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| ID | Type | Description | Link |
|---|---|---|---|
| H9X-JE-GBCZ | Other Identifier | Eli Lilly and Company |
Not provided
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The main purpose of this study is to assess dose-response characteristics in Japanese patients with Type 2 Diabetes taking LY2189265 monotherapy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 0.75 mg LY2189265 | Experimental |
| |
| 0.5 mg LY2189265 | Experimental |
| |
| 0.25 mg LY2189265 | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LY2189265 | Drug | Administered by subcutaneous (SC) injection, once weekly (QW) for 12 weeks. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Glycosylated Hemoglobin (HbA1c) at 12 Weeks | Change in HbA1c from baseline following 12 weeks of therapy (that is, HbA1c at week 12 minus HbA1c at baseline). Changes in HbA1c were analyzed by a mixed model repeated measures (MMRM) model that included dose, pre-study therapy, body mass index (BMI) group at baseline, baseline value, visit, and dose*visit, where the participant was treated as a random effect. | Baseline, 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Achieving Glycosylated Hemoglobin (HbA1c)<7% up to 12 Weeks | Percentage of participants who achieved HbA1c<7% up to the 12-week endpoint. | up to 12 weeks |
| Percentage of Participants Achieving Glycosylated Hemoglobin (HbA1c)<6.5% up to 12 Weeks |
Not provided
Inclusion Criteria:
Exclusion Criteria:
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Not provided
Not provided
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| Name | Affiliation | Role |
|---|---|---|
| Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9AM - 5PM 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. | Chiba | 276-0049 |
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| ID | Title | Description |
|---|---|---|
| FG000 | 0.75 mg LY2189265 | Administered by subcutaneous (SC) injection, once weekly (QW) for 12 weeks. |
| FG001 | 0.5 mg LY2189265 | Administered by SC injection, QW for 12 weeks. |
| FG002 | 0.25 mg LY2189265 | Administered by SC injection, QW for 12 weeks. |
| FG003 | Placebo | Administered by SC injection, QW for 12 weeks. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 0.75 mg LY2189265 | Administered by subcutaneous (SC) injection, once weekly (QW) for 12 weeks. |
| BG001 | 0.5 mg LY2189265 | Administered by SC injection, QW for 12 weeks. |
| 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 | Change From Baseline in Glycosylated Hemoglobin (HbA1c) at 12 Weeks | Change in HbA1c from baseline following 12 weeks of therapy (that is, HbA1c at week 12 minus HbA1c at baseline). Changes in HbA1c were analyzed by a mixed model repeated measures (MMRM) model that included dose, pre-study therapy, body mass index (BMI) group at baseline, baseline value, visit, and dose*visit, where the participant was treated as a random effect. | Full analysis set: All randomized participants who received at least 1 dose of the study drug. | Posted | Least Squares Mean | 95% Confidence Interval | percentage glycosylated hemoglobin | Baseline, 12 weeks |
|
Not provided
Not provided
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 | Placebo | Administered by subcutaneous (SC) injection, once weekly (QW) for 12 weeks. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pancreatic carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 14.0 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Tinnitus | Ear and labyrinth disorders | MedDRA 14.0 | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Chief Medical Officer | Eli Lilly and Company | 800-545-5979 |
Not provided
| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| D008659 | Metabolic Diseases |
| D044882 | Glucose Metabolism Disorders |
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C555680 | dulaglutide |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Placebo | Drug | Administered by SC injection, QW for 12 weeks. |
|
Percentage of participants achieving HbA1c<6.5% up to the 12-week endpoint. |
| up to 12 weeks |
| Change From Baseline in Fasting Blood Glucose (FBG) Values to 12 Weeks | Change in FBG following 12 weeks of therapy (that is, FBG at week 12 minus FBG at baseline). The change in FBG was analyzed using a mixed model repeated measures (MMRM) model that included dose, pre-study therapy, body mass index (BMI) group at baseline, baseline value, visit, and dose*visit, where the participant was treated as a random effect. | Baseline, 12 weeks |
| Change From Baseline in the Mean Daily Blood Glucose (Based on Self-Monitoring Blood Glucose [SMBG]) at 12 Weeks | SMBG levels were measured at the following 7 timepoints during the day: fasting prebreakfast, 2 hours postbreakfast, prior to lunch, 2 hours postlunch, prior to dinner, 2 hours postdinner, and prior to bed. The change in mean daily blood glucose was analyzed by a mixed model repeated measures (MMRM) model that included dose, pre-study therapy, body mass index (BMI) group at baseline, baseline value, and dose*visit, where the participant was treated as a random effect. | Baseline, 12 weeks |
| Change From Baseline in Total Body Weight at 12 Weeks | Changes in body weight were analyzed by a mixed model repeated measures (MMRM) model that included dose, pre-study therapy, body mass index (BMI) group at baseline, baseline value, visit, and dose*visit, where the participant was treated as a random effect. | Baseline, 12 weeks |
| Change From Baseline in Insulin Sensitivity Using the Updated Homeostasis Model Assessment Insulin Sensitivity (HOMA2-S) at 12 Weeks | HOMA2-S is an estimated insulin sensitivity based on updated HOMA2 model. The HOMA2 model is a computer model that estimates insulin sensitivity (%S) as percentages of a normal reference population using simultaneously measured fasting plasma glucose and fasting insulin. Changes in HOMA2-S were analyzed by a mixed model repeated measures (MMRM) model that included dose, pre-study therapy, body mass index (BMI) group at baseline, baseline value, visit, and dose*visit, where the participant was treated as a random effect. | Baseline, 12 weeks |
| Change From Baseline in Beta-Cell Function Using the Updated Homeostasis Model Assessment Beta-Cell Function (HOMA2-B) at 12 Weeks | HOMA2-B is an estimated steady state beta cell function based on updated HOMA2 model. The HOMA2 model estimates steady state pancreatic beta cell function (%B) as a percentage of a normal reference population using simultaneously measured fasting plasma glucose and fasting insulin. Changes in HOMA2-B were analyzed by a mixed model repeated measures (MMRM) model that included dose, pre-study therapy, body mass index (BMI) group at baseline, baseline value, visit, and dose*visit, where the participant was treated as a random effect. | Baseline, 12 weeks |
| Steady-State Concentrations of LY2189265 | Evaluable pharmacokinetics (PK) concentrations from all sampling time-points were combined and utilized in a population approach to determine the population mean estimate and standard deviation at 12 weeks. The model predicted LY2189265 steady state concentrations in each dose level were calculated as estimated area under the curve (AUC)/dosing period of 168 hours. The models and model parameters were described by nonlinear, mixed-effects regression modeling (NONMEM) using the program NONMEM 7®. | 12 weeks |
| Percentage of Participants With Self-Reported Hypoglycemic Episodes During the 12-week Treatment Period | Assessed the percentage of participants who reported a hypoglycemic episode during the 12-week treatment period. Hypoglycemia was defined as a measured plasma glucose level of ≤70 milligrams per deciliter (mg/dL) or ≤3.9 millimoles per liter (mmol/L). | 12 weeks |
| Japan |
| 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. | Kanagawa | 359-1161 | Japan |
| 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. | Kochi | 781-8555 | Japan |
| 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. | Kyoto | 604-8151 | Japan |
| 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. | Osaka | 530-0047 | Japan |
| 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. | Tokyo | 171-0021 | Japan |
| Lost to Follow-up |
|
| Entry Criteria Not Met |
|
| Withdrawal by Subject |
|
| BG002 | 0.25 mg LY2189265 | Administered by SC injection, QW for 12 weeks. |
| BG003 | Placebo | Administered by SC injection, QW for 12 weeks. |
| BG004 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Number | participants |
|
| Region of Enrollment | Number | participants |
|
| Percentage of Glycosylated Hemoglobin (HbA1c) | Mean | Standard Deviation | percentage of glycosylated hemoglobin |
|
| Fasting Blood Glucose (FBG) | Mean | Standard Deviation | milligrams per deciliter (mg/dL) |
|
| 0.5 mg LY2189265 |
Administered by SC injection, QW for 12 weeks. |
| OG002 | 0.25 mg LY2189265 | Administered by SC injection, QW for 12 weeks. |
