Phase 3
Completed N=1,392
A Study of LY900014 in Participants With Type 1 Diabetes
Source: ClinicalTrials.gov NCT03214367 ↗Enrolled (actual)
1,392
Serious AEs
7.9%
Results posted
May 2020
Primary outcomePrimary: Change From Baseline in Hemoglobin A1c (HbA1c) Efficacy Estimand at Week 26 — -0.13; 0.08; -0.05 Percentage of HbA1c — p=0.060
Summary
The main purpose of this study is to evaluate the efficacy of the study drug LY900014 compared to insulin lispro, both in combination with insulin glargine or insulin degludec, in adults with type 1 diabetes (T1D).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Hemoglobin A1c (HbA1c) Efficacy Estimand at Week 26 |
-0.13; 0.08; -0.05 | 0.060 |
| SECONDARY Change From Baseline in 1-hour Postprandial Glucose (PPG) Excursion During Mixed-Meal Tolerance Test (MMTT) Efficacy Estimand at Week 26 |
-28.6; 12.5; -0.7 | <0.001 sig |
| SECONDARY Change From Baseline in 2-hour PPG Excursion During MMTT Efficacy Estimand at Week 26 |
-34.7; -10.2; -3.5 | <0.001 sig |
| SECONDARY Rate of Severe Hypoglycemia at Week 26 |
16.50; 13.70; 18.34 | — |
| SECONDARY Rate of Documented Symptomatic Hypoglycemia at Week 26 |
6.71; 7.75; 7.35 | — |
| SECONDARY Change From Baseline in 1,5-Anhydroglucitol (1,5-AG) at Week 26 |
0.19; -0.38; -0.22 | — |
| SECONDARY Change From Baseline in 10-Point Self-Monitoring Blood Glucose (SMBG) Values at Week 26 |
-1.1; 2.9; -3.3; -14.8; 5.4; -1.0 | — |
| SECONDARY Change From Baseline in Insulin Dose at Week 26 |
2.9; 2.2; 2.0; 1.0; 1.2; 0.9 | — |
| SECONDARY Change From Baseline in Insulin Treatment Satisfaction Questionnaire (ITSQ) Regimen Inconvenience Domain Score at Week 26 |
1.4; 1.5; 0.7 | — |
| SECONDARY Change From Baseline in ITSQ Lifestyle Flexibility Domain Score at Week 26 |
2.1; 3.7; 1.3 | — |
| SECONDARY Percentage of Participants With HbA1c <7% |
36.00; 24.84; 33.94 | — |
| SECONDARY Change From Baseline in HbA1c at Week 52 |
0.13; 0.20 | 0.184 |
Eligibility Criteria
Inclusion Criteria
- Have T1D for at least 1 year prior to screening and continuously using insulin for at least 1 year.
- HbA1c of ≥7.0 and ≤9.5%.
- Use insulin lispro, insulin aspart, or insulin glulisine as prandial insulin.
- Use insulin glargine, insulin detemir, insulin degludec, or neutral protamine Hagedorn (NPH) insulin as basal insulin.
Exclusion Criteria
- Have used other antihyperglycemic medications or therapies (inhaled, oral or injectable) within 90-days of screening.
- Have had more than 1 severe hypoglycemic episode within 6 months of screening.
- Have had more than 1 hospitalization related to hyperglycemia or diabetic ketoacidosis within 6 months of screening.
- Have clinically significant gastrointestinal disease.
Data sourced from ClinicalTrials.gov (NCT03214367). 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.