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| ID | Type | Description | Link |
|---|---|---|---|
| I2R-MC-BIDB | Other Identifier | Eli Lilly and Company |
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Lilly's decision to cancel this trial is due to regulatory uncertainty in China.
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The main purpose of this study is to compare the efficacy and safety of a new basal insulin, insulin peglispro, to insulin glargine in participants with type 2 diabetes mellitus (T2DM). Both drugs will be given by an injection under the skin. Participants may continue to take oral antihyperglycemic medication (OAM) during the study, as prescribed by their personal physician. The study is expected to last about 12 months for each participant.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LY2605541 | Experimental | LY2605541 administered by subcutaneous (SQ) injection once daily for 52 weeks. Initial dose is 10 units (10 U) and is titrated by investigator. Participants may continue oral antihyperglycemic medication (OAM) as prescribed by their personal physician. |
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| Insulin Glargine | Active Comparator | Insulin glargine administered by SQ injection once daily for 52 weeks. Initial dose is 10 U and is titrated by investigator. Participants may continue OAM as prescribed by their personal physician. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Insulin Peglispro | Drug | Administered SQ |
|
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| Measure | Description | Time Frame |
|---|---|---|
| Change from Baseline in Hemoglobin A1c (HbA1c) at 26 Week Endpoint | Baseline, 26 Weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of Participants with HbA1c ≤6.5% and <7.0% | Week 26 and Week 52 | |
| Proportion of Participants with HbA1c <7.0% Without Nocturnal Hypoglycemia Event | Baseline through 26 Weeks and Baseline through 52 Weeks |
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Inclusion Criteria:
Exclusion Criteria:
Insulin therapy: have used insulin therapy (outside of pregnancy) anytime in the past 2 years, except for short-term treatment of acute conditions, and up to a maximum of 4 continuous weeks. Insulin use of any duration during pregnancy is not considered an exclusion criterion.
Concomitant medications: rosiglitazone, pramlintide, glucagon-like peptide-1 (GLP-1) receptor agonist (for example, exenatide, exenatide once weekly, or liraglutide) used concurrently or within 3 months prior to screening.
Local OAM restrictions: for participants on OAMs, restrictions for cardiac, renal, hepatic diseases and maximum dose, local product regulations must apply.
Weight loss medications: are currently taking, or have taken within the 3 months preceding screening, prescription or over-the-counter medications to promote weight loss.
Severe hypoglycemia history: have had any episodes of severe hypoglycemia within 6 months prior to screening.
Diabetic ketoacidosis (DKA) or hyperglycemic hyperosmolar nonketotic coma (HHNKC): have had 1 or more episodes of DKA or hyperosmolar state/coma in the past 6 months.
Cardiovascular: have cardiac disease with functional status that is New York Heart Association Class III or IV (per New York Heart Association [NYHA] Cardiac Disease Classification).
Renal: have a history of renal transplantation, or are currently receiving renal dialysis or have serum creatinine ≥2 milligram/deciliter (mg/dL) (177 micromole/liter [mol/L]).
Hepatic: have obvious clinical signs or symptoms of liver disease (excluding non-alcoholic fatty liver disease [NAFLD]), acute or chronic hepatitis, non-alcoholic steatohepatitis (NASH), or elevated liver enzyme measurements.
Lipid-lowering medications:
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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 |
|---|---|---|---|---|---|---|
| Rheumatology Associates PC | Birmingham | Alabama | 35205 | United States | ||
| Florida Medical Clinic PA |
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| Insulin Glargine | Drug | Administered SQ |
|
| Rate of Total and Nocturnal Hypoglycemia Events | Baseline to 26 Weeks |
| Fasting Serum Glucose (FSG) by Laboratory Measurements | 26 Weeks |
| 9 Point Self Monitored Blood Glucose | 26 Weeks |
| Change from Baseline in Body Weight at Week 26 Endpoint | Baseline, 26 Weeks |
| Change from Baseline in HbA1c at 52 Week Endpoint | Baseline, Week 52 |
| Insulin Dose by Unit | 26 Weeks |
| Time to Reach Steady-State | Baseline through 52 Weeks |
| Fasting Blood Glucose by Self Monitoring | Baseline through 52 Weeks |
| Intra-Participant Variability in Fasting Blood Glucose | Baseline through 52 Weeks |
| Change from Baseline in EuroQol-5 Dimension Questionnaire (EQ-5D) Score | Baseline, Week 26, Week 52 |
| Change from Baseline in the Low Blood Sugar Survey (LBSS) | Baseline, Week 26, Week 52 |
| Number of Participants Developing Anti-Insulin Peglispro Antibodies | Week 26 and Week 52 |
| Change from Baseline in Lipid Profile | Baseline, Week 26 |
| Zephyrhills |
| Florida |
| 33542-7505 |
| United States |
| Diagnostic Rheumatology and Research | Indianapolis | Indiana | 46227 | United States |
| Heartland Research Associates | Wichita | Kansas | 67207 | United States |
| Washington University Medical Center | St Louis | Missouri | 63110 | United States |
| Albuquerque Rehabilitation & Rheumatology, PC | Albuquerque | New Mexico | 87102 | United States |
| PMG Research of Hickory, LLC | Hickory | North Carolina | 28602 | United States |
| Carolina Arthritis Associates | Wilmington | North Carolina | 28401 | United States |
| STAT Research | Dayton | Ohio | 45417 | United States |
| Apex Clinical Research | Kennewick | Washington | 99336 | United States |
| 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 |
| 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 |
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