To Evaluate the Effect on Post-prandial Glycemia Safety, and Tolerability of Viaject 7 vs. Lispro Insulin During Subcutaneous Insulin Pump Therapy

What Was Tested

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

The purpose of this study is to evaluate the Effect on Post-prandial Glycemia Safety, and Tolerability of Viaject 7 vs.

Lispro Insulin during SC Insulin Pump Therapy.

It had two arms (groups): Formulation A (experimental) and Formulation B (experimental).

Single Injection.

Single Injection.

The registry classes the interventions as drug.

Who Took Part

The registry lists 20 actual participants took part.

It was open to people of any sex aged from 18 years up to 75 years.

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

Examples of who could join: Males or females diagnosed with type 1 diabetes mellitus for at least 6 months. Current usage of subcutaneous insulin pump treatment with one of the following pumps:. Age 18-75 years. Willingness to attend 9 clinic visits.

The full record lists 9 inclusion and 21 exclusion criteria; among the exclusions: pregnancy or lactation; congestive heart failure; active coronary artery disease or heart procedure within the past 4 months.

How the Study Was Run

The set-up was randomized, crossover and double-blind.

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.

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

As a double-blind Insulin Lispro study, the assignments were hidden from both participants and investigators until the end.

Those kept unaware of assignments: participant and investigator.

It started in 2010-02 with completion listed for 2010-06.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): 3 hour incremental area under the glucose curve after a standardized high glycemic index meal (time frame: 3 hours).

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Insulin Lispro in 20 people.

Its size is small, so on its own it can only give an early look.

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.