A Study of LY2963016 Compared to Lantus® in Adult Chinese Participants With Type 2 Diabetes Mellitus
- Registration Number
- NCT03338010
- Lead Sponsor
- Eli Lilly and Company
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 536
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Lantus® Lantus® Insulin naive participants started on 10 U Lantus® given SC QD for 24 weeks. Participants-driven titration was supervised by investigators through the course of the study to maintain the FBG ≤100 mg/dL (5.6 mmol/L) while avoiding hypoglycemia. Participants were allowed to continue oral OAM. LY2963016 LY2963016 Insulin naive participants started on 10 units (U) LY2963016 given subcutaneously (SC) once a day (QD) for 24 weeks. Participants-driven titration was supervised by investigators through the course of the study to maintain the fasting blood glucose (FBG) ≤100 milligram per deciliter (mg/dL) (5.6 millimoles per litre \[mmol/L\]) while avoiding hypoglycemia. Participants were allowed to continue oral antihyperglycemic medication (OAM).
- Primary Outcome Measures
Name Time Method Change From Baseline in Hemoglobin A1c (HbA1c) (LY2963016 to Lantus®) Baseline, Week 24 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.
- Secondary Outcome Measures
Name Time Method Percentage of Participants With HbA1c ≤6.5% at Week 24 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.
Rate of Total Symptomatic and Nocturnal Hypoglycemia Events (Adjusted by 1 Year) Baseline through 24 weeks 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.
Percentage of Participants With HbA1c <7% at Week 24 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.
Basal Insulin Dose Units Per Day At Week 24 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.
Change From Baseline in Basal Insulin Dose Units Per Day Baseline, Week 24 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.
Change From Baseline in Glycemic Variability of Fasting Blood Glucose Baseline, Week 24 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.
Change From Baseline in Body Weight Baseline, Week 24 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.
Insulin Treatment Satisfaction Questionnaire (ITSQ) At Week 24 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.
Change From Baseline in HbA1c (Lantus® to LY2963016) Baseline, Week 24 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.
Change From Baseline in 7-Point Self-Monitored Blood Glucose (SMBG) Values Baseline, Week 24 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.
Number of Participants With Detectable Anti-Glargine Antibodies Baseline through 24 weeks Number of participants with detectable anti-glargine antibodies were reported.
Trial Locations
- Locations (32)
Wuxi People's Hospital
🇨🇳Wuxi, Jiangsu, China
No.2 Hospital Affiliated to Jilin University
🇨🇳Changchun City, Jilin, China
Dalian Med. Univ. No 2 Affiliate Hospital
🇨🇳Dalian, Liao Ning, China
Siping central people's hospital
🇨🇳Siping, Jilin, China
Shantou University Medical College No.2 Affiliated Hospital
🇨🇳Shantou, Guang Dong Province, China
Tongji Hosp Tongji Med Col Huazhong Univ of Sci & Tech
🇨🇳Wu Han, Hubei, China
Changzhou No.2 People's Hospital
🇨🇳Changzhou, Jiangsu, China
Nanjing Drum Tower Hosp Affiliated Hosp of Nanjing Univ Med
🇨🇳Nanjing, Jiangsu, China
The First Affiliated Hospital with Nanjing Medical Universit
🇨🇳Nanjing, Nanjing, China
1st affiliated Hospital of Shanxi Medical University
🇨🇳Tai Yuan, Shan XI, China
Jinan Central Hospital
🇨🇳Jinan, Shandong, China
West China Hospital of Sichuan University
🇨🇳Chengdu, Sichuan, China
The Second Affiliated Hospital of Nanjing Medical University
🇨🇳Nanjing, Jiangsu, China
General Hospital of Ningxia Medical University
🇨🇳Yinchuan, Ningxia, China
Nanjing Jiangning Hospital
🇨🇳Nanjing, Jiangsu, China
Peking Union Medical College Hospital
🇨🇳Beijing, China
Chongqing General Hospital
🇨🇳Chongqing, China
Shanghai Putuo District Center Hospital
🇨🇳Shanghai, China
Anhui Provincial Hospital
🇨🇳Hefei, Anhui, China
The First Affiliated Hospital of Lanzhou University
🇨🇳Lanzhou, Gansu, China
Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University
🇨🇳Guangzhou, Guangdong, China
Guangdong Province People's Hospital
🇨🇳Guangzhou, Guangdong, China
The First Affiliated Hospital, Sun-Yat Sen University
🇨🇳Guangzhou, Guangdong, China
The 1st Affiliated Hospital of Henan Science and technology
🇨🇳Luoyang, Henan, China
Wuhan Central Hospital
🇨🇳Wuhan, Hubei, China
The First People Hospital of Yueyang
🇨🇳Yueyang, Hunan, China
The Affliated Jiangyin Hospital of Southeast University Medical College
🇨🇳Jiangyin, Jiangsu, China
Nanjing First Hospital
🇨🇳Nanjing, Jiangsu, China
Xuzhou central Hospital
🇨🇳Xuzhou, Jiangsu, China
Affiliated Hospital of Jiangsu University
🇨🇳Zhenjiang, Jiangsu, China
Shengjing Hospital of China Medical University
🇨🇳Shenyang, Liaoning, China
Tianjin Medical University General Hospital
🇨🇳Tianjin, China