A Study Comparing LY900014 to Insulin Lispro (Humalog) in Adults With Type 1 Diabetes Using Insulin Pump Therapy
PRONTO-Pump-2
A Prospective, Randomized, Double-Blind Comparison of LY900014 to Humalog in Adults With Type 1 Diabetes Using Continuous Subcutaneous Insulin Infusion
3 other identifiers
interventional
471
10 countries
79
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 Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Feb 2019
Shorter than P25 for phase_3
79 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 4, 2019
CompletedFirst Posted
Study publicly available on registry
February 5, 2019
CompletedStudy Start
First participant enrolled
February 14, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 6, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
January 6, 2020
CompletedResults Posted
Study results publicly available
January 22, 2021
CompletedJanuary 22, 2021
January 1, 2020
11 months
February 4, 2019
January 4, 2021
January 4, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
Change From Baseline in Hemoglobin A1c (HbA1c) Efficacy Estimand at Week 16
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.
Baseline, Week 16
Secondary Outcomes (12)
Change From Baseline in 1-hour Postprandial Glucose (PPG) During Mixed-Meal Tolerance Test (MMTT) Efficacy Estimand at Week 16
Baseline, Week 16
Change From Baseline in 2-hour PPG During MMTT Efficacy Estimand at Week 16
Baseline, Week 16
Percentage of Time With Sensor Glucose Values Between 70 and 180 mg/dL Efficacy Estimand at Week 16
Week 16
Rate of Severe Hypoglycemia at Week 16
Baseline through Week 16
Rate of Documented Symptomatic Hypoglycemia at Week 16
Baseline through Week 16
- +7 more secondary outcomes
Study Arms (2)
Insulin Lispro (Humalog)
ACTIVE COMPARATORParticipants 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.
Ultra-Rapid Lispro
EXPERIMENTALParticipants 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.
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (83)
John Muir Physician Network Clinical Research Center
Concord, California, 94520, United States
Valley Research
Fresno, California, 93720, United States
Marin Endocrine Associates
Greenbrae, California, 94904, United States
Diabetes and Endocrine Associates
La Mesa, California, 91942, United States
First Valley Medical Group
Lancaster, California, 93534, United States
Center of Excellence in Diabetes & Endocrinology
Sacramento, California, 95821, United States
University Clinical Investigators, Inc.
Tustin, California, 92780, United States
Coastal Metabolic Research Centre
Ventura, California, 93003, United States
Barbara Davis Center for Childhood Diabetes
Aurora, Colorado, 80045, United States
ALL Medical Research, LLC
Cooper City, Florida, 33024, United States
Sun Coast Clinical Research, Inc
New Port Richey, Florida, 34652, United States
Metabolic Research Institute Inc.
West Palm Beach, Florida, 33401, United States
Atlanta Diabetes Associates
Atlanta, Georgia, 30318, United States
Endocrine Research Solutions, Inc.
Roswell, Georgia, 30076, United States
East West Medical Institute
Honolulu, Hawaii, 96814, United States
Rocky Mountain Diabetes and Osteoporosis Center
Idaho Falls, Idaho, 83404, United States
Northwestern Feinberg School of Medicine
Chicago, Illinois, 60611, United States
Prairie Education and Research Cooperative
Springfield, Illinois, 62711, United States
Iderc, P.L.C.
West Des Moines, Iowa, 50265, United States
Kentucky Diabetes Endocrinology Center
Lexington, Kentucky, 40503, United States
Endocrine and Metabolic Consultants
Rockville, Maryland, 20852, United States
Palm Research Center
Las Vegas, Nevada, 89128, United States
Palm Research Center
Las Vegas, Nevada, 89148, United States
Southern New Hampshire Diabetes and Endocrinology
Nashua, New Hampshire, 03063, United States
Physicians East
Greenville, North Carolina, 27843, United States
Thomas Jefferson University
Philadelphia, Pennsylvania, 19107, United States
Texas Diabetes and Endocrinology-Austin South
Austin, Texas, 78749, United States
Dallas Diabetes Endocrine Center
Dallas, Texas, 75230, United States
Texas Diabetes and Endocrinology, P.A.
Round Rock, Texas, 78681, United States
Private: Dr. Larry Stonesifer
Federal Way, Washington, 98003, United States
Rainier Clinical Research Center
Renton, Washington, 98057, United States
Tacoma Center for Arthritis Research, PS
Tacoma, Washington, 98405, United States
The AIM Centre
Merewether, New South Wales, 2291, Australia
GP Plus Marion
Oaklands Park, South Australia, 5046, Australia
Box Hill Hospital
Box Hill, Victoria, 3128, Australia
Barwon Health - The Geelong Hospital
Geelong, Victoria, 3220, Australia
Fremantle Hospital
Fremantle, Western Australia, 6160, Australia
Universitätsklinikum Graz
Graz, Styria, 8036, Austria
VIVIT Institut am LKH Feldkirch
Feldkirch, Vorarlberg, 6800, Austria
Universitätsklinikum Salzburg
Salzburg, 5020, Austria
KA Rudolfstiftung
Vienna, 1030, Austria
LMC Endocrinology Centres Ltd.
