A 24-week Open-Label, Phase 3b Trial With a 28-week Extension to Evaluate the Efficacy and Safety of Saxagliptin Co-administered With Dapagliflozin Compared to Insulin Glargine in Subjects withType 2 Diabetes Who Have Glycemic Control on Metformin

What Was Tested

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

This research study of subjects with inadequately controlled type 2 diabetes mellitus (T2DM) will compare the glycemic control (measured by HbA1c) in subjects co-administered saxagliptin and dapagliflozin, in addition to metformin with or without sulfonylurea, to subjects receiving insulin glargine, in addition to metformin with or without sulfonylurea, over a treatment period of 52 weeks.

It had two arms (groups): Saxagliptin/Dapagliflozin/Metformin (experimental) and Insulin Glargine, Lantos/Metformin (active comparator).

The registry classes the interventions as drug.

Who Took Part

650 actual participants took part.

It was open to people of any sex aged from 18 years up to 120 years.

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

Examples of who could join: At least 18 years of age at screening. Body Mass Index ≤ 45.0 kg/m2.

The full record lists 6 inclusion and 5 exclusion criteria; among the exclusions: clinical diagnosis of type 1 diabetes; history of ketoacidosis; renal, hepatic or pancreatic disease.

How the Study Was Run

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

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

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

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

It started in 2015-10-20 with completion listed for 2017-05-08.

It ran at 40 sites in United States (20), Mexico (4), Romania (4), Hungary (3), Poland (3) and Czechia (2).

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Mean Change From Baseline in HbA1c at Week 24 (time frame: Baseline and Week 24).

It also tracked 5 secondary outcomes, for example Mean Change From Baseline in Total Body Weight at Week 24, Percentage of Subjects With Confirmed Hypoglycaemia at Week 24, Percentage of Subjects Achieving a Therapeutic Glycemic Response, Without Hypoglycaemia, at Week 24, Percentage of Subjects Achieving a Therapeutic Glycemic Response at Week 24 and Change From Baseline in the Mean Value of 24-hour Glucose at Week 2.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Insulin Glargine in 650 people.

With 650 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, all human trials.