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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00121966
Recruitment Status : Completed
First Posted : July 21, 2005
Last Update Posted : June 19, 2008
Information provided by:
Odense University Hospital

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.

Condition or disease Intervention/treatment Phase
Type 2 Diabetes Mellitus Drug: Insulin Aspart Drug: Insulin NPH Drug: Metformin Drug: Rosiglitazone Phase 4

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 400 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Double
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
Study Start Date : January 2003
Primary Completion Date : July 2007
Study Completion Date : July 2007

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Primary Outcome Measures :
  1. HbA1c following two years of treatment

Secondary Outcome Measures :
  1. body weight
  2. blood pressure
  3. fasting blood glucose
  4. diurnal blood glucose profiles (self monitored and continuously monitored)
  5. fasting cholesterol (including HDL, LDL, and triglyceride)
  6. free fatty acids
  7. lactate
  8. fasting insulin, proinsulin-C-peptide
  9. urine glucose
  10. urine albumin/creatinine ratio

Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00121966

Diabetes Research Center
Odense, Denmark, 5000
Sponsors and Collaborators
Odense University Hospital
Principal Investigator: Jeppe Gram, MD, PhD Esbjerg Hospital

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
First Posted: July 21, 2005    Key Record Dates
Last Update Posted: June 19, 2008
Last Verified: June 2008

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

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