Barrie, Ontario, L4N 7L3, Canada
LMC Endocrinology Centres Ltd.
Concord, Ontario, L4K 4M2, Canada
LMC Endocrinology Centres
Oakville, Ontario, L6M 4H8, Canada
LMC Endocrinology Centres Ltd.
Toronto, Ontario, M4G 3E8, Canada
IRCM
Montreal, Quebec, H2W 1R7, Canada
LMC Endocrinology Centres Ltd.
Saint-Laurent, Quebec, H4T 1Z9, Canada
CHU Toulouse Hopital de Rangueil
Toulouse, Cedex 9, 31059, France
Clinique Hotel Dieu
Le Creusot, 71200, France
Centre hospitalier universitaire Lapeyronie
Montpellier, 34295, France
Hopital Cochin
Paris, 75679, France
Hôpital de HautePierre
Strasbourg, 67098, France
Groupe hospitalier mutualiste Les Portes du sud
Vénissieux, 69200, France
Arztpraxis Dr. Cornelia Marck
Pohlheim, Hesse, 35415, Germany
Institut für Diabetesforschung Münster GmbH
Münster, North Rhine-Westphalia, 48145, Germany
Praxis Dr. Kempe - Dr. Stemler
Ludwigshafen am Rhein, Rhineland-Palatinate, 67059, Germany
Schwerpunktpraxis Diabetes
Saint Ingbert-Oberwürzbach, Saarland, 66386, Germany
RED-Institut GmbH
Oldenburg in Holstein, Schleswig-Holstein, 23758, Germany
Diabetespraxis Prenzlauer Allee
Berlin, 10409, Germany
Diabetologische Schwerpunktpraxis B. Scholz/Dr. B. Paschen
Hamburg, 21073, Germany
Gemeinschaftspraxis für innere Medizin und Diabetologie
Hamburg, 22607, Germany
Budai Irgalmasrendi Korhaz
Budapest, 1023, Hungary
ClinDiab Kft.
Budapest, 1089, Hungary
UNO Medical Trials Kft.
Budapest, 1135, Hungary
TRANTOR 99 Bt.
Budapest, 1213, Hungary
Soroka Medical Center - Pediatric Outpatient Clinic
Beersheba, 8410101, Israel
Rambam Health Care Campus
Haifa, 31096, Israel
Hadassah Medical Center
Jerusalem, 91120, Israel
Schneider Medical Center
Petah Tikva, 4920235, Israel
Sheba Medical Center
Ramat Gan, 5266202, Israel
Azienda Ospedaliera Papa Giovanni XXIII
Bergamo, 24128, Italy
IRCCS Ospedale San Raffaele
Milan, 20132, Italy
Ospedale San Giovanni di Dio
Olbia, 07026, Italy
Ospedale Santa Maria delle Croci
Ravenna, 48121, Italy
Dip.to Med. Sperimentale -Polic.Umberto I -Univ. La Sapienza
Roma, 00161, Italy
Advanced Clinical Research, LLC
Bayamón, PR, 00961, Puerto Rico
Centro de Endocrinologia Alcantara Gonzalez
Lomas Verdes, 00956, Puerto Rico
Corporació Sanitaria Parc Tauli
Sabadell, Barcelona, 08208, Spain
Hospital Universitari Arnau de Vilanova
Lleida, Catalonia, 25198, Spain
Hospital Clinic I Provincial
Barcelona, 08036, Spain
Hospital Universitario La Paz
Madrid, 28046, Spain
Hospital Universitario Virgen Macarena
Seville, 41009, Spain
Hospital Clínico Universitario de Valencia
Valencia, 46010, Spain
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Chief Medical Officer
- Organization
- Eli Lilly and Company
Study Officials
- STUDY DIRECTOR
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)
Eli Lilly and Company
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 4, 2019
First Posted
February 5, 2019
Study Start
February 14, 2019
Primary Completion
January 6, 2020
Study Completion
January 6, 2020
Last Updated
January 22, 2021
Results First Posted
January 22, 2021
Record last verified: 2020-01
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, CSR
- Time Frame
- Data are available 6 months after the primary publication and approval of the indication studied in the US and European Union (EU), whichever is later. Data will be indefinitely available for requesting.
- Access Criteria
- A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
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.