Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| I8B-MC-ITSZ | Other Identifier | Eli Lilly and Company |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
In this study, participants with type 1 diabetes (T1D) will take the study drug LY900014 and insulin degludec. The reason for this study is to evaluate the amount of time with glucose values within target range.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LY900014 + Insulin Degludec | Experimental | LY900014 (100 units/milliliter (U/mL)) is a prandial insulin administered subcutaneously (SC) 0-2 minutes before meals. Insulin degludec (100 U/mL) is a basal insulin administered once daily SC. Participants received individually adjusted insulin doses during the 35-day titration period. The target glucose values were: fasting glucose 80-110 milligrams per deciliter (mg/dL), overnight glucose excursion (the difference between bedtime and prebreakfast glucose levels) < or = +/- 30 mg/dL, postprandial glucose peak <140 mg/dL or <20% increase from premeal level. Following the titration period, there was an 11-day maintenance period during which the doses were kept unchanged unless for safety reasons. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LY900014 | Drug | Administered SC |
| |
| Insulin Degludec |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Time With Sensor Glucose Values Between 70 and 180 Milligrams Per Deciliter (mg/dL) With Continuous Glucose Monitoring (CGM) | Percentage of Time with Sensor Glucose Values Between 70 and 180 mg/dL (both inclusive) with CGM. | Day 46 |
| Measure | Description | Time Frame |
|---|---|---|
| Insulin to Carbohydrate Ratio (ICR) | ICR was evaluated to estimate how many carbohydrates will be covered by one unit of insulin. | Day 46 |
| Ratio of Prandial Dose to Total Daily Dose (TDD) of Insulin |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| 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 |
|---|---|---|---|---|---|---|
| Atlanta Diabetes Associates | Atlanta | Georgia | 30318 | United States | ||
| Iowa Diabetes and Endocrinology Research Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37740871 | Derived | Bergenstal RM, Bode BW, Bhargava A, Wang Q, Knights AW, Chang AM. Assessing Time in Range with Postprandial Glucose-Focused Titration of Ultra Rapid Lispro (URLi) in People with Type 1 Diabetes. Diabetes Ther. 2023 Nov;14(11):1933-1945. doi: 10.1007/s13300-023-01476-4. Epub 2023 Sep 23. |
| Label | URL |
|---|---|
| A Study of LY900014 and Insulin Degludec in Participants With Type 1 Diabetes. | View source |
Not provided
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 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.
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | LY900014 + Insulin Degludec | LY900014 (100 units/milliliter (U/mL)) is a prandial insulin administered subcutaneously (SC) 0-2 minutes before meals. Insulin degludec (100 U/mL) is a basal insulin administered once daily SC. Participants received individually adjusted insulin doses during the 35-day titration period. The target glucose values were: fasting glucose 80-110 milligrams per deciliter (mg/dL), overnight glucose excursion (the difference between bedtime and prebreakfast glucose levels) < or = +/- 30 mg/dL, postprandial glucose peak <140 mg/dL or <20% increase from premeal level. Following the titration period, there was an 11-day maintenance period during which the doses were kept unchanged unless for safety reasons. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
All enrolled participants.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | LY900014 + Insulin Degludec | LY900014 (100 U/mL) is a prandial insulin administered SC 0-2 minutes before meals. Insulin degludec (100 U/mL) is a basal insulin administered once daily SC. Participants received individually adjusted insulin doses during the 35-day titration period. The target glucose values were: fasting glucose 80-110 mg/dL, overnight glucose excursion (the difference between bedtime and prebreakfast glucose levels) < or = +/- 30 mg/dL, postprandial glucose peak <140 mg/dL or <20% increase from premeal level. Following the titration period, there was an 11-day maintenance period during which the doses were kept unchanged unless for safety reasons. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Percentage of Time With Sensor Glucose Values Between 70 and 180 Milligrams Per Deciliter (mg/dL) With Continuous Glucose Monitoring (CGM) | Percentage of Time with Sensor Glucose Values Between 70 and 180 mg/dL (both inclusive) with CGM. | All participants who received at least one dose of study drug and had post-baseline sensor glucose values. | Posted | Mean | Standard Deviation | percentage of time | Day 46 |
|
Baseline to Follow-up (Up To 53 days)
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 + Insulin Degludec | LY900014 (100 U/mL) is a prandial insulin administered SC 0-2 minutes before meals. Insulin degludec (100 U/mL) is a basal insulin administered once daily SC. Participants received individually adjusted insulin doses during the 35-day titration period. The target glucose values were: fasting glucose 80-110 mg/dL, overnight glucose excursion (the difference between bedtime and prebreakfast glucose levels) < or = +/- 30 mg/dL, postprandial glucose peak <140 mg/dL or <20% increase from premeal level. Following the titration period, there was an 11-day maintenance period during which the doses were kept unchanged unless for safety reasons. |
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Chief Medical Officer | Eli Lilly and Company | 800-545-5979 | ClinicalTrials.gov@lilly.com |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Nov 24, 2020 | Mar 4, 2022 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Oct 5, 2020 | Mar 4, 2022 | SAP_001.pdf |
Not provided
| ID | Term |
|---|---|
| D003922 | Diabetes Mellitus, Type 1 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C571886 | insulin degludec |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Drug |
Administered SC |
|
Prandial:TDD ratio
| Day 46 |
| Product of Insulin to Carbohydrate Ratio and Total Daily Dose (ICR×TDD) | ICR×TDD is determined to evaluate the relationship between insulin to carbohydrate ratio (g/U) and the total daily insulin dose (U/day). | Day 46 |
| West Des Moines |
| Iowa |
| 50265 |
| United States |
| HealthPartners Institute dba International Diabetes Center | Minneapolis | Minnesota | 55416 | United States |
| 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 |
|
|
|
| Secondary | Insulin to Carbohydrate Ratio (ICR) | ICR was evaluated to estimate how many carbohydrates will be covered by one unit of insulin. | All participants who received at least one dose of study drug and had post-baseline ICR values. | Posted | Mean | Standard Deviation | grams per insulin unit (g/U) | Day 46 |
|
|
|
| Secondary | Ratio of Prandial Dose to Total Daily Dose (TDD) of Insulin | Prandial:TDD ratio | All participants who received at least one dose of study drug and had post-baseline values for prandial and total daily insulin dose. | Posted | Mean | Standard Deviation | percentage of insulin dose | Day 46 |
|
|
|
| Secondary | Product of Insulin to Carbohydrate Ratio and Total Daily Dose (ICR×TDD) | ICR×TDD is determined to evaluate the relationship between insulin to carbohydrate ratio (g/U) and the total daily insulin dose (U/day). | All participants who received at least one dose of study drug and had post-baseline values for ICR and TDD. | Posted | Mean | Standard Deviation | g/day | Day 46 |
|
|
|
| 0 |
| 31 |
| 0 |
| 31 |
| 0 |
| 31 |
Not provided
| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
|
| Dinner |
|
|
| Across meals |
|
|
| Title | Measurements |
|---|---|
|
| Across meals |
|