin or glitazones
S-ALAT/S-ASAT > 2.5 x upper normal limit
Total cholesterol > 10 mmol/l
Total triglyceride > 8 mmol/l
Hemoglobin (Hb) < normal range
Treatment with glitazone preceding 30 days New York Heart Association (NYHA) functional class III or IV
Night work
Present or planned pregnancy
Poor vision impeding insulin administration
Unawareness of hypoglycaemia (complete or partly)
Mental illness or alcohol abuse
Clinically relevant major organ or systemic illness
Uncontrolled hypertension >180/110 mmHg, systolic or diastolic
Steroid treatment
Severe lung disease
A history of malign disease
An expectation that the patient will not be collaborative or will not be able to understand the character of this trial

Gender

Both

Ages

30 Years to 70 Years

Accepts Healthy Volunteers

Contacts ^††

Location Countries ^†

Denmark

Expanded Access Status

Administrative Information

NCT ID ^†

NCT00121966

Responsible Party

Jeppe Gram/MD, Ribe County Hospital, Esbjerg, Denmark

Secondary IDs ^††

Study Sponsor ^†

Odense University Hospital

Collaborators ^††

Investigators ^†

Principal Investigator:

Jeppe Gram, MD, PhD

Esbjerg Hospital

Information Provided By

Odense University Hospital

Verification Date

June 2008

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.