Status:
COMPLETED
A Study of LY2963016 Compared to Lantus® in Adult Chinese Participants With Type 2 Diabetes Mellitus
Lead Sponsor:
Eli Lilly and Company
Conditions:
Type 2 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 insulin naïve adult Chinese participants with Type 2 Diabetes Mellitus (T2DM) on 2 or more oral antihyp...
Eligibility Criteria
Inclusion
- Have T2DM based on the disease diagnostic criteria World Health Organization (WHO) classification.
- Have been receiving 2 or more OAMs at stable doses for the 12 weeks prior to screening.
- Have a HbA1c ≥7.0% and ≤11.0%.
- Body mass index (BMI) ≤35 kilograms per meter squared.
Exclusion
- Have used insulin therapy (outside of pregnancy) anytime in the past 1 year, except for short-term treatment of acute conditions, and up to a maximum of 4 continuous weeks.
- Have used any glucagon like peptide (GLP-1) receptor agonists within the previous 90 days.
- Are currently taking traditional medicine (herbal medicine or patent medicine) with known/specified content of anti-hyperglycemic effects within 3 months before screening.
- Have had more than one episode of severe hypoglycemia within 6 months prior to entry into the study.
- Have had ≥2 emergency room visits or hospitalizations due to poor glucose control.
- Have known hypersensitivity or allergy to Lantus® or its excipients.
- Are receiving chronic systemic glucocorticoid therapy at pharmacological doses or have received such therapy within 4 weeks immediately preceding screening.
- Have obvious signs or symptoms, or laboratory evidence, of liver disease.
- Have one of the following concomitant diseases: significant cardiac or gastrointestinal disease.
- Have a history of renal transplantation, are currently receiving renal dialysis or have a serum creatinine greater than 2.0 milligrams per deciliter.
- Have had a blood transfusion or severe blood loss within 3 months prior to screening or have known hemoglobinopathy, hemolytic anemia, or sickle cell anemia.
- Participants with active cancer or personal history of cancer within the previous 5 years.
- Are pregnant or intend to become pregnant during the course of the study.
- Are women who are breastfeeding.
Key Trial Info
Start Date :
March 22 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 18 2020
Estimated Enrollment :
536 Patients enrolled
Trial Details
Trial ID
NCT03338010
Start Date
March 22 2018
End Date
March 18 2020
Last Update
May 25 2021
Active Locations (32)
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1
Anhui Provincial Hospital
Hefei, Anhui, China, 230001
2
The First Affiliated Hospital of Lanzhou University
Lanzhou, Gansu, China, 730000
3
Guangdong Province People's Hospital
Guangzhou, Guangdong, China, 510080
4
The First Affiliated Hospital, Sun-Yat Sen University
Guangzhou, Guangdong, China, 510080