Patient Preference and Satisfaction With Insulin Glargine (Lantus) Solostar Pen vs Conventional Vial-Syringe Method of Lantus Injection Therapy in Patients With Type 2 Diabetes Mellitus

What Was Tested

The trial (phase 4) is built around Insulin Glargine.

It had two arms (groups): Lantus (insulin glargine) vial & syringe (experimental) and Lantus (insulin glargine) SoloSTAR pen (experimental).

The registry classes the interventions as drug.

More on the Plan

This study consisted of a 1 week Screening Phase, a 4-week Randomization/Crossover Phase, a 6-week Re-randomization Phase, followed by a 30 week Observational Phase.

The total duration of study participation was up to 41 weeks with a total treatment duration of up to 40 weeks of Lantus exposure.

Who Took Part

The registry lists 405 actual participants took part.

It was open to people of any sex aged from 18 years up to 85 years.

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

Examples of who could join: Metformin + sulfonylurea + thiazolidinedione (Pioglitazone). Metformin + sulfonylurea. Metformin + thiazolidinedione (Pioglitazone). Metformin + dipeptidyl peptidase (DPPIV).

The full record lists 4 inclusion and 17 exclusion criteria; among the exclusions: patients less than 18 years or greater than 85 years of age (ie, have not reached the age of 86 at the screening visit); patients with a confirmed diagnosis of type 1 diabetes mellitus; patients with current addiction or current alcohol / drug abuse.

How the Study Was Run

Design: randomized, crossover and open-label.

Because people in this Insulin Glargine study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

Each person switched between Insulin Glargine and the comparison at some point, usually with a gap in between.

Everyone knew when Insulin Glargine was being given (open label), which is simpler to run but leaves more room for expectations to affect what is reported.

It started in 2010-10 with completion listed for 2012-05.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Patient Overall Preference (time frame: At week 4 (end of crossover phase)).

It also tracked 10 secondary outcomes, for example Patient Preference Composite Score, Healthcare Professional's (HCP) Recommendation, Change in Fasting Plasma Glucose (FPG), Percentage of Patients Achieving HbA1c Goal, Percentage of Patients Who Discontinued Investigational Product (IP) During the Crossover Phase and Percentage of Patients Who Discontinued Investigational Product During the Re-randomization Phase.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Insulin Glargine in 405 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.