Back to resultsA Study of LY900014 Compared to Insulin Lispro (Humalog) in Adults With Type 1 Diabetes
Primary Purpose
Type 1 Diabetes Mellitus
Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
LY900014
Insulin Lispro
Insulin Glargine
Insulin Degludec
Sponsored by
About this trial
This is an interventional treatment trial for Type 1 Diabetes Mellitus
Eligibility Criteria
Inclusion Criteria:
- 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).
Exclusion Criteria:
- Participants must not have used other anti-hyperglycemic medications or therapies (inhaled, oral or injectable) except for metformin within 90-days of screening.
- Participants must not have had more than 1 severe hypoglycemic episode within 6 months of screening.
- Participants must not have had more than 1 hospitalization related to hyperglycemia or diabetic ketoacidosis within 6 months of screening.
Sites / Locations
- Centro de Investigaciones Metabólicas (CINME)
- Centro Médico Viamonte
- Cent Priva Especiali Médicas Ambulatorias Inve Clin CEMAIC
- The Second People's Hospital of Hefei
- Shantou University Medical College No.2 Affiliated Hospital
- Dongguan people's hospital
- Sun Yat-sen Memorial Hospital, Sun Yat-sen University
- Shenzhen Second People's Hospital
- The Fourth Affiliated Hospital of Harbin Medical University
- The First Affiliated Hospital of Henan University of Science &Technology
- The First People's Hospital of Changde City
- The Second Xiangya Hospital of Central South University
- Changzhou No.2 People's Hospital
- Nanjing Drum Tower Hospital The Affiliated Hospital of Nanjing University Medical School
- The First Hospital of Nanjing
- Sir Run Run Hospital of Nanjing Medical University
- The Second Affiliated Hospital of Soochow University
- Affiliated Hospital of Jiangsu University
- No.2 Hospital Affiliated to Jilin University
- The First Hospital of Jilin University
- Shengjing Hospital of China Medical University
- Jiangsu Province Hospital
- Shanghai Tenth People's Hospital
- West China Hospital Sichuan University
- Beijing Peking Union Medical College Hospital
- Shanghai Putuo District Center Hospital
- Xinhua Hospital Affiliated to Shanghai Jiaotong University School of Medicine
- Unidad de Investigaci�n Cl�nica Cardiometabolica de Occidente
- Unidad de patologia Clinica
- Hospital Universitario "Dr. Jose Eleuterio Gonzalez"
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
LY900014
Insulin Lispro (Humalog)
Arm Description
Participants 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.
Participants 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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
1-hour Postprandial Glucose (PPG) Excursion During Mixed-Meal Tolerance Test (MMTT)
A standardized MMTT was used to characterize postprandial glucose control following administration of the study insulin. Serum glucose measured at 1-hour timepoint after the start of meal minus fasting serum glucose. LS mean was determined by analysis of covariance (ANCOVA) model with Baseline + Pooled Country + Hemoglobin A1c Stratum at Baseline + Use of Metformin at Study Entry + Type of Basal at Lead-in Stratum + Treatment (Type III sum of squares) as variables.
2-hour PPG Excursion During MMTT
A standardized MMTT was used to characterize postprandial glucose control following administration of the study insulin. Serum glucose measured at 2-hour timepoint after the start of meal minus fasting serum glucose. LS mean was determined by analysis of covariance (ANCOVA) model with Baseline + Pooled Country + Hemoglobin A1c Stratum at Baseline + Use of Metformin at Study Entry + Type of Basal at Lead-in Stratum + Treatment (Type III sum of squares) as variables.
Rate of Severe Hypoglycemia
Severe hypoglycemia is defined as an event requiring assistance of another person to administer carbohydrate, glucagon, or other resuscitative actions. Rate of severe hypoglycemia events per 100 years during a defined period was calculated by total number of severe hypoglycemia episodes within the period divided by the cumulative days on treatment from all participants within that treatment group *36525 days.
