Phase 3 Type 2 Diabetes Trial, Completed NCT03214380 Sponsor: Eli Lilly and Company Condition: Type 2 Diabetes
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Trial results

AI generated results summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

According to the results reported on ClinicalTrials.gov, this trial (NCT03214380) involved people with diabetes who use mealtime insulin. During a lead-in period, 933 people started on a standard insulin called insulin lispro (Humalog). After that phase, 837 people moved into the main treatment period, where they were split into groups: some continued on insulin lispro, and others switched to a newer insulin called LY900014 (also known as ultra-rapid lispro). The trial's main goal was to measure changes in a blood sugar control marker called HbA1c — a percentage figure that reflects average blood sugar levels over roughly three months — after 26 weeks of treatment. The reported data shows that, at 26 weeks, both groups had lower HbA1c levels than at the start. The insulin lispro group's HbA1c fell by an average of 0.43 percentage points, while the LY900014 group's fell by 0.38 percentage points. For the secondary measurements, which looked at blood sugar rises after a test meal, the LY900014 group had a reported 1-hour post-meal blood sugar rise of 63.1 mg/dL compared to 74.9 mg/dL in the insulin lispro group, and a 2-hour post-meal rise of 80.4 mg/dL compared to 97.8 mg/dL. Regarding low blood sugar (hypoglycaemia) episodes, the reported rate of severe episodes was 2.44 per 100 participant-years for LY900014 and 4.19 for insulin lispro. The rate of documented symptomatic low blood sugar episodes was reported as 2.21 events per participant per 30 days for LY900014 and 1.34 for insulin lispro. A separate blood marker called 1,5-AG, which also reflects blood sugar control, showed a reported increase of 1.99 mg/L for LY900014 and 2.15 mg/L for insulin lispro over the 26-week period. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

These are the results as reported to ClinicalTrials.gov, not medical advice. Verify independently with the trial site and discuss what they mean for you with your doctor.

Phase 3 Type 2 Diabetes Trial, Completed

NCT03214380
Completed Phase 3 🇦🇺 Australian site

voxsanity.com.au · Eligibility summary from public government registries · 18 August 2026 · not medical advice

Who may and may not be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who may be able to join

  • You have been diagnosed with type 2 diabetes (based on World Health Organization guidelines) for at least 1 year before the screening visit.
  • You have been using a long-acting (basal) insulin plus at least one mealtime (bolus) insulin injection for at least 90 days before screening, OR you have been using a premixed insulin injected at least twice daily for at least 90 days before screening.
  • You may also be taking up to 3 of the following diabetes pills: metformin, a DPP-4 inhibitor, an SGLT2 inhibitor, a sulfonylurea, a meglitinide, or an alpha-glucoside inhibitor (confirm with trial site if you are unsure which category your medication falls into).
  • Your HbA1c blood sugar level (a measure of average blood sugar over roughly 3 months) is between 7.0% and 10.0% at the time of screening.
  • Your body mass index (BMI — a measure based on your height and weight) is 45.0 or below at the time of screening.

Who may not be able to join

Each point below is a reason the trial team may not be able to accept someone. It is not a list of requirements to meet.

  • You have ever been diagnosed with type 1 diabetes or a condition called Latent Autoimmune Diabetes in Adults (LADA).
  • You are unable to feel the warning signs of low blood sugar (a condition called hypoglycemia unawareness), as assessed by the study doctor.
  • You have had a severe low blood sugar episode in the 6 months before screening.
  • You have had one or more episodes of diabetic ketoacidosis or a serious high blood sugar emergency called hyperglycemic hyperosmolar state in the 6 months before screening.
  • You have used certain diabetes medications — thiazolidinediones (such as pioglitazone), GLP-1 receptor agonists (such as semaglutide or liraglutide), or pramlintide — within 90 days before screening.

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 30 June 2026

GP referral letter

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Trial details

Status
Completed
Phase
Phase 3
Registry
ClinicalTrials.gov
Start date
14 July 2017
Est. completion
14 August 2018

Where this trial was run

🇦🇷 Argentina 🇦🇺 Australia 🇨🇿 Czechia 🇩🇪 Germany 🇭🇺 Hungary 🇮🇳 India 🇮🇹 Italy 🇯🇵 Japan 🇲🇽 Mexico Puerto Rico 🇷🇺 Russia 🇸🇰 Slovakia 🇰🇷 South Korea 🇪🇸 Spain 🇹🇼 Taiwan 🇺🇸 United States

These are the locations recorded on the registry, including 5 in Australia. They are a historical record: this trial is not enrolling, so they are not places you can join it.

Primary endpoints

Change From Baseline in Hemoglobin A1c (HbA1c) Efficacy Estimand at Week 26

Other options

Expanded access pathways

This trial is not enrolling. Other access pathways exist in general: in Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients. Whether it applies to any treatment studied here is a question for your doctor — nothing on this page says it does.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 30 June 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov