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

NCT00121966 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 400

Last updated 2008-06-19

No results posted yet for this study

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.

Conditions

  • Type 2 Diabetes Mellitus

Interventions

DRUG

Insulin Aspart

DRUG

Insulin NPH

DRUG

Metformin

DRUG

Rosiglitazone

Sponsors & Collaborators

  • Odense University Hospital

    lead OTHER

Principal Investigators

  • Jeppe Gram, MD, PhD · Esbjerg Hospital - University Hospital of Southern Denmark

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
FACTORIAL

Eligibility

Min Age
30 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2003-01-31
Primary Completion
2007-07-31
Completion
2007-07-31

Countries

  • Denmark

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00121966 on ClinicalTrials.gov