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| ID | Type | Description | Link |
|---|---|---|---|
| I8B-MC-ITSU | Other Identifier | Eli Lilly and Company |
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This study will be conducted in participants with type 1 diabetes mellitus on continuous subcutaneous insulin infusion (CSII) or pump therapy to evaluate the effect of LY900014 (Lyumjev) on blood sugar levels during exercise using different approaches on basal rate reduction and following a test meal compared to insulin lispro (Humalog). The study may last up to approximately 10 weeks and may include up to 7 visits.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment Sequence 1: ADBC | Experimental | Period 1: Lyumjev with 50% basal rate reduction (Treatment A) Period 2: Humalog with 100% basal rate reduction (Treatment D) Period 3: Lyumjev with 100% basal rate reduction (Treatment B) Period 4: Humalog with 50% basal rate reduction (Treatment C) Participants received their assigned treatments in each of the above treatment period on Day 1 subcutaneously. |
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| Treatment Sequence 2: BACD | Experimental | Period 1: Lyumjev with 100% basal rate reduction (Treatment B) Period 2: Lyumjev with 50% basal rate reduction (Treatment A) Period 3: Humalog with 50% basal rate reduction (Treatment C) Period 4: Humalog with 100% basal rate reduction (Treatment D) Participants received their assigned treatments in each of the above treatment period on Day 1 subcutaneously. |
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| Treatment Sequence 3: CBDA | Experimental | Period 1: Humalog with 50% basal rate reduction (Treatment C) Period 2: Lyumjev with 100% basal rate reduction (Treatment B) Period 3: Humalog with 100% basal rate reduction (Treatment D) Period 4: Lyumjev with 50% basal rate reduction (Treatment A) Participants received their assigned treatments in each of the above treatment period on Day 1 subcutaneously. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lyumjev with 50% basal rate reduction | Drug | Administered SC. |
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| Measure | Description | Time Frame |
|---|---|---|
| Pharmacodynamics (PD): Change in Plasma Glucose (PG) From the Start to the End of Exercise | Changes in PG from the start (0 minute) to end of exercise (60 minutes) were analyzed using a mixed-effect model. The model included treatment (Lyumjev with 50% basal reduction, Lyumjev with 100% basal reduction, Humalog with 50% basal reduction, and Humalog with 100% basal reduction), sequence, period, timepoint, treatment-by-timepoint interaction as fixed effects, and participant-within-sequence as a random effect. | Start (0 minute) to end of exercise (60 minutes) |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacodynamics (PD): Change From Baseline in Area Under the Concentration Versus Time Curve From Time 0 to 4 Hours [AUC(0-4)] of Postprandial Plasma Glucose (PPG) Post Mixed-Meal Tolerance Test (MMTT) | The outcome measure was analyzed using a mixed-effect model. The model included treatment (Lyumjev with 50% basal reduction, Lyumjev with 100% basal reduction, Humalog with 50% basal reduction, and Humalog with 100% basal reduction), sequence, and period as fixed effects, and participant-within-sequence will be included as a random effect. |
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Inclusion Criteria:
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 |
|---|---|---|---|---|---|---|
| LMC Clinical Research Inc. (Bayview) | Toronto | Ontario | M4G 3E8 | Canada |
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Participants were randomized to 4 treatment sequences (ADBC, BACD, CBDA, and DCAB), with each sequence having 4 periods where participants were crossed over between the periods. A washout period of at least 3 days was maintained between each treatment period.
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| ID | Title | Description |
|---|---|---|
| FG000 | Treatment Sequence 1: ADBC | Period 1: Lyumjev with 50% basal rate reduction (Treatment A) Period 2: Humalog with 100% basal rate reduction (Treatment D) Period 3: Lyumjev with 100% basal rate reduction (Treatment B) Period 4: Humalog with 50% basal rate reduction (Treatment C) Participants received their assigned treatments in each of the above treatment period on Day 1 subcutaneously. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Treatment Period 1 |
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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 | May 9, 2022 | Jan 2, 2024 |
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| Treatment Sequence 4: DCAB | Experimental | Period 1: Humalog with 100% basal rate reduction (Treatment D) Period 2: Humalog with 50% basal rate reduction (Treatment C) Period 3: Lyumjev with 50% basal rate reduction (Treatment A) Period 4: Lyumjev with 100% basal rate reduction (Treatment B) Participants received their assigned treatments in each of the above treatment period on Day 1 subcutaneously. |
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| Humalog with 50% basal rate reduction | Drug | Administered SC. |
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| Humalog with 100% basal rate reduction | Drug | Administered SC. |
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| Lyumjev with 100% basal rate reduction | Drug | Administered SC. |
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| Baseline (0-hour time point prior of the MMTT), 4 hour post-meal MMTT |
| FG001 | Treatment Sequence 2: BACD | Period 1: Lyumjev with 100% basal rate reduction (Treatment B) Period 2: Lyumjev with 50% basal rate reduction (Treatment A) Period 3: Humalog with 50% basal rate reduction (Treatment C) Period 4: Humalog with 100% basal rate reduction (Treatment D) Participants received their assigned treatments in each of the above treatment period on Day 1 subcutaneously. |
| FG002 | Treatment Sequence 3: CBDA | Period 1: Humalog with 50% basal rate reduction (Treatment C) Period 2: Lyumjev with 100% basal rate reduction (Treatment B) Period 3: Humalog with 100% basal rate reduction (Treatment D) Period 4: Lyumjev with 50% basal rate reduction (Treatment A) Participants received their assigned treatments in each of the above treatment period on Day 1 subcutaneously. |
| FG003 | Treatment Sequence 4: DCAB | Period 1: Humalog with 100% basal rate reduction (Treatment D) Period 2: Humalog with 50% basal rate reduction (Treatment C) Period 3: Lyumjev with 50% basal rate reduction (Treatment A) Period 4: Lyumjev with 100% basal rate reduction (Treatment B) Participants received their assigned treatments in each of the above treatment period on Day 1 subcutaneously. |
| Received at Least 1 Dose of Study Drug |
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| COMPLETED |
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| NOT COMPLETED |
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| Treatment Period 2 |
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| Treatment Period 3 |
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| Treatment Period 4 |
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All participants who received at least one dose of study drug.
