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

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ClinicalTrials.gov Identifier: NCT04605991
Recruitment Status : Recruiting
First Posted : October 28, 2020
Last Update Posted : November 18, 2021
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 167 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 : November 4, 2020
Estimated Primary Completion Date : February 4, 2022
Estimated Study Completion Date : February 4, 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: LY900014
LY900014 given via subcutaneous (SC) injection
Drug: LY900014
Administered SC

Drug: Insulin Glargine
Administered SC




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 [ Time Frame: 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) [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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% [ Time Frame: Week 12 ]
    Percentage of Participants with HbA1c <7% and ≤6.5%

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

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

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

  11. Change from Baseline in Bolus/Total Insulin Dose Ratio [ Time Frame: 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 [ Time Frame: Baseline, Week 12 ]
    Change from Baseline in ITSQ Glycemic Control Domain Scores



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04605991


Contacts
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Contact: There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Clinicaltrials.gov@lilly.com

Locations
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Sponsors and Collaborators
Eli Lilly and Company
Investigators
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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
Additional Information:
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Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT04605991    
Other Study ID Numbers: 17428
I8B-MC-ITSW ( Other Identifier: Eli Lilly and Company )
First Posted: October 28, 2020    Key Record Dates
Last Update Posted: November 18, 2021
Last Verified: November 2, 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
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.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Clinical Study Report (CSR)
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.
Access Criteria: A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
URL: https://vivli.org/

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Insulin Glargine
Hypoglycemic Agents
Physiological Effects of Drugs