Phase 3
Completed N=933
A Study of LY900014 Compared to Insulin Lispro in Participants With Type 2 Diabetes
Source: ClinicalTrials.gov NCT03214380 ↗Enrolled (actual)
933
Serious AEs
4.2%
Results posted
Mar 2020
Primary outcomePrimary: Change From Baseline in Hemoglobin A1c (HbA1c) Efficacy Estimand at Week 26 — -0.43; -0.38 percentage of HbA1c
Summary
The purpose of this study is to compare LY900014 to insulin lispro, both in combination with insulin glargine or insulin degludec, in participants with type 2 diabetes (T2D).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Hemoglobin A1c (HbA1c) Efficacy Estimand at Week 26 |
-0.43; -0.38 | — |
| SECONDARY 1-hour Postprandial Glucose (PPG) Excursion During Mixed-Meal Tolerance Test (MMTT) Efficacy Estimand |
74.9; 63.1 | <0.001 sig |
| SECONDARY 2-hour PPG Excursion During MMTT Efficacy Estimand |
97.8; 80.4 | <0.001 sig |
| SECONDARY Rate of Severe Hypoglycemia |
4.19; 2.44 | — |
| SECONDARY Rate of Documented Symptomatic Hypoglycemia |
1.34; 2.21 | — |
| SECONDARY Change From Baseline in 1,5-Anhydroglucitol (1,5-AG) at Week 26 |
2.15; 1.99 | — |
| SECONDARY Change From Baseline in 10-Point Self-Monitoring Blood Glucose (SMBG) Values at Week 26 |
-0.8; 1.5; -2.0; -14.1; 0.6; -14.9 | — |
| SECONDARY Change From Baseline in Insulin Dose at Week 26 |
4.2; 4.6; 8.3; 12.0; 12.1; 17.3 | — |
| SECONDARY Change From Baseline in Insulin Treatment Satisfaction Questionnaire (ITSQ) Regimen Inconvenience Domain Score at Week 26 |
-0.9; -2.4 | — |
| SECONDARY Change From Baseline in ITSQ Lifestyle Flexibility Domain Score at Week 26 |
1.4; 0.2 | — |
| SECONDARY Number of Participants With HbA1c <7% |
168; 184 | — |
Eligibility Criteria
Inclusion Criteria
- Have been diagnosed (clinically) with T2D, based on the World Health Organization (WHO) classification for at least 1 year prior to screening.
- Have been treated for at least 90 days prior to screening with:
- Basal insulin (insulin glargine U-100 [Basaglar/Abasaglar or LANTUS] or U-300, insulin detemir, insulin degludec U-100 or U-200, or neutral protamine Hagedorn [NPH] insulin) in combination with at least 1 prandial injection of bolus insulin (insulin lispro U-100 or U-200, insulin aspart, insulin glulisine, or regular insulin) Or
- Premixed analog or human insulin regimens with any basal and bolus insulin combination injected at least twice daily
- Participants may be treated with up to 3 of the following oral antihyperglycemic medications (OAMs) in accordance with local regulations:
- Metformin
- Dipeptidyl peptidase-4 (DPP-4) inhibitor
- Sodium glucose cotransporter 2 (SGLT2) inhibitor
- Sulfonylurea
- Meglitinide
- Alpha-glucoside inhibitor
- Have an HbA1c value between ≥7.0 and ≤10.0%, according to the central laboratory at the time of screening.
- Have a body mass index (BMI) of ≤45.0 kilograms per meter squared at screening.
Exclusion Criteria
- Have been diagnosed, at any time, with type 1 diabetes (T1D) or Latent Autoimmune Diabetes in Adults.
- Have hypoglycemia unawareness as judged by the investigator.
- Have had any episode of severe hypoglycemia within the 6 months prior to screening.
- Have had 1 or more episodes of diabetic ketoacidosis or hyperglycemic hyperosmolar state within the 6 months prior to screening.
- Have used thiazolidinediones, Glucagon-Like Peptide 1 (GLP-1) receptor agonist, or pramlintide within 90 days prior to screening.
Data sourced from ClinicalTrials.gov (NCT03214380). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.