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| ID | Type | Description | Link |
|---|---|---|---|
| I8B-MC-ITSW | Other Identifier | Eli Lilly and Company |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LY900014 | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LY900014 | Drug | Administered SC |
| |
| Insulin Glargine |
| 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 | Least Squares (LS) mean was determined by mixed-model repeated measures (MMRM) model with Baseline + Time as variables. | Baseline, Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| 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 |
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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:
Participants may be treated with up to 3 of the following oral antihyperglycemic medications (OAMs) for T2D in accordance with local regulations:
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:
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| Name | Affiliation | Role |
|---|---|---|
| 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 Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| John Muir Physician Network Clinical Research Center | Concord | California | 94520 | United States | ||
| AMCR Institute |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37029268 | Derived | Bailey TS, Bode BW, Wang Q, Knights AW, Chang AM. Increased Time in Range with Ultra Rapid Lispro Treatment in Participants with Type 2 Diabetes: PRONTO-Time in Range. Diabetes Ther. 2023 May;14(5):883-897. doi: 10.1007/s13300-023-01400-w. Epub 2023 Apr 7. |
| Label | URL |
|---|---|
| A Study of Mealtime Insulin LY900014 in Participants with Type 2 Diabetes Using Continuous Glucose Monitoring (PRONTO-Time in Range) | View source |
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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.
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.
A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jul 13, 2020 | Nov 30, 2022 |
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| Drug |
Administered SC |
|
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 | 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 | 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 | 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 | 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 | 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% | 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 | 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 | 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 | 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 |
| Escondido |
| California |
| 92025 |
| United States |
| Valley Endocrine, Fresno | Fresno | California | 93720 | United States |
| University Clinical Investigators, Inc. | Tustin | California | 92780 | United States |
| Coastal Metabolic Research Centre | Ventura | California | 93003 | United States |
| CMR of Greater New Haven | Hamden | Connecticut | 06517 | United States |
| Encore Medical Research | Hollywood | Florida | 33021 | United States |
| Sun Coast Clinical Research, Inc | New Port Richey | Florida | 34652 | United States |
| Metabolic Research Institute, Inc. | West Palm Beach | Florida | 33401 | United States |
| Atlanta Diabetes Associates | Atlanta | Georgia | 30318 | United States |
| East Coast Institute for Research at The Jones Center | Macon | Georgia | 31210 | United States |
| Rocky Mountain Clinical Research | Idaho Falls | Idaho | 83404 | United States |
| Central Illinois Diabetes and Clinical Research a Division of Prairie Education and Research Cooperative | Springfield | Illinois | 62711 | United States |
| Iowa Diabetes and Endocrinology Research Center | West Des Moines | Iowa | 50265 | United States |
| Maryland Cardiovascular Specialists | Baltimore | Maryland | 21229 | United States |
| Endocrine and Metabolic Consultants | Rockville | Maryland | 20852 | United States |
| Palm Research Center Tenaya | Las Vegas | Nevada | 89128 | United States |
| Palm Research Center Tenaya | Las Vegas | Nevada | 89148 | United States |
| Research NYC, Inc | New York | New York | 10016 | United States |
| Suny Health Science Center at Syracuse | Syracuse | New York | 13210 | United States |
| Cataret Medical Group | Morehead City | North Carolina | 28557 | United States |
| Intend Research, LLC | Norman | Oklahoma | 73069 | United States |
| Texas Diabetes & Endocrinology, P.A. | Austin | Texas | 78749 | United States |
| Dallas Diabetes Research Center | Dallas | Texas | 75230 | United States |
| Biopharma Informatic, LLC | Houston | Texas | 77043 | United States |
| Endocrine Ips, Pllc | Houston | Texas | 77079 | United States |
| Consano Clinical Research, LLC | Shavano Park | Texas | 78231 | United States |
| Burke Internal Medicine and Research | Burke | Virginia | 22015 | United States |
| Manassas Clinical Research Center | Manassas | Virginia | 20110 | United States |
| Rainier Clinical Research Center | Renton | Washington | 98057 | United States |
| Manati Center for Clinical Research Inc | Manati | PR | 00674 | Puerto Rico |
| Advanced Clinical Research, LLC | Bayamón | 00961 | Puerto Rico |
| Received at Least 1 Dose of Study Drug |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
All enrolled participants.
