Status:
COMPLETED
A Study of LY2963016 Compared to Lantus® in Adult Chinese Participants With Type 1 Diabetes Mellitus
Lead Sponsor:
Eli Lilly and Company
Conditions:
Type 1 Diabetes
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief 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 (T...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
March 23 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 5 2020
Estimated Enrollment :
272 Patients enrolled
Trial Details
Trial ID
NCT03338023
Start Date
March 23 2018
End Date
March 5 2020
Last Update
March 29 2021
Active Locations (20)
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1
Peking University Peoples Hospital
Beijing, Beijing Municipality, China, 100044
2
Guangdong Province People's Hospital
Guangzhou, Guangdong, China, 510080
3
The First Affiliated Hospital, Sun-Yat Sen University
Guangzhou, Guangdong, China, 510080
4
Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University
Guangzhou, Guangdong, China, 510120