| ID | Type | Description | Link |
|---|---|---|---|
| I2R-MC-BIDO | Other Identifier | Eli Lilly and Company |
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This is a two-period study of participants with type 1 diabetes mellitus (T1DM). In each period, participants will receive once daily injections of stable dose LY2605541 or insulin glargine for 28 to 35 days followed by procedures to look at how the body uses or stores fats and sugars. Participants will continue to use meal time insulin throughout the study. Healthy participants will also enroll in the study. They will not receive any study medication.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Insulin Peglispro/Insulin Glargine | Experimental | Insulin peglispro (LY2605541) administered to participants with T1DM subcutaneously (SQ) once daily (QD) for 28 to 35 days in one of two treatment periods. Dose is based on participant's prestudy basal insulin dosing regimen. Insulin glargine administered to participants with T1DM SQ QD for 28 to 35 days in one of two treatment periods. Dose is based on participant's prestudy basal insulin dosing regimen. Participants continue to use mealtime insulin. |
|
| Insulin Glargine/Insulin Peglispro | Active Comparator | Insulin glargine administered to participants with T1DM SQ QD for 28 to 35 days in one of two treatment periods. Dose is based on participant's prestudy basal insulin dosing regimen. Participants continue to use mealtime insulin. Insulin peglispro (LY2605541) administered to participants with T1DM subcutaneously (SQ) once daily (QD) for 28 to 35 days in one of two treatment periods. Dose is based on participant's prestudy basal insulin dosing regimen. |
|
| Control | No Intervention | Control Arm. Untreated healthy participants. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LY2605541 | Biological | Administered SQ |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Sleep Respiratory Quotient (RQ) in Type 1 Diabetes Mellitus (T1DM) | Lipid or glucose metabolism was assessed by the measurement of respiratory quotient (RQ) during sleep using whole room calorimetry. RQ is a calculation of basal metabolic rate (BMR) when estimated from carbon dioxide production. It is calculated from the ratio of carbon dioxide produced by the body to oxygen consumed by the body using whole room calorimetry (WRC). | Day 30 post dose, overnight period (0000 to 0600 hours) |
| Measure | Description | Time Frame |
|---|---|---|
| Lipid Oxidation in T1DM and Healthy Participants | Lipid oxidation is derived from RQ, basal metabolic rate and urinary nitrogen, a value of 0.7 indicates that lipids are being metabolized. | Day 30 post dose, overnight period (0000 to 0600 hours) |
| Basal Metabolic Rate (BMR) for T1DM |
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Inclusion Criteria:
Type 1 Diabetics:
- T1DM for more than 1 year with Hemoglobin A1c (HbA1c) of less than 9.5%
All Participants:
Exclusion Criteria:
Type 1 Diabetics:
All Participants:
- Taking fibrates, thyroid replacement therapy, testosterone, beta blockers or systemic corticosteroids
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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 |
|---|---|---|---|---|---|---|
| Translational Research Institute for Metabolism and Diabetes | Orlando | Florida | 32804 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Sequence Insulin Peglispro/Insulin Glargine | Insulin peglispro (LY2605541) administered to participants with T1DM subcutaneously (SQ) once daily (QD) for 28 to 35 days in one of two treatment periods. Dose based on participant's prestudy basal insulin dosing regimen. Insulin glargine administered to participants with T1DM SQ QD for 28 to 35 days in one of two treatment periods. Dose based on participant's prestudy basal insulin dosing regimen. Participants continue to use mealtime insulin. |
| FG001 | Sequence Insulin Glargine/Insulin Peglispro | Insulin glargine administered to participants with T1DM SQ QD for 28 to 35 days in one of two treatment periods. Dose based on participant's prestudy basal insulin dosing regimen. Participants continue to use mealtime insulin.Insulin peglispro (LY2605541) administered to participants with T1DM subcutaneously (SQ) once daily (QD) for 28 to 35 days in one of two treatment periods. Dose based on participant's prestudy basal insulin dosing regimen. |
