Clinical trial NCT04605991: A Study of Mealtime Insulin LY900014 in Participants With Type 2 Diabetes Using Continuous Glucose Monitoring (PRONTO-Time in Range)
Official title: A Study of LY900014 in Participants With Type 2 Diabetes Using Continuous Glucose Monitoring
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Type 2 Diabetes
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2020-10-28
Enrollment: 187
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study is being done to evaluate glycemic control in participants with type 2 diabetes who are taking mealtime insulin LY900014 in combination with long-acting insulin glargine. Participants will use continuous glucose monitoring (CGM) (Freestyle Libre 14-day system) during the study.


Eligibility criteria: Inclusion Criteria:

* Participants diagnosed (clinically) with type 2 diabetes mellitus (T2D) for at least 1 year prior to screening.
* Have been treated with basal-bolus multiple daily injection (MDI) therapy for at least 90 days prior to screening including:

  * Basal insulin glargine U-100, in combination with bolus insulin analog (insulin lispro, insulin aspart, or insulin glulisine) with meals.
  * Participant must have been treated with the same type of allowed bolus insulin analog for at least 30 days prior to screening.
* Participants may be treated with up to 3 of the following oral antihyperglycemic medications (OAMs) for T2D in accordance with local regulations:

  1. Metformin
  2. Dipeptidyl peptidase-4 (DPP-4) inhibitor
  3. sodium glucose cotransporter 2 (SGLT2) inhibitor
  4. oral glucagon-like peptide 1 (GLP-1) agonist
* Doses of OAMs are required to have been stable for at least 90 days prior to screening.
* Participants may be treated with injectable GLP-1 receptor agonist for T2D in accordance with local regulations. The GLP-1 receptor agonist dose is required to have been stable for at least 90 days prior to screening.
* Have an HbA1c value ≥7.5% and ≤10% according to the central laboratory at screening.

Exclusion Criteria:

* Have been diagnosed at any time with type 1 diabetes mellitus or latent autoimmune diabetes in adults.
* Have had any episode of severe hypoglycemia (defined as requiring assistance due to neurologically disabling hypoglycemia) within 6 months prior to screening.
* Have had any episode of hyperglycemic hyperosmolar state or diabetic ketoacidosis within 6 months prior to screening.
* Have hypoglycemia unawareness as judged by the investigator.

Primary outcomes:
measure: Change From Baseline in Percentage of Time With Continuous Glucose Monitoring (CGM) Sensor Glucose Values Between 70-180 Milligrams/Deciliter (mg/dL) (3.9-10.0 Millimoles/Liter [mmol/L]) (Both Inclusive) During Daytime Period at Week 12
timeFrame: Baseline, Week 12
Secondary outcomes:
measure: Change From Baseline in Hemoglobin A1c (HbA1c) at Week 12
timeFrame: Baseline, Week 12
measure: Change From Baseline in Percentage of Time With CGM Sensor Glucose Values Between 70-180 mg/dL (3.9-10.0 mmol/L) (Both Inclusive) During the 24-hour Period at Week 12
timeFrame: Baseline, Week 12
measure: Change From Baseline in Percentage of Time With CGM Sensor Glucose Values <54 mg/dL (<3.0 mmol/L) During Daytime and 24-hour Periods at Week 12
timeFrame: Baseline, Week 12
measure: Change From Baseline in Percentage of Time With CGM Sensor Glucose Values >180 mg/dL (>10.0 mmol/L) During Daytime and 24-hour Period at Week 12
timeFrame: Baseline, Week 12
measure: Change From Baseline in Percentage of Time With CGM Sensor Glucose Value >250 mg/dL (>13.9 mmol/L) During Daytime and 24-hour Period at Week 12
timeFrame: Baseline, Week 12
measure: Change From Baseline in Postprandial Incremental Area Under the Glucose Curve (iAUC) 0-1 Hour at Week 12
timeFrame: Baseline, Week 12
measure: Change From Baseline in Postprandial Incremental Area Under the Glucose Curve (iAUC) 0-2 Hour at Week 12
timeFrame: Baseline, Week 12
measure: Percentage of Participants With HbA1c <7% and ≤6.5%
timeFrame: Week 12
measure: Change From Baseline in Daily Insulin Dose at Week 12
timeFrame: Baseline, Week 12
measure: Change From Baseline in Bolus/Total Insulin Dose Percentage at Week 12
timeFrame: Baseline, Week 12
measure: Change From Baseline in Insulin Treatment Satisfaction Questionnaire (ITSQ) - Glycemic Control Domain Score at Week 12
timeFrame: Baseline, Week 12
Other outcomes:
Locations:
city: Concord
country: United States
facility: John Muir Physician Network Clinical Research Center
state: California
city: Escondido
country: United States
facility: AMCR Institute
state: California
city: Fresno
country: United States
facility: Valley Endocrine, Fresno
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: Hamden
country: United States
facility: CMR of Greater New Haven
state: Connecticut
city: Hollywood
country: United States
facility: Encore Medical Research
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: Macon
country: United States
facility: East Coast Institute for Research at The Jones Center
state: Georgia
city: Idaho Falls
country: United States
facility: Rocky Mountain Clinical Research
state: Idaho
city: Springfield
country: United States
facility: Central Illinois Diabetes and Clinical Research a Division of Prairie Education and Research Cooperative
state: Illinois
city: West Des Moines
country: United States
facility: Iowa Diabetes and Endocrinology Research Center
state: Iowa
city: Baltimore
country: United States
facility: Maryland Cardiovascular Specialists
state: Maryland
city: Rockville
country: United States
facility: Endocrine and Metabolic Consultants
state: Maryland
city: Las Vegas
country: United States
facility: Palm Research Center Tenaya
state: Nevada
city: Las Vegas
country: United States
facility: Palm Research Center Tenaya
state: Nevada
city: New York
country: United States
facility: Research NYC, Inc
state: New York
city: Syracuse
country: United States
facility: Suny Health Science Center at Syracuse
state: New York
city: Morehead City
country: United States
facility: Cataret Medical Group
state: North Carolina
city: Norman
country: United States
facility: Intend Research, LLC
state: Oklahoma
city: Austin
country: United States
facility: Texas Diabetes & Endocrinology, P.A.
state: Texas
city: Dallas
country: United States
facility: Dallas Diabetes Research Center
state: Texas
city: Houston
country: United States
facility: Biopharma Informatic, LLC
state: Texas
city: Houston
country: United States
facility: Endocrine Ips, Pllc
state: Texas
city: Shavano Park
country: United States
facility: Consano Clinical Research, LLC
state: Texas
city: Burke
country: United States
facility: Burke Internal Medicine and Research
state: Virginia
city: Manassas
country: United States
facility: Manassas Clinical Research Center
state: Virginia
city: Renton
country: United States
facility: Rainier Clinical Research Center
state: Washington
city: Bayamon
country: Puerto Rico
facility: Advanced Clinical Research, LLC
city: Manati
country: Puerto Rico
facility: Manati Center for Clinical Research Inc
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: