Phase 3
Completed N=272
A Study of LY2963016 Compared to Lantus® in Adult Chinese Participants With Type 1 Diabetes Mellitus
Source: ClinicalTrials.gov NCT03338023 ↗Enrolled (actual)
272
Serious AEs
6.3%
Results posted
Mar 2021
Primary outcomePrimary: Change From Baseline in Hemoglobin A1c (HbA1c) (LY2963016 Noninferior to Lantus®) — -0.20; -0.08 Percentage of HbA1c
◆ Published Evidence
Emerging
2citations · ~1 / year
Efficacy and Safety of LY2963016 Insulin Glargine in Chinese Patients with Type 1 Diabetes Previously Treated with Insulin Glargine (Lantus<sup>®</sup>): a Post Hoc Analysis of a Randomized, Open-Label, Phase 3 Trial.
Summary
The purpose of this study is to compare long-acting basal insulin analog LY2963016 to Lantus® in combination with mealtime insulin lispro in adult Chinese participants with Type 1 Diabetes Mellitus (T1DM).
Linked Publications
-
Efficacy and Safety of LY2963016 Insulin Glargine in Chinese Patients with Type 1 Diabetes Previously Treated with Insulin Glargine (Lantus<sup>®</sup>): a Post Hoc Analysis of a Randomized, Open-Label, Phase 3 Trial.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Hemoglobin A1c (HbA1c) (LY2963016 Noninferior to Lantus®) |
-0.20; -0.08 | — |
| SECONDARY Change From Baseline in HbA1c (Lantus® Noninferior to LY2963016) |
-0.20; -0.08 | — |
| SECONDARY Change From Baseline in 7-Point Self-Monitored Blood Glucose (SMBG) Values |
-7.2; -0.4; -10.6; -2.8; -4.6; 8.5 | 0.191 |
| SECONDARY Percentage of Participants With HbA1c <7% |
30.7; 32.8 | 0.787 |
| SECONDARY Percentage of Participants With HbA1c ≤6.5% |
15.7; 22.4 | 0.201 |
| SECONDARY Change From Baseline in Intrapatient Blood Glucose (BG) Variability, Measured by the Standard Deviation of 7-point SMBG |
-2.9; -2.6 | 0.885 |
| SECONDARY Change From Baseline in Glycemic Variability of Fasting Blood Glucose |
-9.0; -5.5; -10.4; -8.6 | 0.328 |
| SECONDARY Change From Baseline in Basal Insulin Dose |
0.7; 1.5 | 0.090 |
| SECONDARY Change From Baseline in Prandial Insulin Dose |
0.2; 1.4 | 0.089 |
| SECONDARY Change From Baseline in Body Weight |
0.8; 0.9 | 0.770 |
| SECONDARY Change From Baseline in Insulin Treatment Satisfaction Questionnaire (ITSQ) |
3.5; 3.8; 1.3; 2.0; 3.2; 3.8 | 0.879 |
| SECONDARY Number of Participants With Detectable Anti-Glargine Antibodies |
76; 68; 67; 58; 42; 35 | — |
| SECONDARY Rate of Documented Symptomatic Hypoglycemia |
12.6; 14.0 | — |
Eligibility Criteria
Inclusion Criteria
- Have T1DM based on the disease diagnostic criteria (World Health Organization [WHO] Classification).
- Have duration of T1DM ≥1 year.
- Have HbA1c ≤11 %.
- Have been administered with basal-bolus insulins or pre-mixed insulins for at least 90 days prior to screening.
- Have a body mass index (BMI) ≤35 kilograms per meter squared.
Exclusion Criteria
- Exposure to an insulin glargine other than Lantus® within previous 30 days.
- Have had more than one episode of severe hypoglycemia within 6 months prior to entry into the study.
- Have had more than one episode of diabetic ketoacidosis or emergency room visits for uncontrolled diabetes leading to hospitalization within 6 months prior to entry into the study.
- Have known hypersensitivity or allergy to any of the study insulins (Lantus® or insulin lispro) or to excipients of the study insulins.
- Are pregnant, intend to become pregnant during the course of the study.
- Women who are breastfeeding.
- Are currently taking traditional medicine (herbal medicine or patent medicine) with known/specified content of anti-hyperglycemic effects within 3 months before screening.
- Have congestive heart failure Class III and IV.
- Have obvious clinical signs or symptoms, or laboratory evidence, of liver disease.
- Have any active cancer.
- Have a history or diagnosis of human immunodeficiency virus (HIV) infection.
- Have presence of clinically significant gastrointestinal disease.
- Have a history of renal transplantation, or are currently receiving renal dialysis.
- Are receiving chronic systemic glucocorticoid therapy at pharmacological doses.
Data sourced from ClinicalTrials.gov (NCT03338023) and the linked publication. 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.