Comparison of Two Basal Insulins for Patients With Type 2 Diabetes Taking Oral Diabetes Medicines and Exenatide

What Was Tested

The trial (phase 3) is built around Insulin Glargine and Insulin Lispro.

This study will compare insulin lispro protamine suspension (ILPS) and insulin glargine in combination with the patient's oral diabetes medications and exenatide, for their ability to control blood sugar in patients with type 2 diabetes.

It had two arms (groups): ILPS (active comparator) and Glargine (active comparator).

Insulin Lispro Protamine Suspension (ILPS).

Insulin Glargine.

The registry classes the interventions as drug.

Who Took Part

The registry lists 339 actual participants took part.

It was open to people of any sex aged from 18 years up to 74 years.

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

The full record lists 5 inclusion and 5 exclusion criteria; among the exclusions: must not have used insulin on a regular basis during the past 2 years; must not have taken any glucose-lowering medications not included in the inclusion criteria in the past 3 months; must not have had more than one episode of severe hypoglycemia in the past 6 months.

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 2007-11 with completion listed for 2009-12.

It ran at 52 sites in United States (49) and Puerto Rico (3).

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Change From Baseline in Hemoglobin A1C (HbA1c) at Endpoint (Last Observation Carried Forward [LOCF]) (time frame: Baseline, Endpoint (LOCF) up to 24 weeks).

It also tracked 10 secondary outcomes, for example Actual Hemoglobin A1C at 24 Weeks and Endpoint (LOCF), Change From Baseline in Hemoglobin A1C at 24 Weeks and Endpoint (LOCF), 7-Point Self-Monitored Blood Glucose (SMBG) Profiles at Baseline and Endpoint (LOCF), Glycemic Variability at Baseline and Endpoint (LOCF), Incidence of Self-reported Hypoglycemic Episodes (All, Non-Nocturnal, Nocturnal, and Severe) and Rate of All, Non-Nocturnal, and Nocturnal Self-Reported Hypoglycemic Episodes (Adjusted for One Year).

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Insulin Glargine and Insulin Lispro in 339 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 Lispro compound page, all human trials.