| FG002 | Control | Untreated healthy participants who received no study drug. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Period 1 |
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| Period 2 |
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| ID | Title | Description |
|---|---|---|
| BG000 | All T1DM | Participants with T1DM who received Insulin peglispro (LY260551) and insulin glargine SQ in either sequence group. |
| BG001 | Control | Untreated healthy participants who received no 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 | Sleep Respiratory Quotient (RQ) in Type 1 Diabetes Mellitus (T1DM) | Lipid or glucose metabolism was assessed by the measurement of respiratory quotient (RQ) during sleep using whole room calorimetry. RQ is a calculation of basal metabolic rate (BMR) when estimated from carbon dioxide production. It is calculated from the ratio of carbon dioxide produced by the body to oxygen consumed by the body using whole room calorimetry (WRC). | All randomized participants with T1DM that received at least 1 dose of study drug. Data from 2 participants could not be used: one due to uncontrolled blood glucose and one due to an increase in thyroid medication. | Posted | Mean | Standard Deviation | ratio | Day 30 post dose, overnight period (0000 to 0600 hours) |
|
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One participant in the Insulin Glargine/Insulin Peglispro arm withdrew consent prior to being dosed with study drug and is included in the AE section.
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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 | Insulin Peglispro | Insulin peglispro (LY2605541) administered to participants with T1DM subcutaneously (SQ) once daily (QD) for 28 to 35 days in one of two treatment periods. Dose is based on participant's prestudy basal insulin dosing regimen. Participants continue to use mealtime insulin. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Retinal haemorrhage | Eye disorders | MedDRA 17.0 | Systematic Assessment |
One participant in the Insulin Glargine/Insulin Peglispro arm withdrew consent prior to being dosed with study drug and is included in the Adverse Event (AE) section.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Chief Medical Officer | Eli Lilly and Company | 800-545-5979 |
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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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| Insulin Glargine |
| Biological |
Administered SQ |
|
BMR is the metabolic rate determined at rest 12 to 14 hours after the last meal. |
| Day 30 post dose, overnight period (0000 to 0600 hours) |
| Sleep Respiratory Quotient (RQ) of Untreated Healthy Participants | The respiratory quotient (or RQ or respiratory coefficient), is a number used in calculations of basal metabolic rate (BMR) when estimated from carbon dioxide production. It is calculated from the ratio of carbon dioxide produced by the body to oxygen consumed by the body using whole room calorimetry. The overnight period was averaged based on all 1-minutes interval measurements for the duration of the overnight period. | Day 5, overnight period (0000 to 0600 hours) |
| Total Number of Minutes of Lipid Oxidation (RQ Below 7.6) in T1DM and Healthy Participants | The respiratory quotient (or RQ or respiratory coefficient), is a number used in calculations of basal metabolic rate (BMR) when estimated from carbon dioxide production. It is calculated from the ratio of carbon dioxide produced by the body to oxygen consumed by the body using whole room calorimetry.It is calculated from the ratio of carbon dioxide produced by the body to oxygen consumed by the body using whole data based on all 1-minutes interval measurements for the duration of the overnight period. | Day 5, every minute through 23 hour period |
| Change in RQ, Pre-breakfast to Post-breakfast Meal, in T1DM | The respiratory quotient (or RQ or respiratory coefficient), is a number used in calculations of basal metabolic rate (BMR) when estimated from carbon dioxide production. It is calculated from the ratio of carbon dioxide produced by the body to oxygen consumed by the body using whole room calorimetry. | Day 30 0830 to 0854 hours, Day 30 1000 to 1054 hours |
| NOT COMPLETED |
