A Study of Mealtime Insulin LY900014 in Participants With Type 2 Diabetes Using Continuous Glucose Monitoring (PRONTO-Time in Range)

Type 2 Diabetes Clinical Trial

Official title:

A Study of LY900014 in Participants With Type 2 Diabetes Using Continuous Glucose Monitoring

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04605991
• Other study ID #: 17428
• Secondary ID: I8B-MC-ITSW
• Status: Completed
• Phase: Phase 3
• Start date: November 4, 2020
• Est. completion date: February 4, 2022

Study information

• Verified date: February 2023
• Source: Eli Lilly and Company
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 187
• Est. completion date: February 4, 2022
• Est. primary completion date: February 4, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type 2 Diabetes

Intervention

Drug:
• LY900014
Administered SC
• Insulin Glargine
Administered SC

Locations

Country	Name	City	State
Puerto Rico	Advanced Clinical Research, LLC	Bayamon
Puerto Rico	Manati Center for Clinical Research Inc	Manati
United States	Atlanta Diabetes Associates	Atlanta	Georgia
United States	Texas Diabetes & Endocrinology, P.A.	Austin	Texas
United States	Maryland Cardiovascular Specialists	Baltimore	Maryland
United States	Burke Internal Medicine and Research	Burke	Virginia
United States	John Muir Physician Network Clinical Research Center	Concord	California
United States	Dallas Diabetes Research Center	Dallas	Texas
United States	AMCR Institute	Escondido	California
United States	Valley Endocrine, Fresno	Fresno	California
United States	CMR of Greater New Haven	Hamden	Connecticut
United States	Encore Medical Research	Hollywood	Florida
United States	Biopharma Informatic, LLC	Houston	Texas
United States	Endocrine Ips, Pllc	Houston	Texas
United States	Rocky Mountain Clinical Research	Idaho Falls	Idaho
United States	Palm Research Center Tenaya	Las Vegas	Nevada
United States	Palm Research Center Tenaya	Las Vegas	Nevada
United States	East Coast Institute for Research at The Jones Center	Macon	Georgia
United States	Manassas Clinical Research Center	Manassas	Virginia
United States	Cataret Medical Group	Morehead City	North Carolina
United States	Sun Coast Clinical Research, Inc	New Port Richey	Florida
United States	Research NYC, Inc	New York	New York
United States	Intend Research, LLC	Norman	Oklahoma
United States	Rainier Clinical Research Center	Renton	Washington
United States	Endocrine and Metabolic Consultants	Rockville	Maryland
United States	Consano Clinical Research, LLC	Shavano Park	Texas
United States	Central Illinois Diabetes and Clinical Research a Division of Prairie Education and Research Cooperative	Springfield	Illinois
United States	Suny Health Science Center at Syracuse	Syracuse	New York
United States	University Clinical Investigators, Inc.	Tustin	California
United States	Coastal Metabolic Research Centre	Ventura	California
United States	Iowa Diabetes and Endocrinology Research Center	West Des Moines	Iowa
United States	Metabolic Research Institute, Inc.	West Palm Beach	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Eli Lilly and Company

Countries where clinical trial is conducted

United States,  Puerto Rico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Least Squares (LS) mean was determined by mixed-model repeated measures (MMRM) model with Baseline + Time as variables.	Baseline, Week 12
Secondary	Change From Baseline in Hemoglobin A1c (HbA1c) at Week 12	HbA1c is the glycosylated fraction of hemoglobin A. It is measured to identify average plasma glucose concentration over prolonged periods of time. LS mean was determined by MMRM model with Baseline + Time as variables.	Baseline, Week 12
Secondary	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	LS mean was determined by MMRM model with Baseline + Time as variables.	Baseline, Week 12
Secondary	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	LS mean was determined by MMRM model with Baseline + Time as variables.	Baseline, Week 12
Secondary	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	LS mean was determined by MMRM model with Baseline + Time as variables.	Baseline, Week 12
Secondary	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	LS mean was determined by MMRM model with Baseline + Time as variables.	Baseline, Week 12
Secondary	Change From Baseline in Postprandial Incremental Area Under the Glucose Curve (iAUC) 0-1 Hour at Week 12	iAUC reflects the metabolic control and is calculated using the standard trapezoidal rule from Glucose measures taken every 15 minutes from 0 to 1 hour after meal using CGM sensor (i.e., 0, 15, 30, 45, 60 minutes after meal). LS mean was determined by ANCOVA (analysis of covariance) with Baseline as covariate.	Baseline, Week 12
Secondary	Change From Baseline in Postprandial Incremental Area Under the Glucose Curve (iAUC) 0-2 Hour at Week 12	iAUC reflects the metabolic control and is calculated using the standard trapezoidal rule from glucose measures taken every 15 minutes from 0 to 2 hours after meal using CGM sensor (i.e., 0, 15, 30, 45, 60, 75, 90, 105, 120 minutes after meal). LS mean was determined by ANCOVA (analysis of covariance) with Baseline as covariate.	Baseline, Week 12
Secondary	Percentage of Participants With HbA1c <7% and =6.5%	HbA1c is the glycosylated fraction of hemoglobin A. It is measured to identify average plasma glucose concentration over prolonged periods of time.	Week 12
Secondary	Change From Baseline in Daily Insulin Dose at Week 12	LS mean was determined by MMRM model with Baseline + Time as variables.	Baseline, Week 12
Secondary	Change From Baseline in Bolus/Total Insulin Dose Percentage at Week 12	LS mean was determined by MMRM model with Baseline + Time as variables.	Baseline, Week 12
Secondary	Change From Baseline in Insulin Treatment Satisfaction Questionnaire (ITSQ) - Glycemic Control Domain Score at Week 12	The ITSQ is a 22-item questionnaire that assesses treatment satisfaction for subjects taking insulin under 5 domains: Inconvenience of Regimen [IR - 5 items], Lifestyle Flexibility [LF - 3 items], Glycemic Control [GC - 3 items], Hypoglycemic Control [HC - 5 items], Insulin Delivery Device [IDD - 6 items]. Each Item is measured on a 7-point scale, with scores ranging for IR from 5 to 35, LF from 3 to 21, GC from 3 to 21, HC from 5 to 35, IDD from 6 to 42. Lower scores reflect better outcomes. Data presented are for Glycemic Control Domain Scores transformed on a 0-100 scale, where transformed domain score = 100×[(7-raw domain score)/6]. Higher scores indicate better glycemic control. Least squares (LS) mean estimated from analysis of covariance (ANCOVA) model that included baseline score as a covariate.	Baseline, Week 12

External Links

•   A Study of Mealtime Insulin LY900014 in Participants with Type 2 Diabetes Using Continuous Glucose Monitoring (PRONTO-Time in Range)