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| ID | Type | Description | Link |
|---|---|---|---|
| H9X-MC-GBDN | Other Identifier | Eli Lilly and Company | |
| CTRI/2010/091/001444 | Registry Identifier | Clinical Trials Register India |
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The purpose of this study is to assess the effects of 2 doses of LY2189265 on blood pressure and heart rate using 24-hour ambulatory blood pressure monitoring (ABPM), in participants with type 2 diabetes mellitus treated with oral antihyperglycemic medications (OAMs).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1.5 milligram (mg) LY2189265 | Experimental | LY2189265: 1.5 milligram (mg), subcutaneous (SC), once weekly (QW) |
|
| 0.75 milligram (mg) LY2189265 | Experimental | LY2189265: 0.75 milligram (mg), subcutaneous (SC), once weekly (QW) |
|
| Placebo | Placebo Comparator | Placebo: subcutaneous (SC), once weekly (QW) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LY2189265 | Drug | Administered as a subcutaneous injection once weekly for 26 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline to 16 Weeks in Mean 24-hour Systolic Blood Pressure (SBP) | Mean 24-hour systolic blood pressure (SBP) was measured by using a 24-hour ambulatory blood pressure monitoring (ABPM) device attached to the participant's nondominant arm. Ambulatory blood pressure measurements were recorded every 20 minutes during the daytime (0700 to 2200 hours) and every 30 minutes during the nighttime hours (2200 to 0700), as preprogrammed into the device. For statistical analyses, diurnal hours were defined as 0800 to 2100 and nocturnal hours were defined as 0000 to 0600. Least Squares (LS) means were calculated using mixed model repeated measures (MMRM) adjusting for baseline, pooled sites, treatment, visit, treatment-by-visit interaction, and the stratified variable of diagnosis of hypertension. | Baseline, 16 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline to 26 Weeks in Mean 24-hour Systolic Blood Pressure (SBP) | Mean 24-hour systolic blood pressure (SBP) was measured by using a 24-hour ambulatory blood pressure monitoring (ABPM) device attached to the participant's nondominant arm. Ambulatory blood pressure measurements were recorded every 20 minutes during the daytime (0700 to 2200 hours) and every 30 minutes during the nighttime hours (2200 to 0700), as preprogrammed into the device. For statistical analyses, diurnal hours were defined as 0800 to 2100 and nocturnal hours were defined as 0000 to 0600. Least Squares (LS) means were calculated using mixed model repeated measures (MMRM) adjusting for baseline, pooled sites, treatment, visit, treatment-by-visit interaction, and the stratified variable of diagnosis of hypertension. |
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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. | Phoenix | Arizona | 85013 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36894938 | Derived | Ferdinand KC, Dunn J, Nicolay C, Sam F, Blue EK, Wang H. Weight-dependent and weight-independent effects of dulaglutide on blood pressure in patients with type 2 diabetes. Cardiovasc Diabetol. 2023 Mar 9;22(1):49. doi: 10.1186/s12933-023-01775-x. |
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| ID | Title | Description |
|---|---|---|
| FG000 | 1.5 Milligram (mg) LY2189265 | LY2189265: 1.5 milligram (mg), subcutaneous (SC), once weekly (QW) for 26 weeks |
| FG001 | 0.75 Milligram (mg) LY2189265 | LY2189265: 0.75 milligram (mg), subcutaneous (SC), once weekly (QW) for 26 weeks |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Placebo | Drug | Administered as a subcutaneous injection once weekly for 26 weeks |
|
| Baseline, 26 weeks |
| Change From Baseline to 16 and 26 Weeks in Mean 24-hour Diastolic Blood Pressure (DBP) | Mean 24-hour diastolic blood pressure (DBP) was measured by using a 24-hour ambulatory blood pressure monitoring (ABPM) device attached to the participant's nondominant arm. Ambulatory blood pressure measurements were recorded every 20 minutes during the daytime (0700 to 2200 hours) and every 30 minutes during the nighttime hours (2200 to 0700), as preprogrammed into the device. For statistical analyses, diurnal hours were defined as 0800 to 2100 and nocturnal hours were defined as 0000 to 0600. Least Squares (LS) means of change from baseline was analyzed using mixed model repeated measures (MMRM) adjusted by baseline, pooled sites, treatment, visit, treatment-by-visit interaction, and the stratified variable of diagnosis of hypertension. | Baseline, 16 and 26 weeks |
| Change From Baseline to 16 and 26 Weeks in Mean 24-Hour Heart Rate (HR) | Mean 24-hour heart rate (HR) was measured by using a 24-hour ambulatory blood pressure monitoring (ABPM) device attached to the participant's nondominant arm. Heart rate measurements were recorded every 20 minutes during the daytime (0700 to 2200 hours) and every 30 minutes during the nighttime hours (2200 to 0700), as preprogrammed into the device. For statistical analyses, diurnal hours were defined as 0800 to 2100 and nocturnal hours were defined as 0000 to 0600. Least Squares (LS) means were calculated using mixed model repeated measures (MMRM) adjusting for baseline, pooled sites, treatment, visit, treatment-by-visit interaction, and the stratified variable of diagnosis of hypertension. | Baseline, 16 and 26 weeks |
| Change From Baseline to 16 and 26 Weeks in Mean 24-hour Pulse Pressure | Mean 24-hour pulse pressure (PP) was measured by using a 24-hour ambulatory blood pressure monitoring (ABPM) device attached to the participant's nondominant arm. Pulse pressure (PP) measurements were recorded every 20 minutes during the daytime (0700 to 2200 hours) and every 30 minutes during the nighttime hours (2200 to 0700), as preprogrammed into the device. For statistical analyses, diurnal hours were defined as 0800 to 2100 and nocturnal hours were defined as 0000 to 0600. Least Squares (LS) means were calculated using mixed model repeated measures (MMRM) adjusting for baseline, pooled sites, treatment, visit, treatment-by-visit interaction, and the stratified variable of diagnosis of hypertension. | Baseline, 16 and 26 weeks |
