Clinical trial NCT03338023: A Study of LY2963016 Compared to Lantus® in Adult Chinese Participants With Type 1 Diabetes Mellitus
Official title: A Prospective, Randomized, Open-Label Comparison of a Long-Acting Basal Insulin Analog, LY2963016, to Lantus® in Combination With Mealtime Insulin Lispro in Adult Chinese Patients With Type 1 Diabetes Mellitus
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Type 1 Diabetes
Keywords: Insulin Glargine
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2017-11-09
Enrollment: 272
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 (T1DM).


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.

Primary outcomes:
measure: Change From Baseline in Hemoglobin A1c (HbA1c) (LY2963016 Noninferior to Lantus®)
timeFrame: Baseline, Week 24
Secondary outcomes:
measure: Change From Baseline in HbA1c (Lantus® Noninferior to LY2963016)
timeFrame: Baseline, Week 24
measure: Change From Baseline in 7-Point Self-Monitored Blood Glucose (SMBG) Values
timeFrame: Baseline, Week 24
measure: Percentage of Participants With HbA1c <7%
timeFrame: Week 24
measure: Percentage of Participants With HbA1c ≤6.5%
timeFrame: Week 24
measure: Change From Baseline in Intrapatient Blood Glucose (BG) Variability, Measured by the Standard Deviation of 7-point SMBG
timeFrame: Baseline, Week 24
measure: Change From Baseline in Glycemic Variability of Fasting Blood Glucose
timeFrame: Baseline, Week 24
measure: Change From Baseline in Basal Insulin Dose
timeFrame: Baseline, Week 24
measure: Change From Baseline in Prandial Insulin Dose
timeFrame: Baseline, Week 24
measure: Change From Baseline in Body Weight
timeFrame: Baseline, Week 24
measure: Change From Baseline in Insulin Treatment Satisfaction Questionnaire (ITSQ)
timeFrame: Baseline, Week 24
measure: Number of Participants With Detectable Anti-Glargine Antibodies
timeFrame: Baseline through Week 24
measure: Rate of Documented Symptomatic Hypoglycemia
timeFrame: Baseline through Week 24
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University Peoples Hospital
state: Beijing
city: Shantou
country: China
facility: Shantou University Medical College No.2 Affiliated Hospital
state: Guang Dong Province
city: Guangzhou
country: China
facility: Guangdong Province People's Hospital
state: Guangdong
city: Guangzhou
country: China
facility: The First Affiliated Hospital, Sun-Yat Sen University
state: Guangdong
city: Guangzhou
country: China
facility: Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University
state: Guangdong
city: Luoyang
country: China
facility: The 1st Affiliated Hospital of Henan Science and technology
state: Henan
city: Wu Han
country: China
facility: Wu Han Tongji Hospital
state: Hu Bei
city: Changsha
country: China
facility: The Second Xiangya Hospital of Central South University
state: Hunan
city: Changzhou
country: China
facility: Changzhou No.2 People's Hospital
state: Jiangsu
city: Nanjing
country: China
facility: The Second Affiliated Hospital of Nanjing Medical University
state: Jiangsu
city: Nanjing
country: China
facility: Nanjing First Hospital
state: Jiangsu
city: Zhenjiang
country: China
facility: Affiliated Hospital of Jiangsu University
state: Jiangsu
city: Changchun City
country: China
facility: No.2 Hospital Affiliated to Jilin University
state: Jilin
city: Dalian
country: China
facility: Dalian Med. Univ. No 2 Affiliate Hospital
state: Liao Ning
city: Nanjing
country: China
facility: The First Affiliated Hospital with Nanjing Medical Universit
state: Nanjing
city: Shanghai
country: China
facility: Shanghai Tenth People's Hospital
state: Shanghai
city: Chengdu
country: China
facility: West China Hospital of Sichuan University
state: Sichuan
city: Kunming
country: China
facility: First People's Hospital of Yunnan Province
state: Yunnan
city: Beijing
country: China
facility: Peking Union Medical College Hospital
city: Shanghai
country: China
facility: Shanghai Putuo District Center Hospital
Study officials:
affiliation: Eli Lilly and Company
name: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
role: STUDY_DIRECTOR
References:
citation: Yan X, Feng C, Lou Y, Zhou Z. Efficacy and Safety of LY2963016 Insulin Glargine in Chinese Patients with Type 1 Diabetes Previously Treated with Insulin Glargine (Lantus(R)): a Post Hoc Analysis of a Randomized, Open-Label, Phase 3 Trial. Diabetes Ther. 2022 Jun;13(6):1161-1174. doi: 10.1007/s13300-022-01262-8. Epub 2022 Apr 26.