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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT03214380




Registration number
NCT03214380
Ethics application status
Date submitted
10/07/2017
Date registered
11/07/2017

Titles & IDs
Public title
A Study of LY900014 Compared to Insulin Lispro in Participants With Type 2 Diabetes
Scientific title
A Prospective, Randomized, Double-Blind Comparison of LY900014 to Insulin Lispro, Both in Combination With Insulin Glargine or Insulin Degludec in Adults With Type 2 Diabetes PRONTO-T2D
Secondary ID [1] 0 0
I8B-MC-ITRN
Secondary ID [2] 0 0
16314
Universal Trial Number (UTN)
Trial acronym
PRONTO-T2D
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Type 2 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
Treatment: Drugs - Metformin
Treatment: Drugs - SGLT2 inhibitor

Experimental: LY900014 - LY900014 given subcutaneously (SC) with each meal with either 100 U/mL (U-100) basal insulin glargine given SC once or twice daily or U-100 or 200 U/mL (U-200) insulin degludec given SC once daily. Prandial insulin doses were individualized and titrated according to protocol-defined targets.

Active comparator: Insulin Lispro (Humalog) - Insulin lispro given SC with each meal with either U-100 basal insulin glargine given SC once or twice daily or U-100 or U-200 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) with each meal with either U-100 basal insulin glargine given SC once or twice daily or U-100 or U-200 insulin degludec given SC once daily. Prandial insulin doses were individualized and titrated according to protocol-defined targets.

Active comparator: Insulin Lispro (Humalog) MEE - Insulin lispro given SC with each meal with either U-100 basal insulin glargine given SC once or twice daily or U-100 or U-200 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

Treatment: Drugs: Metformin
Administered orally.

Treatment: Drugs: SGLT2 inhibitor
Administered orally.
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
1-hour Postprandial Glucose (PPG) Excursion During Mixed-Meal Tolerance Test (MMTT) Efficacy Estimand
Timepoint [1] 0 0
Week 26
Secondary outcome [2] 0 0
2-hour PPG Excursion During MMTT Efficacy Estimand
Timepoint [2] 0 0
Week 26
Secondary outcome [3] 0 0
Rate of Severe Hypoglycemia
Timepoint [3] 0 0
Baseline through Week 26
Secondary outcome [4] 0 0
Rate of Documented Symptomatic Hypoglycemia
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
Number of Participants With HbA1c <7%
Timepoint [10] 0 0
Week 26

Eligibility
Key inclusion criteria
* Have been diagnosed (clinically) with T2D, based on the World Health Organization (WHO) classification for at least 1 year prior to screening.
* Have been treated for at least 90 days prior to screening with:

* Basal insulin (insulin glargine U-100 [Basaglar/Abasaglar or LANTUS] or U-300, insulin detemir, insulin degludec U-100 or U-200, or neutral protamine Hagedorn [NPH] insulin) in combination with at least 1 prandial injection of bolus insulin (insulin lispro U-100 or U-200, insulin aspart, insulin glulisine, or regular insulin) Or
* Premixed analog or human insulin regimens with any basal and bolus insulin combination injected at least twice daily
* Participants may be treated with up to 3 of the following oral antihyperglycemic medications (OAMs) in accordance with local regulations:

* Metformin
* Dipeptidyl peptidase-4 (DPP-4) inhibitor
* Sodium glucose cotransporter 2 (SGLT2) inhibitor
* Sulfonylurea
* Meglitinide
* Alpha-glucoside inhibitor
* Have an HbA1c value between =7.0 and =10.0%, according to the central laboratory at the time of screening.
* Have a body mass index (BMI) of =45.0 kilograms per meter squared at screening.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Have been diagnosed, at any time, with type 1 diabetes (T1D) or Latent Autoimmune Diabetes in Adults.
* Have hypoglycemia unawareness as judged by the investigator.
* Have had any episode of severe hypoglycemia within the 6 months prior to screening.
* Have had 1 or more episodes of diabetic ketoacidosis or hyperglycemic hyperosmolar state within the 6 months prior to screening.
* Have used thiazolidinediones, Glucagon-Like Peptide 1 (GLP-1) receptor agonist, or pramlintide within 90 days prior to screening.