| OG003 | Placebo | Administered by SC injection, QW for 12 weeks. |
|
|
|
| Secondary | Percentage of Participants Achieving Glycosylated Hemoglobin (HbA1c)<7% up to 12 Weeks | Percentage of participants who achieved HbA1c<7% up to the 12-week endpoint. | All randomized participants who received at least 1 dose of the study drug, last observation carried forward (LOCF). | Posted | Number | percentage of participants | up to 12 weeks |
|
|
|
|
| Secondary | Percentage of Participants Achieving Glycosylated Hemoglobin (HbA1c)<6.5% up to 12 Weeks | Percentage of participants achieving HbA1c<6.5% up to the 12-week endpoint. | All randomized participants who received at least 1 dose of the study drug, last observation carried forward (LOCF). | Posted | Number | percentage of participants | up to 12 weeks |
|
|
|
|
| Secondary | Change From Baseline in Fasting Blood Glucose (FBG) Values to 12 Weeks | Change in FBG following 12 weeks of therapy (that is, FBG at week 12 minus FBG at baseline). The change in FBG was analyzed using a mixed model repeated measures (MMRM) model that included dose, pre-study therapy, body mass index (BMI) group at baseline, baseline value, visit, and dose*visit, where the participant was treated as a random effect. | Full analysis set: All randomized participants who received at least 1 dose of the study drug. | Posted | Least Squares Mean | 95% Confidence Interval | milligrams per deciliter (mg/dL) | Baseline, 12 weeks |
|
|
|
|
| Secondary | Change From Baseline in the Mean Daily Blood Glucose (Based on Self-Monitoring Blood Glucose [SMBG]) at 12 Weeks | SMBG levels were measured at the following 7 timepoints during the day: fasting prebreakfast, 2 hours postbreakfast, prior to lunch, 2 hours postlunch, prior to dinner, 2 hours postdinner, and prior to bed. The change in mean daily blood glucose was analyzed by a mixed model repeated measures (MMRM) model that included dose, pre-study therapy, body mass index (BMI) group at baseline, baseline value, and dose*visit, where the participant was treated as a random effect. | Full analysis set: All randomized participants who received at least 1 dose of the study drug. | Posted | Least Squares Mean | 95% Confidence Interval | milligrams per deciliter (mg/dL) | Baseline, 12 weeks |
|
|
|
|
| Secondary | Change From Baseline in Total Body Weight at 12 Weeks | Changes in body weight were analyzed by a mixed model repeated measures (MMRM) model that included dose, pre-study therapy, body mass index (BMI) group at baseline, baseline value, visit, and dose*visit, where the participant was treated as a random effect. | Full analysis set: All randomized participants who received at least 1 dose of the study drug. | Posted | Least Squares Mean | 95% Confidence Interval | kilograms (kg) | Baseline, 12 weeks |
|
|
|
|
| Secondary | Change From Baseline in Insulin Sensitivity Using the Updated Homeostasis Model Assessment Insulin Sensitivity (HOMA2-S) at 12 Weeks | HOMA2-S is an estimated insulin sensitivity based on updated HOMA2 model. The HOMA2 model is a computer model that estimates insulin sensitivity (%S) as percentages of a normal reference population using simultaneously measured fasting plasma glucose and fasting insulin. Changes in HOMA2-S were analyzed by a mixed model repeated measures (MMRM) model that included dose, pre-study therapy, body mass index (BMI) group at baseline, baseline value, visit, and dose*visit, where the participant was treated as a random effect. | Full analysis set: All randomized participants who received at least 1 dose of the study drug. | Posted | Least Squares Mean | 95% Confidence Interval | percentage insulin sensitivity (%S) | Baseline, 12 weeks |
|
|
|
|
| Secondary | Change From Baseline in Beta-Cell Function Using the Updated Homeostasis Model Assessment Beta-Cell Function (HOMA2-B) at 12 Weeks | HOMA2-B is an estimated steady state beta cell function based on updated HOMA2 model. The HOMA2 model estimates steady state pancreatic beta cell function (%B) as a percentage of a normal reference population using simultaneously measured fasting plasma glucose and fasting insulin. Changes in HOMA2-B were analyzed by a mixed model repeated measures (MMRM) model that included dose, pre-study therapy, body mass index (BMI) group at baseline, baseline value, visit, and dose*visit, where the participant was treated as a random effect. | Full analysis set: All randomized participants who received at least 1 dose of the study drug. | Posted | Least Squares Mean | 95% Confidence Interval | percentage beta-cell function | Baseline, 12 weeks |
