A Study to Characterize Regimens of Basal Insulin Intensified With Either Symlin® or Rapid Acting Insulin in Patients With Type 2 Diabetes

What Was Tested

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

This will be a randomized, open label, parallel group, multicenter study.

There will be two phases in the study.

It had two arms (groups): Group A (experimental) and Group B (active comparator).

The registry classes the interventions as drug.

Who Took Part

Enrollment: 112 actual participants took part.

It was open to people of any sex aged from 18 years up to 75 years.

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

Examples of who could join: Has a clinical diagnosis of type 2 diabetes mellitus. Has a BMI of ≥25 kg/m\^2 and ≤50 kg/m\^2.

The full record lists 4 inclusion and 7 exclusion criteria; among the exclusions: has experienced recurrent severe hypoglycemia requiring assistance during the past 6 months; requires the use of drugs that stimulate gastrointestinal motility; has been previously treated with symlin (or has participated in a symlin clinical study).

How the Study Was Run

The set-up was randomized, parallel-group and open-label.

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

Groups ran in parallel: each of the participants stayed in one arm throughout.

Everyone knew when Insulin Glargine was being given (open label), which is simpler to run but leaves more room for expectations to affect what is reported.

It started in 2007-05 with completion listed for 2008-04.

It ran at 37 sites in United States (37).

Its stated primary purpose is treatment.

What Was Measured

It also tracked 10 secondary outcomes, for example Percentage of Patients With no Weight Gain at Week 24, Percentage of Patients With a Severe Hypoglycemia Adverse Event, Change in HbA1c From Baseline at Week 24, Change in Body Weight From Baseline at Week 24, Change in Waist Circumference From Baseline at Week 24 and Change in Fasting Plasma Glucose From Baseline at Week 24.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Insulin Glargine and Insulin Aspart in 112 people.

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

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