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
14/07/2017
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
13/03/2019
Sample size
Target
Accrual to date
Final
933
Recruitment in Australia
Recruitment state(s)
SA,VIC,WA
Recruitment hospital [1] 0 0
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. - Keswick
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. - Oaklands Park
Recruitment hospital [3] 0 0
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. - Box Hill
Recruitment hospital [4] 0 0
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. - Geelong
Recruitment hospital [5] 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. - Fremantle
Recruitment postcode(s) [1] 0 0
5035 - Keswick
Recruitment postcode(s) [2] 0 0
5046 - Oaklands Park
Recruitment postcode(s) [3] 0 0
3128 - Box Hill
Recruitment postcode(s) [4] 0 0
3220 - Geelong
Recruitment postcode(s) [5] 0 0
6959 - Fremantle
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Florida
Country [3] 0 0
United States of America
State/province [3] 0 0
Hawaii
Country [4] 0 0
United States of America
State/province [4] 0 0
Idaho
Country [5] 0 0
United States of America
State/province [5] 0 0
Illinois
Country [6] 0 0
United States of America
State/province [6] 0 0
Iowa
Country [7] 0 0
United States of America
State/province [7] 0 0
Kansas
Country [8] 0 0
United States of America
State/province [8] 0 0
Nevada
Country [9] 0 0
United States of America
State/province [9] 0 0
New York
Country [10] 0 0
United States of America
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Ohio
Country [11] 0 0
United States of America
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Pennsylvania
Country [12] 0 0
United States of America
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Texas
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United States of America
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Utah
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United States of America
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Washington
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Argentina
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Buenos Aires
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Czechia
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Krnov
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Czechia
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Pardubice
Country [18] 0 0
Czechia
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Praha
Country [19] 0 0
Germany
State/province [19] 0 0
Baden-Württemberg
Country [20] 0 0
Germany
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Brandenburg
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Germany
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Hessen
Country [22] 0 0
Germany
State/province [22] 0 0
Nordrhein-Westfalen
Country [23] 0 0
Germany
State/province [23] 0 0
Rheinland-Pfalz
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Germany
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Saarland
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Germany
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Sachsen-Anhalt
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Germany
State/province [26] 0 0
Schleswig-Holstein
Country [27] 0 0
Germany
State/province [27] 0 0
Hamburg
Country [28] 0 0
Hungary
State/province [28] 0 0
Budapest
Country [29] 0 0
Hungary
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Nagykanizsa
Country [30] 0 0
India
State/province [30] 0 0
Gujarat
Country [31] 0 0
India
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Karnataka
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India
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Maharashtra
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India
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Maharshtra
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India
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Rajasthan
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India
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Tamil Nadu
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India
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Telangana
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Italy
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Palmero
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Italy
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Sesto San Giovanni
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Japan
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Chiba
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Japan
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Fukuoka
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Japan
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Hyogo
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Japan
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Kanagawa
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Japan
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Kumamoto
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Japan
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Miyazaki
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Japan
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Naka
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Japan
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Sapporo
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Japan
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Sasebo
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Japan
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Sendai
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Japan
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Tama
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Japan
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Tokyo
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Japan
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Yamato
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Japan
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Oita
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Japan
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Osaka
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Korea, Republic of
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Gyeonggi-do
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Korea, Republic of
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Ansan-si
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Korea, Republic of
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Daegu
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Korea, Republic of
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Daejeon
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Korea, Republic of
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Gangwon-do
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Korea, Republic of
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Seoul
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Mexico
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Jalisco
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Mexico
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Monterrey
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Mexico
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Zapopan
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Puerto Rico
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Caguas
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Puerto Rico
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Manati
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Puerto Rico
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Ponce
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Puerto Rico
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San Juan
Country [67] 0 0
Russian Federation
State/province [67] 0 0
Arkhangel'sk
Country [68] 0 0
Russian Federation
State/province [68] 0 0
Kursk
Country [69] 0 0
Russian Federation
State/province [69] 0 0
Moscow
Country [70] 0 0
Russian Federation
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Saint Petersburg
Country [71] 0 0
Russian Federation
State/province [71] 0 0
Saratov
Country [72] 0 0
Slovakia
State/province [72] 0 0
Slovak Republic
Country [73] 0 0
Slovakia
State/province [73] 0 0
Malacky
Country [74] 0 0
Slovakia
State/province [74] 0 0
Nove Mesto nad Vahom
Country [75] 0 0
Slovakia
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Púchov
Country [76] 0 0
Slovakia
State/province [76] 0 0
Rožnava
Country [77] 0 0
Spain
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Lleida
Country [78] 0 0
Spain
State/province [78] 0 0
Málaga
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Spain
State/province [79] 0 0
Sevilla
Country [80] 0 0
Taiwan
State/province [80] 0 0
Taichung
Country [81] 0 0
Taiwan
State/province [81] 0 0
Taipei
Country [82] 0 0
Taiwan
State/province [82] 0 0
Yongkang

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/NCT03214380