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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT03830281




Registration number
NCT03830281
Ethics application status
Date submitted
4/02/2019
Date registered
5/02/2019
Date last updated
20/08/2019

Titles & IDs
Public title
A Study Comparing LY900014 to Insulin Lispro (Humalog) in Adults With Type 1 Diabetes Using Insulin Pump Therapy
Scientific title
A Prospective, Randomized, Double-Blind Comparison of LY900014 to Humalog in Adults With Type 1 Diabetes Using Continuous Subcutaneous Insulin Infusion
Secondary ID [1] 0 0
I8B-MC-ITRO
Secondary ID [2] 0 0
16315
Universal Trial Number (UTN)
Trial acronym
PRONTO-Pump-2
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

Experimental: LY900014 - LY900014 administered via continuous subcutaneous (SC) insulin infusion (CSII).

Active Comparator: Insulin Lispro - Insulin lispro (Humalog) administered via CSII.


Treatment: Drugs: LY900014
Administered SC

Treatment: Drugs: Insulin Lispro
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) - Change from baseline in HbA1c
Timepoint [1] 0 0
Baseline, Week 16
Secondary outcome [1] 0 0
1-hour Postprandial Glucose (PPG) Excursion during Mixed-Meal Tolerance Test (MMTT) - 1-hour PPG excursion during MMTT
Timepoint [1] 0 0
Week 16
Secondary outcome [2] 0 0
2-hour PPG Excursion during MMTT - 2-hour PPG excursion during MMTT
Timepoint [2] 0 0
Week 16
Secondary outcome [3] 0 0
Rate of Severe Hypoglycemia - Rate of severe hypoglycemia
Timepoint [3] 0 0
Baseline through Week 16
Secondary outcome [4] 0 0
Rate of Documented Symptomatic Hypoglycemia - Rate of documented symptomatic hypoglycemia
Timepoint [4] 0 0
Baseline through Week 16
Secondary outcome [5] 0 0
Change From Baseline in 1,5-Anhydroglucitol (1,5-AG) - Change from baseline in 1,5-AG
Timepoint [5] 0 0
Baseline, Week 16
Secondary outcome [6] 0 0
Change from Baseline in 10-Point Self-Monitoring Blood Glucose (SMBG) Values - Change from baseline in 10-point SMBG values
Timepoint [6] 0 0
Baseline, Week 16
Secondary outcome [7] 0 0
Change from Baseline in Bolus/Total Insulin Dose Ratio - Change from baseline in bolus/total insulin dose ratio
Timepoint [7] 0 0
Baseline, Week 16
Secondary outcome [8] 0 0
Percentage of Participants with HbA1c <7% and =6.5% - Percentage of participants with HbA1c <7% and =6.5%
Timepoint [8] 0 0
Week 16
Secondary outcome [9] 0 0
Percentage of Time with Sensor Glucose Values between 70 and 180 milligrams per deciliter (mg/dL) - Percentage of time with sensor glucose values between 70 and 180 mg/dL
Timepoint [9] 0 0
Week 16
Secondary outcome [10] 0 0
Percentage of Participants with at Least 1 Pump Occlusion Alarm that Leads to an Unplanned Infusion Set Change - Percentage of participants with at least 1 pump occlusion alarm that leads to an unplanned infusion set change
Timepoint [10] 0 0
Baseline through Week 16
Secondary outcome [11] 0 0
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 - 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
Timepoint [11] 0 0
Baseline through Week 16