| Change From Baseline to 16 and 26 Weeks in Mean 24-hour Mean Arterial Pressure (MAP) | Mean 24-hour mean arterial pressure (MAP) was measured by a using 24-hour ambulatory blood pressure monitoring (ABPM) device attached to the participant's nondominant arm. Ambulatory blood pressure measurements were recorded every 20 minutes during the daytime (0700 to 2200 hours) and every 30 minutes during the nighttime hours (2200 to 0700), as preprogrammed into the device. For statistical analyses, diurnal hours were defined as 0800 to 2100 and nocturnal hours were defined as 0000 to 0600. Least Squares (LS) means were calculated using mixed model repeated measures (MMRM) adjusting for baseline, pooled sites, treatment, visit, treatment-by-visit interaction, and the stratified variable of diagnosis of hypertension. | Baseline, 16 and 26 weeks |
| Change From Baseline to 16 and 26 Weeks in Mean Daytime, Nighttime, and Clinic Systolic Blood Pressure (SBP) | Mean daytime and nighttime systolic blood pressure (SBP) was measured by using a 24-hour ambulatory blood pressure monitoring (ABPM) device attached to the participant's nondominant arm. Ambulatory blood pressure measurements were recorded every 20 minutes during the daytime (0700 to 2200 hours) and every 30 minutes during the nighttime hours (2200 to 0700), as preprogrammed into the device. For statistical analyses, diurnal hours were defined as 0800 to 2100 and nocturnal hours were defined as 0000 to 0600. Least Squares (LS) means were calculated using mixed model repeated measures (MMRM) adjusting for baseline, pooled sites, treatment, visit, treatment-by-visit interaction, and the stratified variable of diagnosis of hypertension. Clinic SBP was measured in the clinic using the Omron HEM 907XL Blood Pressure monitor. | Baseline, 16 and 26 weeks |
| Change From Baseline to 16 and 26 Weeks in Mean Daytime, Nighttime, and Clinic Diastolic Blood Pressure (DBP) | Mean daytime and nighttime diastolic blood pressure (DBP) was measured by using a 24-hour ambulatory blood pressure monitoring (ABPM) device attached to the participant's nondominant arm. Ambulatory blood pressure measurements were recorded every 20 minutes during the daytime (0700 to 2200 hours) and every 30 minutes during the nighttime hours (2200 to 0700), as preprogrammed into the device. For statistical analyses, diurnal hours were defined as 0800 to 2100 and nocturnal hours were defined as 0000 to 0600. Least Squares (LS) means of change from baseline was analyzed using mixed model repeated measures (MMRM) adjusted by baseline, pooled sites, treatment, visit, treatment-by-visit interaction, and the stratified variable of diagnosis of hypertension. Clinic DBP was measured in the clinic using the Omron HEM 907XL Blood Pressure monitor. | Baseline, 16 and 26 weeks |
| Change From Baseline to 16 and 26 Weeks in Mean Daytime, Nighttime, and Clinic Heart Rate (HR) | Daytime and nighttime heart rate (HR) was measured by using a 24-hour ambulatory blood pressure monitoring (ABPM) device attached to the participant's nondominant arm. Heart rate measurements were recorded every 20 minutes during the daytime (0700 to 2200 hours) and every 30 minutes during the nighttime hours (2200 to 0700), as preprogrammed into the device. For statistical analyses, diurnal hours were defined as 0800 to 2100 and nocturnal hours were defined as 0000 to 0600. Least Squares (LS) means were calculated using mixed model repeated measures (MMRM) adjusting for baseline, pooled sites, treatment, visit, treatment-by-visit interaction, and the stratified variable of diagnosis of hypertension. Clinic HR was measured in the clinic using the Omron HEM 907XL Blood Pressure monitor. | Baseline, 16 and 26 weeks |
| Change From Baseline to 16 and 26 Weeks in Mean Daytime and Nighttime Pulse Pressure | Mean daytime and nighttime pulse pressure (PP) was measured by using a 24-hour ambulatory blood pressure monitoring (ABPM) device attached to the participant's nondominant arm. Pulse pressure (PP) measurements were recorded every 20 minutes during the daytime (0700 to 2200 hours) and every 30 minutes during the nighttime hours (2200 to 0700), as preprogrammed into the device. For statistical analyses, diurnal hours were defined as 0800 to 2100 and nocturnal hours were defined as 0000 to 0600. Least Squares (LS) means were calculated using mixed model repeated measures (MMRM) adjusting for baseline, pooled sites, treatment, visit, treatment-by-visit interaction, and the stratified variable of diagnosis of hypertension. | Baseline, 16 and 26 weeks |
| Change From Baseline to 16 and 26 Weeks in Mean Daytime and Nighttime Mean Arterial Pressure (MAP) | Mean daytime and nighttime mean arterial pressure (MAP) was measured by a using 24-hour ambulatory blood pressure monitoring (ABPM) device attached to the participant's nondominant arm. Ambulatory blood pressure measurements were recorded every 20 minutes during the daytime (0700 to 2200 hours) and every 30 minutes during the nighttime hours (2200 to 0700), as preprogrammed into the device. For statistical analyses, diurnal hours were defined as 0800 to 2100 and nocturnal hours were defined as 0000 to 0600. Least Squares (LS) means were calculated using mixed model repeated measures (MMRM) adjusting for baseline, pooled sites, treatment, visit, treatment-by-visit interaction, and the stratified variable of diagnosis of hypertension. | Baseline, 16 and 26 weeks |
| Change From Baseline to 16 and 26 Weeks in Glycosylated Hemoglobin (HbA1c) | Glycosylated hemoglobin (HbA1c) is a form of hemoglobin that is measured primarily to identify the average plasma glucose concentration over prolonged periods of time. Least Squares (LS) means were calculated using mixed model repeated measures (MMRM) adjusting for baseline, pooled sites, treatment, visit, treatment-by-visit interaction, and the stratified variable of diagnosis of hypertension. | Baseline, 16 and 26 weeks |
| Change From Baseline to 16 and 26 Weeks in Fasting Blood Glucose (FBG) | Fasting blood glucose (FBG) is a test to determine how much glucose (sugar) is in a blood sample after an overnight fast. Least Squares (LS) means were calculated using mixed model repeated measures (MMRM) adjusting for baseline, pooled sites, treatment, visit, treatment-by-visit interaction, and the stratified variable of diagnosis of hypertension. | Baseline, 16 and 26 weeks |
| Percentage of Participants Achieving an Glycosylated Hemoglobin (HbA1c) of <7% or ≤6.5% | Percentages of participants who achieved glycosylated hemoglobin (HbA1c) levels of <7% or ≤6.5% were analyzed with Chi-squared test/Fisher's exact test. | Baseline and 16 and 26 weeks |
