Clinical trial NCT03952130: 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
Overall status: COMPLETED
Phase: PHASE3
Conditions: Type 1 Diabetes Mellitus
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2019-05-16
Enrollment: 354
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).


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.

Primary outcomes:
measure: Change From Baseline in Hemoglobin A1c (HbA1c)
timeFrame: Baseline, Week 26
Secondary outcomes:
measure: 1-hour Postprandial Glucose (PPG) Excursion During Mixed-Meal Tolerance Test (MMTT)
timeFrame: Week 26
measure: 2-hour PPG Excursion During MMTT
timeFrame: Week 26
measure: Rate of Severe Hypoglycemia
timeFrame: Baseline through Week 26
measure: Rate of Documented Symptomatic Post Meal Hypoglycemia
timeFrame: Baseline through Week 26
measure: Change From Baseline in 1,5-Anhydroglucitol (1,5-AG)
timeFrame: Baseline, Week 26
measure: Change From Baseline in 10-Point Self-Monitoring Blood Glucose (SMBG) Values
timeFrame: Baseline, Week 26
measure: Change From Baseline in Daily Insulin Dose
timeFrame: Baseline, Week 26
measure: Percentage of Participants With HbA1c <7% and ≤6.5%
timeFrame: Week 26
Other outcomes:
Locations:
city: Caba
country: Argentina
facility: Centro de Investigaciones Metabólicas (CINME)
state: Buenos Aires
city: Caba
country: Argentina
facility: Centro Médico Viamonte
state: Buenos Aires
city: Cordoba
country: Argentina
facility: Cent Priva Especiali Médicas Ambulatorias Inve Clin CEMAIC
city: Hefei
country: China
facility: The Second People's Hospital of Hefei
state: Anhui
city: Shantou
country: China
facility: Shantou University Medical College No.2 Affiliated Hospital
state: Guang Dong Province
city: Dongguan
country: China
facility: Dongguan people's hospital
state: Guangdong
city: Guangzhou
country: China
facility: Sun Yat-sen Memorial Hospital, Sun Yat-sen University
state: Guangdong
city: Shenzhen
country: China
facility: Shenzhen Second People's Hospital
state: Guangdong
city: Harbin
country: China
facility: The Fourth Affiliated Hospital of Harbin Medical University
state: Heilongjiang
city: Luoyang
country: China
facility: The First Affiliated Hospital of Henan University of Science &Technology
state: Henan
city: Changde
country: China
facility: The First People's Hospital of Changde City
state: Hunan
city: Changsha
country: China
facility: The Second Xiangya Hospital of Central South University
state: Hunan
city: Changzhou
country: China
facility: Changzhou No.2 People's Hospital
state: Jiangsu
city: Nanjing
country: China
facility: Nanjing Drum Tower Hospital The Affiliated Hospital of Nanjing University Medical School
state: Jiangsu
city: Nanjing
country: China
facility: The First Hospital of Nanjing
state: Jiangsu
city: Nanjing
country: China
facility: Sir Run Run Hospital of Nanjing Medical University
state: Jiangsu
city: Suzhou
country: China
facility: The Second Affiliated Hospital of Soochow University
state: Jiangsu
city: Zhenjiang
country: China
facility: Affiliated Hospital of Jiangsu University
state: Jiangsu
city: Changchun City
country: China
facility: No.2 Hospital Affiliated to Jilin University
state: Jilin
city: Changchun
country: China
facility: The First Hospital of Jilin University
state: Jilin
city: Shenyang
country: China
facility: Shengjing Hospital of China Medical University
state: Liaoning
city: Nanjing
country: China
facility: Jiangsu Province Hospital
state: Nanjing
city: Shanghai
country: China
facility: Shanghai Tenth People's Hospital
state: Shanghai
city: Chengdu
country: China
facility: West China Hospital Sichuan University
state: Sichuan
city: Beijing
country: China
facility: Beijing Peking Union Medical College Hospital
city: Shanghai
country: China
facility: Shanghai Putuo District Center Hospital
city: Shanghai
country: China
facility: Xinhua Hospital Affiliated to Shanghai Jiaotong University School of Medicine
city: Guadalajara
country: Mexico
facility: Unidad de Investigaci�n Cl�nica Cardiometabolica de Occidente
state: Jalisco
city: Guadalajara
country: Mexico
facility: Unidad de patologia Clinica
state: Jalisco
city: Monterrey
country: Mexico
facility: Hospital Universitario "Dr. Jose Eleuterio Gonzalez"
state: N.l.
Study officials:
affiliation: Eli Lilly and Company
name: 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)
role: STUDY_DIRECTOR
References: