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| ID | Type | Description | Link |
|---|---|---|---|
| I2R-MC-BIDM | Other Identifier | Eli Lilly and Company |
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This study has 2 parts. Each participant will receive a daily injection of LY2605541 during one treatment period and a daily injection of insulin glargine during one treatment period. Each treatment period is 2 to 3 weeks and is followed by a procedure to lower blood sugar levels to see how the body recovers after each treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LY2605541 | Experimental | Stable dose of LY2605541 (0.2 to 0.6 units per kilogram [U/kg]) administered subcutaneously (SQ) once daily for at least 14 days in 1 of 2 treatment periods. Dose based on prestudy basal insulin dosing regimen. |
|
| Insulin Glargine | Active Comparator | Stable dose of insulin glargine (0.2 to 0.6 U/kg) administered SQ once daily for at least 14 days in 1 of 2 treatment periods. Dose based on prestudy basal insulin dosing regimen. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LY2605541 | Biological |
| ||
| Insulin Glargine |
| Measure | Description | Time Frame |
|---|---|---|
| Concentration of Epinephrine | Epinephrine levels are presented. Each participant's measurements at 30, 15, and 0 minutes preclamp on the day of the clamp were averaged for the baseline value, and measurements at blood glucose (BG) level attainment and +10, 20, and 30 minutes were averaged for the BG nadir value. | 30, 15, and 0 minutes Preclamp; 10, 20, and 30 minutes Post-Clamp |
| Measure | Description | Time Frame |
|---|---|---|
| Amount of Glucose Required to Reach Blood Glucose (BG) of 72 mg/dL | The amount of infused glucose required to reach BG of 72 milligrams per deciliter (mg/dL) is presented. | 30, 15, and 0 minutes Preclamp; 10, 20, and 30 minutes Post-Clamp |
| Amount of Glucose Required to Maintain BG of 72 mg/dL |
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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 |
|---|---|---|---|---|---|---|
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Neuss | 41460 |
As per protocol amendment, no participants in cohort 1 were analyzed and only cohort 2 participants were analyzed for efficacy.
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| ID | Title | Description |
|---|---|---|
| FG000 | Cohort 1 (LY2605541, Then Insulin Glargine) | Participants received a stable dose of 0.2 to 0.6 U/kg LY2605541, administered subcutaneously (SQ), once daily for 14 days in Treatment Period 1, followed by a stable dose of 0.2 to 0.6 U/kg insulin glargine, administered SQ, once daily for 14 days in Treatment Period 2. |
| FG001 | Cohort 2 (Insulin Glargine, Then LY2605541) | Participants received a stable dose of 0.2 to 0.6 U/kg insulin glargine, administered SQ, once daily for 14 days in Treatment Period 1, followed by a stable dose of 0.2 to 0.6 U/kg LY2605541, administered SQ, once daily for 14 days in Treatment Period 2. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Treatment Period 1 |
|
| ||||||||||||||||||||||||
| Treatment Period 2 |
|
All participants who received at least 1 dose of study drug.
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| ID | Title | Description |
|---|---|---|
| BG000 | All Participants | All participants who received at least 1 dose of study drug. |
| 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 | Concentration of Epinephrine | Epinephrine levels are presented. Each participant's measurements at 30, 15, and 0 minutes preclamp on the day of the clamp were averaged for the baseline value, and measurements at blood glucose (BG) level attainment and +10, 20, and 30 minutes were averaged for the BG nadir value. | All participants in Cohort 2 who received at least 1 dose of study drug with evaluable epinephrine data. As per protocol amendment, no participants in cohort 1 were analyzed and only cohort 2 participants were analyzed for efficacy. | Posted | Mean | Standard Deviation | picomole per liter (pmol/L) | 30, 15, and 0 minutes Preclamp; 10, 20, and 30 minutes Post-Clamp |
|
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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 | Cohort 1: 0.2-0.6 U/kg LY2605541 | Participants received a stable dose of LY2605541 (0.2 to 0.6 U/kg) administered SQ once daily for at least 14 days in Treatment Period 1 or 2. Dose based on prestudy basal insulin dosing regimen. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
As per protocol amendment, no participants in cohort 1 were analyzed and only cohort 2 participants were analyzed for efficacy.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Chief Medical Officer | Eli Lilly and Company | 800-545-5979 | ClinicalTrials.gov@lilly.com |
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| ID | Term |
|---|---|
| D003922 | Diabetes Mellitus, Type 1 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| C587357 | LY2605541 |
| D000069036 | Insulin Glargine |
| ID | Term |
|---|---|
| D049528 | Insulin, Long-Acting |
| D061385 | Insulins |
| D010187 | Pancreatic Hormones |
| D036361 | Peptide Hormones |
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|
The amount of infused glucose required to maintain BG of 72 mg/dL for 1 hour is presented. |
| 30, 15, and 0 minutes Preclamp; 10, 20, and 30 minutes Post-Clamp |
| Concentration of Cortisol | Cortisol levels are presented. Each participant's measurements at 30, 15, and 0 minutes preclamp on the day of the clamp were averaged for the baseline value, and measurements at BG level attainment and +30 minutes were averaged for the BG nadir value. | 30, 15, and 0 minutes Preclamp; 10, 20, and 30 minutes Post-Clamp |
| Concentration of Glucagon | Glucagon levels are presented. Each participant's measurements at 30, 15, and 0 minutes preclamp on the day of the clamp were averaged for the baseline value, and measurements at BG level attainment and +30 minutes were averaged for the BG nadir value. | 30, 15, and 0 minutes Preclamp; 10, 20, and 30 minutes Post-Clamp |
| Concentration of Growth Hormone | Growth hormone levels are presented. Each participant's measurements at 30, 15, and 0 minutes preclamp on the day of the clamp were averaged for the baseline value, and measurements at BG level attainment and +30 minutes were averaged for the BG nadir value. | 30, 15, and 0 minutes Preclamp; 10, 20, and 30 minutes Post-Clamp |
| Concentration of Norepinephrine | Norepinephrine values are presented. Each participant's measurements at 30, 15, and 0 minutes preclamp on the day of the clamp were averaged for the baseline value, and measurements at BG level attainment and +10, 20, and 30 minutes were averaged for the BG nadir value. | 30, 15, and 0 minutes Preclamp; 10, 20, and 30 minutes Post-Clamp |
| Germany |
| Sponsor decision |
|
| NOT COMPLETED |
|
|
| 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 |
|
| OG001 | Insulin Glargine | Participants received a stable dose of insulin glargine (0.2 to 0.6 U/kg) administered SQ once daily for at least 14 days. Dose based on prestudy basal insulin dosing regimen. |
|
|
| Secondary | Amount of Glucose Required to Reach Blood Glucose (BG) of 72 mg/dL | The amount of infused glucose required to reach BG of 72 milligrams per deciliter (mg/dL) is presented. | All participants in Cohort 2 who received at least 1 dose of study drug with evaluable BG data. As per protocol amendment, no participants in cohort 1 were analyzed and only cohort 2 participants were analyzed for efficacy. | Posted | Geometric Mean | Geometric Coefficient of Variation | milligrams (mg) | 30, 15, and 0 minutes Preclamp; 10, 20, and 30 minutes Post-Clamp |
|
|
|
