Clinical trial NCT03338010: A Study of LY2963016 Compared to Lantus® in Adult Chinese Participants With Type 2 Diabetes Mellitus
Official title: A Prospective, Randomized, Open-Label Comparison of a Long-Acting Basal Insulin Analog LY2963016 to Lantus® in Adult Chinese Patients With Type 2 Diabetes Mellitus
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Type 2 Diabetes
Keywords: Insulin glargine
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2017-11-09
Enrollment: 536
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 insulin naïve adult Chinese participants with Type 2 Diabetes Mellitus (T2DM) on 2 or more oral antihyperglycemic medications (OAMs). Participants will continue their OAMs throughout the study.


Eligibility criteria: Inclusion Criteria:

* 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 Criteria:

* 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.

Primary outcomes:
measure: Change From Baseline in Hemoglobin A1c (HbA1c) (LY2963016 to Lantus®)
timeFrame: Baseline, Week 24
Secondary outcomes:
measure: Change From Baseline in HbA1c (Lantus® 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% at Week 24
timeFrame: Week 24
measure: Percentage of Participants With HbA1c ≤6.5% at Week 24
timeFrame: Week 24
measure: Change From Baseline in Glycemic Variability of Fasting Blood Glucose
timeFrame: Baseline, Week 24
measure: Basal Insulin Dose Units Per Day
timeFrame: At Week 24
measure: Change From Baseline in Basal Insulin Dose Units Per Day
timeFrame: Baseline, Week 24
measure: Change From Baseline in Body Weight
timeFrame: Baseline, Week 24
measure: Insulin Treatment Satisfaction Questionnaire (ITSQ)
timeFrame: At Week 24
measure: Number of Participants With Detectable Anti-Glargine Antibodies
timeFrame: Baseline through 24 weeks
measure: Rate of Total Symptomatic and Nocturnal Hypoglycemia Events (Adjusted by 1 Year)
timeFrame: Baseline through 24 weeks
Other outcomes:
Locations:
city: Hefei
country: China
facility: Anhui Provincial Hospital
state: Anhui
city: Lanzhou
country: China
facility: The First Affiliated Hospital of Lanzhou University
state: Gansu
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: Tongji Hosp Tongji Med Col Huazhong Univ of Sci & Tech
state: Hubei
city: Wuhan
country: China
facility: Wuhan Central Hospital
state: Hubei
city: Yueyang
country: China
facility: The First People Hospital of Yueyang
state: Hunan
city: Changzhou
country: China
facility: Changzhou No.2 People's Hospital
state: Jiangsu
city: Jiangyin
country: China
facility: The Affliated Jiangyin Hospital of Southeast University Medical College
state: Jiangsu
city: Nanjing
country: China
facility: Nanjing Drum Tower Hosp Affiliated Hosp of Nanjing Univ Med
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: Nanjing
country: China
facility: Nanjing Jiangning Hospital
state: Jiangsu
city: Wuxi
country: China
facility: Wuxi People's Hospital
state: Jiangsu
city: Xuzhou
country: China
facility: Xuzhou central 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: Siping
country: China
facility: Siping central people's hospital
state: Jilin
city: Dalian
country: China
facility: Dalian Med. Univ. No 2 Affiliate Hospital
state: Liao Ning
city: Shenyang
country: China
facility: Shengjing Hospital of China Medical University
state: Liaoning
city: Nanjing
country: China
facility: The First Affiliated Hospital with Nanjing Medical Universit
state: Nanjing
city: Yinchuan
country: China
facility: General Hospital of Ningxia Medical University
state: Ningxia
city: Tai Yuan
country: China
facility: 1st affiliated Hospital of Shanxi Medical University
state: Shan XI
city: Jinan
country: China
facility: Jinan Central Hospital
state: Shandong
city: Chengdu
country: China
facility: West China Hospital of Sichuan University
state: Sichuan
city: Beijing
country: China
facility: Peking Union Medical College Hospital
city: Chongqing
country: China
facility: Chongqing General Hospital
city: Shanghai
country: China
facility: Shanghai Putuo District Center Hospital
city: Tianjin
country: China
facility: Tianjin Medical University General 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: