The DURABLE Trial: Evaluating the Durability of Starter Insulin Regimens in Patients With Type 2 Diabetes (IOOV)

What Was Tested

This registered phase 4 trial tested Insulin Glargine and Insulin Lispro.

This study will compare insulin lispro low mixture \[LM\] and insulin glargine both in combination with the patient's oral diabetes medicines, for their ability to control blood sugar in patients with type 2 diabetes and compare insulin lispro LM to insulin glargine with regard to the length of time that the overall blood sugar can be controlled.

The addendum study (Intensification Addendum) will compare how different insulin treatments work to control blood sugar in patients whose diabetes could not be controlled by either insulin lispro LM or insulin glargine.

It had six arms (groups): Insulin glargine (active comparator), Lispro Low Mix (experimental), Lispro Mid Mix prior Lispro Low Mix addendum (experimental), Lispro Low Mix prior Glargine addendum (experimental) and Basal bolus prior Lispro Low Mix addendum (active comparator).

Initiation Phase: Insulin glargine for 24 weeks Maintenance: Up to an additional 2 years of insulin glargine if glycosylated hemoglobin (HbA1c) less than or equal to 7.0 at 24 weeks.

Initiation Phase: Lispro Low Mix (LM) for 24 weeks Maintenance Phase: Up to an additional 2 years of Lispro LM if HbA1c less than or equal to 7.0 at 24 weeks.

Following Lispro LM Initiation Phase, if HbA1c greater than 7.0 after 24 weeks, then instead of entering Maintenance Phase, participants could be randomized to receive Lispro Mid Mix for 24 weeks in the Intensification Addendum Phase.

The registry classes the interventions as drug.

Who Took Part

2091 actual participants took part.

It was open to people of any sex aged from 30 years up to 79 years.

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

Examples of who could join: Must have type 2 diabetes. Must be at least 30 and less than 80 years of age at the time of Visit 1. Must be on at least two oral antidiabetes medications for at least 90 days. Must have an HbA1c 1.2 to 2.0 times the upper limit of normal reference range at the local lab.

The full record lists 4 inclusion and 5 exclusion criteria; among the exclusions: must not have used insulin on a regular basis in the last 12 months; must not have had more than one episode of severe hypoglycemia in the last 24 weeks; must not have a body mass index (bmi) of greater than 45 (morbid obesity).

How the Study Was Run

It was run as a randomized, parallel-group and open-label study.

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

Groups ran in parallel: each of the participants stayed in one arm throughout.

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

It started in 2005-12 with completion listed for 2009-11.

It ran at 199 sites in United States (138), Canada (9), India (7), Netherlands (7), Spain (7) and Australia (6).

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): INITIATION: 24-Week Endpoint Glycosylated Hemoglobin (HbA1c) (time frame: Endpoint (Initiation: Week 24)). MAINTENANCE: Duration of Time HbA1c Maintained at Goal by Initiation Regimen (Insulin Glargine or Lispro Low Mix) (time frame: Endpoint (Last Observation Carried Forward [LOCF]) (Maintenance: up to 2.5 years)). ADDENDUM: 24-Week Endpoint HbA1c (time frame: Endpoint (Addendum) (24 weeks: Week 48)).

It also tracked 53 secondary outcomes, for example INITIATION: Change in HbA1c From Baseline to 24 Weeks, INITIATION: HbA1c, INITIATION: 7-point Self-monitored Plasma Glucose (SMPG) Profiles and Postprandial Excursions, INITIATION: Incremental Change From Baseline in Body Weight, INITIATION: Body Weight and INITIATION: Percentage of Participants With Self-reported Hypoglycemic Episodes.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Insulin Glargine and Insulin Lispro in 2091 people.

With 2091 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.