| Number of Participants With Treatment Emergent Adverse Events at 26 Weeks | A treatment-emergent adverse event (TEAE) was defined as an event that first occurs or worsens (increases in severity) after baseline regardless of causality or severity. The number of participants with one or more TEAE is summarized cumulatively at 26 weeks. A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module. | Baseline through 26 weeks |
| Change From Baseline to 16 and 26 Weeks on Pancreatic Enzymes | Amylase (total and pancreas-derived) and lipase concentrations were measured. | Baseline, 16 and 26 weeks |
| Change From Baseline to 16 and 26 Weeks on Serum Calcitonin | Baseline, 16 and 26 weeks |
| Change From Baseline to 16 Weeks in High-Sensitivity C-Reactive Protein (Hs-CRP) | Baseline, 16 weeks |
| Change From Baseline to 16 and 26 Weeks on Electrocardiogram Parameters, Fridericia Corrected QT (QTcF) Interval and PR Interval | The QT interval is a measure of the time between the start of the Q wave and the end of the T wave and was calculated from electrocardiogram (ECG) data using Fridericia's formula: QTc = QT/RR^0.33. Corrected QT (QTc) is the QT interval corrected for heart rate and RR, which is the interval between two R waves. PR is the interval between the P wave and the QRS complex. Least Squares (LS) means were calculated using mixed model repeated measures (MMRM) adjusting for baseline, pooled sites, treatment, visit, treatment-by-visit interaction, and the stratified variable of diagnosis of hypertension. | Baseline, 16 and 26 weeks |
| Number of Events of Adjudicated Pancreatitis up to 26 Weeks | The number of adjudicated (by an independent Clinical Endpoint Committee [CEC]) pancreatic events is summarized at 26 weeks. A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module. | Baseline through 26 weeks |
| Number of Participants With Adjudicated Cardiovascular Events up to 26 Weeks | Deaths and nonfatal cardiovascular adverse events (AEs) were adjudicated by a committee of physicians with cardiology expertise external to the Sponsor. The nonfatal cardiovascular AEs to be adjudicated include myocardial infarction, hospitalization for unstable angina, hospitalization for heart failure, coronary interventions (such as coronary artery bypass graft or percutaneous coronary intervention), and cerebrovascular events including cerebrovascular accident (stroke) and transient ischemic attack. A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module. | Baseline through 26 weeks |
| Anti-LY2189265 Antibodies | LY2189265 anti-drug antibodies (ADA) were assessed at baseline, 16 and 26 weeks, and at the safety follow-up visit 4 weeks after study drug discontinuation (30 weeks). The number of participants with initial postbaseline detection of treatment-emergent (defined as a 4-fold increase in the ADA titer from baseline) anti-drug (LY2189265) ADA at each time point were summarized. | Baseline, 16, 26, and 30 weeks |
| Rate of Hypoglycemic Episodes | Hypoglycemic events (HE) were classified as severe (defined as an HE requiring assistance of another person to actively administer resuscitative actions), documented symptomatic (defined as an HE with typical symptoms of hypoglycemia and a blood glucose level of ≤3.9 millimoles per liter [mmol/L]), asymptomatic (defined as an HE without typical symptoms of hypoglycemia but with a measured blood glucose of ≤3.9 mmol/L), nocturnal (defined as any HE occurring between bedtime and waking with a measured blood glucose of ≤3.9 mmol/L), or non-nocturnal. Hypoglycemia rate per 30 days was summarized at each visit by treatment group. The rate of hypoglycemia was analyzed using a generalized estimation equations model with a negative binomial distribution and a Logit link. Negative binomial mean was adjusted by treatment, visit, and visit by treatment interaction. A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module. | Baseline, 16 and 26 weeks |
| Change From Baseline to 16 and 26 Weeks in Body Weight | Least Squares (LS) means was calculated using mixed model repeated measures (MMRM) adjusting for baseline, pooled sites, treatment, visit, treatment-by-visit interaction, and the stratified variable of diagnosis of hypertension. | Baseline, 16 and 26 weeks |
| Measurement of LY2189265 Drug Concentration for Pharmacokinetics - Area Under the Concentration Time Curve (AUC) | The population mean estimates and standard deviations were calculated for pharmacokinetic parameters (area under the concentration time curve [AUC] at steady state from time zero to 168 hours after study drug administration). Evaluable pharmacokinetic concentrations from the 4, 8, 12, 16, and 26 weeks timepoints were combined and utilized in a population approach to determine the population mean estimate and standard deviation at steady-state. | 4, 8, 12, 16, and 26 weeks |
| United States |
| 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. | Anaheim | California | 92801 | United States |
| 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. | Greenbrae | California | 94904 | United States |
| 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. | Lancaster | California | 93534 | United States |
| 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. | Los Angeles | California | 90057 | United States |
| 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. | Sacramento | California | 95825 | United States |
| 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. | Spring Valley | California | 91978 | United States |
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| 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. | Winter Haven | Florida | 33880 | United States |
| 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. | Cartersville | Georgia | 30121 | United States |
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| 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. | Caba | C1050AAK | Argentina |
| 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. | Mar del Plata | B7600FZN | Argentina |
| 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. | Mendoza | 5500 | Argentina |
| 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. | Santa Fe | 3000 | Argentina |
| 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. | Rio de Janeiro | 22271-100 | Brazil |
| 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. | São Paulo | 04020-041 | Brazil |
| 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. | Calgary | Alberta | T2H 2G4 | Canada |
