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Completed

NCT Number: NCT00121966

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

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.

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Key information

Conditions

Type 2 Diabetes Mellitus Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

30 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Diabetes Research Center

Odense, 5000, Denmark

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

insulin aspart

Drug

insulin NPH

Drug

metformin

Drug

rosiglitazone

Drug

Primary outcomes

  1. HbA1c following two years of treatment

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Odense University Hospital

Other

Registry information

Official study 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

Acronym: SDDS

Important dates

Study start
2003
Primary completion
2007
Study completion
2007
First posted
Jul 21, 2005
Registry last updated
Jun 19, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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