A Study of LY900014 Compared to Insulin Lispro (Humalog) in Adults With Type 1 Diabetes

Type 1 Diabetes Mellitus Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03952130
• Other study ID #: 16829
• Secondary ID: I8B-FH-ITSD
• Status: Completed
• Phase: Phase 3
• Start date: May 29, 2019
• Est. completion date: January 10, 2022

Study information

• Verified date: February 2023
• Source: Eli Lilly and Company
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 354
• Est. completion date: January 10, 2022
• Est. primary completion date: January 10, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 1
• Type 1 Diabetes Mellitus

Intervention

Drug:
• LY900014
Administered SC
• Insulin Lispro
Administered SC
• Insulin Glargine
Administered SC
• Insulin Degludec
Administered SC

Locations

Country	Name	City	State
Argentina	Centro de Investigaciones Metabólicas (CINME)	Caba	Buenos Aires
Argentina	Centro Médico Viamonte	Caba	Buenos Aires
Argentina	Cent Priva Especiali Médicas Ambulatorias Inve Clin CEMAIC	Cordoba
China	Beijing Peking Union Medical College Hospital	Beijing
China	The First Hospital of Jilin University	Changchun	Jilin
China	No.2 Hospital Affiliated to Jilin University	Changchun City	Jilin
China	The First People's Hospital of Changde City	Changde	Hunan
China	The Second Xiangya Hospital of Central South University	Changsha	Hunan
China	Changzhou No.2 People's Hospital	Changzhou	Jiangsu
China	West China Hospital Sichuan University	Chengdu	Sichuan
China	Dongguan people's hospital	Dongguan	Guangdong
China	Sun Yat-sen Memorial Hospital, Sun Yat-sen University	Guangzhou	Guangdong
China	The Fourth Affiliated Hospital of Harbin Medical University	Harbin	Heilongjiang
China	The Second People's Hospital of Hefei	Hefei	Anhui
China	The First Affiliated Hospital of Henan University of Science &Technology	Luoyang	Henan
China	Jiangsu Province Hospital	Nanjing	Nanjing
China	Nanjing Drum Tower Hospital The Affiliated Hospital of Nanjing University Medical School	Nanjing	Jiangsu
China	Sir Run Run Hospital of Nanjing Medical University	Nanjing	Jiangsu
China	The First Hospital of Nanjing	Nanjing	Jiangsu
China	Shanghai Putuo District Center Hospital	Shanghai
China	Shanghai Tenth People's Hospital	Shanghai	Shanghai
China	Xinhua Hospital Affiliated to Shanghai Jiaotong University School of Medicine	Shanghai
China	Shantou University Medical College No.2 Affiliated Hospital	Shantou	Guang Dong Province
China	Shengjing Hospital of China Medical University	Shenyang	Liaoning
China	Shenzhen Second People's Hospital	Shenzhen	Guangdong
China	The Second Affiliated Hospital of Soochow University	Suzhou	Jiangsu
China	Affiliated Hospital of Jiangsu University	Zhenjiang	Jiangsu
Mexico	Unidad de Investigaci?n Cl?nica Cardiometabolica de Occidente	Guadalajara	Jalisco
Mexico	Unidad de patologia Clinica	Guadalajara	Jalisco
Mexico	Hospital Universitario "Dr. Jose Eleuterio Gonzalez"	Monterrey	N.l.

Sponsors (1)

Lead Sponsor	Collaborator
Eli Lilly and Company

Countries where clinical trial is conducted

Argentina,  China,  Mexico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	Week 26
Secondary	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.	Week 26
Secondary	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.	Baseline through Week 26
Secondary	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.	Baseline through Week 26
Secondary	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.	Baseline, Week 26
Secondary	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.	Baseline, Week 26
Secondary	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.	Baseline, Week 26
Secondary	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.	Week 26

External Links

•   A Study of LY900014 Compared to Insulin Lispro (Humalog) in Adults With Type 1 Diabetes