| 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. | Red Deer | Alberta | T4N 6V7 | Canada |
| 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. | Vancouver | British Columbia | V6H 3X8 | Canada |
| 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. | Victoria | British Columbia | V8V 3N7 | Canada |
| 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. | Winnipeg | Manitoba | R3P 3P4 | Canada |
| 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. | St. John's | Newfoundland and Labrador | A1B 3V6 | Canada |
| 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. | Hamilton | Ontario | L8L 2X2 | Canada |
| 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. | Oakville | Ontario | L6H 3P1 | Canada |
| 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. | Toronto | Ontario | M4G 3E8 | Canada |
| 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. | Laval | Quebec | H7T 2P5 | Canada |
| 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. | Saint-Laurent | Quebec | H4T 1Z9 | Canada |
| 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. | České Budějovice | 370 01 | Czechia |
| 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. | Český Krumlov | 381 01 | Czechia |
| 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. | Prague | 181 00 | Czechia |
| 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. | Přerov | 750 02 | Czechia |
| 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. | Aalborg | 9000 | Denmark |
| 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. | Ballerup Municipality | 2750 | Denmark |
| 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. | Vejle | 7100 | Denmark |
| 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. | Ahmedabad | 380006 | India |
| 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. | Coimbatore | 641009 | India |
| 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. | Indore | 452002 | India |
| 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. | Jaipur | 302001 | India |
| 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. | Ludhiana | 141001 | India |
| 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. | Ponce | 00717-2075 | Puerto Rico |
| 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. | Rio Piedras | 00921 | Puerto Rico |
| 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. | San Juan | 00917-3104 | Puerto Rico |
| 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. | Santurce | 00909 | Puerto Rico |
| FG002 | Placebo | Placebo: subcutaneous (SC), once weekly (QW) for 26 weeks |
| Received at Least One Dose of Study Drug |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
Participants who received at least one dose of LY2189265 or Placebo.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 1.5 Milligram (mg) LY2189265 | LY2189265: 1.5 milligram (mg), subcutaneous (SC), once weekly (QW) for 26 weeks |
| BG001 | 0.75 Milligram (mg) LY2189265 | LY2189265: 0.75 milligram (mg), subcutaneous (SC), once weekly (QW) for 26 weeks |
| BG002 | Placebo | Placebo: subcutaneous (SC), once weekly (QW) for 26 weeks |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Number | participants |
| ||||||||||||||||
| Body Mass Index (BMI) | Body mass index is an estimate of body fat based on body weight divided by height squared. | Mean | Standard Deviation | kilograms/square meters (kg/m^2) |
| ||||||||||||||
| Glycosylated Hemoglobin (HbA1c) | Mean | Standard Deviation | percentage of glycosylated hemoglobin |
| |||||||||||||||
| Body Weight | Mean | Standard Deviation | kilogram (kg) |
| |||||||||||||||
| Duration of Diabetes | Mean | Standard Deviation | years |
| |||||||||||||||
| Mean Systolic Blood Pressure (SBP) | Clinic systolic blood pressure (SBP) measurements were taken in triplicate after the participant was seated for 5 minutes using an automated digital professional blood pressure monitor. The mean of the last 2 clinic readings at screening determined study eligibility; the mean of 3 readings at baseline and all post-baseline visits was used for analyses. | Mean | Standard Deviation | millimeters of mercury (mmHg) |
| ||||||||||||||
| Mean Diastolic Blood Pressure (DBP) | Clinic diastolic blood pressure (DBP) measurements were taken in triplicate after the participant was seated for 5 minutes using an automated digital professional blood pressure monitor. The mean of the last 2 clinic readings at screening determined study eligibility; the mean of 3 readings at baseline and all post-baseline visits was used for analyses. | Mean | Standard Deviation | millimeters of mercury (mmHg) |
| ||||||||||||||
| Mean Heart Rate (HR) | Clinic heart rate (HR) measurements were taken in triplicate after the participant was seated for 5 minutes using an automated digital professional blood pressure monitor. The mean of the last 2 clinic readings at screening determined study eligibility; the mean of 3 readings at baseline and all post-baseline visits was used for analyses. | Mean | Standard Deviation | beats per minute (bpm) |
|
| 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 | Change From Baseline to 16 Weeks in Mean 24-hour Systolic Blood Pressure (SBP) | Mean 24-hour systolic blood pressure (SBP) was measured by using a 24-hour ambulatory blood pressure monitoring (ABPM) device attached to the participant's nondominant arm. Ambulatory blood pressure measurements were recorded every 20 minutes during the daytime (0700 to 2200 hours) and every 30 minutes during the nighttime hours (2200 to 0700), as preprogrammed into the device. For statistical analyses, diurnal hours were defined as 0800 to 2100 and nocturnal hours were defined as 0000 to 0600. Least Squares (LS) means were calculated using mixed model repeated measures (MMRM) adjusting for baseline, pooled sites, treatment, visit, treatment-by-visit interaction, and the stratified variable of diagnosis of hypertension. | Participants who received at least one dose of LY2189265 or Placebo with evaluable blood pressure data. | Posted | Least Squares Mean | Standard Error | millimeters of mercury (mmHg) | Baseline, 16 weeks |
|
|
