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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT03214367
Registration number
NCT03214367
Ethics application status
Date submitted
10/07/2017
Date registered
11/07/2017
Date last updated
1/05/2020
Titles & IDs
Public title
A Study of LY900014 in Participants With Type 1 Diabetes
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Scientific title
A Prospective, Randomized, Double-Blind Comparison of LY900014 to Insulin Lispro With an Open-Label Postprandial LY900014 Treatment Group, in Combination With Insulin Glargine or Insulin Degludec, in Adults With Type 1 Diabetes PRONTO-T1D
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Secondary ID [1]
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I8B-MC-ITRM
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Secondary ID [2]
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16313
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Universal Trial Number (UTN)
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Trial acronym
PRONTO-T1D
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Type 1 Diabetes Mellitus
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Condition category
Condition code
Metabolic and Endocrine
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Diabetes
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - LY900014
Treatment: Drugs - Insulin Lispro
Treatment: Drugs - Insulin Glargine
Treatment: Drugs - Insulin Degludec
Experimental: LY900014 - LY900014 given subcutaneously (SC) 0-2 minutes before each meal with either basal insulin glargine given SC once or twice daily or insulin degludec given SC once daily. Preprandial insulin doses were individualized and titrated according to protocol-defined targets.
Active Comparator: Insulin Lispro (Humalog) - Insulin lispro given SC 0-2 minutes before each meal with either basal insulin glargine given SC once or twice daily or insulin degludec given SC once daily. Preprandial insulin doses were individualized and titrated according to protocol-defined targets.
Experimental: LY900014 Postmeal (Open Label) - LY900014 given SC 20 minutes after the start of each meal with either basal insulin glargine given SC once or twice daily or insulin degludec given SC once daily. Prandial insulin doses were individualized and titrated according to protocol-defined targets.
Experimental: LY900014 - Maximum Extended Enrollment (MEE) - LY900014 given subcutaneously (SC) 0-2 minutes before each meal with either basal insulin glargine given SC once or twice daily or insulin degludec given SC once daily. Preprandial insulin doses were individualized and titrated according to protocol-defined targets.
Active Comparator: Insulin Lispro (Humalog)-MEE - Insulin lispro given SC 0-2 minutes before each meal with either basal insulin glargine given SC once or twice daily or insulin degludec given SC once daily. Preprandial insulin doses were individualized and titrated according to protocol-defined targets.
Experimental: LY900014 Postmeal (Open Label)-MEE - LY900014 given SC 20 minutes after the start of each meal with either basal insulin glargine given SC once or twice daily or insulin degludec given SC once daily. Prandial insulin doses were individualized and titrated according to protocol-defined targets.
Treatment: Drugs: LY900014
Administered SC
Treatment: Drugs: Insulin Lispro
Administered SC
Treatment: Drugs: Insulin Glargine
Administered SC
Treatment: Drugs: Insulin Degludec
Administered SC
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Change From Baseline in Hemoglobin A1c (HbA1c) Efficacy Estimand at Week 26
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Assessment method [1]
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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 strata (pooled country, type of basal insulin, prandial insulin dosing plan, and HbA1c stratum) and treatment as fixed effects and baseline as a covariate. The efficacy estimand included participant data when baseline and at least one post-baseline measurement were available prior to permanent discontinuation of study drug.
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Timepoint [1]
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Baseline, Week 26
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Secondary outcome [1]
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Change From Baseline in 1-hour Postprandial Glucose (PPG) Excursion During Mixed-Meal Tolerance Test (MMTT) Efficacy Estimand at Week 26
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Assessment method [1]
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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. 1-hour PPG excursion during MMTT uses the ANCOVA model with strata (pooled country, type of basal insulin, prandial insulin dosing plan, and HbA1c stratum) and treatment as fixed effects and baseline as a covariate. The efficacy estimand included participant data when baseline and at least one post-baseline measurement were available prior to permanent discontinuation of study drug.
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Timepoint [1]
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Baseline, Week 26
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Secondary outcome [2]
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Change From Baseline in 2-hour PPG Excursion During MMTT Efficacy Estimand at Week 26
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Assessment method [2]
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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. 2-hour PPG excursion during MMTT uses the ANCOVA model with strata (pooled country, type of basal insulin, prandial insulin dosing plan, and HbA1c stratum) and treatment as fixed effects and baseline as a covariate. The efficacy estimand included participant data when baseline and at least one post-baseline measurement were available prior to permanent discontinuation of study drug.
