A Study of LY900014 Compared to Insulin Lispro (Humalog) in Adults With Type 2 Diabetes
A Prospective, Randomized, Double-Blind Comparison of LY900014 to Insulin Lispro, Both in Combination With Insulin Glargine or Insulin Degludec in Adults With Type 2 Diabetes
2 other identifiers
interventional
628
3 countries
41
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 2 diabetes (T2D).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3 type-2-diabetes-mellitus
Started May 2019
41 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
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 27, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 20, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
January 20, 2021
CompletedResults Posted
Study results publicly available
February 8, 2022
CompletedFebruary 8, 2022
January 1, 2022
1.7 years
May 14, 2019
January 11, 2022
January 11, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
Change From Baseline in Hemoglobin A1c (HbA1c)
HbA1c is the glycosylated fraction of hemoglobin A. HbA1c 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).
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 Postmeal 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
ACTIVE COMPARATORParticipants received 100 U/mL insulin lispro (Humalog) given 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 T2D based on the disease diagnostic criteria World Health Organization (WHO) classification.
- Participants must have been treated for at least 90 days prior to screening with either basal insulin + at least 1 prandial injection of bolus insulin or premixed analog/human insulin regimens at least twice daily.
- Participants must be treated no more than 3 oral anti-hyperglycemic medications (OAMs).
- Participants must have a HbA1c ≥7.0% and ≤11.0%.
- Participants must have body mass index (BMI) of ≤35.0 kilograms per meter squared (kg/m2).
You may not qualify if:
- Participants must not have been diagnosed, at any time, with type 1 diabetes (T1D) or latent autoimmune diabetes in adults.
- Participants must not have had any episode of severe hypoglycemia within the 6 months prior to screening.
- Participants must not have had 1 or more episodes of diabetic ketoacidosis or hyperglycemic hyperosmolar state within the 6 months prior to screening.
- Participants must not have used thiazolidinediones, glucagon-like peptide 1 (GLP-1) receptor agonist, or pramlintide within 90 days prior to screening.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (41)
Centro Médico Viamonte
Buenos Aires, AR-C, C1120AAC, Argentina
Centro de Investigaciones Metabólicas (CINME)
CABA, Buenos Aires, C1056ABJ, Argentina
Cent Priva Especiali Médicas Ambulatorias Inve Clin CEMAIC
Córdoba, X5008HHW, Argentina
Beijing Pinggu District Hospital
Beijing, Cn-11, 101200, China
Tianjin Medical University General Hospital
Tianjin, Cn-12, 300052, China
Cangzhou People's Hospital
Cangzhou, Cn-13, 061000, China
The First Hospital of Qinhuangdao
Qinhuangdao Shi, Cn-13, 066000, China
Inner Mongolia People's Hospital
Hohhot, Cn-15, 010017, China
Dalian Municipal Central Hospital Affiliated of Dalian Medical University
Dalian, Cn-21, 116033, China
Shengjing Hospital of China Medical University
Shenyang, Cn-21, 110004, China
Shanghai Putuo District Center Hospital
Shanghai, Cn-31, 200062, China
Shanghai 6th people's hospital
Shanghai, Cn-31, China
The Affiliated Jiangyin Hospital of Southeast University Medical College
Jiangyin, Cn-32, 214400, China
Zhongda Hospital Southeast University
Nanjing, Cn-32, 210009, China
Nanjing Medical University - Nanjing Jiangning Hospital
Nanjing, Cn-32, 211100, China
Affiliated Hospital of Jiangsu University
Zhenjiang, Cn-32, 212000, China
The Third Hospital of Nanchang
Nanchang, Cn-36, 330009, China
The Central Hospital of Wuhan
Wuhan, Cn-42, China
The First People's Hospital of Yueyang
Yueyang, Cn-43, 414000, China
Chongqing General Hospital
Chongqing, Cn-50, 400014, China
Fujian Medical University Union Hospital
Fuzhou, Fujian, 350001, China
Xingtai People's Hospital
Xingtai, Hebei, 054031, China
The Fourth Affiliated Hospital of Harbin Medical University
Harbin, Heilongjiang, 150001, China
The First Hospital of Qiqihar
Qiqihar, Heilongjiang, 161006, China
The First Affiliated Hospital of Henan University of Science &Technology
Luoyang, Henan, 471003, China
Wuhan Pu'ai Hospital
Wuhan, Hubei, 430000, China
Yichang Central People's Hospital
Yichang, Hubei, 443003, China
Chenzhou NO.1 People's Hospital
Chenzhou, Hunan, 424300, China
Changzhou No.2 People's Hospital
Changzhou, Jiangsu, 213003, China
The First Hospital of Nanjing
Nanjing, Jiangsu, 210012, China
China-Japan Union Hospital, CJUH.
Changchun, Jilin, 130033, China
Siping Central People's Hospital
Siping, Jilin, 136000, China
Qinghai University Affiliated Hospital
Xining, Qinghai, 810001, China
Jinan Central Hospital
Jinan, Shandong, 250013, China
The First Affiliated Hospital of Xi'an Medical University
Xi’an, Shanxi, China
Beijing Peking Union Medical College Hospital
Beijing, 100730, China
Pingxiang People's Hospital
Pingxiang, 337000, China
Unidad de patologia Clinica
Guadalajara, Jalisco, 44650, Mexico
Centro de Inv. Medica de Occidente, SC
Zapopan, Jalisco, 45116, Mexico
Unidad Médica para la Salud Integral
San Nicolás de los Garza, Mx-nle, 66465, 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 27, 2019
Primary Completion
January 20, 2021
Study Completion
January 20, 2021
Last Updated
February 8, 2022
Results First Posted
February 8, 2022
Record last verified: 2022-01
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.