Rate of Documented Symptomatic Post Meal Hypoglycemia
Documented symptomatic post meal hypoglycemia is an event during which typical symptoms of hypoglycemia are accompanied by blood glucose (BG) of ≤70 mg/dL [3.9 millimole per liter (mmol/L)]. The rate of documented symptomatic post meal hypoglycemia per year during a defined period is calculated by the total number of documented symptomatic post meal hypoglycemia events within the period divided by the cumulative days on treatment from all participants within that treatment group *365.25.
Change From Baseline in 1,5-Anhydroglucitol (1,5-AG)
1,5-anhydroglucitol (1,5-AG) is a marker of short-term glycemic control especially postprandial hyperglycemia. It accurately predicts rapid changes in glycemia and is tightly associated with glucose fluctuations and postprandial glucose. LS mean was determined by MMRM model with Baseline + Pooled Country + Hemoglobin A1c Stratum at Baseline + Use of Metformin at Study Entry + Type of Basal at Lead-in Stratum + Treatment + Time + Treatment*Time (Type III sum of squares) as variables.
Change From Baseline in 10-Point Self-Monitoring Blood Glucose (SMBG) Values
SMBG 10-point profiles were measured at morning (premeal-fasting, 1-hour post meal, 2-hour post meal), midday (premeal, 1-hour post meal, 2-hour post meal), evening (premeal, 1-hour post meal, 2-hour post meal) and bedtime. LS Mean was determined by MMRM model with Baseline + Pooled Country + Hemoglobin A1c Stratum at Baseline + Use of Metformin at Study Entry + Type of Basal at Lead-in Stratum + Treatment + Time + Treatment*Time (Type III sum of squares) as variables.
Change From Baseline in Daily Insulin Dose
LS mean was determined by MMRM model with Baseline + Pooled Country + Hemoglobin A1c Stratum at Baseline + Use of Metformin at Study Entry + Type of Basal at Lead-in Stratum + Treatment + Time + Treatment*Time (Type III sum of squares) as variables.
Percentage of Participants With HbA1c <7% and ≤6.5%
HbA1c is the glycosylated fraction of hemoglobin A. It is measured to identify average plasma glucose concentration over prolonged periods of time.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03952130
Brief Title
A Study of LY900014 Compared to Insulin Lispro (Humalog) in Adults With Type 1 Diabetes
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Completed
Study Start Date
May 29, 2019 (Actual)
Primary Completion Date
January 10, 2022 (Actual)
Study Completion Date
January 10, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Eli Lilly and Company
4. Oversight
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
Data Monitoring Committee
No
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 1 Diabetes Mellitus
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
354 (Actual)
8. Arms, Groups, and Interventions
Arm Title
LY900014
Arm Type
Experimental
Arm Description
Participants 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.
Arm Title
Insulin Lispro (Humalog)
Arm Type
Active Comparator
Arm Description
Participants 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.
Intervention Type
Drug
Intervention Name(s)
LY900014
Other Intervention Name(s)
Ultra-Rapid Lispro
Intervention Description
Administered SC
Intervention Type
Drug
Intervention Name(s)
Insulin Lispro
Other Intervention Name(s)
LY275585, Humalog
Intervention Description
Administered SC
Intervention Type
Drug
Intervention Name(s)
Insulin Glargine
Intervention Description
Administered SC
Intervention Type
Drug
Intervention Name(s)
Insulin Degludec
Intervention Description
Administered SC
Primary Outcome Measure Information:
Title
Change From Baseline in Hemoglobin A1c (HbA1c)
Description
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.
Time Frame
Baseline, Week 26
Secondary Outcome Measure Information:
Title
1-hour Postprandial Glucose (PPG) Excursion During Mixed-Meal Tolerance Test (MMTT)
Description
A standardized MMTT was used to characterize postprandial glucose control following administration of the study insulin. Serum glucose measured at 1-hour timepoint after the start of meal minus fasting serum glucose. LS mean was determined by analysis of covariance (ANCOVA) model with Baseline + Pooled Country + Hemoglobin A1c Stratum at Baseline + Use of Metformin at Study Entry + Type of Basal at Lead-in Stratum + Treatment (Type III sum of squares) as variables.