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Timepoint [2]
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Baseline, Week 26
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Secondary outcome [3]
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Rate of Severe Hypoglycemia at Week 26
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Assessment method [3]
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Severe hypoglycemia is defined as an event requiring assistance of another person to administer carbohydrate, glucagon, or other resuscitative actions. During these episodes, the participant has an altered mental status and cannot assist in his or her own care, or may be semiconscious or unconscious, or experience coma with or without seizures, and may require parenteral therapy. 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 a treatment group *36525.
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Timepoint [3]
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Baseline through Week 26
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Secondary outcome [4]
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Rate of Documented Symptomatic Hypoglycemia at Week 26
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Assessment method [4]
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Documented symptomatic hypoglycemia is an event during which typical symptoms of hypoglycemia are accompanied by blood glucose (BG) of <54 mg/dL [3.0 millimole per liter (mmol/L)]. The rate of documented symptomatic hypoglycemia was estimated by negative binomial model: number of episodes = treatment with log (treatment exposure in days/365.25) as an offset variable.
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Timepoint [4]
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Baseline through Week 26
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Secondary outcome [5]
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Change From Baseline in 1,5-Anhydroglucitol (1,5-AG) at Week 26
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Assessment method [5]
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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) including fixed class effects of treatment, strata (pooled country, type of basal insulin, HbA1c stratum and number of prandial doses at study entry), visit, and treatment-by-visit interaction, as well as the continuous, fixed covariates of baseline value. The analysis included data collected prior to permanent discontinuation of study drug.
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Timepoint [5]
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Baseline, Week 26
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Secondary outcome [6]
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Change From Baseline in 10-Point Self-Monitoring Blood Glucose (SMBG) Values at Week 26
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Assessment method [6]
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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) including fixed class effects of treatment, strata (pooled country, type of basal insulin, HbA1c stratum and number of prandial doses at study entry), visit, and treatment-by-visit interaction, as well as the continuous, fixed covariates of baseline value. The efficacy estimand included participant data when baseline and at least one post-baseline measurement prior to permanent discontinuation of study drug.
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Timepoint [6]
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Baseline, Week 26
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Secondary outcome [7]
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Change From Baseline in Insulin Dose at Week 26
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Assessment method [7]
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LS Mean was analyzed using mixed model repeated measures (MMRM) including fixed class effects of treatment, strata (pooled country, type of basal insulin, HbA1c stratum and number of prandial doses at study entry), visit, and treatment-by-visit interaction, as well as the continuous, fixed covariates of baseline value. The analysis included data prior to permanent discontinuation of study drug.
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Timepoint [7]
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Baseline, Week 26
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Secondary outcome [8]
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Change From Baseline in Insulin Treatment Satisfaction Questionnaire (ITSQ) Regimen Inconvenience Domain Score at Week 26
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Assessment method [8]
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ITSQ is a validated instrument containing 22 items that assess treatment satisfaction for participants with diabetes and on insulin. The questionnaire measures satisfaction from the following 5 domains: Inconvenience of Regimen, Lifestyle Flexibility, Glycemic Control, Hypoglycemic Control, and Insulin Delivery Device. Data presented are the transformed overall score on a scale of 0-100, where higher scores indicate better treatment satisfaction. LS Mean was calculated using the ANCOVA model with strata (pooled country, type of basal insulin, number of prandial doses at study entry, and HbA1c stratum), and treatment as fixed effects and baseline as covariate. The analysis included data prior to permanent discontinuation of study drug. The analysis included data prior to permanent discontinuation of study drug.
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Timepoint [8]
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Baseline, Week 26
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Secondary outcome [9]
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Change From Baseline in ITSQ Lifestyle Flexibility Domain Score at Week 26
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Assessment method [9]
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ITSQ is a validated instrument containing 22 items that assess treatment satisfaction for participants with diabetes and on insulin. The questionnaire measures satisfaction from the following 5 domains: Inconvenience of Regimen, Lifestyle Flexibility, Glycemic Control, Hypoglycemic Control, and Insulin Delivery Device. Data presented are the transformed overall score on a scale of 0-100, where higher scores indicate better treatment satisfaction. LS Mean was calculated using the analysis of covariance (ANCOVA) with strata (pooled country, type of basal insulin, number of prandial doses at study entry, and HbA1c stratum), and treatment as fixed effects and baseline as covariate. The analysis included data prior to permanent discontinuation of study drug. The analysis included data prior to permanent discontinuation of study drug.
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Timepoint [9]
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Baseline, Week 26
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Secondary outcome [10]
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Percentage of Participants With HbA1c <7%
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Assessment method [10]
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Hemoglobin A1c (HbA1c) is the glycosylated fraction of hemoglobin A. HbA1c is measured to identify average plasma glucose concentration over prolonged periods of time.
