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

Purpose

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.

Condition	Intervention	Phase
Type 2 Diabetes Mellitus	Drug: Insulin Aspart Drug: Insulin NPH Drug: Metformin Drug: Rosiglitazone	Phase IV

MedlinePlus related topics:

Diabetes

Drug Information available for:

Insulin Insulin aspart Metformin Metformin hydrochloride Rosiglitazone Rosiglitazone Maleate Insulin, isophane

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Uncontrolled, Factorial Assignment, Safety/Efficacy Study

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

Further study details as provided by Odense University Hospital:

Primary Outcome Measures:

HbA1c following two years of treatment

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

Estimated Enrollment:	400
Study Start Date:	January 2003
Study Completion Date:	July 2007
Primary Completion Date:	July 2007 (Final data collection date for primary outcome measure)

Eligibility

Ages Eligible for Study:	30 Years to 70 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00121966

Locations


Denmark
	Diabetes Research Center
	Odense, Denmark, 5000

Sponsors and Collaborators

Odense University Hospital

Investigators


Principal Investigator:	Jeppe Gram, MD, PhD	Esbjerg Hospital

More Information

Responsible Party:	Ribe County Hospital, Esbjerg, Denmark ( Jeppe Gram/MD )
Study ID Numbers:	001
First Received:	July 8, 2005
Last Updated:	June 18, 2008
ClinicalTrials.gov Identifier:	NCT00121966
Health Authority:	Denmark: National Board of Health

Keywords provided by Odense University Hospital:

Type 2 diabetes

Insulin Aspart

Insulin NPH

Metformin

Rosiglitazone

Study placed in the following topic categories:

Metabolic Diseases

Metformin

Diabetes Mellitus, Type 2

Insulin, Asp(B28)-

Diabetes Mellitus

Endocrine System Diseases

Endocrinopathy

Metabolic disorder

Glucose Metabolism Disorders

Rosiglitazone

Insulin, Isophane

Insulin

Additional relevant MeSH terms:

Hypoglycemic Agents

Physiological Effects of Drugs

Pharmacologic Actions

ClinicalTrials.gov processed this record on October 28, 2008

Sponsored by:	Odense University Hospital
Information provided by:	Odense University Hospital
ClinicalTrials.gov Identifier:	NCT00121966