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A Study Comparing LY900014 to Insulin Lispro (Humalog) in Adults With Type 1 Diabetes Using Insulin Pump Therapy (PRONTO-Pump-2)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03830281
Recruitment Status : Active, not recruiting
First Posted : February 5, 2019
Last Update Posted : November 6, 2019
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company

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).

Condition or disease Intervention/treatment Phase
Type 1 Diabetes Mellitus Drug: LY900014 Drug: Insulin Lispro Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 526 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Prospective, Randomized, Double-Blind Comparison of LY900014 to Humalog in Adults With Type 1 Diabetes Using Continuous Subcutaneous Insulin Infusion
Actual Study Start Date : February 14, 2019
Estimated Primary Completion Date : January 3, 2020
Estimated Study Completion Date : January 3, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diabetes Type 1

Arm Intervention/treatment
Experimental: LY900014
LY900014 administered via continuous subcutaneous (SC) insulin infusion (CSII).
Drug: LY900014
Administered SC
Other Name: Ultra-Rapid Lispro

Active Comparator: Insulin Lispro
Insulin lispro (Humalog) administered via CSII.
Drug: Insulin Lispro
Administered SC
Other Names:
  • Humalog
  • LY275585




Primary Outcome Measures :
  1. Change from Baseline in Hemoglobin A1c (HbA1c) [ Time Frame: Baseline, Week 16 ]
    Change from baseline in HbA1c


Secondary Outcome Measures :
  1. 1-hour Postprandial Glucose (PPG) During Mixed-Meal Tolerance Test (MMTT) [ Time Frame: Week 16 ]
    1-hour PPG during MMTT

  2. 2-hour PPG During MMTT [ Time Frame: Week 16 ]
    2-hour PPG during MMTT

  3. Percentage of Time with Sensor Glucose Values between 70 and 180 milligrams per deciliter (mg/dL) [ Time Frame: Week 16 ]
    Percentage of time with sensor glucose values between 70 and 180 mg/dL

  4. Rate of Severe Hypoglycemia [ Time Frame: Baseline through Week 16 ]
    Rate of severe hypoglycemia

  5. Rate of Documented Symptomatic Hypoglycemia [ Time Frame: Baseline through Week 16 ]
    Rate of documented symptomatic hypoglycemia

  6. Change From Baseline in 1,5-Anhydroglucitol (1,5-AG) [ Time Frame: Baseline, Week 16 ]
    Change from baseline in 1,5-AG

  7. Change from Baseline in 10-Point Self-Monitoring Blood Glucose (SMBG) Values [ Time Frame: Baseline, Week 16 ]
    Change from baseline in 10-point SMBG values

  8. Change from Baseline in Bolus/Total Insulin Dose Ratio [ Time Frame: Baseline, Week 16 ]
    Change from baseline in bolus/total insulin dose ratio

  9. Percentage of Participants with HbA1c <7% and ≤6.5% [ Time Frame: Week 16 ]
    Percentage of participants with HbA1c <7% and ≤6.5%

  10. Percentage of Participants with at Least 1 Pump Occlusion Alarm that Leads to an Unplanned Infusion Set Change [ Time Frame: Baseline through Week 16 ]
    Percentage of participants with at least 1 pump occlusion alarm that leads to an unplanned infusion set change

  11. 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 [ Time Frame: Baseline through Week 16 ]
    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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03830281


