A Study to Determine the Safety and Efficacy of Albiglutide Administered in Combination With Insulin Glargine

What Was Tested

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

It had two arms (groups): albiglutide + insulin glargine (active comparator) and insulin glargine + preprandial lispro insulin (active comparator).

Albiglutide in combination with insulin glargine.

Insulin glargine in combination with preprandial lispro insulin.

The registry classes the interventions as biological and drug.

More on the Plan

Subjects must also be willing and capable of pursuing an intensive regimen of both basal and preprandial insulin.

Who Took Part

586 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: BMI \>/= 20kg/m2 and \</=45 kg/m2. Use of oral or systemically injected glucocorticoids is generally not allowed within 3 months before randomization; inhaled, intra articular, and topical corticosteroids are allowed. Able and willing to monitor his or her own blood glucose concentrations with a home glucose monitor as per the protocol recommendations of self administration. No major illness or debility that in the investigator's opinion prohibits the subject from actively participating in their diabetes management and completing the study. Able and willing to provide written informed consent.

The full record lists 12 inclusion and 33 exclusion criteria; among the exclusions: history of treated diabetic gastroparesis; current ongoing symptomatic biliary disease or history of pancreatitis; previous history of stroke or transient ischemic attack within 1 month before screening.

How the Study Was Run

Design: randomized, parallel-group and open-label.

Random assignment meant chance, not the researchers, decided who got Insulin Glargine and who got the comparison, which limits bias.

The Insulin Glargine group and the comparison group ran side by side rather than switching.

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

It started in 2009-09 with completion listed for 2011-10.

It ran at 209 sites in United States (142), South Africa (14), South Korea (8), Philippines (7), Spain (6) and India (5).

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Change From Baseline (BL) in Glycosylated Hemoglobin (HbA1c) at Week 26 (time frame: Baseline and Week 26).

It also tracked 7 secondary outcomes, for example Change From Baseline in HbA1c at Weeks 36, 48 and 52, Change From Baseline in Fasting Plasma Glucose (FPG) at Week 26, Change From Baseline in Fasting Plasma Glucose (FPG) at Weeks 36, 48 and 52, Time to Hyperglycemia Rescue, Change From Baseline in Body Weight at Week 26 and Change From Baseline in Body Weight at Weeks 36, 48 and 52.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Insulin Glargine and Insulin Lispro in 586 people.

With 586 participants it is a large trial for this field.

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.