A Study of LY2963016 Compared to Lantus® in Adult Chinese Participants With Type 2 Diabetes Mellitus

Type 2 Diabetes Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03338010
• Other study ID #: 16037
• Secondary ID: I4L-GH-ABET
• Status: Completed
• Phase: Phase 3
• Start date: March 22, 2018
• Est. completion date: March 18, 2020

Study information

• Verified date: May 2021
• Source: Eli Lilly and Company
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 536
• Est. completion date: March 18, 2020
• Est. primary completion date: March 18, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type 2 Diabetes

Intervention

Drug:
• LY2963016
Administered SC
• Lantus®
Administered SC

Locations

Country	Name	City	State
China	Peking Union Medical College Hospital	Beijing
China	No.2 Hospital Affiliated to Jilin University	Changchun City	Jilin
China	Changzhou No.2 People's Hospital	Changzhou	Jiangsu
China	West China Hospital of Sichuan University	Chengdu	Sichuan
China	Chongqing General Hospital	Chongqing
China	Dalian Med. Univ. No 2 Affiliate Hospital	Dalian	Liao Ning
China	Guangdong Province People's Hospital	Guangzhou	Guangdong
China	Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University	Guangzhou	Guangdong
China	The First Affiliated Hospital, Sun-Yat Sen University	Guangzhou	Guangdong
China	Anhui Provincial Hospital	Hefei	Anhui
China	The Affliated Jiangyin Hospital of Southeast University Medical College	Jiangyin	Jiangsu
China	Jinan Central Hospital	Jinan	Shandong
China	The First Affiliated Hospital of Lanzhou University	Lanzhou	Gansu
China	The 1st Affiliated Hospital of Henan Science and technology	Luoyang	Henan
China	Nanjing Drum Tower Hosp Affiliated Hosp of Nanjing Univ Med	Nanjing	Jiangsu
China	Nanjing First Hospital	Nanjing	Jiangsu
China	Nanjing Jiangning Hospital	Nanjing	Jiangsu
China	The First Affiliated Hospital with Nanjing Medical Universit	Nanjing	Nanjing
China	The Second Affiliated Hospital of Nanjing Medical University	Nanjing	Jiangsu
China	Shanghai Putuo District Center Hospital	Shanghai
China	Shantou University Medical College No.2 Affiliated Hospital	Shantou	Guang Dong Province
China	Shengjing Hospital of China Medical University	Shenyang	Liaoning
China	Siping central people's hospital	Siping	Jilin
China	1st affiliated Hospital of Shanxi Medical University	Tai Yuan	Shan XI
China	Tianjin Medical University General Hospital	Tianjin
China	Tongji Hosp Tongji Med Col Huazhong Univ of Sci & Tech	Wu Han	Hubei
China	Wuhan Central Hospital	Wuhan	Hubei
China	Wuxi People's Hospital	Wuxi	Jiangsu
China	Xuzhou central Hospital	Xuzhou	Jiangsu
China	General Hospital of Ningxia Medical University	Yinchuan	Ningxia
China	The First People Hospital of Yueyang	Yueyang	Hunan
China	Affiliated Hospital of Jiangsu University	Zhenjiang	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
Eli Lilly and Company