Time Frame
Week 26
Title
2-hour PPG Excursion During MMTT
Description
A standardized MMTT was used to characterize postprandial glucose control following administration of the study insulin. Serum glucose measured at 2-hour timepoint after the start of meal minus fasting serum glucose. LS mean was determined by analysis of covariance (ANCOVA) model with Baseline + Pooled Country + Hemoglobin A1c Stratum at Baseline + Use of Metformin at Study Entry + Type of Basal at Lead-in Stratum + Treatment (Type III sum of squares) as variables.
Time Frame
Week 26
Title
Rate of Severe Hypoglycemia
Description
Severe hypoglycemia is defined as an event requiring assistance of another person to administer carbohydrate, glucagon, or other resuscitative actions. Rate of severe hypoglycemia events per 100 years during a defined period was calculated by total number of severe hypoglycemia episodes within the period divided by the cumulative days on treatment from all participants within that treatment group *36525 days.
Time Frame
Baseline through Week 26
Title
Rate of Documented Symptomatic Post Meal Hypoglycemia
Description
Documented symptomatic post meal hypoglycemia is an event during which typical symptoms of hypoglycemia are accompanied by blood glucose (BG) of ≤70 mg/dL [3.9 millimole per liter (mmol/L)]. The rate of documented symptomatic post meal hypoglycemia per year during a defined period is calculated by the total number of documented symptomatic post meal hypoglycemia events within the period divided by the cumulative days on treatment from all participants within that treatment group *365.25.
Time Frame
Baseline through Week 26
Title
Change From Baseline in 1,5-Anhydroglucitol (1,5-AG)
Description
1,5-anhydroglucitol (1,5-AG) is a marker of short-term glycemic control especially postprandial hyperglycemia. It accurately predicts rapid changes in glycemia and is tightly associated with glucose fluctuations and postprandial glucose. LS mean was determined by MMRM model with Baseline + Pooled Country + Hemoglobin A1c Stratum at Baseline + Use of Metformin at Study Entry + Type of Basal at Lead-in Stratum + Treatment + Time + Treatment*Time (Type III sum of squares) as variables.
Time Frame
Baseline, Week 26
Title
Change From Baseline in 10-Point Self-Monitoring Blood Glucose (SMBG) Values
Description
SMBG 10-point profiles were measured at morning (premeal-fasting, 1-hour post meal, 2-hour post meal), midday (premeal, 1-hour post meal, 2-hour post meal), evening (premeal, 1-hour post meal, 2-hour post meal) and bedtime. LS Mean was determined by MMRM model with Baseline + Pooled Country + Hemoglobin A1c Stratum at Baseline + Use of Metformin at Study Entry + Type of Basal at Lead-in Stratum + Treatment + Time + Treatment*Time (Type III sum of squares) as variables.
Time Frame
Baseline, Week 26
Title
Change From Baseline in Daily Insulin Dose
Description
LS mean was determined by MMRM model with Baseline + Pooled Country + Hemoglobin A1c Stratum at Baseline + Use of Metformin at Study Entry + Type of Basal at Lead-in Stratum + Treatment + Time + Treatment*Time (Type III sum of squares) as variables.
Time Frame
Baseline, Week 26
Title
Percentage of Participants With HbA1c <7% and ≤6.5%
Description
HbA1c is the glycosylated fraction of hemoglobin A. It is measured to identify average plasma glucose concentration over prolonged periods of time.
Time Frame
Week 26
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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).
Exclusion Criteria:
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
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)
Organizational Affiliation
Eli Lilly and Company
Official's Role
Study Director
Facility Information:
Facility Name
Centro de Investigaciones Metabólicas (CINME)
City
Caba
State/Province
Buenos Aires
ZIP/Postal Code
C1056ABJ
Country
Argentina
Facility Name
Centro Médico Viamonte
City
Caba
State/Province
Buenos Aires
ZIP/Postal Code
C1120AAC
Country
Argentina
Facility Name
Cent Priva Especiali Médicas Ambulatorias Inve Clin CEMAIC
City
Cordoba
ZIP/Postal Code
X5008HHW
Country
Argentina
Facility Name
The Second People's Hospital of Hefei
City
Hefei
State/Province
Anhui
ZIP/Postal Code
230011
Country
China
Facility Name
Shantou University Medical College No.2 Affiliated Hospital
City
Shantou
State/Province
Guang Dong Province
ZIP/Postal Code
515041
Country
China
Facility Name
Dongguan people's hospital
City
Dongguan
State/Province
Guangdong
ZIP/Postal Code
523059
Country
China
Facility Name
Sun Yat-sen Memorial Hospital, Sun Yat-sen University
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510120
Country
China
Facility Name
Shenzhen Second People's Hospital
City
Shenzhen
State/Province
Guangdong
ZIP/Postal Code
518039
Country
China
Facility Name
The Fourth Affiliated Hospital of Harbin Medical University
City
Harbin
State/Province
Heilongjiang
ZIP/Postal Code
150001
Country
China
Facility Name
The First Affiliated Hospital of Henan University of Science &Technology
City
Luoyang
State/Province
Henan
ZIP/Postal Code
471003
Country
China
Facility Name
The First People's Hospital of Changde City
City
Changde
State/Province
Hunan
ZIP/Postal Code
415003
Country
China
Facility Name
The Second Xiangya Hospital of Central South University
City
Changsha
State/Province
Hunan
ZIP/Postal Code
410011
Country
China
Facility Name
Changzhou No.2 People's Hospital
City
Changzhou
State/Province
Jiangsu
ZIP/Postal Code
213003
Country
China
Facility Name
Nanjing Drum Tower Hospital The Affiliated Hospital of Nanjing University Medical School
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210000
Country
China
Facility Name
The First Hospital of Nanjing
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210006
Country
China
Facility Name
Sir Run Run Hospital of Nanjing Medical University
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
211166
Country
China
Facility Name
The Second Affiliated Hospital of Soochow University
City
Suzhou
State/Province
Jiangsu
ZIP/Postal Code
215004
Country
China
Facility Name
Affiliated Hospital of Jiangsu University
City
Zhenjiang
State/Province
Jiangsu
ZIP/Postal Code
212000
Country
China
Facility Name
No.2 Hospital Affiliated to Jilin University
City
Changchun City
State/Province
Jilin
ZIP/Postal Code
130041
Country
China
Facility Name
The First Hospital of Jilin University
City
Changchun
State/Province
Jilin
ZIP/Postal Code
130021
Country
China
Facility Name
Shengjing Hospital of China Medical University
City
Shenyang
State/Province
Liaoning
ZIP/Postal Code
110004
Country
China
Facility Name
Jiangsu Province Hospital
City
Nanjing
State/Province
Nanjing
ZIP/Postal Code
210029
Country
China
Facility Name
Shanghai Tenth People's Hospital
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200072
Country
China
Facility Name
West China Hospital Sichuan University
City
Chengdu
State/Province
Sichuan
ZIP/Postal Code
610041
Country
China
Facility Name
Beijing Peking Union Medical College Hospital
City
Beijing
ZIP/Postal Code
100730
Country
China
Facility Name
Shanghai Putuo District Center Hospital
City
Shanghai
ZIP/Postal Code
200062
Country
China
Facility Name
Xinhua Hospital Affiliated to Shanghai Jiaotong University School of Medicine
City
Shanghai
ZIP/Postal Code
200092
Country
China
Facility Name
Unidad de Investigaci�n Cl�nica Cardiometabolica de Occidente
City
Guadalajara
State/Province
Jalisco
ZIP/Postal Code
44150
Country
Mexico
Facility Name
Unidad de patologia Clinica
City
Guadalajara
State/Province
Jalisco
ZIP/Postal Code
44650
Country
Mexico
Facility Name
Hospital Universitario "Dr. Jose Eleuterio Gonzalez"
City
Monterrey
State/Province
N.l.
ZIP/Postal Code
64460
Country
Mexico
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
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.
IPD Sharing 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.
IPD Sharing Access Criteria
A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
IPD Sharing URL
https://vivli.org/
Links:
URL
https://www.lillytrialguide.com/en-US/studies/type-1-diabetes/ITSD#?postal=
Description
A Study of LY900014 Compared to Insulin Lispro (Humalog) in Adults With Type 1 Diabetes
Learn more about this trial
A Study of LY900014 Compared to Insulin Lispro (Humalog) in Adults With Type 1 Diabetes
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