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

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
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,SA,VIC,WA
Recruitment hospital [1] 0 0
The AIM Centre - Merewether
Recruitment hospital [2] 0 0
GP Plus Marion - Oaklands Park
Recruitment hospital [3] 0 0
Box Hill Hospital - Box Hill
Recruitment hospital [4] 0 0
Barwon Health - The Geelong Hospital - Geelong
Recruitment hospital [5] 0 0
Fremantle Hospital - Fremantle
Recruitment postcode(s) [1] 0 0
2291 - Merewether
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
6160 - 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
Colorado
Country [3] 0 0
United States of America
State/province [3] 0 0
Florida
Country [4] 0 0
United States of America
State/province [4] 0 0
Georgia
Country [5] 0 0
United States of America
State/province [5] 0 0
Hawaii
Country [6] 0 0
United States of America
State/province [6] 0 0
Idaho
Country [7] 0 0
United States of America
State/province [7] 0 0
Illinois
Country [8] 0 0
United States of America
State/province [8] 0 0
Iowa
Country [9] 0 0
United States of America
State/province [9] 0 0
Kentucky
Country [10] 0 0
United States of America
State/province [10] 0 0
Maryland
Country [11] 0 0
United States of America
State/province [11] 0 0
Nevada
Country [12] 0 0
United States of America
State/province [12] 0 0
New Hampshire
Country [13] 0 0
United States of America
State/province [13] 0 0
North Carolina
Country [14] 0 0
United States of America
State/province [14] 0 0
Pennsylvania
Country [15] 0 0
United States of America
State/province [15] 0 0
Texas
Country [16] 0 0
United States of America
State/province [16] 0 0
Washington
Country [17] 0 0
Austria
State/province [17] 0 0
Steiermark
Country [18] 0 0
Austria
State/province [18] 0 0
Vorarlberg
Country [19] 0 0
Austria
State/province [19] 0 0
Salzburg
Country [20] 0 0
Austria
State/province [20] 0 0
Vienna
Country [21] 0 0
Canada
State/province [21] 0 0
Ontario
Country [22] 0 0
Canada
State/province [22] 0 0
Quebec
Country [23] 0 0
France
State/province [23] 0 0
Cedex 9
Country [24] 0 0
France
State/province [24] 0 0
Le Creusot
Country [25] 0 0
France
State/province [25] 0 0
Montpellier Cedex 5
Country [26] 0 0
France
State/province [26] 0 0
Paris CEDEX 14
Country [27] 0 0
France
State/province [27] 0 0
Strasbourg
Country [28] 0 0
France
State/province [28] 0 0
Venissieux
Country [29] 0 0
Germany
State/province [29] 0 0
Hessen
Country [30] 0 0
Germany
State/province [30] 0 0
Nordrhein-Westfalen
Country [31] 0 0
Germany
State/province [31] 0 0
Rheinland-Pfalz
Country [32] 0 0
Germany
State/province [32] 0 0
Saarland
Country [33] 0 0
Germany
State/province [33] 0 0
Schleswig-Holstein
Country [34] 0 0
Germany
State/province [34] 0 0
Berlin
Country [35] 0 0
Germany
State/province [35] 0 0
Hamburg
Country [36] 0 0
Hungary
State/province [36] 0 0
Budapest
Country [37] 0 0
Israel
State/province [37] 0 0
Beer-Sheva
Country [38] 0 0
Israel
State/province [38] 0 0
Haifa
Country [39] 0 0
Israel
State/province [39] 0 0
Jerusalem
Country [40] 0 0
Israel
State/province [40] 0 0
Petah Tiqva
Country [41] 0 0
Israel
State/province [41] 0 0
Ramat Gan
Country [42] 0 0
Italy
State/province [42] 0 0
Bergamo
Country [43] 0 0
Italy
State/province [43] 0 0
Milano
Country [44] 0 0
Italy
State/province [44] 0 0
Olbia
Country [45] 0 0
Italy
State/province [45] 0 0
Ravenna
Country [46] 0 0
Italy
State/province [46] 0 0
Roma
Country [47] 0 0
Puerto Rico
State/province [47] 0 0
Bayamon
Country [48] 0 0
Puerto Rico
State/province [48] 0 0
Lomas Verdes
Country [49] 0 0
Spain
State/province [49] 0 0
Barcelona
Country [50] 0 0
Spain
State/province [50] 0 0
Cataluña
Country [51] 0 0
Spain
State/province [51] 0 0
Madrid
Country [52] 0 0
Spain
State/province [52] 0 0
Sevilla
Country [53] 0 0
Spain
State/province [53] 0 0
Valencia

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Eli Lilly and Company
Address
Country

Ethics approval
Ethics application status

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).
Trial website
https://clinicaltrials.gov/show/NCT03830281
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
There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or
Address 0 0
Country 0 0
Phone 0 0
1-317-615-4559
Fax 0 0
Email 0 0
ClinicalTrials.gov@lilly.com
Contact person for scientific queries

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT03830281