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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/NCT03830281
Registration number
NCT03830281
Ethics application status
Date submitted
4/02/2019
Date registered
5/02/2019
Date last updated
22/01/2021
Titles & IDs
Public title
A Study Comparing LY900014 to Insulin Lispro (Humalog) in Adults With Type 1 Diabetes Using Insulin Pump Therapy
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Scientific title
A Prospective, Randomized, Double-Blind Comparison of LY900014 to Humalog in Adults With Type 1 Diabetes Using Continuous Subcutaneous Insulin Infusion
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Secondary ID [1]
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I8B-MC-ITRO
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Secondary ID [2]
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16315
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Universal Trial Number (UTN)
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Trial acronym
PRONTO-Pump-2
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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 - Ultra-Rapid Lispro
Treatment: Drugs - Insulin Lispro
Active Comparator: Insulin Lispro (Humalog) - Participants received individual dose of 100 U/mL insulin lispro (Humalog) by CSII; where mealtime boluses were delivered 0 to 2 minutes prior to the start of each meal, with basal infusion rates 24 hours/day, and correction boluses as necessary.
Experimental: Ultra-Rapid Lispro - Participants received individual dose of 100 units per milliliter (U/mL) ultra rapid lispro by continuous subcutaneous insulin infusion (CSII); where mealtime boluses were delivered 0 to 2 minutes prior to the start of each meal, with basal infusion rates 24 hours/day, and correction boluses as necessary.
Treatment: Drugs: Ultra-Rapid Lispro
Administered SC
Treatment: Drugs: Insulin Lispro
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 16
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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 covariates: Baseline + Pooled Country + Personal continuous glucose Monitor (CGM) or Flash glucose monitor (FGM) use during study flag + Treatment + Time + Treatment*Time (Type III sum of squares). 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 16
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Secondary outcome [1]
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Change From Baseline in 1-hour Postprandial Glucose (PPG) During Mixed-Meal Tolerance Test (MMTT) Efficacy Estimand at Week 16
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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. Least Squares (LS) mean was determined by analysis of variance (ANCOVA) model with independent variables: Baseline + Pooled Country + Hemoglobin A1C Stratum + Personal CGM/FGM use during study Flag + Treatment (Type III sum of squares).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 16
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Secondary outcome [2]
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Change From Baseline in 2-hour PPG During MMTT Efficacy Estimand at Week 16
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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. Least Squares (LS) mean was determined by analysis of variance (ANCOVA) model with independent variables: Baseline + Pooled Country + Hemoglobin A1C Stratum + Personal CGM/FGM use during study Flag + Treatment (Type III sum of squares).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 16
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Secondary outcome [3]
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Percentage of Time With Sensor Glucose Values Between 70 and 180 mg/dL Efficacy Estimand at Week 16
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Assessment method [3]
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Percentage of time with sensor glucose values between 70 and 180 mg/dL using continuous glucose monitoring (CGM). Least square (LS) mean difference will provided for CGM data normalized to a 24hrs period. Daytime: 0600 hours to midnight (06:00:00-23:59:59 on the 24-hour clock). Least Squares (LS) mean was determined by mixed-model repeated measures (MMRM) model with covariates: Baseline + Pooled Country + Hemoglobin A1C Stratum + Personal continuous glucose Monitor (CGM) or Flash glucose monitor (FGM) use during study flag + Treatment + Time + Treatment*Time (Type III sum of squares).
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Timepoint [3]
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Week 16
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Secondary outcome [4]
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Rate of Severe Hypoglycemia at Week 16
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Assessment method [4]
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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 [4]
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Baseline through Week 16
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Secondary outcome [5]
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Rate of Documented Symptomatic Hypoglycemia at Week 16
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Assessment method [5]
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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 [5]
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Baseline through Week 16
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Secondary outcome [6]
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Change From Baseline in 1,5-Anhydroglucitol (1,5-AG) at Week 16
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Assessment method [6]
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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 + Hemoglobin A1C Stratum + Personal continuous glucose Monitor (CGM) or Flash glucose monitor (FGM) use during study flag), 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 [6]
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Baseline, Week 16
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Secondary outcome [7]
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Change From Baseline in 10-Point Self-Monitoring Blood Glucose (SMBG) Values at Week 16
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Assessment method [7]
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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, HbA1c stratum : less than or equal to (=)7.5%, greater than (>)7.5% and participant's personal CGM or FGM use during the study), 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 [7]
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Baseline, Week 16
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Secondary outcome [8]
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Change From Baseline in Insulin Dose at Week 16
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Assessment method [8]
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LS mean was determined by MMRM model with covariates: Baseline + Pooled Country + + Hemoglobin A1C Stratum + Personal CGM or FGM use during study flag + Treatment + Time + Treatment*Time (Type III sum of squares). The analysis included data prior to permanent discontinuation of study drug.
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Timepoint [8]
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Baseline, Week 16
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Secondary outcome [9]
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Change From Baseline in Bolus/Total Insulin Dose Ratio at Week 16
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Assessment method [9]
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The bolus/total ratio was derived as the bolus dose divided by the total insulin dose at each visit. LS mean was determined by MMRM model with covariates: Baseline + Pooled Country + + Hemoglobin A1C Stratum + Personal CGM or FGM use during study flag + Treatment + Time + Treatment*Time (Type III sum of squares). The analysis included data prior to permanent discontinuation of study drug.
