Safety and Efficacy of Technosphere® Insulin Inhalation Powder and Lantus® Compared to Humalog® and Lantus® Over 16-Weeks

Plain-language guide to NCT00700622: phase 3 randomized trial of Insulin Glargine and Insulin Lispro, 130 participants. Who took part, design and what was measured.

Key Facts

Registry ID: NCT00700622
Phase: phase 3
Status: terminated early
Start: 2008-05
Completion (planned or actual): 2009-11
Participants: 130 (actual)
Design: randomized, open label (everyone knows who gets what), treatment
Conditions studied: Diabetes, Type 1
Results posted: yes

What This Study Did, in Plain Language

What Was Tested

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

It had two arms (groups): TI + Insulin glargine (experimental) and Insulin lispro + Insulin glargine (experimental).

Technosphere Insulin Inhalation Powder in combination with Lantus (insulin glargine).

Humalog (insulin lispro) in combination with Lantus (insulin glargine).

The registry classes the interventions as drug.

Who Took Part

130 actual participants took part.

It was open to people of any sex aged from 18 years up to 80 years.

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

Examples of who could join: Men or women ≥ 18 and ≤ 80 years old. Clinical diagnosis of type 1 diabetes mellitus for more than 12 months. Body mass index (BMI) ≤ 30 kg/m2. Nonsmokers (includes cigarettes, cigars, pipes, and chewing tobacco) for at least the preceding 6 months. Negative urine cotinine defined as ≤ 100 ng/mL.

The full record lists 15 inclusion and 42 exclusion criteria; among the exclusions: treatment with any type of antidiabetic drugs, other than sc insulin, within the preceding 12 weeks; two or more severe hypoglycemic episodes within 6 months of screening or episode of severe hypoglycemia between visit 1 and visit 5; previous exposure to an inhaled insulin product within 3 months of visit 1.

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.

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

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

It started in 2008-05 with completion listed for 2009-11.

It ran at 22 sites in United States (20) and Brazil (2).

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Change From Baseline in HbA1c to Week 16 (time frame: Baseline to Week 16).

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Insulin Glargine and Insulin Lispro in 130 people.

It ended early (terminated); 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.

Our Notes on the Compounds

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

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

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.