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Timepoint [10]
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Week 26
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Secondary outcome [11]
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Change From Baseline in HbA1c at Week 52
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Assessment method [11]
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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 MMRM model with variables of baseline, pooled country, type of basal insulin during lead-in, prandial Insulin Dosing Plan, treatment (Type III sum of squares) as fixed factors. The analysis included data prior to permanent discontinuation of study drug.
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Timepoint [11]
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Baseline, Week 52
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Eligibility
Key inclusion criteria
- Have T1D for at least 1 year prior to screening and continuously using insulin for at
least 1 year.
- HbA1c of =7.0 and =9.5%.
- Use insulin lispro, insulin aspart, or insulin glulisine as prandial insulin.
- Use insulin glargine, insulin detemir, insulin degludec, or neutral protamine Hagedorn
(NPH) insulin as basal insulin.
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
- Have used other antihyperglycemic medications or therapies (inhaled, oral or
injectable) within 90-days of screening.
- Have had more than 1 severe hypoglycemic episode within 6 months of screening.
- Have had more than 1 hospitalization related to hyperglycemia or diabetic ketoacidosis
within 6 months of screening.
- Have clinically significant gastrointestinal disease.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
17/07/2017
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
22/08/2019
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Sample size
Target
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Accrual to date
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Final
1392
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Recruitment in Australia
Recruitment state(s)
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Recruitment hospital [1]
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For additional information regarding investigative sites for this trial, contact 1-888-545-5972 Mon - Fri, 9 AM to 4 PM or 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri, 9 AM to 5 PM Eastern Time or speak with your personal physician. - Box Hill
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Recruitment hospital [2]
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For additional information regarding investigative sites for this trial, contact 1-888-545-5972 Mon - Fri, 9 AM to 4 PM or 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri, 9 AM to 5 PM Eastern Time or speak with your personal physician. - Geelong
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Recruitment hospital [3]
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For additional information regarding investigative sites for this trial, contact 1-888-545-5972 Mon - Fri, 9 AM to 4 PM or 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri, 9 AM to 5 PM Eastern Time or speak with your personal physician. - Merewether
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Recruitment hospital [4]
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For additional information regarding investigative sites for this trial, contact 1-888-545-5972 Mon - Fri, 9 AM to 4 PM or 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri, 9 AM to 5 PM Eastern Time or speak with your personal physician. - Oaklands Park
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Recruitment postcode(s) [1]
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3128 - Box Hill
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Recruitment postcode(s) [2]
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3220 - Geelong
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Recruitment postcode(s) [3]
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2291 - Merewether
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Recruitment postcode(s) [4]
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5046 - Oaklands Park
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Recruitment outside Australia
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Alabama
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Colorado
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Poland
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Szczecin
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Poland
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Warsaw
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Poland
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Warszawa
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Poland
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Wroclaw
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Lódz
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Bayamon
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Manati
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San Juan
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Puerto Rico
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Yabucoa
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Romania
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Bacau
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Romania
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Brasov
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Romania
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Bucuresti
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Romania
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Lasi
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Romania
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Oradea
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Romania
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Ploiesti
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Romania
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Satu Mare
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Romania
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Timisoara
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Romania
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Târgu-Mures
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Russian Federation
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Arkhangel'sk
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Russian Federation
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Kursk
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Russian Federation
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Moscow
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Russian Federation
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Saint Petersburg
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Russian Federation
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Saratov
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Slovakia
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Košice
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Malacky
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Slovakia
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Nové Mesto nad Váhom
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Slovakia
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Rožnava
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Spain
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Barcelona
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Valencia
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Spain
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Málaga
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Spain
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Sevilla
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Spain
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Teruel
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Sweden
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Göteborg
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Sweden
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Linköping
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Sweden
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Lund
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Sweden
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Stockholm
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Taiwan
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Chang-hua
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Taichung
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Tainan
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Taipei
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Taiwan
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Yongkang
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Eli Lilly and Company
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Address
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Ethics approval
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Summary
Brief summary
The main purpose of this study is to evaluate the efficacy of the study drug LY900014
compared to insulin lispro, both in combination with insulin glargine or insulin degludec, in
adults with type 1 diabetes (T1D).
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Trial website
https://clinicaltrials.gov/ct2/show/NCT03214367
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Public notes
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Contacts
Principal investigator
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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)
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Eli Lilly and Company
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Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT03214367
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