Clinical trial NCT03830281: A Study Comparing LY900014 to Insulin Lispro (Humalog) in Adults With Type 1 Diabetes Using Insulin Pump Therapy
Official title: A Prospective, Randomized, Double-Blind Comparison of LY900014 to Humalog in Adults With Type 1 Diabetes Using Continuous Subcutaneous Insulin Infusion
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Type 1 Diabetes Mellitus
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2019-02-05
Enrollment: 471
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).


Eligibility 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

Primary outcomes:
measure: Change From Baseline in Hemoglobin A1c (HbA1c) Efficacy Estimand at Week 16
timeFrame: Baseline, Week 16
Secondary outcomes:
measure: Change From Baseline in 1-hour Postprandial Glucose (PPG) During Mixed-Meal Tolerance Test (MMTT) Efficacy Estimand at Week 16
timeFrame: Baseline, Week 16
measure: Change From Baseline in 2-hour PPG During MMTT Efficacy Estimand at Week 16
timeFrame: Baseline, Week 16
measure: Percentage of Time With Sensor Glucose Values Between 70 and 180 mg/dL Efficacy Estimand at Week 16
timeFrame: Week 16
measure: Rate of Severe Hypoglycemia at Week 16
timeFrame: Baseline through Week 16
measure: Rate of Documented Symptomatic Hypoglycemia at Week 16
timeFrame: Baseline through Week 16
measure: Change From Baseline in 1,5-Anhydroglucitol (1,5-AG) at Week 16
timeFrame: Baseline, Week 16
measure: Change From Baseline in 10-Point Self-Monitoring Blood Glucose (SMBG) Values at Week 16
timeFrame: Baseline, Week 16
measure: Change From Baseline in Insulin Dose at Week 16
timeFrame: Baseline, Week 16
measure: Change From Baseline in Bolus/Total Insulin Dose Ratio at Week 16
timeFrame: Baseline, Week 16
measure: Percentage of Participants With HbA1c <7%
timeFrame: Week 16
measure: Percentage of Participants With at Least 1 Pump Occlusion Alarm That Leads to an Unplanned Infusion Set Change
timeFrame: Baseline through Week 16
measure: 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
timeFrame: Baseline through Week 16
Other outcomes:
Locations:
city: Concord
country: United States
facility: John Muir Physician Network Clinical Research Center
state: California
city: Fresno
country: United States
facility: Valley Research
state: California
city: Greenbrae
country: United States
facility: Marin Endocrine Associates
state: California
city: La Mesa
country: United States
facility: Diabetes and Endocrine Associates
state: California
city: Lancaster
country: United States
facility: First Valley Medical Group
state: California
city: Sacramento
country: United States
facility: Center of Excellence in Diabetes & Endocrinology
state: California
city: Tustin
country: United States
facility: University Clinical Investigators, Inc.
state: California
city: Ventura
country: United States
facility: Coastal Metabolic Research Centre
state: California
city: Aurora
country: United States
facility: Barbara Davis Center for Childhood Diabetes
state: Colorado
city: Cooper City
country: United States
facility: ALL Medical Research, LLC
state: Florida
city: New Port Richey
country: United States
facility: Sun Coast Clinical Research, Inc
state: Florida
city: West Palm Beach
country: United States
facility: Metabolic Research Institute Inc.
state: Florida
city: Atlanta
country: United States
facility: Atlanta Diabetes Associates
state: Georgia
city: Roswell
country: United States
facility: Endocrine Research Solutions, Inc.
state: Georgia
city: Honolulu
country: United States
facility: East West Medical Institute
state: Hawaii
city: Idaho Falls
country: United States
facility: Rocky Mountain Diabetes and Osteoporosis Center
state: Idaho
city: Chicago
country: United States
facility: Northwestern Feinberg School of Medicine
state: Illinois
city: Springfield
country: United States
facility: Prairie Education and Research Cooperative
state: Illinois
city: West Des Moines
country: United States
facility: Iderc, P.L.C.
state: Iowa
city: Lexington
country: United States
facility: Kentucky Diabetes Endocrinology Center
state: Kentucky
city: Rockville
country: United States
facility: Endocrine and Metabolic Consultants
state: Maryland
city: Las Vegas
country: United States
facility: Palm Research Center
state: Nevada
city: Las Vegas
country: United States
facility: Palm Research Center
state: Nevada
city: Nashua
country: United States
facility: Southern New Hampshire Diabetes and Endocrinology
state: New Hampshire
city: Greenville
country: United States
facility: Physicians East
state: North Carolina
city: Philadelphia
country: United States
facility: Thomas Jefferson University
state: Pennsylvania
city: Austin
country: United States
facility: Texas Diabetes and Endocrinology-Austin South
state: Texas
city: Dallas
country: United States
facility: Dallas Diabetes Endocrine Center
state: Texas
city: Round Rock
country: United States
facility: Texas Diabetes and Endocrinology, P.A.