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Timepoint [9]
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Baseline, Week 16
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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 16
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Secondary outcome [11]
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Percentage of Participants With at Least 1 Pump Occlusion Alarm That Leads to an Unplanned Infusion Set Change
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Assessment method [11]
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Percentage of participants with at least 1 pump occlusion alarm that leads to an unplanned infusion set change was evaluated.
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Timepoint [11]
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Baseline through Week 16
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Secondary outcome [12]
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Percentage of Participants With at Least 1 Event of Unexplained Hyperglycemia >300 mg/dL Confirmed by SMBG That Leads to an Unplanned Infusion Set Change
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Assessment method [12]
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Percentage of participants with at least 1 event of unexplained hyperglycemia >300 milligrams per deciliter (mg/dL) confirmed by SMBG that leads to an unplanned infusion set change was evaluated.
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Timepoint [12]
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Baseline through Week 16
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Eligibility
Key inclusion criteria
- Have been diagnosed with T1D and continuously using insulin for at least 1 year
- Have been using CSII therapy for a minimum of 6 months
- Currently treated with <100 Units of one of following rapid-acting analog insulin via
CSII for at least the past 30 days: insulin lispro U-100, insulin aspart, fast-acting
insulin aspart, insulin glulisine
- Must be using a MiniMed 530G (US), Paradigm Revel (US), or MiniMed 630G (US and
Canada), MiniMed 640G or Paradigm Veo (select countries outside the US), insulin pump
for at least the past 90 days
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Minimum age
18
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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 hypoglycemia unawareness
- Have had more than 1 episode of severe hypoglycemia within 6 months prior to screening
- Have had more than 1 emergency room visit or hospitalization due to poor glucose
control (hyperglycemia or diabetic ketoacidosis) within 6 months prior to screening
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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
14/02/2019
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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
6/01/2020
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Sample size
Target
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Accrual to date
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Final
471
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Recruitment in Australia
Recruitment state(s)
NSW,SA,VIC,WA
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Recruitment hospital [1]
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The AIM Centre - Merewether
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Recruitment hospital [2]
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GP Plus Marion - Oaklands Park
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Recruitment hospital [3]
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Box Hill Hospital - Box Hill
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Recruitment hospital [4]
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Barwon Health - The Geelong Hospital - Geelong
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Recruitment hospital [5]
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Fremantle Hospital - Fremantle
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Recruitment postcode(s) [1]
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2291 - Merewether
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Recruitment postcode(s) [2]
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5046 - Oaklands Park
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Recruitment postcode(s) [3]
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3128 - Box Hill
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Recruitment postcode(s) [4]
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3220 - Geelong
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Recruitment postcode(s) [5]
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6160 - Fremantle
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Recruitment outside Australia
Country [1]
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United States of America
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State/province [1]
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California
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United States of America
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Colorado
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United States of America
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Florida
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United States of America
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Georgia
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United States of America
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State/province [5]
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Hawaii
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United States of America
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State/province [6]
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Idaho
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Country [7]
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United States of America
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Illinois
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Country [8]
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United States of America
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Iowa
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Country [9]
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United States of America
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Kentucky
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United States of America
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State/province [10]
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Maryland
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United States of America
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Nevada
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United States of America
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New Hampshire
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United States of America
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North Carolina
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Pennsylvania
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United States of America
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Texas
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United States of America
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Washington
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Country [17]
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Austria
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Steiermark
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Austria
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Vorarlberg
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Austria
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Salzburg
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Austria
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Vienna
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Canada
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Ontario
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Canada
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Quebec
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France
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Cedex 9
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France
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Le Creusot
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France
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Montpellier Cedex 5
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France
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State/province [26]
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Paris CEDEX 14
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France
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Strasbourg
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France
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Venissieux
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Germany
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Hessen
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Germany
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Nordrhein-Westfalen
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Germany
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Rheinland-Pfalz
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Germany
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State/province [32]
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Saarland
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Germany
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State/province [33]
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Schleswig-Holstein
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Germany
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State/province [34]
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Berlin
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Germany
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Hamburg
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Hungary
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Budapest
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Israel
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Beer-Sheva
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Israel
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State/province [38]
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Haifa
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Country [39]
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Israel
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State/province [39]
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Jerusalem
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Country [40]
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Israel
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State/province [40]
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Petah Tiqva
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Israel
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State/province [41]
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Ramat Gan
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Italy
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Bergamo
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Italy
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Milano
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Italy
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Olbia
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Italy
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Ravenna
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Italy
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Roma
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Puerto Rico
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Bayamon
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Puerto Rico
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State/province [48]
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Lomas Verdes
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Spain
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State/province [49]
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Barcelona
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Country [50]
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Spain
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Cataluña
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Spain
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Madrid
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Spain
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Sevilla
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Spain
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State/province [53]
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Valencia
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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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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
The reason for this study is to compare the study drug LY900014 to insulin lispro (Humalog)
when both are used in insulin pump therapy in adults with type 1 diabetes (T1D).
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Trial website
https://clinicaltrials.gov/ct2/show/NCT03830281
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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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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Address
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Eli Lilly and Company
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT03830281
Download to PDF