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

NCT00121966 | Completed Phase 4

• 1 other identifier: 001
• Study Type: interventional
• Target: 400
• Locations: 1 country
• Sites: 1

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.

Conditions

Type 2 Diabetes Mellitus

Keywords

Type 2 diabetes; Insulin Aspart; Insulin NPH; Metformin; Rosiglitazone

Outcome Measures

Primary Outcomes (1)

• HbA1c following two years of treatment

Secondary Outcomes (10)

• body weight

• blood pressure

• fasting blood glucose

• diurnal blood glucose profiles (self monitored and continuously monitored)

• fasting cholesterol (including HDL, LDL, and triglyceride)

Interventions

Insulin Aspart DRUG

Insulin NPH DRUG

Metformin DRUG

Rosiglitazone DRUG

Eligibility Criteria

• Age: 30 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• %\<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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Odense University Hospital: lead

Study Sites (1)

Diabetes Research Center

Odense, 5000, Denmark

Location

Related Publications (1)

• Skov V, Cangemi C, Gram J, Christensen MM, Grodum E, Sorensen D, Argraves WS, Henriksen JE, Rasmussen LM. Metformin, but not rosiglitazone, attenuates the increasing plasma levels of a new cardiovascular marker, fibulin-1, in patients with type 2 diabetes. Diabetes Care. 2014;37(3):760-6. doi: 10.2337/dc13-1022. Epub 2013 Oct 17.

  PMID: 24135389 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Insulin Aspart; Insulin, Isophane; Metformin; Rosiglitazone

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Insulin, Short-Acting; Insulins; Pancreatic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins; Insulin, Long-Acting; Biguanides; Guanidines; Amidines; Organic Chemicals; Thiazolidinediones; Thiazoles; Sulfur Compounds; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Jeppe Gram, MD, PhD

  Esbjerg Hospital - University Hospital of Southern Denmark

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: July 8, 2005
• First Posted: July 21, 2005
• Study Start: January 1, 2003
• Primary Completion: July 1, 2007
• Study Completion: July 1, 2007
• Last Updated: June 19, 2008

Record last verified: 2008-06

Locations

DK (1)