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

South Danish Diabetes Study: A Prospective Randomised Multi-Centre Study for the Evaluation of the Optimal Pharmacological 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.

Study Overview

• Status: Completed
• Conditions: Type 2 Diabetes Mellitus
• Intervention / Treatment: Drug: Metformin; Drug: Rosiglitazone; Drug: Insulin Aspart; Drug: Insulin NPH

• Study Type: Interventional
• Enrollment: 400
• Phase: Phase 4

Contacts and Locations

Study Locations

• Denmark
  • Odense, Denmark, 5000
    • Diabetes Research Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
HbA1c following two years of treatment

Secondary Outcome Measures

Outcome Measure
blood pressure
body weight
free fatty acids
fasting blood glucose
diurnal blood glucose profiles (self monitored and continuously monitored)
fasting cholesterol (including HDL, LDL, and triglyceride)
lactate
fasting insulin, proinsulin-C-peptide
urine glucose
urine albumin/creatinine ratio

Collaborators and Investigators

• Sponsor: Odense University Hospital
• Investigators: Principal Investigator: Jeppe Gram, MD, PhD, Esbjerg Hospital

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: January 1, 2003
• Primary Completion (Actual): July 1, 2007
• Study Completion (Actual): July 1, 2007

Study Registration Dates

• First Submitted: July 8, 2005
• First Submitted That Met QC Criteria: July 14, 2005
• First Posted (Estimate): July 21, 2005

Study Record Updates

• Last Update Posted (Estimate): June 19, 2008
• Last Update Submitted That Met QC Criteria: June 18, 2008
• Last Verified: June 1, 2008

More Information

Terms related to this study

• Keywords: Type 2 diabetes; Metformin; Rosiglitazone; Insulin Aspart; Insulin NPH
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2; Hypoglycemic Agents; Physiological Effects of Drugs; Insulin; Insulin, Globin Zinc; Insulin Aspart; Metformin; Rosiglitazone; Insulin, Isophane; Isophane Insulin, Human; Isophane insulin, beef
• Other Study ID Numbers: 001 (NavyGHB)