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

Overview[ - collapse ][ - ]

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.
ConditionType 2 Diabetes Mellitus
InterventionDrug: Insulin Aspart
Drug: Insulin NPH
Drug: Metformin
Drug: Rosiglitazone
PhasePhase 4
SponsorOdense University Hospital
Responsible PartyOdense University Hospital
ClinicalTrials.gov IdentifierNCT00121966
First ReceivedJuly 8, 2005
Last UpdatedJune 18, 2008
Last verifiedJune 2008

Tracking Information[ + expand ][ + ]

First Received DateJuly 8, 2005
Last Updated DateJune 18, 2008
Start DateJanuary 2003
Estimated Primary Completion DateJuly 2007
Current Primary Outcome MeasuresHbA1c following two years of treatment
Current 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

Descriptive Information[ + expand ][ + ]

Brief TitleSouth Danish Diabetes Study: Evaluation of the Antidiabetic Treatment of Type 2 Diabetes Mellitus
Official TitleSouth Danish Diabetes Study: A Prospective Randomised Multi-Centre Study for the Evaluation of the Optimal Pharmacological Antidiabetic Treatment of Type 2 Diabetes Mellitus
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.
Detailed DescriptionNot Provided
Study TypeInterventional
Study PhasePhase 4
Study DesignAllocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Factorial Assignment, Masking: Double-Blind, Primary Purpose: Treatment
ConditionType 2 Diabetes Mellitus
InterventionDrug: Insulin Aspart
Drug: Insulin NPH
Drug: Metformin
Drug: Rosiglitazone
Study Arm (s)Not Provided

Recruitment Information[ + expand ][ + ]

Recruitment StatusCompleted
Estimated Enrollment400
Estimated Completion DateJuly 2007
Estimated Primary Completion DateJuly 2007
Eligibility 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%
- 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
GenderBoth
Ages30 Years
Accepts Healthy VolunteersNo
ContactsNot Provided
Location CountriesDenmark

Administrative Information[ + expand ][ + ]

NCT Number NCT00121966
Other Study ID Numbers001
Has Data Monitoring CommitteeNot Provided
Information Provided ByOdense University Hospital
Study SponsorOdense University Hospital
CollaboratorsNot Provided
Investigators Principal Investigator: Jeppe Gram, MD, PhD Esbjerg Hospital
Verification DateJune 2008

Locations[ + expand ][ + ]

Diabetes Research Center
Odense, Denmark, 5000