Switching From Insulin Glargine to Insulin Degludec in Subjects With Type 2 Diabetes Mellitus (BEGIN™)

Plain-language guide to NCT01135992: phase 3 non-randomized trial of Insulin Glargine, 143 participants. Who took part, design and what was measured.

Key Facts

Registry ID: NCT01135992
Phase: phase 3
Status: completed
Start: 2010-06
Completion (planned or actual): 2010-11
Participants: 143 (actual)
Design: non-randomized, open label (everyone knows who gets what), treatment
Conditions studied: Diabetes; Diabetes Mellitus, Type 2
Results posted: yes

What This Study Did, in Plain Language

What Was Tested

This registered phase 3 trial tested Insulin Glargine.

This trial is conducted in the United States of America (USA).

The aim of this clinical trial is to assess the implications of switching from insulin glargine (IGlar) to insulin degludec (IDeg) in subjects with type 2 diabetes mellitus.

It had two arms (groups): IGlar/IDeg (experimental) and IDeg 3TW (experimental).

The registry classes the interventions as drug.

Who Took Part

143 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: Type 2 diabetes mellitus (diagnosed clinically) for at least 6 months.

The full record lists 3 inclusion and 6 exclusion criteria; among the exclusions: use within the last three months prior to visit 1 of: exenatide, liraglutide or thiazoledinediones (tzds) other than pioglitazone; pregnancy, breast-feeding, the intention of becoming pregnant or not using adequate contraceptive measures according to local requirements; known or suspected hypersensitivity to trial products or related products.

How the Study Was Run

Design: non-randomized, 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 2010-06 with completion listed for 2010-11.

It ran at 27 sites in United States (27).

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: HbA1c (Glycosylated Haemoglobin) (time frame: Week 4 and Week 16).

It also tracked 5 secondary outcomes, for example Fasting Plasma Glucose (FPG), Change in Body Weight, Rate of Treatment Emergent Adverse Events (AEs), Rate of Confirmed Hypoglycaemic Episodes and Rate of Nocturnal Confirmed Hypoglycaemic Episodes.

What This Means in Plain Language

Put simply, this is a phase 3, non-randomized trial of Insulin Glargine in 143 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.

Our Notes on the Compound

Insulin Glargine: A long-acting insulin analog given once daily; brands include Lantus, Toujeo, Basaglar and Semglee.

Insulin Glargine in the library

Source: ClinicalTrials.gov record. This explanation is written by PeptideWhiz from the public record. For research and education only. Not medical advice; no dosing information is given.