A Study of LY900014 Compared to Insulin Lispro (Humalog) in Adults With Type 1 Diabetes
- Conditions
- Type 1 Diabetes Mellitus
- Interventions
- Registration Number
- NCT03952130
- 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 1 diabetes (T1D).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 354
- 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).
- 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.
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 (Humalog) Insulin Lispro Participants received 100 U/mL insulin lispro SC 0-2 minutes before each meal with either basal insulin glargine or insulin degludec given SC once daily. Insulin Lispro (Humalog) Insulin Glargine Participants received 100 U/mL insulin lispro SC 0-2 minutes before each meal with either basal insulin glargine or insulin degludec given SC once daily. Insulin Lispro (Humalog) Insulin Degludec Participants received 100 U/mL insulin lispro 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. 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.
- Secondary Outcome Measures
Name Time Method Rate of Documented Symptomatic Post Meal Hypoglycemia Baseline through Week 26 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.
Change From Baseline in 10-Point Self-Monitoring Blood Glucose (SMBG) Values Baseline, Week 26 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.
Percentage of Participants With HbA1c <7% and ≤6.5% Week 26 HbA1c is the glycosylated fraction of hemoglobin A. It is measured to identify average plasma glucose concentration over prolonged periods of time.
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. 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.
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. 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.
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 days.
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. 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.
Change From Baseline in Daily Insulin Dose Baseline, Week 26 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.
Trial Locations
- Locations (30)
Centro Médico Viamonte
🇦🇷Caba, Buenos Aires, Argentina
Cent Priva Especiali Médicas Ambulatorias Inve Clin CEMAIC
🇦🇷Cordoba, Argentina
Dongguan people's hospital
🇨🇳Dongguan, Guangdong, China
The Fourth Affiliated Hospital of Harbin Medical University
🇨🇳Harbin, Heilongjiang, China
The First People's Hospital of Changde City
🇨🇳Changde, Hunan, China
The First Hospital of Nanjing
🇨🇳Nanjing, Jiangsu, China
Xinhua Hospital Affiliated to Shanghai Jiaotong University School of Medicine
🇨🇳Shanghai, China
Centro de Investigaciones Metabólicas (CINME)
🇦🇷Caba, Buenos Aires, Argentina
The Second People's Hospital of Hefei
🇨🇳Hefei, Anhui, China
Sun Yat-sen Memorial Hospital, Sun Yat-sen University
🇨🇳Guangzhou, Guangdong, China
Shantou University Medical College No.2 Affiliated Hospital
🇨🇳Shantou, Guang Dong Province, China
Shenzhen Second People's Hospital
🇨🇳Shenzhen, Guangdong, China
The First Affiliated Hospital of Henan University of Science &Technology
🇨🇳Luoyang, Henan, China
The Second Xiangya Hospital of Central South University
🇨🇳Changsha, Hunan, China
Changzhou No.2 People's Hospital
🇨🇳Changzhou, Jiangsu, 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
Affiliated Hospital of Jiangsu University
🇨🇳Zhenjiang, Jiangsu, China
The Second Affiliated Hospital of Soochow University
🇨🇳Suzhou, Jiangsu, China
No.2 Hospital Affiliated to Jilin University
🇨🇳Changchun City, Jilin, China
The First Hospital of Jilin University
🇨🇳Changchun, Jilin, China
Shengjing Hospital of China Medical University
🇨🇳Shenyang, Liaoning, China
Jiangsu Province Hospital
🇨🇳Nanjing, Nanjing, China
Shanghai Putuo District Center Hospital
🇨🇳Shanghai, China
West China Hospital Sichuan University
🇨🇳Chengdu, Sichuan, China
Beijing Peking Union Medical College Hospital
🇨🇳Beijing, China
Shanghai Tenth People's Hospital
🇨🇳Shanghai, Shanghai, China
Unidad de patologia Clinica
🇲🇽Guadalajara, Jalisco, Mexico
Hospital Universitario "Dr. Jose Eleuterio Gonzalez"
🇲🇽Monterrey, N.l., Mexico
Unidad de Investigaci�n Cl�nica Cardiometabolica de Occidente
🇲🇽Guadalajara, Jalisco, Mexico