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This trial is complete. It is no longer accepting participants. Results may be available on ClinicalTrials.gov.

NCT03214380

NCT03214380
Completed Phase 3 🇦🇺 Australian site

Who may be able to join

Who might be able to join this trial:

  • 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:

  • 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.

Phase 3: approximately ~65% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.

Trial details

Status
Completed
Phase
Phase 3
Sponsor
Eli Lilly and Company
Registry
clinicaltrials_gov
Start date
14 July 2017
Est. completion
14 August 2018

Where this trial is recruiting

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

5 site(s) in Australia. Confirm current status and contact details directly with the trial site.

Primary endpoints

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

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

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.

View original record on ClinicalTrials.gov