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A Study of LY2963016 Compared to Lantus® in Adult Chinese Participants With Type 1 Diabetes Mellitus

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ClinicalTrials.gov Identifier: NCT03338023
Recruitment Status : Recruiting
First Posted : November 9, 2017
Last Update Posted : May 22, 2019
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company

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).

Condition or disease Intervention/treatment Phase
Type 1 Diabetes Drug: LY2963016 Drug: Lantus® Drug: Insulin Lispro Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 258 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : March 23, 2018
Estimated Primary Completion Date : April 27, 2020
Estimated Study Completion Date : April 27, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diabetes Type 1

Arm Intervention/treatment
Experimental: LY2963016 + Insulin Lispro
LY2963016 administered subcutaneously (SC) with insulin lispro administered SC.
Drug: LY2963016
Administered SC

Drug: Insulin Lispro
Administered SC

Active Comparator: Lantus® + Insulin Lispro
Lantus® administered SC with insulin lispro administered SC.
Drug: Lantus®
Administered SC

Drug: Insulin Lispro
Administered SC




Primary Outcome Measures :
  1. Change from Baseline in Hemoglobin A1c (HbA1c) (LY2963016 Noninferior to Lantus®) [ Time Frame: Baseline, 24 Weeks ]
    Change from baseline in HbA1c (LY2963016 noninferior to Lantus®)


Secondary Outcome Measures :
  1. Change from Baseline in HbA1c (Lantus® Noninferior to LY2963016) [ Time Frame: Baseline, 24 Weeks ]
    Change from baseline in HbA1c (Lantus® noninferior to LY2963016)

  2. Change from Baseline in 7-Point Self-Monitored Blood Glucose (SMBG) Values [ Time Frame: Baseline, 24 Weeks ]
    Change from baseline in 7-point SMBG values

  3. Percentage of Participants with HbA1c <7% [ Time Frame: 24 Weeks ]
    Percentage of participants with HbA1c <7%

  4. Percentage of Participants with HbA1c ≤6.5% [ Time Frame: 24 Weeks ]
    Percentage of participants with HbA1c ≤6.5%

  5. Glycemic Variability of Fasting Blood Glucose [ Time Frame: 24 Weeks ]
    Glycemic variability of fasting blood glucose

  6. Change from Baseline in Basal Insulin Dose [ Time Frame: 24 Weeks ]
    Change from baseline in basal insulin dose

  7. Prandial Insulin Dose [ Time Frame: 24 Weeks ]
    Prandial insulin dose

  8. Change from Baseline in Body Weight [ Time Frame: Baseline, 24 Weeks ]
    Change from baseline in body weight

  9. Insulin Treatment Satisfaction Questionnaire (ITSQ) [ Time Frame: 24 Weeks ]
    ITSQ

  10. Number of Participants with Detectable Anti-Glargine Antibodies [ Time Frame: Baseline through 24 Weeks ]
    Number of participants with detectable anti-glargine antibodies

  11. Rate of Documented Symptomatic Hypoglycemia [ Time Frame: Baseline through 24 Weeks ]
    Rate of documented symptomatic hypoglycemia



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03338023


Contacts
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Contact: There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 clinicaltrials.gov@lilly.com

