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

February 3, 2023 updated by: Eli Lilly and Company

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
187

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: LY900014
LY900014 (100 units/milliliter (U/mL)) is a mealtime insulin administered subcutaneously (SC) 0-2 minutes prior to each meal in combination with insulin glargine (100 U/mL) SC as long-acting insulin. Mealtime (bolus) and long-acting (basal) insulin doses were titrated to achieve glucose targets during the study.
Drug: LY900014
Administered SC
Drug: Insulin Glargine
Administered SC

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
Time Frame: Baseline, Week 12
Least Squares (LS) mean was determined by mixed-model repeated measures (MMRM) model with Baseline + Time as variables.
Baseline, Week 12

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change From Baseline in Hemoglobin A1c (HbA1c) at Week 12
Time Frame: Baseline, 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
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
Time Frame: Baseline, Week 12
LS mean was determined by MMRM model with Baseline + Time as variables.
Baseline, Week 12
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
Time Frame: Baseline, Week 12
LS mean was determined by MMRM model with Baseline + Time as variables.
Baseline, Week 12
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
Time Frame: Baseline, Week 12
LS mean was determined by MMRM model with Baseline + Time as variables.
Baseline, Week 12
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
Time Frame: Baseline, Week 12
LS mean was determined by MMRM model with Baseline + Time as variables.
Baseline, Week 12
Change From Baseline in Postprandial Incremental Area Under the Glucose Curve (iAUC) 0-1 Hour at Week 12
Time Frame: Baseline, 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
Change From Baseline in Postprandial Incremental Area Under the Glucose Curve (iAUC) 0-2 Hour at Week 12
Time Frame: Baseline, 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
Percentage of Participants With HbA1c <7% and ≤6.5%
Time Frame: Week 12
HbA1c is the glycosylated fraction of hemoglobin A. It is measured to identify average plasma glucose concentration over prolonged periods of time.
Week 12
Change From Baseline in Daily Insulin Dose at Week 12
Time Frame: Baseline, Week 12
LS mean was determined by MMRM model with Baseline + Time as variables.
Baseline, Week 12
Change From Baseline in Bolus/Total Insulin Dose Percentage at Week 12
Time Frame: Baseline, Week 12
LS mean was determined by MMRM model with Baseline + Time as variables.
Baseline, Week 12
Change From Baseline in Insulin Treatment Satisfaction Questionnaire (ITSQ) - Glycemic Control Domain Score at Week 12
Time Frame: Baseline, 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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Eli Lilly and Company

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 4, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 4, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 4, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 26, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 26, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 28, 2020

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 3, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 3, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 17428 (Other Identifier: City of Hope Medical Center)
  • I8B-MC-ITSW (Other Identifier: Eli Lilly and Company)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD 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.

IPD Sharing Time Frame

Data are available 6 months after the primary publication and approval of the indication studied in the US and European Union (EU), whichever is later. Data will be indefinitely available for requesting.

IPD Sharing Access Criteria

A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings