A Study for Patients With Diabetes Mellitus (IOPA)

What Was Tested

The trial (phase 4) is built around Insulin Lispro.

The purpose of this study is to compare glycemic control (HbA1c) in Chinese patients with type 1 or type 2 diabetes when treated with insulin lispro low mixture and human insulin 30/70.

It had two arms (groups): 1 (active comparator) and 2 (experimental).

Human insulin mix 30/70.

Insulin lispro low mix.

The registry classes the interventions as drug.

Who Took Part

117 actual participants took part.

It was open to people of any sex aged from 18 years up to 70 years.

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

Examples of who could join: Clinically diagnosed type 1or type 2 diabetes for at least 2 months. Aged between 18 and 70 (inclusive). Have been treated with human insulin mix 30/70 twice daily for at least 2 months prior to entering the study. Have glycosylated hemoglobin (Hb1Ac) between 1.2 and 1.7 times the upper limit of normal reference range within 2 weeks prior to or at Visit 1. Compliance with diet and insulin therapy and performs regular blood glucose monitoring.

The full record lists 5 inclusion and 5 exclusion criteria; among the exclusions: have used oral antidiabetic agents within 30 days prior to entry into the study; have had more than two episodes of severe hypoglycemia within 6 months prior to entry into the study; have a body mass index \>35 kilograms per square meter (kg/m2).

How the Study Was Run

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

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

In the crossover set-up each of the participants took both Insulin Lispro and the comparison in turn, acting as their own control.

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

It started in 2007-01 with completion listed for 2008-01.

It ran at 4 sites in China (4).

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Glycosylated Hemoglobin (HbA1c) Value at 12 Week Endpoint (time frame: Baseline and 12 weeks of each treatment).

It also tracked 6 secondary outcomes, for example Changes in Glycosylated Hemoglobin (HbA1c) From Baseline to 12 Weeks of Treatment, Change in Fasting Blood Glucose Values From Baseline to 12 Weeks of Treatment and Hypoglycemia Rate Per Participant Per 30 Days.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Insulin Lispro in 117 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, all human trials.