Locations
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China, Beijing
Peking University Peoples Hospital Recruiting
Beijing, Beijing, China, 100044
Contact    8913910978815      
Principal Investigator: Li Nong Ji         
China, Guang Dong Province
Shantou University Medical College No.2 Affiliated Hospital Recruiting
Shantou, Guang Dong Province, China, 515041
Contact    8613502776666      
Principal Investigator: LiShu Chen         
China, Guangdong
Guangdong Province People's Hospital Recruiting
Guangzhou, Guangdong, China, 510080
Contact    8613802511168      
Principal Investigator: Jian Kuang         
The First Affiliated Hospital, Sun-Yat Sen University Recruiting
Guangzhou, Guangdong, China, 510080
Contact    8613925111691      
Principal Investigator: Yan Bing Li         
Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University Recruiting
Guangzhou, Guangdong, China, 510120
Contact    862081332518      
Principal Investigator: Yan Li         
China, Henan
The 1st Affiliated Hospital of Henan Science and technology Recruiting
Luoyang, Henan, China, 471003
Contact    8637964815362      
Principal Investigator: Jie LIU         
China, Hu Bei
Wu Han Tongji Hospital Recruiting
Wu Han, Hu Bei, China, 430030
Contact    862783663323      
Principal Investigator: Xuefeng Yu         
China, Hunan
The Second Xiangya Hospital of Central South University Recruiting
Changsha, Hunan, China, 410011
Contact    8613873104348      
Principal Investigator: Zhou Zhiguang         
China, Jiangsu
Changzhou No.2 People's Hospital Recruiting
Changzhou, Jiangsu, China, 213003
Contact    8613776803256      
Principal Investigator: Yun Xue         
The Second Affiliated Hospital of Nanjing Medical University Recruiting
Nanjing, Jiangsu, China, 210011
Contact    8618951762690      
Principal Investigator: Yi Bing LU         
Nanjing First Hospital Recruiting
Nanjing, Jiangsu, China, 210012
Contact    862552887091      
Principal Investigator: Jianhua Ma         
Affiliated Hospital of Jiangsu University Recruiting
Zhenjiang, Jiangsu, China, 212001
Contact    86051185026805      
Principal Investigator: Guoyue Yuan         
China, Jilin
No.2 Hospital Affiliated to Jilin University Recruiting
Changchun City, Jilin, China, 130041
Contact    8643188796974      
Principal Investigator: Han Qing Cai         
China, Liao Ning
Dalian Med. Univ. No 2 Affiliate Hospital Recruiting
Dalian, Liao Ning, China, 116023
Contact    8615541178798      
Principal Investigator: Benli Su         
China, Nanjing
The First Affiliated Hospital with Nanjing Medical Universit Recruiting
Nanjing, Nanjing, China, 210029
Contact    862568136466      
Principal Investigator: Tao Yang         
China, Shanghai
Shanghai Tenth People's Hospital Recruiting
Shanghai, Shanghai, China, 200072
Contact    8613585792519      
Principal Investigator: Shen Qu         
China, Sichuan
West China Hospital of Sichuan University Recruiting
Chengdu, Sichuan, China, 610041
Contact    8613980548888      
Principal Investigator: Zhenmei An         
China, Yunnan
First People's Hospital of Yunnan Province Recruiting
Kunming, Yunnan, China, 650034
Contact    8613759143562      
Principal Investigator: Heng Su         
China
Peking Union Medical College Hospital Recruiting
Beijing, China, 88798
Contact    8613581705295      
Principal Investigator: Yuxiu Li         
Shanghai Putuo District Center Hospital Recruiting
Shanghai, China, 200062
Contact    8613611756518      
Principal Investigator: Tao Lei         
Sponsors and Collaborators
Eli Lilly and Company
Investigators
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Study Director: 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) Eli Lilly and Company

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Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT03338023     History of Changes
Other Study ID Numbers: 16036
I4L-GH-ABES ( Other Identifier: Eli Lilly and Company )
First Posted: November 9, 2017    Key Record Dates
Last Update Posted: May 22, 2019
Last Verified: May 1, 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Lilly provides access to the individual patient data from studies on approved medicines and indications as defined by the sponsor specific information on ClinicalStudyDataRequest.com This access is provided in a timely fashion after the primary publication is accepted. Researchers need to have an approved research proposal submitted through ClinicalStudyDataRequest.com. Access to the data will be provided in a secure data sharing environment after signing a data sharing agreement.

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes

Keywords provided by Eli Lilly and Company:
Insulin Glargine

Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Insulin
Insulin, Globin Zinc
Insulin Lispro
Insulin Glargine
Hypoglycemic Agents
Physiological Effects of Drugs