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline to 26 Weeks in Mean 24-hour Systolic Blood Pressure (SBP) | Mean 24-hour systolic blood pressure (SBP) was measured by using a 24-hour ambulatory blood pressure monitoring (ABPM) device attached to the participant's nondominant arm. Ambulatory blood pressure measurements were recorded every 20 minutes during the daytime (0700 to 2200 hours) and every 30 minutes during the nighttime hours (2200 to 0700), as preprogrammed into the device. For statistical analyses, diurnal hours were defined as 0800 to 2100 and nocturnal hours were defined as 0000 to 0600. Least Squares (LS) means were calculated using mixed model repeated measures (MMRM) adjusting for baseline, pooled sites, treatment, visit, treatment-by-visit interaction, and the stratified variable of diagnosis of hypertension. | Participants who received at least one dose of LY2189265 or Placebo with evaluable systolic blood pressure data. | Posted | Least Squares Mean | Standard Error | millimeters of mercury (mmHg) | Baseline, 26 weeks |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline to 16 and 26 Weeks in Mean 24-hour Diastolic Blood Pressure (DBP) | Mean 24-hour diastolic blood pressure (DBP) was measured by using a 24-hour ambulatory blood pressure monitoring (ABPM) device attached to the participant's nondominant arm. Ambulatory blood pressure measurements were recorded every 20 minutes during the daytime (0700 to 2200 hours) and every 30 minutes during the nighttime hours (2200 to 0700), as preprogrammed into the device. For statistical analyses, diurnal hours were defined as 0800 to 2100 and nocturnal hours were defined as 0000 to 0600. Least Squares (LS) means of change from baseline was analyzed using mixed model repeated measures (MMRM) adjusted by baseline, pooled sites, treatment, visit, treatment-by-visit interaction, and the stratified variable of diagnosis of hypertension. | Participants who received at least one dose of LY2189265 or Placebo with evaluable diastolic blood pressure data. | Posted | Least Squares Mean | Standard Error | millimeters of mercury (mmHg)] | Baseline, 16 and 26 weeks |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline to 16 and 26 Weeks in Mean 24-Hour Heart Rate (HR) | Mean 24-hour heart rate (HR) was measured by using a 24-hour ambulatory blood pressure monitoring (ABPM) device attached to the participant's nondominant arm. Heart rate measurements were recorded every 20 minutes during the daytime (0700 to 2200 hours) and every 30 minutes during the nighttime hours (2200 to 0700), as preprogrammed into the device. For statistical analyses, diurnal hours were defined as 0800 to 2100 and nocturnal hours were defined as 0000 to 0600. Least Squares (LS) means were calculated using mixed model repeated measures (MMRM) adjusting for baseline, pooled sites, treatment, visit, treatment-by-visit interaction, and the stratified variable of diagnosis of hypertension. | Participants who received at least one dose of LY2189265 or Placebo with evaluable heart rate data. | Posted | Least Squares Mean | Standard Error | beats per minute (bpm) | Baseline, 16 and 26 weeks |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline to 16 and 26 Weeks in Mean 24-hour Pulse Pressure | Mean 24-hour pulse pressure (PP) was measured by using a 24-hour ambulatory blood pressure monitoring (ABPM) device attached to the participant's nondominant arm. Pulse pressure (PP) measurements were recorded every 20 minutes during the daytime (0700 to 2200 hours) and every 30 minutes during the nighttime hours (2200 to 0700), as preprogrammed into the device. For statistical analyses, diurnal hours were defined as 0800 to 2100 and nocturnal hours were defined as 0000 to 0600. Least Squares (LS) means were calculated using mixed model repeated measures (MMRM) adjusting for baseline, pooled sites, treatment, visit, treatment-by-visit interaction, and the stratified variable of diagnosis of hypertension. | Participants who received at least one dose of LY2189265 or Placebo with evaluable pulse pressure data. | Posted | Least Squares Mean | Standard Error | millimeters of mercury (mmHg) | Baseline, 16 and 26 weeks |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline to 16 and 26 Weeks in Mean 24-hour Mean Arterial Pressure (MAP) | Mean 24-hour mean arterial pressure (MAP) was measured by a using 24-hour ambulatory blood pressure monitoring (ABPM) device attached to the participant's nondominant arm. Ambulatory blood pressure measurements were recorded every 20 minutes during the daytime (0700 to 2200 hours) and every 30 minutes during the nighttime hours (2200 to 0700), as preprogrammed into the device. For statistical analyses, diurnal hours were defined as 0800 to 2100 and nocturnal hours were defined as 0000 to 0600. Least Squares (LS) means were calculated using mixed model repeated measures (MMRM) adjusting for baseline, pooled sites, treatment, visit, treatment-by-visit interaction, and the stratified variable of diagnosis of hypertension. | Participants who received at least one dose of LY2189265 or Placebo with evaluable mean arterial pressure data. | Posted | Least Squares Mean | Standard Error | millimeters of mercury (mmHg) | Baseline, 16 and 26 weeks |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline to 16 and 26 Weeks in Mean Daytime, Nighttime, and Clinic Systolic Blood Pressure (SBP) | Mean daytime and nighttime systolic blood pressure (SBP) was measured by using a 24-hour ambulatory blood pressure monitoring (ABPM) device attached to the participant's nondominant arm. Ambulatory blood pressure measurements were recorded every 20 minutes during the daytime (0700 to 2200 hours) and every 30 minutes during the nighttime hours (2200 to 0700), as preprogrammed into the device. For statistical analyses, diurnal hours were defined as 0800 to 2100 and nocturnal hours were defined as 0000 to 0600. Least Squares (LS) means were calculated using mixed model repeated measures (MMRM) adjusting for baseline, pooled sites, treatment, visit, treatment-by-visit interaction, and the stratified variable of diagnosis of hypertension. Clinic SBP was measured in the clinic using the Omron HEM 907XL Blood Pressure monitor. | Participants who received at least one dose of LY2189265 or Placebo with evaluable systolic blood pressure data. | Posted | Least Squares Mean | Standard Error | millimeters of mercury (mmHg) | Baseline, 16 and 26 weeks |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline to 16 and 26 Weeks in Mean Daytime, Nighttime, and Clinic Diastolic Blood Pressure (DBP) | Mean daytime and nighttime diastolic blood pressure (DBP) was measured by using a 24-hour ambulatory blood pressure monitoring (ABPM) device attached to the participant's nondominant arm. Ambulatory blood pressure measurements