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Locations
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United States, California
John Muir Physician Network Clinical Research Center
Concord, California, United States, 94520
Valley Research
Fresno, California, United States, 93720
Marin Endocrine Associates
Greenbrae, California, United States, 94904
Diabetes and Endocrine Associates
La Mesa, California, United States, 91942
First Valley Medical Group
Lancaster, California, United States, 93534
Center of Excellence in Diabetes & Endocrinology
Sacramento, California, United States, 95821
University Clinical Investigators, Inc.
Tustin, California, United States, 92780
Coastal Metabolic Research Centre
Ventura, California, United States, 93003
United States, Colorado
Barbara Davis Center for Childhood Diabetes
Aurora, Colorado, United States, 80045
United States, Florida
ALL Medical Research, LLC
Cooper City, Florida, United States, 33024
Sun Coast Clinical Research, Inc
New Port Richey, Florida, United States, 34652
Metabolic Research Institute Inc.
West Palm Beach, Florida, United States, 33401
United States, Georgia
Atlanta Diabetes Associates
Atlanta, Georgia, United States, 30318
Endocrine Research Solutions, Inc.
Roswell, Georgia, United States, 30076
United States, Hawaii
East West Medical Institute
Honolulu, Hawaii, United States, 96814
United States, Idaho
Rocky Mountain Diabetes and Osteoporosis Center
Idaho Falls, Idaho, United States, 83404
United States, Illinois
Northwestern Feinberg School of Medicine
Chicago, Illinois, United States, 60611
Prairie Education and Research Cooperative
Springfield, Illinois, United States, 62711
United States, Iowa
Iderc, P.L.C.
West Des Moines, Iowa, United States, 50265
United States, Kentucky
Kentucky Diabetes Endocrinology Center
Lexington, Kentucky, United States, 40503
United States, Maryland
Endocrine and Metabolic Consultants
Rockville, Maryland, United States, 20852
United States, Nevada
Palm Research Center
Las Vegas, Nevada, United States, 89128
Palm Research Center
Las Vegas, Nevada, United States, 89148
United States, New Hampshire
Southern New Hampshire Diabetes and Endocrinology
Nashua, New Hampshire, United States, 03063
United States, North Carolina
Physicians East
Greenville, North Carolina, United States, 27843
United States, Pennsylvania
Thomas Jefferson University
Philadelphia, Pennsylvania, United States, 19107
United States, Texas
Texas Diabetes and Endocrinology-Austin South
Austin, Texas, United States, 78749
Dallas Diabetes Endocrine Center
Dallas, Texas, United States, 75230
Texas Diabetes and Endocrinology, P.A.
Round Rock, Texas, United States, 78681
United States, Washington
Private: Dr. Larry Stonesifer
Federal Way, Washington, United States, 98003
Rainier Clinical Research Center
Renton, Washington, United States, 98057
Tacoma Center for Arthritis Research, PS
Tacoma, Washington, United States, 98405
Australia, New South Wales
The AIM Centre
Merewether, New South Wales, Australia, 2291
Australia, South Australia
GP Plus Marion
Oaklands Park, South Australia, Australia, 5046
Australia, Victoria
Box Hill Hospital
Box Hill, Victoria, Australia, 3128
Barwon Health - The Geelong Hospital
Geelong, Victoria, Australia, 3220
Australia, Western Australia
Fremantle Hospital
Fremantle, Western Australia, Australia, 6160
Austria
Universitätsklinikum Graz
Graz, Steiermark, Austria, 8036
VIVIT Institut am LKH Feldkirch
Feldkirch, Vorarlberg, Austria, 6800
Universitätsklinikum Salzburg
Salzburg, Austria, 5020
KA Rudolfstiftung
Vienna, Austria, 1030
Canada, Ontario
LMC Endocrinology Centres Ltd.
Barrie, Ontario, Canada, L4N 7L3