|
|
|
|
| Secondary | Steady-State Concentrations of LY2189265 | Evaluable pharmacokinetics (PK) concentrations from all sampling time-points were combined and utilized in a population approach to determine the population mean estimate and standard deviation at 12 weeks. The model predicted LY2189265 steady state concentrations in each dose level were calculated as estimated area under the curve (AUC)/dosing period of 168 hours. The models and model parameters were described by nonlinear, mixed-effects regression modeling (NONMEM) using the program NONMEM 7®. | Full analysis set: All randomized participants who received at least 1 dose of the study drug. | Posted | Median | 90% Confidence Interval | nanograms per milliliter (ng/mL) | 12 weeks |
|
|
|
| Secondary | Percentage of Participants With Self-Reported Hypoglycemic Episodes During the 12-week Treatment Period | Assessed the percentage of participants who reported a hypoglycemic episode during the 12-week treatment period. Hypoglycemia was defined as a measured plasma glucose level of ≤70 milligrams per deciliter (mg/dL) or ≤3.9 millimoles per liter (mmol/L). | Full analysis set: All randomized participants who received at least 1 dose of the study drug. | Posted | Number | percentage of participants | 12 weeks |
|
|
|
|
| 0 |
| 37 |
| 16 |
| 37 |
| EG001 | 0.25 mg LY2189265 | Administered by SC injection, QW for 12 weeks. | 1 | 36 | 17 | 36 |
| EG002 | 0.5 mg LY2189265 | Administered by SC injection, QW for 12 weeks. | 0 | 37 | 18 | 37 |
| EG003 | 0.75 mg LY2189265 | Administered by SC injection, QW for 12 weeks. | 1 | 35 | 15 | 35 |
| VIIth nerve paralysis | Nervous system disorders | MedDRA 14.0 | Systematic Assessment |
|
| Cataract | Eye disorders | MedDRA 14.0 | Systematic Assessment |
|
| Conjunctivitis allergic | Eye disorders | MedDRA 14.0 | Systematic Assessment |
|
| Abdominal discomfort | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
|
| Abdominal distension | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
|
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
|
| Dental caries | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
|
| Flatulence | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
|
| Gastritis | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
|
| Gastritis erosive | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
|
| Gingivitis | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
|
| Chest pain | General disorders | MedDRA 14.0 | Systematic Assessment |
|
| Fatigue | General disorders | MedDRA 14.0 | Systematic Assessment |
|
| Pain | General disorders | MedDRA 14.0 | Systematic Assessment |
|
| Hepatic steatosis | Hepatobiliary disorders | MedDRA 14.0 | Systematic Assessment |
|
| Hyperplastic cholecystopathy | Hepatobiliary disorders | MedDRA 14.0 | Systematic Assessment |
|
| Seasonal allergy | Immune system disorders | MedDRA 14.0 | Systematic Assessment |
|
| Bronchitis | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
|
| Laryngitis | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
|
| Rhinitis | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
|
| Contusion | Injury, poisoning and procedural complications | MedDRA 14.0 | Systematic Assessment |
|
| Foot fracture | Injury, poisoning and procedural complications | MedDRA 14.0 | Systematic Assessment |
|
| Hand fracture | Injury, poisoning and procedural complications | MedDRA 14.0 | Systematic Assessment |
|
| Thermal burn | Injury, poisoning and procedural complications | MedDRA 14.0 | Systematic Assessment |
|
| Blood amylase increased | Investigations | MedDRA 14.0 | Systematic Assessment |
|
| Blood creatine phosphokinase increased | Investigations | MedDRA 14.0 | Systematic Assessment |
|
| Blood triglycerides increased | Investigations | MedDRA 14.0 | Systematic Assessment |
|
| Electrocardiogram abnormal | Investigations | MedDRA 14.0 | Systematic Assessment |
|
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 14.0 | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 14.0 | Systematic Assessment |
|
| Intervertebral disc protrusion | Musculoskeletal and connective tissue disorders | MedDRA 14.0 | Systematic Assessment |
|
| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | MedDRA 14.0 | Systematic Assessment |
|
| Periarthritis | Musculoskeletal and connective tissue disorders | MedDRA 14.0 | Systematic Assessment |