state: Texas
city: Federal Way
country: United States
facility: Private: Dr. Larry Stonesifer
state: Washington
city: Renton
country: United States
facility: Rainier Clinical Research Center
state: Washington
city: Tacoma
country: United States
facility: Tacoma Center for Arthritis Research, PS
state: Washington
city: Merewether
country: Australia
facility: The AIM Centre
state: New South Wales
city: Oaklands Park
country: Australia
facility: GP Plus Marion
state: South Australia
city: Box Hill
country: Australia
facility: Box Hill Hospital
state: Victoria
city: Geelong
country: Australia
facility: Barwon Health - The Geelong Hospital
state: Victoria
city: Fremantle
country: Australia
facility: Fremantle Hospital
state: Western Australia
city: Graz
country: Austria
facility: Universitätsklinikum Graz
state: Steiermark
city: Feldkirch
country: Austria
facility: VIVIT Institut am LKH Feldkirch
state: Vorarlberg
city: Salzburg
country: Austria
facility: Universitätsklinikum Salzburg
city: Vienna
country: Austria
facility: KA Rudolfstiftung
city: Barrie
country: Canada
facility: LMC Endocrinology Centres Ltd.
state: Ontario
city: Concord
country: Canada
facility: LMC Endocrinology Centres Ltd.
state: Ontario
city: Oakville
country: Canada
facility: LMC Endocrinology Centres
state: Ontario
city: Toronto
country: Canada
facility: LMC Endocrinology Centres Ltd.
state: Ontario
city: Montreal
country: Canada
facility: IRCM
state: Quebec
city: Ville St-Laurent
country: Canada
facility: LMC Endocrinology Centres Ltd.
state: Quebec
city: Toulouse
country: France
facility: CHU Toulouse Hopital de Rangueil
state: Cedex 9
city: Le Creusot
country: France
facility: Clinique Hotel Dieu
city: Montpellier Cedex 5
country: France
facility: Centre hospitalier universitaire Lapeyronie
city: Paris CEDEX 14
country: France
facility: Hopital Cochin
city: Strasbourg
country: France
facility: Hôpital de HautePierre
city: Venissieux
country: France
facility: Groupe hospitalier mutualiste Les Portes du sud
city: Pohlheim
country: Germany
facility: Arztpraxis Dr. Cornelia Marck
state: Hessen
city: Münster
country: Germany
facility: Institut für Diabetesforschung Münster GmbH
state: Nordrhein-Westfalen
city: Ludwigshafen am Rhein
country: Germany
facility: Praxis Dr. Kempe - Dr. Stemler
state: Rheinland-Pfalz
city: Saint Ingbert-Oberwürzbach
country: Germany
facility: Schwerpunktpraxis Diabetes
state: Saarland
city: Oldenburg
country: Germany
facility: RED-Institut GmbH
state: Schleswig-Holstein
city: Berlin
country: Germany
facility: Diabetespraxis Prenzlauer Allee
city: Hamburg
country: Germany
facility: Diabetologische Schwerpunktpraxis B. Scholz/Dr. B. Paschen
city: Hamburg
country: Germany
facility: Gemeinschaftspraxis für innere Medizin und Diabetologie
city: Budapest
country: Hungary
facility: Budai Irgalmasrendi Korhaz
city: Budapest
country: Hungary
facility: ClinDiab Kft.
city: Budapest
country: Hungary
facility: UNO Medical Trials Kft.
city: Budapest
country: Hungary
facility: TRANTOR 99 Bt.
city: Beer-Sheva
country: Israel
facility: Soroka Medical Center - Pediatric Outpatient Clinic
city: Haifa
country: Israel
facility: Rambam Health Care Campus
city: Jerusalem
country: Israel
facility: Hadassah Medical Center
city: Petah Tiqva
country: Israel
facility: Schneider Medical Center
city: Ramat Gan
country: Israel
facility: Sheba Medical Center
city: Bergamo
country: Italy
facility: Azienda Ospedaliera Papa Giovanni XXIII
city: Milano
country: Italy
facility: IRCCS Ospedale San Raffaele
city: Olbia
country: Italy
facility: Ospedale San Giovanni di Dio
city: Ravenna
country: Italy
facility: Ospedale Santa Maria delle Croci
city: Roma
country: Italy
facility: Dip.to Med. Sperimentale -Polic.Umberto I -Univ. La Sapienza
city: Bayamon
country: Puerto Rico
facility: Advanced Clinical Research, LLC
city: Lomas Verdes
country: Puerto Rico
facility: Centro de Endocrinologia Alcantara Gonzalez
city: Sabadell
country: Spain
facility: Corporació Sanitaria Parc Tauli
state: Barcelona
city: Lleida
country: Spain
facility: Hospital Universitari Arnau de Vilanova
state: Cataluña
city: Barcelona
country: Spain
facility: Hospital Clinic I Provincial
city: Madrid
country: Spain
facility: Hospital Universitario La Paz
city: Sevilla
country: Spain
facility: Hospital Universitario Virgen Macarena
city: Valencia
country: Spain
facility: Hospital Clínico Universitario de Valencia
Study officials:
affiliation: Eli Lilly and Company
name: 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)
role: STUDY_DIRECTOR
References: