A Study of LY900014 Compared to Insulin Lispro (Humalog) in Adults With Type 2 Diabetes
- Conditions
- Type 2 Diabetes Mellitus
- Interventions
- Registration Number
- NCT03952143
- Lead Sponsor
- Eli Lilly and Company
- 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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 628
- 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).
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description LY900014 LY900014 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. LY900014 Insulin Glargine 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. LY900014 Insulin Degludec 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. Insulin Lispro Insulin Degludec Participants received 100 U/mL insulin lispro (Humalog) given SC 0-2 minutes before each meal with either basal insulin glargine or insulin degludec given SC once daily. Insulin Lispro Insulin Glargine Participants received 100 U/mL insulin lispro (Humalog) given SC 0-2 minutes before each meal with either basal insulin glargine or insulin degludec given SC once daily. Insulin Lispro Insulin Lispro Participants received 100 U/mL insulin lispro (Humalog) given SC 0-2 minutes before each meal with either basal insulin glargine or insulin degludec given SC once daily.
- Primary Outcome Measures
Name Time Method Change From Baseline in Hemoglobin A1c (HbA1c) Baseline, Week 26 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).
- Secondary Outcome Measures
Name Time Method 2-hour PPG Excursion During MMTT Week 26 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).
Percentage of Participants With HbA1c <7% and ≤6.5% Week 26 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.
1-hour Postprandial Glucose (PPG) Excursion During Mixed-Meal Tolerance Test (MMTT) Week 26 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).
Rate of Documented Symptomatic Postmeal Hypoglycemia Baseline through Week 26 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
Change From Baseline in 1,5-Anhydroglucitol (1,5-AG) Baseline, Week 26 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)
Change From Baseline in Insulin Dose Baseline, Week 26 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)
Rate of Severe Hypoglycemia Baseline through Week 26 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.
Change From Baseline in 10-Point Self-Monitoring Blood Glucose (SMBG) Values Baseline, Week 26 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).
Trial Locations
- Locations (41)
Dalian Municipal Central Hospital Affiliated of Dalian Medical University
🇨🇳Dalian, Cn-21, China
Shengjing Hospital of China Medical University
🇨🇳Shenyang, Cn-21, China
Shanghai Putuo District Center Hospital
🇨🇳Shanghai, Cn-31, China
The Central Hospital of Wuhan
🇨🇳Wuhan, Cn-42, China
The First People's Hospital of Yueyang
🇨🇳Yueyang, Cn-43, China
Chongqing General Hospital
🇨🇳Chongqing, Cn-50, China
Xingtai People's Hospital
🇨🇳Xingtai, Hebei, China
The Fourth Affiliated Hospital of Harbin Medical University
🇨🇳Harbin, Heilongjiang, China
The First Hospital of Qiqihar
🇨🇳Qiqihar, Heilongjiang, China
Wuhan Pu'ai Hospital
🇨🇳Wuhan, Hubei, China
The First Hospital of Nanjing
🇨🇳Nanjing, Jiangsu, China
Beijing Peking Union Medical College Hospital
🇨🇳Beijing, China
Jinan Central Hospital
🇨🇳Jinan, Shandong, China
Unidad Médica para la Salud Integral
🇲🇽San Nicolás de los Garza, Mx-nle, Mexico
Centro de Inv. Medica de Occidente, SC
🇲🇽Zapopan, Jalisco, Mexico
Hospital Universitario Dr. Jose Eleuterio Gonzalez
🇲🇽Monterrey, N.l., Mexico
Tianjin Medical University General Hospital
🇨🇳Tianjin, Cn-12, China
Cangzhou People's Hospital
🇨🇳Cangzhou, Cn-13, China
Beijing Pinggu District Hospital
🇨🇳Beijing, Cn-11, China
Centro Médico Viamonte
🇦🇷Buenos Aires, Ar-c, Argentina
The First Hospital of Qinhuangdao
🇨🇳Qinhuangdao Shi, Cn-13, China
Inner Mongolia People's Hospital
🇨🇳Hohhot, Cn-15, China
Nanjing Medical University - Nanjing Jiangning Hospital
🇨🇳Nanjing, Cn-32, China
Affiliated Hospital of Jiangsu University
🇨🇳Zhenjiang, Cn-32, China
Chenzhou NO.1 People's Hospital
🇨🇳Chenzhou, Hunan, China
Cent Priva Especiali Médicas Ambulatorias Inve Clin CEMAIC
🇦🇷Cordoba, Argentina
Centro de Investigaciones Metabólicas (CINME)
🇦🇷Caba, Buenos Aires, Argentina
Shanghai 6th people's hospital
🇨🇳Shanghai, Cn-31, China
The Affiliated Jiangyin Hospital of Southeast University Medical College
🇨🇳Jiangyin, Cn-32, China
Zhongda Hospital Southeast University
🇨🇳Nanjing, Cn-32, China
The Third Hospital of Nanchang
🇨🇳Nanchang, Cn-36, China
Fujian Medical University Union Hospital
🇨🇳Fuzhou, Fujian, China
The First Affiliated Hospital of Henan University of Science &Technology
🇨🇳Luoyang, Henan, China
Yichang Central People's Hospital
🇨🇳Yichang, Hubei, China
Changzhou No.2 People's Hospital
🇨🇳Changzhou, Jiangsu, China
The First Affiliated Hospital of Xi'an Medical University
🇨🇳XI 'an, Shanxi, China
China-Japan Union Hospital, CJUH.
🇨🇳Changchun, Jilin, China
Siping Central People's Hospital
🇨🇳Siping, Jilin, China
Qinghai University Affiliated Hospital
🇨🇳Xining, Qinghai, China
Unidad de patologia Clinica
🇲🇽Guadalajara, Jalisco, Mexico
Pingxiang People's Hospital
🇨🇳Pingxiang, China