Local Registration Trial in China Humalog Mix 50

What Was Tested

This registered phase 3 trial tested Insulin Lispro.

The primary objective of this study is to compare the 2-hour PPBG excursion following a standard test meal in insulin-requiring diabetic patients treated twice daily with human insulin mix 50/50, versus the 2-hour PPBG excursion in patients treated twice daily with insulin lispro mix 50/50.

The registry classes the interventions as drug.

Who Took Part

The registry lists 120 planned participants were the target.

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: Have achieved compliance with their diets and insulin therapies as determined by the investigators and perform regular blood glucose monitoring. Have given informed consent to participate in this study in accordance with local regulations.

The full record lists 5 inclusion and 0 exclusion criteria.

How the Study Was Run

The set-up was randomized, crossover and open-label.

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

Each person switched between Insulin Lispro and the comparison at some point, usually with a gap in between.

Nothing was hidden in this open-label Insulin Lispro study: the participants and staff both knew the treatment.

It started in 2005-03 with completion listed for 2006-04.

It ran at 2 sites in China (2).

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: The primary objective of this study is to compare the 2-hour PPBG excursion following a standard test meal in IDDM patients treated BID with human insulin mix 50/50, vs the 2-hour PPBG excursion in patients treated BID with insulin lispro mix 50/50.

It also tracked 6 secondary outcomes, for example The secondary objectives of the study are:, Assess hemoglobin A1c (HbA1c) values at baseline and after treatment with insulin lispro mix 50/50, Assess HbA1c values at baseline and after treatment with human insulin mix 50/50, To compare human insulin mix 50/50 with insulin lispro mix 50/50 with regard to, Effects on HbA1c values obtained at the end of each treatment period; and Effects on fasting blood glucose values obtained throughout the study;.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Insulin Lispro in 120 people.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

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