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

Odense University Hospital

Status and phase

Completed

Phase 4

Conditions

Type 2 Diabetes Mellitus

Treatments

Drug: Metformin

Drug: Rosiglitazone

Drug: Insulin Aspart

Drug: Insulin NPH

Study type

Interventional

Funder types

Other

Identifiers

001

Details and patient eligibility

About

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.

Sex

All

Ages

30 to 70 years old

Volunteers

No Healthy Volunteers

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