|
| BG002 | Total | Total of all reporting groups |
| 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 | Insulin glargine administered to participants with T1DM SQ QD for 28 to 35 days in one of two treatment periods. Dose based on participant's prestudy basal insulin dosing regimen. |
|
|
| Secondary | Lipid Oxidation in T1DM and Healthy Participants | Lipid oxidation is derived from RQ, basal metabolic rate and urinary nitrogen, a value of 0.7 indicates that lipids are being metabolized. | All randomized participants. | Posted | Mean | Standard Deviation | grams per day (g/day) | Day 30 post dose, overnight period (0000 to 0600 hours) |
|
|
|
| Secondary | Basal Metabolic Rate (BMR) for T1DM | BMR is the metabolic rate determined at rest 12 to 14 hours after the last meal. | All randomized participants with T1DM that received at least 1 dose of study drug. Data from 2 participants could not be used: one due to uncontrolled blood glucose and one due to an increase in thyroid medication. | Posted | Mean | Standard Deviation | kcal/day | Day 30 post dose, overnight period (0000 to 0600 hours) |
|
|
|
| Secondary | Sleep Respiratory Quotient (RQ) of Untreated Healthy Participants | The respiratory quotient (or RQ or respiratory coefficient), is a number used in calculations of basal metabolic rate (BMR) when estimated from carbon dioxide production. It is calculated from the ratio of carbon dioxide produced by the body to oxygen consumed by the body using whole room calorimetry. The overnight period was averaged based on all 1-minutes interval measurements for the duration of the overnight period. | All randomized, health participant who received no study drug. | Posted | Mean | Standard Deviation | ratio | Day 5, overnight period (0000 to 0600 hours) |
|
|
|
| Secondary | Total Number of Minutes of Lipid Oxidation (RQ Below 7.6) in T1DM and Healthy Participants | The respiratory quotient (or RQ or respiratory coefficient), is a number used in calculations of basal metabolic rate (BMR) when estimated from carbon dioxide production. It is calculated from the ratio of carbon dioxide produced by the body to oxygen consumed by the body using whole room calorimetry.It is calculated from the ratio of carbon dioxide produced by the body to oxygen consumed by the body using whole data based on all 1-minutes interval measurements for the duration of the overnight period. | All randomized participants: T1DM participants that received at least 1 dose of study drug, Data from 2 participants could not be used:one due to uncontrolled blood glucose and one due to an increase in thyroid medication,data from 2 participants could not be used: 1 due to uncontrolled blood glucose and 1 due to an increase in thyroid medication. | Posted | Median | Full Range | minutes | Day 5, every minute through 23 hour period |
|
|
|
| Secondary | Change in RQ, Pre-breakfast to Post-breakfast Meal, in T1DM | The respiratory quotient (or RQ or respiratory coefficient), is a number used in calculations of basal metabolic rate (BMR) when estimated from carbon dioxide production. It is calculated from the ratio of carbon dioxide produced by the body to oxygen consumed by the body using whole room calorimetry. | All randomized participants with T1DM that received at least 1 dose of study drug. Data from 2 participants could not be used: one due to uncontrolled blood glucose and one due to an increase in thyroid medication. | Posted | Mean | Standard Deviation | ratio | Day 30 0830 to 0854 hours, Day 30 1000 to 1054 hours |
|
|
|
| 0 |
| 13 |
| 5 |
| 13 |
| EG001 | Insulin Glargine | Insulin glargine administered to participants with T1DM SQ QD for 28 to 35 days in one of two treatment periods. Dose is based on participant's prestudy basal insulin dosing regimen. Participants continue to use mealtime insulin. | 0 | 15 | 3 | 15 |
| EG002 | Control | Control Arm. Untreated healthy participants. | 0 | 12 | 1 | 12 |
| Dyspepsia | Gastrointestinal disorders | MedDRA 17.0 | Systematic Assessment |
|
| Injection site erythema | General disorders | MedDRA 17.0 | Systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA 17.0 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 17.0 | Systematic Assessment |
|
| Erythema | Skin and subcutaneous tissue disorders | MedDRA 17.0 | 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 |