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

What Was Tested

This registered phase 4 trial tested Insulin Aspart and NPH Insulin (isophane).

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 registry classes the interventions as drug.

Who Took Part

Enrollment: 400 planned participants were the target.

It was open to people of any sex aged from 30 years up to 70 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Ages between 30 and 70 years. Body mass index (BMI) \> 25 kg/m2. Diabetes for more than 2 years. Patient willing to sign informed consent. Fertile women: negative pregnancy test and use of oral or intra-uterine contraception or depot gestagen.

The full record lists 8 inclusion and 18 exclusion criteria; among the exclusions: S-creatinine \> 120 μmol/l; history of intolerance to metformin or glitazones; S-ALAT/S-ASAT \> 2.5 x upper normal limit.

How the Study Was Run

The set-up was randomized, factorial and double-blind.

The participants were allocated by chance, so the Insulin Aspart group and the comparison group should start out alike.

Blinding on both sides kept the participants and researchers unaware of who received Insulin Aspart.

It started in 2003-01 with completion listed for 2007-07.

It ran at 1 site in Denmark.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: HbA1c following two years of treatment.

It also tracked 10 secondary outcomes, for example body weight, blood pressure, fasting blood glucose, diurnal blood glucose profiles (self monitored and continuously monitored), fasting cholesterol (including HDL, LDL, and triglyceride) and free fatty acids.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Insulin Aspart and NPH Insulin (isophane) in 400 people.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Insulin Aspart compound page and the NPH Insulin (isophane) compound page, all human trials.