were recorded every 20 minutes during the daytime (0700 to 2200 hours) and every 30 minutes during the nighttime hours (2200 to 0700), as preprogrammed into the device. For statistical analyses, diurnal hours were defined as 0800 to 2100 and nocturnal hours were defined as 0000 to 0600. Least Squares (LS) means of change from baseline was analyzed using mixed model repeated measures (MMRM) adjusted by baseline, pooled sites, treatment, visit, treatment-by-visit interaction, and the stratified variable of diagnosis of hypertension. Clinic DBP was measured in the clinic using the Omron HEM 907XL Blood Pressure monitor. | Participants who received at least one dose of LY2189265 or Placebo with evaluable diastolic blood pressure data. | Posted | Least Squares Mean | Standard Error | millimeters of mercury (mmHg) | Baseline, 16 and 26 weeks |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline to 16 and 26 Weeks in Mean Daytime, Nighttime, and Clinic Heart Rate (HR) | Daytime and nighttime heart rate (HR) was measured by using a 24-hour ambulatory blood pressure monitoring (ABPM) device attached to the participant's nondominant arm. Heart rate measurements were recorded every 20 minutes during the daytime (0700 to 2200 hours) and every 30 minutes during the nighttime hours (2200 to 0700), as preprogrammed into the device. For statistical analyses, diurnal hours were defined as 0800 to 2100 and nocturnal hours were defined as 0000 to 0600. Least Squares (LS) means were calculated using mixed model repeated measures (MMRM) adjusting for baseline, pooled sites, treatment, visit, treatment-by-visit interaction, and the stratified variable of diagnosis of hypertension. Clinic HR was measured in the clinic using the Omron HEM 907XL Blood Pressure monitor. | Participants who received at least one dose of LY2189265 or Placebo with evaluable heart rate data. | Posted | Least Squares Mean | Standard Error | beats per minute (bpm) | Baseline, 16 and 26 weeks |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline to 16 and 26 Weeks in Mean Daytime and Nighttime Pulse Pressure | Mean daytime and nighttime pulse pressure (PP) was measured by using a 24-hour ambulatory blood pressure monitoring (ABPM) device attached to the participant's nondominant arm. Pulse pressure (PP) measurements were recorded every 20 minutes during the daytime (0700 to 2200 hours) and every 30 minutes during the nighttime hours (2200 to 0700), as preprogrammed into the device. For statistical analyses, diurnal hours were defined as 0800 to 2100 and nocturnal hours were defined as 0000 to 0600. Least Squares (LS) means were calculated using mixed model repeated measures (MMRM) adjusting for baseline, pooled sites, treatment, visit, treatment-by-visit interaction, and the stratified variable of diagnosis of hypertension. | Participants who received at least one dose of LY2189265 or Placebo with evaluable pulse pressure data. | Posted | Least Squares Mean | Standard Error | millimeters of mercury (mmHg) | Baseline, 16 and 26 weeks |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline to 16 and 26 Weeks in Mean Daytime and Nighttime Mean Arterial Pressure (MAP) | Mean daytime and nighttime mean arterial pressure (MAP) was measured by a using 24-hour ambulatory blood pressure monitoring (ABPM) device attached to the participant's nondominant arm. Ambulatory blood pressure measurements were recorded every 20 minutes during the daytime (0700 to 2200 hours) and every 30 minutes during the nighttime hours (2200 to 0700), as preprogrammed into the device. For statistical analyses, diurnal hours were defined as 0800 to 2100 and nocturnal hours were defined as 0000 to 0600. Least Squares (LS) means were calculated using mixed model repeated measures (MMRM) adjusting for baseline, pooled sites, treatment, visit, treatment-by-visit interaction, and the stratified variable of diagnosis of hypertension. | Participants who received at least one dose of LY2189265 or Placebo with evaluable mean arterial pressure data. | Posted | Least Squares Mean | Standard Error | millimeters of mercury (mmHg) | Baseline, 16 and 26 weeks |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline to 16 and 26 Weeks in Glycosylated Hemoglobin (HbA1c) | Glycosylated hemoglobin (HbA1c) is a form of hemoglobin that is measured primarily to identify the average plasma glucose concentration over prolonged periods of time. Least Squares (LS) means were calculated using mixed model repeated measures (MMRM) adjusting for baseline, pooled sites, treatment, visit, treatment-by-visit interaction, and the stratified variable of diagnosis of hypertension. | Participants who received at least one dose of LY2189265 or Placebo with evaluable glycosylated hemoglobin (HbA1c) data. | Posted | Least Squares Mean | Standard Error | percentage of HbA1c | Baseline, 16 and 26 weeks |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline to 16 and 26 Weeks in Fasting Blood Glucose (FBG) | Fasting blood glucose (FBG) is a test to determine how much glucose (sugar) is in a blood sample after an overnight fast. Least Squares (LS) means were calculated using mixed model repeated measures (MMRM) adjusting for baseline, pooled sites, treatment, visit, treatment-by-visit interaction, and the stratified variable of diagnosis of hypertension. | Participants who received at least one dose of LY2189265 or Placebo with evaluable fasting blood glucose data. | Posted | Least Squares Mean | Standard Error | millimoles per liter (mmol/L) | Baseline, 16 and 26 weeks |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants Achieving an Glycosylated Hemoglobin (HbA1c) of <7% or ≤6.5% | Percentages of participants who achieved glycosylated hemoglobin (HbA1c) levels of <7% or ≤6.5% were analyzed with Chi-squared test/Fisher's exact test. | Participants who received at least one dose of LY2189265 or Placebo with evaluable glycosylated hemoglobin (HbA1c) data. | Posted | Number | percentage of participants | Baseline and 16 and 26 weeks |
|
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| Secondary | Number of Participants With Treatment Emergent Adverse Events at 26 Weeks | A treatment-emergent adverse event (TEAE) was defined as an event that first occurs or worsens (increases in severity) after baseline regardless of causality or severity. The number of participants with one or more TEAE is summarized cumulatively at 26 weeks. A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module. | Participants who received at least one dose of LY2189265 or Placebo. | Posted | Number | participants | Baseline through 26 weeks |
