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

This study has been completed.
Sponsor:
Information provided by:
Odense University Hospital
ClinicalTrials.gov Identifier:
NCT00121966
First received: July 8, 2005
Last updated: June 18, 2008
Last verified: June 2008
  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 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Factorial Assignment
Masking: Double-Blind
Primary Purpose: Treatment
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

Resource links provided by NLM:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

No publications provided by Odense University Hospital

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Jeppe Gram/MD, Ribe County Hospital, Esbjerg, Denmark
ClinicalTrials.gov Identifier: NCT00121966     History of Changes
Other Study ID Numbers: 001
Study First Received: July 8, 2005
Last Updated: June 18, 2008
Health Authority: Denmark: National Board of Health

Keywords provided by Odense University Hospital:
Type 2 diabetes
Insulin Aspart
Insulin NPH
Metformin
Rosiglitazone

Additional relevant MeSH terms:
Diabetes Mellitus, Type 2
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Insulin, Globin Zinc
Rosiglitazone
Isophane insulin, beef
Insulin
Metformin
Insulin Aspart
Hypoglycemic Agents
Insulin, Isophane
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 16, 2014