Evaluation of Insulin Glargine in Combination With Sitagliptin in Type 2 Diabetes Patients: EASIE Extension Trial

What Was Tested

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

This study was the extension of the LANTU\_C\_02761 study named EASIE and identified as NCT00751114 (core study comparing insulin glargine versus sitagliptin in insulin-naïve patients treated with metformin and not adequately controlled).

The visit 14 of the core study (week 24) was the visit 1 (baseline, week 0) of the extension study which consisted of a 12-week treatment period.

It had 1 arm (groups): Combination insulin glargine and sitagliptin (experimental).

The registry classes the interventions as drug.

Who Took Part

Enrollment: 112 actual participants took part.

It was open to people of any sex aged from 35 years up to 71 years.

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

Examples of who could join: Patients who completed the core study LANTU\_C\_02761 (NCT00751114) i.e. went through the visit 14 investigation,. Signed informed consent obtained prior any study procedure,. Willingness and ability to comply with the study protocol.

The full record lists 6 inclusion and 14 exclusion criteria; among the exclusions: treatment with oral antidiabetic drugs other than metformin and sitagliptin in the core study,; treatment with a non-permitted drug during the core study,; pregnant or lactating women,.

How the Study Was Run

Design: single-group and open-label.

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

Everyone received the same intervention, so there was no separate comparison group inside the trial.

It started in 2009-06 with completion listed for 2011-09.

It ran at 16 sites in United States (1), Austria (1), Brazil (1), Colombia (1), Egypt (1) and Greece (1).

Its stated primary purpose is treatment.

What Was Measured

It also tracked 6 secondary outcomes, for example HbA1c: Change From Baseline to Study Endpoint, Self-Monitored Fasting Plasma Glucose (SMFPG) Mean : Change From Baseline to Study Endpoint, 7-point Plasma Glucose Profile: Change From Baseline to Study Endpoint, Number of Patients With at Least One Episode of Symptomatic Hypoglycemia and Change in Body Weight From Baseline to Study Endpoint.

What This Means in Plain Language

Put simply, this is a phase 3 trial of Insulin Glargine in 112 people.

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.