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| ID | Title | Description |
|---|---|---|
| BG000 | LY900014 | LY900014 (100 U/mL) is a mealtime insulin administered 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants | No |
| |||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants | No |
| |||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants | No |
| |||||||||||||||||
| Region of Enrollment | Count of Participants | Participants | No |
| |||||||||||||||||
| Percentage of Time With Sensor Glucose Values Between 70 and 180 mg/dL During Daytime Period | Percentage of Time with Continuous Glucose Monitoring (CGM) Sensor Glucose Values between 70-180 mg/dL (3.9-10.0 millimoles/liter [mmol/L]) (both inclusive) during Daytime Period | All participants who received at least one dose of study drug and had baseline CGM glucose values. | Mean | Standard Deviation | Percentage of time |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | All participants who received at least one dose of study drug and had baseline, post-baseline CGM glucose values. | Posted | Least Squares Mean | Standard Error | Percentage of time | 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. | All participants who received at least one dose of study drug and had baseline, post-baseline HbA1c values. | Posted | Least Squares Mean | Standard Error | Percentage of HbA1c | 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. | All participants who received at least one dose of study drug and had baseline, post-baseline CGM glucose values. | Posted | Least Squares Mean | Standard Error | Percentage of time | 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. | All participants who received at least one dose of study drug and had baseline, post-baseline CGM glucose values. | Posted | Least Squares Mean | Standard Error | Percentage of time | 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. | All participants who received at least one dose of study drug and had baseline, post-baseline CGM glucose values. | Posted | Least Squares Mean | Standard Error | Percentage of time | 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. | All participants who received at least one dose of study drug and had baseline, post-baseline CGM glucose values. | Posted | Least Squares Mean | Standard Error | Percentage of time | 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. | All participants who received at least one dose of study drug and had baseline, post-baseline iAUC data. | Posted | Least Squares Mean | Standard Error | milligrams*hours per deciliter (mg*h/dl) | 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. | All participants who received at least one dose of study drug and had baseline, post-baseline iAUC data. | Posted | Least Squares Mean | Standard Error | mg*h/dl | 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. | All participants who received at least one dose of study drug and had post-baseline HbA1c values. | Posted | Number | Percentage of participants | 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. | All participants who received at least one dose of study drug and had baseline, post-baseline insulin dose data. | Posted | Least Squares Mean | Standard Error | Units per day | 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. | All participants who received at least one dose of study drug and had baseline, post-baseline values for bolus and total insulin dose. | Posted | Least Squares Mean | Standard Error | percentage of insulin dose | 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. | All participants who received at least one dose of study drug and had baseline, post-baseline ITSQ data. | Posted | Least Squares Mean | Standard Error | score on a scale | Baseline, Week 12 |
|
|
Baseline to Follow-up (Up To 14 weeks)
All participants who received at least one dose of study drug.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | LY900014 | LY900014 (100 U/mL) is a mealtime insulin administered 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. | 0 | 176 | 3 | 176 | 0 | 176 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Iron deficiency anaemia | Blood and lymphatic system disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Vertigo | Ear and labyrinth disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Covid-19 | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Chief Medical Officer | Eli Lilly and Company | 800-545-5979 | ClinicalTrials.gov@lilly.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Oct 27, 2020 | Nov 30, 2022 | SAP_001.pdf |
| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| D000069036 | Insulin Glargine |
| ID | Term |
|---|---|
| D049528 | Insulin, Long-Acting |
| D061385 | Insulins |
| D010187 | Pancreatic Hormones |
| D036361 | Peptide Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
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| Unknown or Not Reported |
|
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
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| Counts |
|---|
| Participants |
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