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change From Baseline in Hemoglobin A1c (HbA1c) (LY2963016 to Lantus®)	HbA1c is the glycosylated fraction of hemoglobin A. HbA1c is measured primarily to identify average plasma glucose concentration over prolonged periods of time. Least square (LS) mean was calculated by mixed-effects model for repeated measures (MMRM) with baseline, insulin secretagogues at study entry, treatment, visit and treatment*visit in the model.	Baseline, Week 24
Secondary	Change From Baseline in HbA1c (Lantus® to LY2963016)	HbA1c is a form of hemoglobin that is measured primarily to identify the average plasma glucose concentration over prolonged periods of time. LS mean was calculated by MMRM with baseline, insulin secretagogues at study entry, treatment, visit and treatment*visit in the model.	Baseline, Week 24
Secondary	Change From Baseline in 7-Point Self-Monitored Blood Glucose (SMBG) Values	Seven-point SMBG are completed at the following timepoints: Before Morning Meal, 2 Hours After Morning Meal, Before Mid-Day Meal, 2 Hours After Mid-Day Meal, Before Evening Meal, 2 Hours After Evening Meal and Bed Time. LS mean was calculated by MMRM with baseline, insulin secretagogues at study entry, baseline HbA1c, treatment, time and treatment*time in the model.	Baseline, Week 24
Secondary	Percentage of Participants With HbA1c <7% at Week 24	The percentage of participants was calculated by dividing the number of participants reaching target HbA1c by the total number of participants analyzed, multiplied by 100.	Week 24
Secondary	Percentage of Participants With HbA1c =6.5% at Week 24	The percentage of participants was calculated by dividing the number of participants reaching target HbA1c by the total number of participants analyzed, multiplied by 100.	Week 24
Secondary	Change From Baseline in Glycemic Variability of Fasting Blood Glucose	Glycemic variability is measured by the intra-participant standard deviation (SD) value of fasting blood glucose as measured by the actual morning and daily pre-meal blood glucose value from the 7-point self-monitoring blood glucose [SMBG] profiles. LS mean was calculated by MMRM with baseline, insulin secretagogues at study entry, baseline HbA1c, treatment, time and treatment*time in the model.	Baseline, Week 24
Secondary	Basal Insulin Dose Units Per Day	Units of basal insulin dose taken per day (U/day). LS mean was calculated by MMRM with baseline, insulin secretagogues at study entry, baseline HbA1c, treatment, time and treatment*time in the model.	At Week 24
Secondary	Change From Baseline in Basal Insulin Dose Units Per Day	Units of basal insulin dose taken per day (U/day). LS mean was calculated by MMRM with baseline, insulin secretagogues at study entry, baseline HbA1c, treatment, time and treatment*time in the model.	Baseline, Week 24
Secondary	Change From Baseline in Body Weight	Change from baseline in body weight was evaluated. LS mean was calculated by MMRM with baseline, insulin secretagogues at study entry, baseline HbA1c, treatment, time and treatment*time in the model.	Baseline, Week 24
Secondary	Insulin Treatment Satisfaction Questionnaire (ITSQ)	ITSQ is a validated instrument containing 22 items that assess treatment satisfaction for participants with diabetes and on insulin. Items divided into 5 domains of satisfaction: Inconvenience of Regimen [(IR) 5 items: domain scores range (DSR) 5-35], Lifestyle Flexibility [(LF) 3 items: DSR 3-21], Glycemic Control [(GC) 3 items: DSR 3-21], Hypoglycemic Control [(HC) 5 items: DSR 5-35], Insulin Delivery Device [(IDD) 6 items: DSR 6-42]. All items measured on a 7-point scale: 1 (no bother at all) to 7 (a tremendous bother), with lower scores reflecting better outcomes. ITSQ Total Overall Raw Scores range from 22-154. Both raw domain and overall scores are transformed on a scale of 0-100, where transformed score=100*[(7-mean raw score)/6]. Higher scores indicate better treatment satisfaction. LS mean was calculated by MMRM with baseline, insulin secretagogues at study entry, baseline HbA1c, treatment, time and treatment*time in the model.	At Week 24
Secondary	Number of Participants With Detectable Anti-Glargine Antibodies	Number of participants with detectable anti-glargine antibodies were reported.	Baseline through 24 weeks
Secondary	Rate of Total Symptomatic and Nocturnal Hypoglycemia Events (Adjusted by 1 Year)	Hypoglycemic episodes are defined as events that are associated with reported signs and symptoms of hypoglycemia and/or documented blood glucose (BG) concentrations of =70 mg/dL (3.9 mmol/L). The overall yearly rates (events/participant/year) of those hypoglycemic events, calculated as, for each participant, the number of episodes times 365.25 and then divided by the participants treatment duration, will be summarized, and analyzed by a negative-binomial regression model with treatment as fixed effects and log of (participant's treatment duration/365.25) as an offset variable. A nocturnal hypoglycemic event is defined as any total hypoglycemia event that occurred between bedtime and waking.	Baseline through 24 weeks