|
| Spinal osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA 14.0 | Systematic Assessment |
|
| Adrenal adenoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 14.0 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 14.0 | Systematic Assessment |
|
| Intercostal neuralgia | Nervous system disorders | MedDRA 14.0 | Systematic Assessment |
|
| Somnolence | Nervous system disorders | MedDRA 14.0 | Systematic Assessment |
|
| Insomnia | Psychiatric disorders | MedDRA 14.0 | Systematic Assessment |
|
| Rhinitis allergic | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 | Systematic Assessment |
|
| Upper respiratory tract inflammation | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 | Systematic Assessment |
|
| Dermatitis | Skin and subcutaneous tissue disorders | MedDRA 14.0 | Systematic Assessment |
|
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA 14.0 | Systematic Assessment |
|
| Dyshidrosis | Skin and subcutaneous tissue disorders | MedDRA 14.0 | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA 14.0 | Systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA 14.0 | Systematic Assessment |
|
| Peripheral coldness | Vascular disorders | MedDRA 14.0 | Systematic Assessment |
|
| Peripheral vascular disorder | Vascular disorders | MedDRA 14.0 | Systematic Assessment |
|
Not provided
| <0.001 |
| 95 |
| No |
| Superiority or Other |
| Fisher Exact | <0.001 | 95 | No | Superiority or Other |
| Fisher Exact | <0.001 | 95 | No | Superiority or Other |
| 0.358 |
| 95 |
| No |
| Superiority or Other |
| Fisher Exact | 0.014 | 95 | No | Superiority or Other |
| Fisher Exact | <0.001 | 95 | No | Superiority or Other |
| 0.003 |
Primary comparisons are based on the MMRM Least Squares (LS) Mean Value at week 12. |
| Least Squares Mean Difference |
| -20.20 |
| 95 |
| No |
| Superiority or Other |
| Mixed Models Analysis | 0.003 | Primary comparisons are based on the MMRM LS Mean Value at week 12. | Least Squares Mean Difference | -19.54 | 95 | No | Superiority or Other |
| Mixed Models Analysis | <0.001 | Primary comparisons are based on the MMRM LS Mean Value at week 12. | Least Squares Mean Difference | -28.48 | 95 | No | Superiority or Other |
| <0.001 |
Primary comparisons are based on the MMRM Least Squares (LS) Mean Value at week 12. |
| Least Squares Mean Difference |
| -33.20 |
| 95 |
| No |
| Superiority or Other |
| Mixed Models Analysis | <0.001 | Primary comparisons are based on the MMRM LS Mean Value at week 12. | Least Squares Mean Difference | -45.63 | 95 | No | Superiority or Other |
| Mixed Models Analysis | <0.001 | Primary comparisons are based on the MMRM LS Mean Value at week 12. | Least Squares Mean Difference | -41.49 | 95 | No | Superiority or Other |
| 0.005 |
Primary comparisons are based on the MMRM Least Squares (LS) Mean Value at week 12. |
| Least Squares Mean Difference |
| 1.26 |
| 95 |
| No |
| Superiority or Other |
| Mixed Models Analysis | 0.311 | Primary comparisons are based on the MMRM LS Mean Value at week 12. | Least Squares Mean Difference | 0.45 | 95 | No | Superiority or Other |
| Mixed Models Analysis | 0.556 | Primary comparisons are based on the MMRM LS Mean Value at week 12. | Least Squares Mean Difference | 0.26 | 95 | No | Superiority or Other |
| 0.917 |
Primary comparisons are based on the MMRM Least Squares (LS) Mean Value at week 12. |
| Least Squares Mean Difference |
| 0.91 |
| 95 |
| No |
| Superiority or Other |
| Mixed Models Analysis | 0.264 | Primary comparisons are based on the MMRM LS Mean Value at week 12. | Least Squares Mean Difference | -9.81 | 95 | No | Superiority or Other |
| Mixed Models Analysis | 0.346 | Primary comparisons are based on the MMRM LS Mean Value at week 12. | Least Squares Mean Difference | -8.40 | 95 | No | Superiority or Other |
| 0.036 |
Primary comparisons are based on the MMRM Least Squares (LS) Mean Value at week 12. |
| Least Squares Mean Difference |
| 13.10 |
| 95 |
| No |
| Superiority or Other |
| Mixed Models Analysis | 0.002 | Primary comparisons are based on the MMRM LS Mean Value at week 12. | Least Squares Mean Difference | 19.73 | 95 | No | Superiority or Other |
| Mixed Models Analysis | <0.001 | Primary comparisons are based on the MMRM LS Mean Value at week 12. | Least Squares Mean Difference | 31.68 | 95 | No | Superiority or Other |
| 1.00 |
| 95 |
| No |
| Superiority or Other |
| Fisher Exact | 0.233 | 95 | No | Superiority or Other |