A Study of LY900014 Compared to Insulin Lispro (Humalog) in Adults With Type 2 Diabetes

Type 2 Diabetes Mellitus Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03952143
• Other study ID #: 16830
• Secondary ID: I8B-FH-ITSE
• Status: Completed
• Phase: Phase 3
• Start date: May 27, 2019
• Est. completion date: January 20, 2021

Study information

• Verified date: January 2022
• 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 2 diabetes (T2D).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 628
• Est. completion date: January 20, 2021
• Est. primary completion date: January 20, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type 2 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 Médico Viamonte	Buenos Aires	Ar-c
Argentina	Centro de Investigaciones Metabólicas (CINME)	Caba	Buenos Aires
Argentina	Cent Priva Especiali Médicas Ambulatorias Inve Clin CEMAIC	Cordoba
China	Beijing Peking Union Medical College Hospital	Beijing
China	Beijing Pinggu District Hospital	Beijing	Cn-11
China	Cangzhou People's Hospital	Cangzhou	Cn-13
China	China-Japan Union Hospital, CJUH.	Changchun	Jilin
China	Changzhou No.2 People's Hospital	Changzhou	Jiangsu
China	Chenzhou NO.1 People's Hospital	Chenzhou	Hunan
China	Chongqing General Hospital	Chongqing	Cn-50
China	Dalian Municipal Central Hospital Affiliated of Dalian Medical University	Dalian	Cn-21
China	Fujian Medical University Union Hospital	Fuzhou	Fujian
China	The Fourth Affiliated Hospital of Harbin Medical University	Harbin	Heilongjiang
China	Inner Mongolia People's Hospital	Hohhot	Cn-15
China	The Affiliated Jiangyin Hospital of Southeast University Medical College	Jiangyin	Cn-32
China	Jinan Central Hospital	Jinan	Shandong
China	The First Affiliated Hospital of Henan University of Science &Technology	Luoyang	Henan
China	The Third Hospital of Nanchang	Nanchang	Cn-36
China	Nanjing Medical University - Nanjing Jiangning Hospital	Nanjing	Cn-32
China	The First Hospital of Nanjing	Nanjing	Jiangsu
China	Zhongda Hospital Southeast University	Nanjing	Cn-32
China	Pingxiang People's Hospital	Pingxiang
China	The First Hospital of Qinhuangdao	Qinhuangdao Shi	Cn-13
China	The First Hospital of Qiqihar	Qiqihar	Heilongjiang
China	Shanghai 6th people's hospital	Shanghai	Cn-31
China	Shanghai Putuo District Center Hospital	Shanghai	Cn-31
China	Shengjing Hospital of China Medical University	Shenyang	Cn-21
China	Siping Central People's Hospital	Siping	Jilin
China	Tianjin Medical University General Hospital	Tianjin	Cn-12
China	The Central Hospital of Wuhan	Wuhan	Cn-42
China	Wuhan Pu'ai Hospital	Wuhan	Hubei
China	The First Affiliated Hospital of Xi'an Medical University	XI 'an	Shanxi
China	Xingtai People's Hospital	Xingtai	Hebei
China	Qinghai University Affiliated Hospital	Xining	Qinghai
China	Yichang Central People's Hospital	Yichang	Hubei
China	The First People's Hospital of Yueyang	Yueyang	Cn-43
China	Affiliated Hospital of Jiangsu University	Zhenjiang	Cn-32
Mexico	Unidad de patologia Clinica	Guadalajara	Jalisco
Mexico	Hospital Universitario Dr. Jose Eleuterio Gonzalez	Monterrey	N.l.
Mexico	Unidad Médica para la Salud Integral	San Nicolás de los Garza	Mx-nle
Mexico	Centro de Inv. Medica de Occidente, SC	Zapopan	Jalisco

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. 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	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. Least Squares (LS) mean was determined by analysis of covariance (ANCOVA) model with Baseline + Pooled Country + Hemoglobin A1c Stratum at Baseline + Number of Bolus at Study Entry Stratum + Type of Basal at Lead-in Stratum + Treatment (Type III sum of squares).	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. Least Squares (LS) mean was determined by analysis of covariance (ANCOVA) model with Baseline + Pooled Country + Hemoglobin A1c Stratum at Baseline + Number of Bolus at Study Entry Stratum + Type of Basal at Lead-in Stratum + Treatment (Type III sum of squares).	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.	Baseline through Week 26
Secondary	Rate of Documented Symptomatic Postmeal Hypoglycemia	Documented symptomatic postmeal 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 postmeal hypoglycemia was estimated by negative binomial model: number of episodes = treatment with log (treatment exposure in days/365.25) as an offset variable	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. 1,5-AG accurately predicts rapid changes in glycemia and is tightly associated with glucose fluctuations and postprandial glucose. LS Mean was calculated using mixed model repeated measures (MMRM) with Baseline + Pooled Country + Hemoglobin A1c Stratum at Baseline + 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	Change From Baseline in 10-Point Self-Monitoring Blood Glucose (SMBG) Values	SMBG 10-point profiles were measured at fasting, 1-hour post morning meal, 2-hours post morning meal, pre midday meal, 1-hour post midday meal, 2-hours post midday meal, pre evening meal, 1-hour post evening meal, 2-hours post evening meal, and bedtime. LS Mean was analyzed using mixed model repeated measures (MMRM) model with Baseline + Pooled Country + Hemoglobin A1c Stratum at Baseline + 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	Change From Baseline in Insulin Dose	LS mean was determined by MMRM model with Baseline + Pooled Country + Hemoglobin A1c Stratum at Baseline + 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	Percentage of Participants With HbA1c <7% and =6.5%	Hemoglobin A1c (HbA1c) is the glycosylated fraction of hemoglobin A. HbA1c is measured to identify average plasma glucose concentration over prolonged periods of time. Only subjects with non-missing baseline value and at least one non-missing post-baseline value of the response variable were included in analysis.	Week 26

External Links

•   A Study of Compared to Insulin Lispro (Humalog) in Adults With Type 2 Diabetes