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| ID | Type | Description | Link |
|---|---|---|---|
| I2R-MC-BIDV | Other Identifier | Eli Lilly and Company |
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This study will look into insulin sensitivity (how the body responds to insulin) and effects of meals on type 2 diabetics comparing insulin peglispro to insulin glargine. The study has two treatment periods, each of which will last about four weeks. One drug (insulin peglispro or insulin glargine) will be administered in each period. Participants will receive both drugs during the study. Participants may remain on stable dose metformin, as prescribed by their personal physician.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Insulin Peglispro (with Insulin Lispro) | Experimental | Insulin peglispro, a once daily subcutaneous(SC) injection at bedtime for 5 weeks |
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| Insulin Glargine (with Insulin Lispro) | Active Comparator | Insulin glargine, a once daily subcutaneous(SC) injection at bedtime for 5 weeks |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Insulin Peglispro | Drug | Administered subcutaneously (SC), (U-100 formulation) |
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| Measure | Description | Time Frame |
|---|---|---|
| Pharmacodynamics (PD): Average Glucose Infusion Rate From Euglycemic 2-step Hyperinsulinemic Clamp (M-value) | During the euglycemic 2-step hyperinsulinemic clamp, both low and high insulin was infused sequentially during the same procedure. The 2-step clamp procedure allowed insulin sensitivity to be measured in participants and uses a lower dose of insulin of which the effect is largely on the liver and a high dose of insulin at which the effect has reached 100% on liver and effects are largely on glucose uptake in peripheral tissues. Measurements for average glucose infusion rate are collected for both steps (low and high) of the clamp procedure. | Day 33, last 30 minutes (final step) of euglycemic 2-step hyperinsulinemic clamp |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacodynamics (PD): Plasma Glucose Area Under the Concentration Curve Zero Through 5 Hours (AUC 0-5h), Above Pre Meal Baseline for Insulin Lispro | Days 30 through 32:Pre-dose, 10, 20, 30, 40, 50, 60, 90, 120, 150, 180, 210, 240, 270, 300 minutes post-breakfast | |
| Pharmacokinetics (PK): Area Under the Concentration Curve Concentration Curve Zero Through 5 Hours (AUC 0-5h) for Prandial Insulin Lispro |
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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 |
|---|---|---|---|---|---|---|
| Profil Institute for Clinical Research Inc | Chula Vista | California | 91911 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Sequence AB | A: Insulin peglispro, administered SC for 33 days B. Insulin glargine, administered SC for 33 days |
| FG001 | Sequence BA | B. Insulin glargine, administered SC for 33 days A: Insulin peglispro, administered SC for 33 days |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Period 1 |
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| Insulin Glargine | Drug | Administered subcutaneously (SC), (U-100 formulation) |
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| Insulin Lispro | Drug | Administered subcutaneously (SC), (U-100 formulation) |
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| Days 30 through 32:Pre-dose, 10, 20, 30, 40, 50, 60, 90, 120, 150, 180, 210, 240, 270, 300 minutes post-breakfast |
| Pharmacokinetics (PK): Area Under the Concentration Curve Zero Through 5 Hours (AUC 0-5h) for Acetaminophen | Day 29:Pre-dose, 10, 20, 30, 40, 50, 60, 90, 120, 150, 180, 210, 240, 270, 300 minutes post-breakfast |
| Appetite and Satiety Ratings, as Measured Using Visual Analog Scale (VAS) on Day 29 | VAS was scored from 0 - 100 millimeters (mm) as a perception of appetite and satiety (Flint et al. 2000), 0 being not hungry at all or nothing at all and 100 being extremely hungry and extremely large amount. The questions are abbreviated in table from: How hungry do you feel right now? to Hunger and How much food do you think you could eat right now? to Food amount. Scores were averaged and will be presented and calculated by a sum of the scores dividing by the total by the number of scores reported for timepoints. | Day 29:Upon waking, pre-breakfast, 1 hour (hr), 2 hr, 3 hr, 4 hr and 5 hr post breakfast |
| Pharmacokinetics (PK): Area Under the Concentration Curve (AUC) for Insulin Lispro During Clamp | Day 33 during euglycemic 2-step hyperinsulinemic clamp |
| COMPLETED |
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| NOT COMPLETED |
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| Period 2 |
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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 Insulin peglispro, administered SC for 33 days then Insulin glargine, administered SC for 33 days or Insulin glargine, administered SC for 33 days then Insulin peglispro, administered SC for 33 days |
| Units | Counts |
|---|---|
| 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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| Ethnicity (NIH/OMB) | 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): Average Glucose Infusion Rate From Euglycemic 2-step Hyperinsulinemic Clamp (M-value) | During the euglycemic 2-step hyperinsulinemic clamp, both low and high insulin was infused sequentially during the same procedure. The 2-step clamp procedure allowed insulin sensitivity to be measured in participants and uses a lower dose of insulin of which the effect is largely on the liver and a high dose of insulin at which the effect has reached 100% on liver and effects are largely on glucose uptake in peripheral tissues. Measurements for average glucose infusion rate are collected for both steps (low and high) of the clamp procedure. | All participants who received at least 1 dose of study drug and had evaluable PD parameters. | Posted | Mean | Standard Deviation | milligram*hour per deciliter | Day 33, last 30 minutes (final step) of euglycemic 2-step hyperinsulinemic clamp |
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| Secondary | Pharmacodynamics (PD): Plasma Glucose Area Under the Concentration Curve Zero Through 5 Hours (AUC 0-5h), Above Pre Meal Baseline for Insulin Lispro | All participants who received at least 1 dose of study drug and had evaluable PD parameters. | Posted | Mean | Standard Deviation | milligram*hour per deciliter | Days 30 through 32:Pre-dose, 10, 20, 30, 40, 50, 60, 90, 120, 150, 180, 210, 240, 270, 300 minutes post-breakfast |
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| Secondary | Pharmacokinetics (PK): Area Under the Concentration Curve Concentration Curve Zero Through 5 Hours (AUC 0-5h) for Prandial Insulin Lispro | All participants who received at least 1 dose of study drug and had evaluable PK parameters. | Posted | Mean | Standard Deviation | picomol*hour per liter | Days 30 through 32:Pre-dose, 10, 20, 30, 40, 50, 60, 90, 120, 150, 180, 210, 240, 270, 300 minutes post-breakfast |
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| Secondary | Pharmacokinetics (PK): Area Under the Concentration Curve Zero Through 5 Hours (AUC 0-5h) for Acetaminophen | All participants who received at least 1 dose of study drug and had evaluable PK data. | Posted | Geometric Mean | Geometric Coefficient of Variation | nanograms*hour per milliliter | Day 29:Pre-dose, 10, 20, 30, 40, 50, 60, 90, 120, 150, 180, 210, 240, 270, 300 minutes post-breakfast |
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| Secondary | Appetite and Satiety Ratings, as Measured Using Visual Analog Scale (VAS) on Day 29 | VAS was scored from 0 - 100 millimeters (mm) as a perception of appetite and satiety (Flint et al. 2000), 0 being not hungry at all or nothing at all and 100 being extremely hungry and extremely large amount. The questions are abbreviated in table from: How hungry do you feel right now? to Hunger and How much food do you think you could eat right now? to Food amount. Scores were averaged and will be presented and calculated by a sum of the scores dividing by the total by the number of scores reported for timepoints. | All participants who received at least 1 dose of study drug and had a VAS score. | Posted | Mean | Standard Deviation | millimeters | Day 29:Upon waking, pre-breakfast, 1 hour (hr), 2 hr, 3 hr, 4 hr and 5 hr post breakfast |
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| Secondary | Pharmacokinetics (PK): Area Under the Concentration Curve (AUC) for Insulin Lispro During Clamp | No participant analyzed because Outcome Measure was incorrectly registered. | Posted | Day 33 during euglycemic 2-step hyperinsulinemic 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 | Insulin Peglispro | Insulin peglispro, a once daily SC | 0 | 24 | 14 | 24 | ||
| EG001 | Insulin Glargine | Insulin glargine, a once daily SC | 0 | 23 | 10 | 23 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 17.0 | Systematic Assessment |
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| Constipation | Gastrointestinal disorders | MedDRA 17.0 | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA 17.0 | Systematic Assessment |
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| Catheter site haemorrhage | General disorders | MedDRA 17.0 | Systematic Assessment |
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| Catheter site related reaction | General disorders | MedDRA 17.0 | Systematic Assessment |
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| Injection site haemorrhage | General disorders | MedDRA 17.0 | Systematic Assessment |
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| Vessel puncture site bruise | General disorders | MedDRA 17.0 | Systematic Assessment |
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| Upper respiratory tract infection | Infections and infestations | MedDRA 17.0 | Systematic Assessment |
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| Urinary tract infection | Infections and infestations | MedDRA 17.0 | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA 17.0 | Systematic Assessment |
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| Dermatitis contact | Skin and subcutaneous tissue disorders | MedDRA 17.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Chief Medical Officer | Eli Lilly and Company | 800-545-5979 |
| 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 |
|---|---|
| C000621851 | basal insulin peglispro |
| C587357 | LY2605541 |
| D000069036 | Insulin Glargine |
| D061268 | Insulin Lispro |
| 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 |
| D061266 | Insulin, Short-Acting |
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| Unknown or Not Reported |
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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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