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| ID | Title | Description |
|---|---|---|
| BG000 | All Participants | Participants received Lyumjev with 50% basal rate reduction (Treatment A) or Lyumjev with 100% basal rate reduction (Treatment B) or Humalog with 50% basal rate reduction (Treatment C) or Humalog with 100% basal rate reduction (Treatment D) subcutaneously on Day 1 in Treatment Period 1 to 4 as per assigned randomized treatment sequence. A washout period of at least 3 days was maintained between all the treatment periods. |
| Units | Counts |
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| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants | No |
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| Race (NIH/OMB) | Count of Participants | Participants | No |
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| Region of Enrollment | Count of Participants | Participants | No |
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| 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 | Pharmacodynamics (PD): Change in Plasma Glucose (PG) From the Start to the End of Exercise | Changes in PG from the start (0 minute) to end of exercise (60 minutes) were analyzed using a mixed-effect model. The model included treatment (Lyumjev with 50% basal reduction, Lyumjev with 100% basal reduction, Humalog with 50% basal reduction, and Humalog with 100% basal reduction), sequence, period, timepoint, treatment-by-timepoint interaction as fixed effects, and participant-within-sequence as a random effect. | All participants who received at least one dose of study drug. | Posted | Mean | Standard Deviation | milligram per Deciliter (mg/dL) | Start (0 minute) to end of exercise (60 minutes) |
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| Secondary | Pharmacodynamics (PD): Change From Baseline in Area Under the Concentration Versus Time Curve From Time 0 to 4 Hours [AUC(0-4)] of Postprandial Plasma Glucose (PPG) Post Mixed-Meal Tolerance Test (MMTT) | The outcome measure was analyzed using a mixed-effect model. The model included treatment (Lyumjev with 50% basal reduction, Lyumjev with 100% basal reduction, Humalog with 50% basal reduction, and Humalog with 100% basal reduction), sequence, and period as fixed effects, and participant-within-sequence will be included as a random effect. | All participants who received at least one dose of study drug. | Posted | Mean | Standard Deviation | milligrams*hour per deciliter (mg*h/dL) | Baseline (0-hour time point prior of the MMTT), 4 hour post-meal MMTT |
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Day 1 up to Day 43
All participants who received at least 1 dose of study drug.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Lyumjev With 50% Basal Rate Reduction | Participants from all the randomly assigned treatment sequence who received, Lyumjev with 50% basal rate reduction (treatment A), subcutaneously. | 0 | 25 | 0 | 25 | 4 | 25 |
| EG001 | Lyumjev With 100% Basal Rate Reduction | Participants from all the randomly assigned treatment sequence who received, Lyumjev with 100% basal rate reduction (treatment B), subcutaneously. | 0 | 25 | 0 | 25 | 2 | 25 |
| EG002 | Humalog With 50% Basal Rate Reduction | Participants from all the randomly assigned treatment sequence who received, Humalog with 50% basal rate reduction (treatment C), subcutaneously. | 0 | 25 | 0 | 25 | 3 | 25 |
| EG003 | Humalog With 100% Basal Rate Reduction | Participants from all the randomly assigned treatment sequence who received, Humalog with 100% basal rate reduction (treatment D), subcutaneously. | 0 | 25 | 0 | 25 | 4 | 25 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea | Gastrointestinal disorders | MedDRA 24.1 | Systematic Assessment |
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| Dizziness | Nervous system disorders | MedDRA version 24.1 | Systematic Assessment |
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| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA version 24.1 | Systematic Assessment |
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| Medical device site pain | General disorders | MedDRA version 24.1 | Systematic Assessment |
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| COVID-19 | Infections and infestations | MedDRA version 24.1 | Systematic Assessment |
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| Wound | Injury, poisoning and procedural complications | MedDRA version 24.1 | Systematic Assessment |
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| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA version 24.1 | Systematic Assessment |
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| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA version 24.1 | Systematic Assessment |
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| Tooth extraction | Surgical and medical procedures | MedDRA version 24.1 | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA version 24.1 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Chief Medical Officer | Eli Lilly and Company | 08005455979 | ClinicalTrials.gov@lilly.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Apr 5, 2023 | Jan 2, 2024 | SAP_001.pdf |
| ID | Term |
|---|---|
| D003922 | Diabetes Mellitus, Type 1 |
| D009043 | Motor Activity |
| D007003 | Hypoglycemia |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D061268 | Insulin Lispro |
| ID | Term |
|---|---|
| D061266 | Insulin, Short-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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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| Mean Difference (Final Values) |
| 14.1 |
| 2-Sided |
| 90 |
| 6.38 |
| 21.9 |
| Other |
Participants from all the randomly assigned treatment sequence who received, Humalog with 50% basal rate reduction (treatment C), subcutaneously.
| OG003 | Humalog With 100% Basal Rate Reduction | Participants from all the randomly assigned treatment sequence who received, Humalog with 100% basal rate reduction (treatment D), subcutaneously. |
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