Comparison of Two Basal Insulin Therapies for Patients With Type 1 Diabetes

What Was Tested

In this phase 3 trial, researchers set out to test Insulin Lispro and Insulin Detemir.

A gatekeeper strategy will be employed for sequentially testing the secondary objectives.

It had two arms (groups): Insulin Lispro Protamine Suspension (experimental) and Detemir (active comparator).

Insulin Lispro Protamine Suspension twice daily.

Insulin Levemir (detemir) subcutaneous (SC) twice daily.

The registry classes the interventions as drug.

Who Took Part

387 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: Clinical diagnosis of type 1 diabetes for one year or more. Age 18 years or older. Body mass index (BMI) less than or equal to 35 kilograms per square meter (kg/m2). As determined by the investigator, are capable and willing to do the following:. Perform self monitoring of blood glucose (SMBG),.

The full record lists 10 inclusion and 5 exclusion criteria; among the exclusions: have taken any oral antihyperglycemic medications (oams) within 3 months prior to visit 1.

How the Study Was Run

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

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

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

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

It started in 2007-06 with completion listed for 2008-08.

It ran at 28 sites in Hungary (5), United States (4), Romania (4), Russia (4), Mexico (3) and Argentina (2).

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Change in Hemoglobin A1c (HbA1c) From Baseline to Endpoint (time frame: baseline and 32 weeks).

It also tracked 10 secondary outcomes, for example Actual and Change From Baseline Hemoglobin A1c (HbA1c) Values, 7-Point Self-Monitored Blood Glucose (SMBG) at Endpoint, Glycemic Variability at Endpoint, Number of Self-Reported Hypoglycemic Episodes (Including Nocturnal, Non-Nocturnal, and Severe Hypoglycemia) Overall and at Endpoint, 1-Year Adjusted Rates of Self-Reported Hypoglycemic Episodes (Including Nocturnal, Non-Nocturnal, and Severe) Overall and at Endpoint and 30-Day Adjusted Rates of Self-Reported Hypoglycemic Episodes (Including Nocturnal, Non-Nocturnal, and Severe) Overall and at Endpoint.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Insulin Lispro and Insulin Detemir in 387 people.

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

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