Insulin Glargine Plus Insulin Glulisine Multiple Daily Injections (MDI) Versus Premix Insulin Treatment in Subjects With Diabetes Mellitus (Type 1 or Type 2)

What Was Tested

In this phase 3 trial, researchers set out to test Insulin Glargine.

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

Sequence 1 (Lantus + Apidra first, then Premix): Subjects randomized to this sequence will receive ApidraTM administered three times per day 0-15 minutes before main meals using a fixed bolus regimen following titration based on preprandial blood glucose values; as well as Lantus qd for 12 weeks. After the first 12 weeks, subjects will cross over to the premix insulin for a further treatment of 12 weeks.

Sequence 2 (Premix first, then Lantus + Apidra): Subjects randomized to this sequence will receive premix insulin (either Humalog Mix 75/25 or Novolog Mix 70/30, depending on which insulin they were taking at entry into the study) once or twice per day for 12 weeks. After the first 12 weeks, subjects will cross over to the Lantus plus Apidra sequence for a further treatment of 12 weeks.

The registry classes the interventions as drug.

Who Took Part

The registry lists 582 actual participants took part.

It was open to people of any sex aged from 21 years up to 70 years.

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

Examples of who could join: Informed consent in writing at enrollment. Subjects with type 1 or type 2 diabetes mellitus for at least six months. Male or female 21 - 70 years of age. Employed, unpaid work or active lifestyle. Willing and able to perform self-monitoring of blood glucose (SMBG) four times a day and continuous glucose monitoring (CGMS) for 48 hours at three time periods during the study.

The full record lists 10 inclusion and 14 exclusion criteria; among the exclusions: cardiac status new york heart association (nyha) iii-iv; clinical evidence of active liver disease or serum alt or ast \> 2.5 times the upper limit of normal range; subjects currently using an insulin pump.

How the Study Was Run

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

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

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

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

It started in 2005-08 with completion listed for 2007-09.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Insulin Glargine in 582 people.

With 582 participants it is a large trial for this field.

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

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