| Secondary | Amount of Glucose Required to Maintain BG of 72 mg/dL | The amount of infused glucose required to maintain BG of 72 mg/dL for 1 hour is presented. | All participants in Cohort 2 who received at least 1 dose of study drug with evaluable BG data. As per protocol amendment, no participants in cohort 1 were analyzed and only cohort 2 participants were analyzed for efficacy. | Posted | Geometric Mean | Geometric Coefficient of Variation | mg | 30, 15, and 0 minutes Preclamp; 10, 20, and 30 minutes Post-Clamp |
|
|
|
| Secondary | Concentration of Cortisol | Cortisol levels are presented. Each participant's measurements at 30, 15, and 0 minutes preclamp on the day of the clamp were averaged for the baseline value, and measurements at BG level attainment and +30 minutes were averaged for the BG nadir value. | All participants in Cohort 2 who received at least 1 dose of study drug with evaluable cortisol data. As per protocol amendment, no participants in cohort 1 were analyzed and only cohort 2 participants were analyzed for efficacy. | Posted | Mean | Standard Deviation | nanomole per liter (nmol/L) | 30, 15, and 0 minutes Preclamp; 10, 20, and 30 minutes Post-Clamp |
|
|
|
| Secondary | Concentration of Glucagon | Glucagon levels are presented. Each participant's measurements at 30, 15, and 0 minutes preclamp on the day of the clamp were averaged for the baseline value, and measurements at BG level attainment and +30 minutes were averaged for the BG nadir value. | All participants in Cohort 2 who received at least 1 dose of study drug with evaluable glucagon data. As per protocol amendment, no participants in cohort 1 were analyzed and only cohort 2 participants were analyzed for efficacy. | Posted | Mean | Standard Deviation | pmol/L | 30, 15, and 0 minutes Preclamp; 10, 20, and 30 minutes Post-Clamp |
|
|
|
| Secondary | Concentration of Growth Hormone | Growth hormone levels are presented. Each participant's measurements at 30, 15, and 0 minutes preclamp on the day of the clamp were averaged for the baseline value, and measurements at BG level attainment and +30 minutes were averaged for the BG nadir value. | All participants in Cohort 2 who received at least 1 dose of study drug with evaluable growth hormone data. As per protocol amendment, no participants in cohort 1 were analyzed and only cohort 2 participants were analyzed for efficacy. | Posted | Mean | Standard Deviation | micrograms per liter (µg/L) | 30, 15, and 0 minutes Preclamp; 10, 20, and 30 minutes Post-Clamp |
|
|
|
| Secondary | Concentration of Norepinephrine | Norepinephrine values are presented. Each participant's measurements at 30, 15, and 0 minutes preclamp on the day of the clamp were averaged for the baseline value, and measurements at BG level attainment and +10, 20, and 30 minutes were averaged for the BG nadir value. | All participants in Cohort 2 who received at least 1 dose of study drug with evaluable norepinephrine data. As per protocol amendment, no participants in cohort 1 were analyzed and only cohort 2 participants were analyzed for efficacy. | Posted | Mean | Standard Deviation | pmol/L | 30, 15, and 0 minutes Preclamp; 10, 20, and 30 minutes Post-Clamp |
|
|
|
| 0 |
| 9 |
| 1 |
| 9 |
| EG001 | Cohort 1: 0.2-0.6 U/kg Insulin Glargine | Participants received a stable dose of insulin glargine (0.2 to 0.6 U/kg) administered SQ once daily for at least 14 days in Treatment Period 1 or 2. Dose based on prestudy basal insulin dosing regimen. | 0 | 7 | 3 | 7 |
| EG002 | Cohort 2: 0.2-0.6 U/kg LY2605541 | Participants received a stable dose of LY2605541 (0.2 to 0.6 U/kg) administered SQ once daily for at least 14 days in Treatment Period 1 or 2. Dose based on prestudy basal insulin dosing regimen. | 0 | 13 | 1 | 13 |
| EG003 | Cohort 2: 0.2-0.6 U/kg Insulin Glargine | Participants received a stable dose of insulin glargine (0.2 to 0.6 U/kg) administered SQ once daily for at least 14 days in Treatment Period 1 or 2. Dose based on prestudy basal insulin dosing regimen. | 0 | 13 | 3 | 13 |
| Vomiting | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
|
| Influenza | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 15.1 | Systematic Assessment |
|
| Presyncope | Nervous system disorders | MedDRA 15.1 | Systematic Assessment |
|
| Phlebitis | Vascular disorders | MedDRA 15.1 | Systematic Assessment |
|
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| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D006728 |
| Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |