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

• Sponsor: Eli Lilly and Company (Industry)
• Overall Status: Completed
• CT.gov ID: NCT04605991
• Collaborator: (none)
• Enrollment: 177
• Locations: 32
• Arm: 1
• Actual Duration (Months): 15
• Patients Per Site: 5.5
• Patients Per Site Per Month: 0.4

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Type 2 Diabetes	Drug: LY900014; Drug: Insulin Glargine	Phase 3

Study Design

• Study Type: Interventional
• Actual Enrollment: 177 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Study of LY900014 in Participants With Type 2 Diabetes Using Continuous Glucose Monitoring
• Actual Study Start Date: Nov 4, 2020
• Actual Primary Completion Date: Feb 4, 2022
• Actual Study Completion Date: Feb 4, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: LY900014 LY900014 given via subcutaneous (SC) injection	Drug: LY900014; Administered SC; Drug: Insulin Glargine; Administered SC

Outcome Measures

Primary Outcome Measures

1. Change from Baseline in Percentage of Time with CGM Glucose Values between 70-180 milligrams/deciliter (mg/dL) (3.9-10.0 millimoles/Liter [mmol/L]) (both inclusive) during Daytime Period with 14 Days of CGM Use [Baseline, Week 12]

   Change from Baseline in Percentage of Time with CGM Glucose Values between 70-180 mg/dL (3.9-10.0 mmol/L) (both inclusive) during Daytime Period with 14 Days of CGM Use

Secondary Outcome Measures

1. Change from Baseline in Hemoglobin A1c (HbA1c) [Baseline, Week 12]

   Change from Baseline in HbA1c

2. Change from Baseline in Percentage of Time with CGM Glucose Values between 70-180 mg/dL (3.9-10.0 mmol/L) (both inclusive) during the 24-hour Period with 14 Days of CGM Use [Baseline, Week 12]

   Change from Baseline in Percentage of Time with CGM Glucose Values between 70-180 mg/dL (3.9-10.0 mmol/L) (both inclusive) during the 24-hour Period with 14 Days of CGM Use

3. Change from Baseline in Percentage of Time with CGM Glucose Values <54 mg/dL (<3.0 mmol/L) during Daytime and 24-hour Periods with 14 Days of CGM Use [Baseline, Week 12]

   Change from Baseline in Percentage of Time with CGM Glucose Values <54 mg/dL (<3.0 mmol/L) during Daytime and 24-hour Periods with 14 Days of CGM Use

4. Change from Baseline in Percentage of Time with Sensor Glucose Values >180 mg/dL (>10.0 mmol/L) and >250 mg/dL (>13.9 mmol/L), during Daytime and 24- Hour Periods with 14 Days of CGM Use [Baseline, Week 12]

   Change from Baseline in Percentage of Time with Sensor Glucose Values >180 mg/dL (>10.0 mmol/L) and >250 mg/dL (>13.9 mmol/L), during Daytime and 24- Hour Periods with 14 Days of CGM Use

5. Change from Baseline in Postprandial Incremental Area Under the Curve (AUC)₀-₁ Hour, obtained from CGM use [Baseline, Week 12]

   Change from Baseline in Postprandial Incremental AUC₀-₁ Hour, obtained from CGM use

6. Change from Baseline in Postprandial Incremental AUC₀-₂ Hour, obtained from CGM use [Baseline, Week 12]

   Change from Baseline in Postprandial Incremental AUC₀-₂ Hour, obtained from CGM use

7. Percentage of Participants with HbA1c <7% and ≤6.5% [Week 12]

   Percentage of Participants with HbA1c <7% and ≤6.5%

8. Change from Baseline in Bolus Insulin Dose [Baseline, Week 12]

   Change from Baseline in Bolus Insulin Dose

9. Change from Baseline in Basal Insulin Dose [Baseline, Week 12]

   Change from Baseline in Basal Insulin Dose

10. Change from Baseline in Total Insulin Dose [Baseline, Week 12]

    Change from Baseline in Total Insulin Dose

11. Change from Baseline in Bolus/Total Insulin Dose Ratio [Baseline, Week 12]

    Change from Baseline in Bolus/Total Insulin Dose Ratio

12. Change from Baseline in Insulin Treatment Satisfaction Questionnaire (ITSQ) Glycemic Control Domain Scores [Baseline, Week 12]

    Change from Baseline in ITSQ Glycemic Control Domain Scores

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	John Muir Physician Network Clinical Research Center	Concord	California	United States	94520
2	AMCR Institute	Escondido	California	United States	92025
3	Valley Endocrine, Fresno	Fresno	California	United States	93720
4	University Clinical Investigators, Inc.	Tustin	California	United States	92780
5	Coastal Metabolic Research Centre	Ventura	California	United States	93003
6	CMR of Greater New Haven	Hamden	Connecticut	United States	06517
7	Encore Medical Research	Hollywood	Florida	United States	33021
8	Sun Coast Clinical Research, Inc	New Port Richey	Florida	United States	34652
9	Metabolic Research Institute, Inc.	West Palm Beach	Florida	United States	33401
10	Atlanta Diabetes Associates	Atlanta	Georgia	United States	30318
11	East Coast Institute for Research at The Jones Center	Macon	Georgia	United States	31210
12	Rocky Mountain Clinical Research	Idaho Falls	Idaho	United States	83404
13	Central Illinois Diabetes and Clinical Research a Division of Prairie Education and Research Cooperative	Springfield	Illinois	United States	62711
14	Iowa Diabetes and Endocrinology Research Center	West Des Moines	Iowa	United States	50265
15	Maryland Cardiovascular Specialists	Baltimore	Maryland	United States	21229
16	Endocrine and Metabolic Consultants	Rockville	Maryland	United States	20852
17	Palm Research Center Tenaya	Las Vegas	Nevada	United States	89128
18	Palm Research Center Tenaya	Las Vegas	Nevada	United States	89148
19	Research NYC, Inc	New York	New York	United States	10016
20	Suny Health Science Center at Syracuse	Syracuse	New York	United States	13210
21	Cataret Medical Group	Morehead City	North Carolina	United States	28557
22	Intend Research, LLC	Norman	Oklahoma	United States	73069
23	Texas Diabetes & Endocrinology, P.A.	Austin	Texas	United States	78749
24	Dallas Diabetes Research Center	Dallas	Texas	United States	75230
25	Biopharma Informatic, LLC	Houston	Texas	United States	77043
26	Endocrine Ips, Pllc	Houston	Texas	United States	77079
27	Consano Clinical Research, LLC	Shavano Park	Texas	United States	78231
28	Burke Internal Medicine and Research	Burke	Virginia	United States	22015
29	Manassas Clinical Research Center	Manassas	Virginia	United States	20110
30	Rainier Clinical Research Center	Renton	Washington	United States	98057
31	Advanced Clinical Research, LLC	Bayamon		Puerto Rico	00961
32	Manati Center for Clinical Research Inc	Manati		Puerto Rico	00674

Sponsors and Collaborators

• Eli Lilly and Company

Investigators

• 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

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

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

Publications

None provided.

• Responsible Party: Eli Lilly and Company
• ClinicalTrials.gov Identifier: NCT04605991
• Other Study ID Numbers: 17428; I8B-MC-ITSW
• First Posted: Oct 28, 2020
• Last Update Posted: Feb 25, 2022
• Last Verified: Feb 1, 2022

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2; Insulin Glargine

Study Results

No Results Posted as of Feb 25, 2022