|
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| Secondary | Change From Baseline to 16 and 26 Weeks on Pancreatic Enzymes | Amylase (total and pancreas-derived) and lipase concentrations were measured. | Participants who received at least one dose of LY2189265 or Placebo with evaluable pancreatic enzyme data. | Posted | Median | Inter-Quartile Range | units per liter | Baseline, 16 and 26 weeks |
|
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| Secondary | Change From Baseline to 16 and 26 Weeks on Serum Calcitonin | Participants who received at least one dose of LY2189265 or Placebo with evaluable serum calcitonin data. | Posted | Mean | Standard Deviation | picograms per milliliter (pg/mL) | Baseline, 16 and 26 weeks |
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| Secondary | Change From Baseline to 16 Weeks in High-Sensitivity C-Reactive Protein (Hs-CRP) | Participants who received at least one dose of LY2189265 or Placebo with evaluable High-Sensitivity C-Reactive Protein (hs-CRP) data. | Posted | Mean | Standard Deviation | milligram per liter (mg/L) | Baseline, 16 weeks |
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| Secondary | Change From Baseline to 16 and 26 Weeks on Electrocardiogram Parameters, Fridericia Corrected QT (QTcF) Interval and PR Interval | The QT interval is a measure of the time between the start of the Q wave and the end of the T wave and was calculated from electrocardiogram (ECG) data using Fridericia's formula: QTc = QT/RR^0.33. Corrected QT (QTc) is the QT interval corrected for heart rate and RR, which is the interval between two R waves. PR is the interval between the P wave and the QRS complex. Least Squares (LS) means were calculated using mixed model repeated measures (MMRM) adjusting for baseline, pooled sites, treatment, visit, treatment-by-visit interaction, and the stratified variable of diagnosis of hypertension. | Participants who received at least one dose of LY2189265 or Placebo with evaluable Fridericia-corrected QT (QTcF) or PR interval change from baseline data. | Posted | Least Squares Mean | Standard Error | milliseconds (msec) | Baseline, 16 and 26 weeks |
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| Secondary | Number of Events of Adjudicated Pancreatitis up to 26 Weeks | The number of adjudicated (by an independent Clinical Endpoint Committee [CEC]) pancreatic events is summarized at 26 weeks. A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module. | Participants who received at least one dose of LY2189265 or Placebo. | Posted | Number | events | Baseline through 26 weeks |
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| Secondary | Number of Participants With Adjudicated Cardiovascular Events up to 26 Weeks | Deaths and nonfatal cardiovascular adverse events (AEs) were adjudicated by a committee of physicians with cardiology expertise external to the Sponsor. The nonfatal cardiovascular AEs to be adjudicated include myocardial infarction, hospitalization for unstable angina, hospitalization for heart failure, coronary interventions (such as coronary artery bypass graft or percutaneous coronary intervention), and cerebrovascular events including cerebrovascular accident (stroke) and transient ischemic attack. A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module. | Participants who received at least one dose of LY2189265 or Placebo. | Posted | Number | participants | Baseline through 26 weeks |
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| Secondary | Anti-LY2189265 Antibodies | LY2189265 anti-drug antibodies (ADA) were assessed at baseline, 16 and 26 weeks, and at the safety follow-up visit 4 weeks after study drug discontinuation (30 weeks). The number of participants with initial postbaseline detection of treatment-emergent (defined as a 4-fold increase in the ADA titer from baseline) anti-drug (LY2189265) ADA at each time point were summarized. | Participants who received at least one dose of LY2189265 or Placebo with evaluable anti-drug (LY2189265) antibodies (ADA) data. | Posted | Number | participants | Baseline, 16, 26, and 30 weeks |
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| Secondary | Rate of Hypoglycemic Episodes | Hypoglycemic events (HE) were classified as severe (defined as an HE requiring assistance of another person to actively administer resuscitative actions), documented symptomatic (defined as an HE with typical symptoms of hypoglycemia and a blood glucose level of ≤3.9 millimoles per liter [mmol/L]), asymptomatic (defined as an HE without typical symptoms of hypoglycemia but with a measured blood glucose of ≤3.9 mmol/L), nocturnal (defined as any HE occurring between bedtime and waking with a measured blood glucose of ≤3.9 mmol/L), or non-nocturnal. Hypoglycemia rate per 30 days was summarized at each visit by treatment group. The rate of hypoglycemia was analyzed using a generalized estimation equations model with a negative binomial distribution and a Logit link. Negative binomial mean was adjusted by treatment, visit, and visit by treatment interaction. A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module. | Participants who received at least one dose of LY2189265 or Placebo. | Posted | Mean | Standard Deviation | events per participant per 30 days | Baseline, 16 and 26 weeks |
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| Secondary | Change From Baseline to 16 and 26 Weeks in Body Weight | Least Squares (LS) means was calculated using mixed model repeated measures (MMRM) adjusting for baseline, pooled sites, treatment, visit, treatment-by-visit interaction, and the stratified variable of diagnosis of hypertension. | Participants who received at least one dose of LY2189265 or Placebo with evaluable body weight data. | Posted | Least Squares Mean | Standard Error | kilogram (kg) | Baseline, 16 and 26 weeks |
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| Secondary | Measurement of LY2189265 Drug Concentration for Pharmacokinetics - Area Under the Concentration Time Curve (AUC) | The population mean estimates and standard deviations were calculated for pharmacokinetic parameters (area under the concentration time curve [AUC] at steady state from time zero to 168 hours after study drug administration). Evaluable pharmacokinetic concentrations from the 4, 8, 12, 16, and 26 weeks timepoints were combined and utilized in a population approach to determine the population mean estimate and standard deviation at steady-state. | Participants who received at least one dose of LY2189265 with evaluable LY2189265 concentration data. | Posted | Mean | Standard Deviation | nanograms*hour per liter (ng*h/L) | 4, 8, 12, 16, and 26 weeks |
