Comparison of Two Basal Insulins for Patients With Type 2 Diabetes on Anti-Hyperglycemic Medications (IOPE)

What Was Tested

This registered phase 3 trial tested Insulin Glargine and Insulin Lispro.

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

The registry classes the interventions as drug.

Who Took Part

Enrollment: 471 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: Have type 2 diabetes mellitus for at least 1 year. Are greater than or equal to 18 years old. Body mass index (BMI) greater than or equal to 25 and less than or equal to 45 kg/meter squared.

The full record lists 5 inclusion and 5 exclusion criteria; among the exclusions: have had 2 or more emergency room visits or hospitalizations due to poor glucose control in the past 6 months.

How the Study Was Run

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

The participants were allocated by chance, so the Insulin Glargine 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 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 2007-08 with completion listed for 2008-10.

It ran at 17 sites in United States (11), Brazil (4), Canada (1) and Puerto Rico (1).

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Change From Baseline to 24 Week Endpoint in Hemoglobin A1c (HbA1c) (time frame: Baseline, 24 Weeks).

It also tracked 10 secondary outcomes, for example Actual and Change From Baseline to 12 Week and 24 Week Endpoint in HbAlc Value, Percentage of Patients With HbAlc Less Than 7.0 Percent and HbAlc Less Than or Equal to 6.5 Percent at Endpoint, Glycemic Variability at Endpoint, 7-Point Self-Monitored Blood Glucose (SMBG) Profile at Endpoint, Number of Participants With Self-Reported Hypoglycemic Episodes (Including All, Nocturnal, and Severe Hypoglycemia) Overall and 1-Year Adjusted Rates of Self-Reported Hypoglycemic Episodes (Including All, Nocturnal, and Severe) Overall.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Insulin Glargine and Insulin Lispro in 471 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.