A Study of LY900014 Compared to Insulin Lispro (Humalog) in Adults With Type 1 Diabetes
A Prospective, Randomized, Double-Blind Comparison of LY900014 to Insulin Lispro in Combination With Insulin Glargine or Insulin Degludec in Adults With Type 1 Diabetes
2 other identifiers
interventional
354
3 countries
30
Brief Summary
The purpose of this study is to see if LY900014 compared to insulin lispro (Humalog), both in combination with insulin glargine or insulin degludec, is safe and effective in participants with type 1 diabetes (T1D).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started May 2019
Typical duration for phase_3
30 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 14, 2019
CompletedFirst Posted
Study publicly available on registry
May 16, 2019
CompletedStudy Start
First participant enrolled
May 29, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 10, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
January 10, 2022
CompletedResults Posted
Study results publicly available
February 8, 2023
CompletedFebruary 8, 2023
February 1, 2023
2.6 years
May 14, 2019
December 21, 2022
February 3, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
Change From Baseline in Hemoglobin A1c (HbA1c)
HbA1c is the glycosylated fraction of hemoglobin A. It is measured to identify average plasma glucose concentration over prolonged periods of time. Least Squares (LS) mean was determined by mixed model repeated measures (MMRM) model with Baseline + Pooled Country + Number of Bolus at Study Entry Stratum + Type of Basal at Lead-in Stratum + Treatment + Time + Treatment\*Time (Type III sum of squares) as variables.
Baseline, Week 26
Secondary Outcomes (8)
1-hour Postprandial Glucose (PPG) Excursion During Mixed-Meal Tolerance Test (MMTT)
Week 26
2-hour PPG Excursion During MMTT
Week 26
Rate of Severe Hypoglycemia
Baseline through Week 26
Rate of Documented Symptomatic Post Meal Hypoglycemia
Baseline through Week 26
Change From Baseline in 1,5-Anhydroglucitol (1,5-AG)
Baseline, Week 26
- +3 more secondary outcomes
Study Arms (2)
LY900014
EXPERIMENTALParticipants received 100 units per milliliter (U/mL) LY900014 subcutaneously (SC) 0-2 minutes before each meal with either basal insulin glargine or insulin degludec given SC once daily.
Insulin Lispro (Humalog)
ACTIVE COMPARATORParticipants received 100 U/mL insulin lispro SC 0-2 minutes before each meal with either basal insulin glargine or insulin degludec given SC once daily.
Interventions
Eligibility Criteria
You may qualify if:
- Participants must have T1D for at least 1 year prior to screening and continuously using insulin for at least 1 year.
- Participants must have HbA1c of ≥7.0 and ≤10.0%.
- Participants must have been treated for at least 90 days prior to screening with either multiple daily injection(s) (MDI) or premixed analog/human insulin regimens at least twice daily.
- Participants must have body mass index (BMI) of ≤35.0 kilograms per square meter (kg/m2).
You may not qualify if:
- Participants must not have used other anti-hyperglycemic medications or therapies (inhaled, oral or injectable) except for metformin within 90-days prior to screening.
- Participants must not have had more than 1 severe hypoglycemic episode within 6 months prior to screening.
- Participants must not have had more than 1 hospitalization related to hyperglycemia or diabetic ketoacidosis within 6 months prior to screening.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (30)
Centro de Investigaciones Metabólicas (CINME)
CABA, Buenos Aires, C1056ABJ, Argentina
Centro Médico Viamonte
CABA, Buenos Aires, C1120AAC, Argentina
Cent Priva Especiali Médicas Ambulatorias Inve Clin CEMAIC
Córdoba, X5008HHW, Argentina
The Second People's Hospital of Hefei
Hefei, Anhui, 230011, China
Dongguan people's hospital
Dongguan, Guangdong, 523059, China
Sun Yat-sen Memorial Hospital, Sun Yat-sen University
Guangzhou, Guangdong, 510120, China
Shantou University Medical College No.2 Affiliated Hospital
Shantou, Guangdong, 515041, China
Shenzhen Second People's Hospital
Shenzhen, Guangdong, 518039, China
The Fourth Affiliated Hospital of Harbin Medical University
Harbin, Heilongjiang, 150001, China
The First Affiliated Hospital of Henan University of Science &Technology
Luoyang, Henan, 471003, China
The First People's Hospital of Changde City
Changde, Hunan, 415003, China
The Second Xiangya Hospital of Central South University
Changsha, Hunan, 410011, China
Changzhou No.2 People's Hospital
Changzhou, Jiangsu, 213003, China
Nanjing Drum Tower Hospital The Affiliated Hospital of Nanjing University Medical School
Nanjing, Jiangsu, 210000, China
The First Hospital of Nanjing
Nanjing, Jiangsu, 210006, China
Sir Run Run Hospital of Nanjing Medical University
Nanjing, Jiangsu, 211166, China
The Second Affiliated Hospital of Soochow University
Suzhou, Jiangsu, 215004, China
Affiliated Hospital of Jiangsu University
Zhenjiang, Jiangsu, 212000, China
The First Hospital of Jilin University
Changchun, Jilin, 130021, China
No.2 Hospital Affiliated to Jilin University
Changchun, Jilin, 130041, China
Shengjing Hospital of China Medical University
Shenyang, Liaoning, 110004, China
Jiangsu Province Hospital
Nanjing, Nanjing, 210029, China
Shanghai Tenth People's Hospital
Shanghai, Shanghai Municipality, 200072, China
West China Hospital Sichuan University
Chengdu, Sichuan, 610041, China
Beijing Peking Union Medical College Hospital
Beijing, 100730, China
Shanghai Putuo District Center Hospital
Shanghai, 200062, China
Xinhua Hospital Affiliated to Shanghai Jiaotong University School of Medicine
Shanghai, 200092, China
Unidad de Investigaci�n Cl�nica Cardiometabolica de Occidente
Guadalajara, Jalisco, 44150, Mexico
Unidad de patologia Clinica
Guadalajara, Jalisco, 44650, Mexico
Hospital Universitario "Dr. Jose Eleuterio Gonzalez"
Monterrey, N.L., 64460, Mexico
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Chief Medical Officer
- Organization
- Eli Lilly and Company
Study Officials
- 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
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- GT60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 14, 2019
First Posted
May 16, 2019
Study Start
May 29, 2019
Primary Completion
January 10, 2022
Study Completion
January 10, 2022
Last Updated
February 8, 2023
Results First Posted
February 8, 2023
Record last verified: 2023-02
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, CSR
- Time Frame
- Data are available 6 months after the primary publication and approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting.
- Access Criteria
- A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.