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Not provided
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Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 1.5 Milligram (mg) LY2189265 | LY2189265: 1.5 milligram (mg), subcutaneous (SC), once weekly (QW) for 26 weeks | 12 | 251 | 164 | 251 | ||
| EG001 | 0.75 Milligram (mg) LY2189265 | LY2189265: 0.75 milligram (mg), subcutaneous (SC), once weekly (QW) for 26 weeks | 8 | 254 | 161 | 254 | ||
| EG002 | Placebo | Placebo: subcutaneous (SC), once weekly (QW) for 26 weeks | 8 | 250 | 163 | 250 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Coronary artery disease | Cardiac disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Ventricular tachycardia | Cardiac disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Abdominal pain lower | Gastrointestinal disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Barrett's oesophagus | Gastrointestinal disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Granuloma | General disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Non-cardiac chest pain | General disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Cholelithiasis | Hepatobiliary disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Appendicitis | Infections and infestations | MedDRA 14.1 | Systematic Assessment |
| |
| Diverticulitis | Infections and infestations | MedDRA 14.1 | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA 14.1 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 14.1 | Systematic Assessment |
| |
| Septic shock | Infections and infestations | MedDRA 14.1 | Systematic Assessment |
| |
| Lower limb fracture | Injury, poisoning and procedural complications | MedDRA 14.1 | Systematic Assessment |
| |
| Diabetic ketoacidosis | Metabolism and nutrition disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Malignant melanoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 14.1 | Systematic Assessment |
| |
| Haemorrhagic stroke | Nervous system disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Ischaemic stroke | Nervous system disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Tonic clonic movements | Nervous system disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Pregnancy | Pregnancy, puerperium and perinatal conditions | MedDRA 14.1 | Systematic Assessment |
| |
| Nephrolithiasis | Renal and urinary disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Renal failure acute | Renal and urinary disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Benign prostatic hyperplasia | Reproductive system and breast disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Asphyxia | Respiratory, thoracic and mediastinal disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Coronary arterial stent insertion | Surgical and medical procedures | MedDRA 14.1 | Systematic Assessment |
| |
| Coronary revascularisation | Surgical and medical procedures | MedDRA 14.1 | Systematic Assessment |
| |
| Uterine dilation and curettage | Surgical and medical procedures | MedDRA 14.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA 14.1 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 14.1 | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 14.1 | Systematic Assessment |
|
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Chief Medical Officer | Eli Lilly and Company | 800-545-5979 |
| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C555680 | dulaglutide |
Not provided
Not provided
Not provided
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Czech Republic |
|
| Puerto Rico |
|
| Canada |
|
| Argentina |
|
| Brazil |
|
| Denmark |
|
| India |
|
| Mean Daytime Systolic Blood Pressure |
|
| Mean Nighttime Systolic Blood Pressure |
|
| Mean Seated Systolic Blood Pressure (Clinic) |
|
| Mean Daytime Diastolic Blood Pressure |
|
| Mean Nighttime Diastolic Blood Pressure |
|
| Mean Seated Diastolic Blood Pressure (Clinic) |
|
| Mean Daytime Heart Rate |
|
| Mean Nighttime Heart Rate |
|
| Mean Seated Heart Rate (Clinic) |
|
| Mixed Models Analysis |
| <0.001 |
P-value reported for non-inferior to Placebo. The adjustment for multiplicity was based on a tree-gatekeeping testing strategy. |
| Least Squares Mean Difference |
| -1.07 |
| 2-Sided |
| 97.3 |
| -2.83 |
| 0.68 |
| Yes |
| Non-Inferiority or Equivalence |
If non-inferiority was confirmed, then superiority analysis was pursued. |
| Mixed Models Analysis | <0.001 | Since non-inferiority was confirmed, superiority analysis was pursued. P-value reported for superior to Placebo. The adjustment for multiplicity was based on a tree-gatekeeping testing strategy. | No | Superiority or Other |
| Mixed Models Analysis | 0.149 | Since non-inferiority was confirmed, superiority analysis was pursued. P-value reported for superior to Placebo. The adjustment for multiplicity was based on a tree-gatekeeping testing strategy. | No | Superiority or Other |
Placebo: subcutaneous (SC), once weekly (QW) for 26 weeks |
|
|
|
| Placebo |
Placebo: subcutaneous (SC), once weekly (QW) for 26 weeks |
|
|
|
Placebo: subcutaneous (SC), once weekly (QW) for 26 weeks
|
|
|
Placebo: subcutaneous (SC), once weekly (QW) for 26 weeks |
|
|
|
Placebo: subcutaneous (SC), once weekly (QW) for 26 weeks |
|
|
|
| OG002 | Placebo | Placebo: subcutaneous (SC), once weekly (QW) for 26 weeks |
|
|
|
| OG002 | Placebo | Placebo: subcutaneous (SC), once weekly (QW) for 26 weeks |
|
|
|
| Placebo |
Placebo: subcutaneous (SC), once weekly (QW) for 26 weeks |
|
|
|
Placebo: subcutaneous (SC), once weekly (QW) for 26 weeks |
|
|
|
| Placebo |
Placebo: subcutaneous (SC), once weekly (QW) for 26 weeks |
|
|
|
| Units | Counts |
|---|
| Participants |
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| Units |
|---|
| Counts |
|---|
| Participants |
|
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|
| Counts |
|---|
| Participants |
|
|
|
|
|
Placebo: subcutaneous (SC), once weekly (QW) for 26 weeks |
|
|
|
|
|
| Counts |
|---|
| Participants |
|
|
| OG002 | Placebo | Placebo: subcutaneous (SC), once weekly (QW) for 26 weeks |
|
|
|
|
|
|