Clinical trial NCT03952143: A Study of LY900014 Compared to Insulin Lispro (Humalog) in Adults With Type 2 Diabetes
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Type 2 Diabetes Mellitus
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2019-05-16
Enrollment: 628
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 2 diabetes (T2D).


Eligibility criteria: Inclusion Criteria:

* 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).

Exclusion Criteria:

* 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.

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 Postmeal 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 Insulin Dose
timeFrame: Baseline, Week 26
measure: Percentage of Participants With HbA1c <7% and ≤6.5%
timeFrame: Week 26
Other outcomes:
Locations:
city: Buenos Aires
country: Argentina
facility: Centro Médico Viamonte
state: Ar-c
city: Caba
country: Argentina
facility: Centro de Investigaciones Metabólicas (CINME)
state: Buenos Aires
city: Cordoba
country: Argentina
facility: Cent Priva Especiali Médicas Ambulatorias Inve Clin CEMAIC
city: Beijing
country: China
facility: Beijing Pinggu District Hospital
state: Cn-11
city: Tianjin
country: China
facility: Tianjin Medical University General Hospital
state: Cn-12
city: Cangzhou
country: China
facility: Cangzhou People's Hospital
state: Cn-13
city: Qinhuangdao Shi
country: China
facility: The First Hospital of Qinhuangdao
state: Cn-13
city: Hohhot
country: China
facility: Inner Mongolia People's Hospital
state: Cn-15
city: Dalian
country: China
facility: Dalian Municipal Central Hospital Affiliated of Dalian Medical University
state: Cn-21
city: Shenyang
country: China
facility: Shengjing Hospital of China Medical University
state: Cn-21
city: Shanghai
country: China
facility: Shanghai Putuo District Center Hospital
state: Cn-31
city: Shanghai
country: China
facility: Shanghai 6th people's hospital
state: Cn-31
city: Jiangyin
country: China
facility: The Affiliated Jiangyin Hospital of Southeast University Medical College
state: Cn-32
city: Nanjing
country: China
facility: Zhongda Hospital Southeast University
state: Cn-32
city: Nanjing
country: China
facility: Nanjing Medical University - Nanjing Jiangning Hospital
state: Cn-32
city: Zhenjiang
country: China
facility: Affiliated Hospital of Jiangsu University
state: Cn-32
city: Nanchang
country: China
facility: The Third Hospital of Nanchang
state: Cn-36
city: Wuhan
country: China
facility: The Central Hospital of Wuhan
state: Cn-42
city: Yueyang
country: China
facility: The First People's Hospital of Yueyang
state: Cn-43
city: Chongqing
country: China
facility: Chongqing General Hospital
state: Cn-50
city: Fuzhou
country: China
facility: Fujian Medical University Union Hospital
state: Fujian
city: Xingtai
country: China
facility: Xingtai People's Hospital
state: Hebei
city: Harbin
country: China
facility: The Fourth Affiliated Hospital of Harbin Medical University
state: Heilongjiang
city: Qiqihar
country: China
facility: The First Hospital of Qiqihar
state: Heilongjiang
city: Luoyang
country: China
facility: The First Affiliated Hospital of Henan University of Science &Technology
state: Henan
city: Wuhan
country: China
facility: Wuhan Pu'ai Hospital
state: Hubei
city: Yichang
country: China
facility: Yichang Central People's Hospital
state: Hubei
city: Chenzhou
country: China
facility: Chenzhou NO.1 People's Hospital
state: Hunan
city: Changzhou
country: China
facility: Changzhou No.2 People's Hospital
state: Jiangsu
city: Nanjing
country: China
facility: The First Hospital of Nanjing
state: Jiangsu
city: Changchun
country: China
facility: China-Japan Union Hospital, CJUH.
state: Jilin
city: Siping
country: China
facility: Siping Central People's Hospital
state: Jilin
city: Xining
country: China
facility: Qinghai University Affiliated Hospital
state: Qinghai
city: Jinan
country: China
facility: Jinan Central Hospital
state: Shandong
city: XI 'an
country: China
facility: The First Affiliated Hospital of Xi'an Medical University
state: Shanxi
city: Beijing
country: China
facility: Beijing Peking Union Medical College Hospital
city: Pingxiang
country: China
facility: Pingxiang People's Hospital
city: Guadalajara
country: Mexico
facility: Unidad de patologia Clinica
state: Jalisco
city: Zapopan
country: Mexico
facility: Centro de Inv. Medica de Occidente, SC
state: Jalisco
city: San Nicolás de los Garza
country: Mexico
facility: Unidad Médica para la Salud Integral
state: Mx-nle
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: