Efficacy and Safety of Basal-bolus Therapy, Comparing Stepwise Addition of Insulin Aspart Versus Complete Basal-bolus Regimen

What Was Tested

The trial (phase 4) is built around Insulin Aspart and Insulin Detemir.

This trial is conducted in Europe, and North and South America.

It had two arms (groups): Step-wise (experimental) and Basal-bolus (active comparator).

The registry classes the interventions as drug.

Who Took Part

Enrollment: 401 actual participants took part.

It was open to people of any sex aged from 18 years with no upper age limit.

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

Examples of who could join: Type 2 diabetes (diagnosed clinically) for at least 12 months. Basal insulin treatment (NPH once or twice daily, insulin glargine once daily or insulin detemir once daily) for at least 6 months. BMI (Body Mass Index) less than 40.0 kg/m\^2.

The full record lists 4 inclusion and 10 exclusion criteria; among the exclusions: use of glp-1 (glucagon-like peptide-1) receptor agonists or pramlintide within the last 6 months prior to prior to screening visit (visit 1); proliferative retinopathy or maculopathy requiring treatment according to the investigator; treatment with oads (oral anti-diabetic drug) contraindicated or unapproved for combination treatment with insulin (according to local oad label).

How the Study Was Run

It was run as a randomized, parallel-group and open-label study.

Because people in this Insulin Aspart study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

The Insulin Aspart group and the comparison group ran side by side rather than switching.

Being open-label, the Insulin Aspart study did not mask who received what.

It started in 2010-10 with completion listed for 2012-04.

It ran at 67 sites in United States (33), Canada (12), Argentina (7), Brazil (5), France (5) and Slovenia (4).

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Change in Glycosylated Haemoglobin (HbA1c) From Baseline to Week 32 (time frame: Week 0, Week 32).

It also tracked 14 secondary outcomes, for example Change in Glycosylated Haemoglobin (HbA1c) From Baseline to Week 10, Change in Glycosylated Haemoglobin (HbA1c) From Baseline to Week 21, Fasting Plasma Glucose (FPG) at Week 10, Fasting Plasma Glucose (FPG) at Week 21, Fasting Plasma Glucose (FPG) at Week 32 and Mean Plasma Glucose Increment Over 3 Meals (Breakfast, Lunch and Dinner) at Week 10.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Insulin Aspart and Insulin Detemir in 401 people.

The trial is marked completed; results are posted on the registry, and this page does not restate them.

More context: the Insulin Aspart compound page and the Insulin Detemir compound page, all human trials.