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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT03214367




Registration number
NCT03214367
Ethics application status
Date submitted
10/07/2017
Date registered
11/07/2017

Titles & IDs
Public title
A Study of LY900014 in Participants With Type 1 Diabetes
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
Secondary ID [1] 0 0
I8B-MC-ITRM
Secondary ID [2] 0 0
16313
Universal Trial Number (UTN)
Trial acronym
PRONTO-T1D
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Type 1 Diabetes Mellitus 0 0
Condition category
Condition code
Metabolic and Endocrine 0 0 0 0
Diabetes

Intervention/exposure
Study type
Interventional
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
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Change From Baseline in Hemoglobin A1c (HbA1c) Efficacy Estimand at Week 26
Timepoint [1] 0 0
Baseline, Week 26
Secondary outcome [1] 0 0
Change From Baseline in 1-hour Postprandial Glucose (PPG) Excursion During Mixed-Meal Tolerance Test (MMTT) Efficacy Estimand at Week 26
Timepoint [1] 0 0
Baseline, Week 26
Secondary outcome [2] 0 0
Change From Baseline in 2-hour PPG Excursion During MMTT Efficacy Estimand at Week 26
Timepoint [2] 0 0
Baseline, Week 26
Secondary outcome [3] 0 0
Rate of Severe Hypoglycemia at Week 26
Timepoint [3] 0 0
Baseline through Week 26
Secondary outcome [4] 0 0
Rate of Documented Symptomatic Hypoglycemia at Week 26
Timepoint [4] 0 0
Baseline through Week 26
Secondary outcome [5] 0 0
Change From Baseline in 1,5-Anhydroglucitol (1,5-AG) at Week 26
Timepoint [5] 0 0
Baseline, Week 26
Secondary outcome [6] 0 0
Change From Baseline in 10-Point Self-Monitoring Blood Glucose (SMBG) Values at Week 26
Timepoint [6] 0 0
Baseline, Week 26
Secondary outcome [7] 0 0
Change From Baseline in Insulin Dose at Week 26
Timepoint [7] 0 0
Baseline, Week 26
Secondary outcome [8] 0 0
Change From Baseline in Insulin Treatment Satisfaction Questionnaire (ITSQ) Regimen Inconvenience Domain Score at Week 26
Timepoint [8] 0 0
Baseline, Week 26
Secondary outcome [9] 0 0
Change From Baseline in ITSQ Lifestyle Flexibility Domain Score at Week 26
Timepoint [9] 0 0
Baseline, Week 26
Secondary outcome [10] 0 0
Percentage of Participants With HbA1c <7%
Timepoint [10] 0 0
Week 26
Secondary outcome [11] 0 0
Change From Baseline in HbA1c at Week 52
Timepoint [11] 0 0
Baseline, Week 52

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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
17/07/2017
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
22/08/2019
Sample size
Target
Accrual to date
Final
1392
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
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
Recruitment hospital [2] 0 0
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
Recruitment hospital [3] 0 0
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
Recruitment hospital [4] 0 0
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
Recruitment postcode(s) [1] 0 0
3128 - Box Hill
Recruitment postcode(s) [2] 0 0
3220 - Geelong
Recruitment postcode(s) [3] 0 0
2291 - Merewether
Recruitment postcode(s) [4] 0 0
5046 - Oaklands Park
Recruitment outside Australia
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Eli Lilly and Company
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
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)
Address 0 0
Eli Lilly and Company
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.

Supporting document/s available: Study protocol, Statistical analysis plan (SAP), Clinical study report (CSR)
When will data be available (start and end dates)?
Data are available 6 months after the primary publication and approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting.
Available to whom?
A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: https://vivli.org/


What supporting documents are/will be available?




Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results are available at https://clinicaltrials.gov/study/NCT03214367