A Study of LY900014 in Adult Participants With Type 2 Diabetes Mellitus in India

What Was Tested

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

The purpose of this study is to assess the safety of insulin lispro-aabc in adult participants with Type 2 diabetes mellitus in India.

The study will last about 33 weeks for each participant, including screening (1 week), Lead-in period (4 weeks), treatment period (26 weeks) and follow up period (2 weeks).

It had 1 arm (groups): Insulin Lispro-aabc (experimental).

The registry classes the interventions as drug.

Who Took Part

Enrollment: 153 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 (T2DM) for ≥1 year prior to screening. Treated for ≥90 days prior to screening with multiple daily injection (MDI) therapy. Premixed analog or human insulin regimens with any basal and bolus insulin. Body mass index ≤45.0 kg/m². Have access to a telephone, or alternative means for close monitoring/communications.

The full record lists 10 inclusion and 17 exclusion criteria; among the exclusions: having any other condition (including known drug or alcohol abuse, psychiatric disorder including eating disorder) that precludes the subject from following and completing the protocol; have been diagnosed, at any time, with type 1 diabetes mellitus (t1dm) or latent autoimmune diabetes in adults; have hypoglycemia unawareness as judged by the investigator.

How the Study Was Run

The set-up was 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 2024-04-18 with completion listed for 2025-09-02.

It ran at 12 sites in India (12).

Its stated primary purpose is treatment.

What Was Measured

It also tracked 15 secondary outcomes, for example Percentage of Participants With Severe Hypoglycemia, Change From Baseline in Body Weight, Change From Baseline in Hemoglobin A1c (HbA1c), Change From Baseline in Insulin Treatment Satisfaction Questionnaire (ITSQ) Score, Change From Baseline in 1- and 2-hour Postprandial Glucose (PPG) Values Estimated From Self-monitored Blood Glucose (SMBG) Values and Change From Baseline in 9-Point Self-Monitored Blood Glucose (SMBG) Values.

What This Means in Plain Language

Put simply, this is a phase 4 trial of Insulin Glargine and Insulin Lispro in 153 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 and the Insulin Lispro compound page, all human trials.