LMC Endocrinology Centres Ltd.
Concord, Ontario, Canada, L4K 4M2
LMC Endocrinology Centres
Oakville, Ontario, Canada, L6M 4H8
LMC Endocrinology Centres Ltd.
Toronto, Ontario, Canada, M4G 3E8
Canada, Quebec
IRCM
Montreal, Quebec, Canada, H2W 1R7
LMC Endocrinology Centres Ltd.
Ville St-Laurent, Quebec, Canada, H4T 1Z9
France
CHU Toulouse Hopital de Rangueil
Toulouse, Cedex 9, France, 31059
Clinique Hotel Dieu
Le Creusot, France, 71200
Centre hospitalier universitaire Lapeyronie
Montpellier Cedex 5, France, 34295
Hopital Cochin
Paris CEDEX 14, France, 75679
Hôpital de HautePierre
Strasbourg, France, 67098
Groupe hospitalier mutualiste Les Portes du sud
Venissieux, France, 69200
Germany
Arztpraxis Dr. Cornelia Marck
Pohlheim, Hessen, Germany, 35415
Institut für Diabetesforschung Münster GmbH
Münster, Nordrhein-Westfalen, Germany, 48145
Praxis Dr. Kempe - Dr. Stemler
Ludwigshafen am Rhein, Rheinland-Pfalz, Germany, 67059
Schwerpunktpraxis Diabetes
Saint Ingbert-Oberwürzbach, Saarland, Germany, 66386
RED-Institut GmbH
Oldenburg, Schleswig-Holstein, Germany, 23758
Diabetespraxis Prenzlauer Allee
Berlin, Germany, 10409
Diabetologische Schwerpunktpraxis B. Scholz/Dr. B. Paschen
Hamburg, Germany, 21073
Gemeinschaftspraxis für innere Medizin und Diabetologie
Hamburg, Germany, 22607
Hungary
Budai Irgalmasrendi Korhaz
Budapest, Hungary, 1023
ClinDiab Kft.
Budapest, Hungary, 1089
UNO Medical Trials Kft.
Budapest, Hungary, 1135
TRANTOR 99 Bt.
Budapest, Hungary, 1213
Israel
Soroka Medical Center - Pediatric Outpatient Clinic
Beer-Sheva, Israel, 8410101
Rambam Health Care Campus
Haifa, Israel, 31096
Hadassah Medical Center
Jerusalem, Israel, 91120
Schneider Medical Center
Petah Tiqva, Israel, 4920235
Sheba Medical Center
Ramat Gan, Israel, 5266202
Italy
Azienda Ospedaliera Papa Giovanni XXIII
Bergamo, Italy, 24128
IRCCS Ospedale San Raffaele
Milano, Italy, 20132
Ospedale San Giovanni di Dio
Olbia, Italy, 07026
Ospedale Santa Maria delle Croci
Ravenna, Italy, 48121
Dip.to Med. Sperimentale -Polic.Umberto I -Univ. La Sapienza
Roma, Italy, 00161
Puerto Rico
Advanced Clinical Research, LLC
Bayamon, Puerto Rico, 00961
Centro de Endocrinologia Alcantara Gonzalez
Lomas Verdes, Puerto Rico, 00956
Spain
Corporació Sanitaria Parc Tauli
Sabadell, Barcelona, Spain, 08208
Hospital Universitari Arnau de Vilanova
Lleida, Cataluña, Spain, 25198
Hospital Clinic I Provincial
Barcelona, Spain, 08036
Hospital Universitario La Paz
Madrid, Spain, 28046
Hospital Universitario Virgen Macarena
Sevilla, Spain, 41009
Hospital Clínico Universitario de Valencia
Valencia, Spain, 46010
Sponsors and Collaborators
Eli Lilly and Company
Investigators
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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

Additional Information:
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Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT03830281     History of Changes
Other Study ID Numbers: 16315
I8B-MC-ITRO ( Other Identifier: Eli Lilly and Company )
2015-005358-36 ( EudraCT Number )
First Posted: February 5, 2019    Key Record Dates
Last Update Posted: November 6, 2019
Last Verified: November 1, 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: 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 Materials: Study Protocol
Statistical Analysis Plan (SAP)
Clinical Study Report (CSR)
Time Frame: 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.
Access Criteria: A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
URL: http://vivli.org/

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Insulin
Insulin, Globin Zinc
Insulin Lispro
Hypoglycemic Agents
Physiological Effects of Drugs