Safety and Efficacy of Albiglutide + Insulin Glargine Versus Insulin Lispro + Insulin Glargine Subjects With Type 2 Diabetes Mellitus

What Was Tested

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

Approximately 794 subjects will be randomly assigned in a 1:1 ratio to 1 of 2 treatment groups: albiglutide + insulin glargine (with insulin lispro discontinuation at Week 4) (with or without metformin) or to intensification of insulin glargine + insulin lispro (with or without metformin).

The study will comprise 4 study periods : Screening (2 weeks), Standardization (4 weeks), Treatment (26 weeks), and Post treatment Follow up (4 weeks).

It had two arms (groups): Albiglutide + Insulin Glargine Arm (experimental) and Insulin Glargine + Insulin Lispro Arm (experimental).

The registry classes the interventions as drug.

Who Took Part

Enrollment: 814 actual participants took part.

It was open to people of any sex aged from 18 years with no upper age limit.

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

Examples of who could join: Male or female, 18 years of age or older (inclusive at the time of Screening) with T2DM. Currently treated with a basal-bolus insulin regimen (with or without metformin) for at least 3 months before Screening. The subject must be taking the following:. Basal insulin (1 or 2 daily injections of neutral protamine Hagedorn insulin, insulin glargine, insulin detemir, or insulin degludec) AND. Fasting C-peptide \>= 0.8 nanogram (ng) per milliliter (mL) \[\>= 0.26 nanomoles per litre (nmol/L)\]. Body mass index \<= 40 kilogram per square meter( kg/m\^2).

The full record lists 13 inclusion and 23 exclusion criteria; among the exclusions: type 1 diabetes mellitus; personal or family history of medullary thyroid carcinoma or multiple endocrine neoplasia type 2; current symptomatic biliary disease or history of acute or chronic pancreatitis.

How the Study Was Run

The set-up was randomized, parallel-group and open-label.

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

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 2014-11-21 with completion listed for 2017-07-24.

It ran at 157 sites in United States (39), Spain (23), Mexico (18), Germany (15), Brazil (11) and Hungary (8).

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 26 (time frame: Baseline (Day -1) and Week 26).

It also tracked 39 secondary outcomes, for example Percentage of Participants With Severe or Documented Symptomatic Hypoglycemia Through Week 26, Change From Baseline in Body Weight at Week 26, Change From Baseline to Week 26 in Body Weight, Change From Baseline to Week 26 in HbA1c, Change From Baseline in Fasting Plasma Glucose (FPG) at Week 26 and Change From Baseline to Week 26 in FPG.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Insulin Glargine and Insulin Lispro in 814 people.

With 814 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.