Comparison of Two Basal Insulins for Patients With Type 2 Diabetes (IOOY)

Plain-language guide to NCT00494013: phase 3 randomized trial of Insulin Lispro and Insulin Detemir, 442 participants. Who took part, design and what was measured.

Key Facts

Registry ID: NCT00494013
Phase: phase 3
Status: completed
Start: 2007-08
Completion (planned or actual): 2008-09
Participants: 442 (actual)
Design: randomized, open label (everyone knows who gets what), treatment
Conditions studied: Diabetes Mellitus Type 2
Results posted: yes

What This Study Did, in Plain Language

What Was Tested

This registered phase 3 trial tested Insulin Lispro and Insulin Detemir.

A gatekeeper strategy will be employed for sequentially testing the secondary objectives.

It had two arms (groups): Insulin Lispro Protamine Suspension (experimental) and Detemir (active comparator).

The registry classes the interventions as drug.

Who Took Part

442 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: Have type 2 diabetes mellitus for at least 1 year. Are at least 18 years old. Body mass index (BMI) greater than or equal to 25 and less than or equal to 45 kilograms per square meter (kg/m2).

The full record lists 5 inclusion and 5 exclusion criteria.

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 Lispro and who got the comparison, which limits bias.

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

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

It started in 2007-08 with completion listed for 2008-09.

It ran at 56 sites in United States (27), Hungary (6), India (5), Taiwan (5), Spain (4) and Poland (3).

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Change From Baseline to 24 Week Endpoint in Hemoglobin A1c (HbA1c) (time frame: Baseline, 24 Weeks).

It also tracked 11 secondary outcomes, for example Actual and Change From Baseline Hemoglobin A1c (HbA1c) Value at 12 Weeks and at 24 Weeks, Glycemic Variability, 7-point Self-monitored Blood Glucose (SMBG) Profile at Endpoint, 1-Year Adjusted Rates of Self-Reported Hypoglycemic Episodes (Including All, Nocturnal, and Severe) Overall, 30-Day Adjusted Rates of Self-Reported Hypoglycemic Episodes (Including All, Nocturnal, and Severe) Overall and Change in Absolute Body Weight (kg) From Baseline to 24 Week Endpoint.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Insulin Lispro and Insulin Detemir in 442 people.

The trial is marked completed; results are posted on the registry, and this page does not restate them.

More context: the Insulin Lispro compound page and the Insulin Detemir compound page, all human trials.

Our Notes on the Compounds

Insulin Lispro: A rapid-acting mealtime insulin analog; brands include Humalog, Admelog and Lyumjev.

Insulin Detemir: A long-acting basal insulin analog sold as Levemir.

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.