Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| I6I-MC-LMRB | Other Identifier | Eli Lilly and Company |
Not provided
Not provided
Not provided
Lack of Efficacy
Not provided
Not provided
Not provided
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The purpose of this study is to investigate the safety and effectiveness of the study drug known as LY3053102 in participants with Type 2 diabetes mellitus. The study drug will be given in different doses as an injection under the skin. The study is expected to last up to 6 months for each participant. Participants may remain on stable-dose metformin as prescribed by their personal physician.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LY3053102 | Experimental | Stage 1: Escalating dose (7 milligrams [mg] up to 200 mg) of LY3053102 administered once a week by subcutaneous (SC) injection for 12 weeks. Stage 2: LY3053102 administered once a week by SC injection for 12 weeks |
|
| Placebo | Placebo Comparator | Stage 1 and Stage 2: Placebo to match LY3053102 administered by SC injection once a week for 12 weeks |
|
| Exenatide Extended-Release (ER) | Active Comparator | Stage 1 and Stage 2: Exenatide ER 2 mg given by SC injection once a week for 12 weeks |
|
| LY3053102 + Exenatide ER | Experimental | Stage 2: LY3053102 administered by SC injection once a week for 12 weeks and exenatide ER 2 mg administered by SC injection once a week for 12 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LY3053102 | Drug | Administered SC |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Hemoglobin A1c (HbA1c) at 12-Week Endpoint | 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) analysis adjusting for metformin use, washout of second oral anti-hyperglycemic medication (OAM), treatment, visit, and treatment-by-visit interaction as fixed effects, baseline as a covariate, and participant as a random effect. | Baseline, Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Achieving HbA1c <7.0% or HbA1c ≤6.5% at 12-Week Endpoint | HbA1c is a form of hemoglobin that is measured primarily to identify the average plasma glucose concentration over prolonged periods of time. | Week 12 |
| Percentage of Participants That Require Rescue Therapy |
Not provided
Inclusion Criteria
Exclusion Criteria
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| 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 |
|---|---|---|---|---|---|---|
| Orange County Research Center | Orange | California | 92868 | United States | ||
| Miami Research Associates |
Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.
Data are available 6 months after the primary publication and approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting.
A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
The study was planned in 2 stages; Stage 1 evaluated up to 5 escalating parallel-dose groups. Stage 2, which was to evaluate participants stratified by Hemoglobin A1c (HbA1c), metformin therapy, and washout of a second oral anti-hyperglycemic medication (OAM) was not conducted because of inadequate efficacy at well-tolerated doses in Stage 1.
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | Placebo administered by subcutaneous injection (SC) once a week (Q1W) for 12 weeks |
| FG001 | 7 mg LY3053102 | 7 mg LY3053102 administered SC Q1W for 12 weeks. |
| FG002 | 15 mg LY3053102 | 15 mg LY3053102 administered SC Q1W for 12 weeks. |
| FG003 | 50 mg LY3053102 | 50 mg LY3053102 administered SC Q1W for 12 weeks. |
| FG004 | 100 mg LY3053102 | 100 mg LY3053102 administered SC Q1W for 12 weeks. |
| FG005 | 200 mg LY3053102 | 200 mg LY3053102 administered SC Q1W for 12 weeks. |
| FG006 | 2 mg Exenatide ER | 2 mg exenatide ER administered SC Q1W for 12 weeks. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
All randomized participants who received at least 1 dose of study drug.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | Placebo administered SC QW for 12 weeks |
| BG001 | 7 mg LY3053102 | 7 mg LY3053102 administered SC 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 Hemoglobin A1c (HbA1c) at 12-Week Endpoint | 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) analysis adjusting for metformin use, washout of second oral anti-hyperglycemic medication (OAM), treatment, visit, and treatment-by-visit interaction as fixed effects, baseline as a covariate, and participant as a random effect. | All randomized participants who received at least 1 dose of study drug, and who had baseline and post-baseline data. | Posted | Least Squares Mean | Standard Error | Percent of HbA1c | Baseline, Week 12 |
|
Not provided
One participant was discontinued from the study before dosing due to meeting exclusion criteria.
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 | Placebo administered by SC QW for 12 weeks |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Angina unstable | Cardiac disorders | MedDRA 16.0 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Angina unstable | Cardiac disorders | MedDRA 16.0 | Systematic Assessment |
Stage 2, which was to evaluate participants stratified by HbA1c, metformin therapy, and washout of a second oral anti-hyperglycemic medication (OAM) was not conducted because of inadequate efficacy at well-tolerated doses in Stage 1.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Chief Medical Officer | Eli Lilly and Company | 800-545-5979 |
| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D008687 | Metformin |
| ID | Term |
|---|---|
| D001645 | Biguanides |
| D006146 | Guanidines |
| D000578 | Amidines |
| D009930 | Organic Chemicals |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Exenatide ER |
| Drug |
Administered SC |
|
| Placebo | Drug | Administered SC |
|
| Metformin | Drug | Administered orally (PO) |
|
Percentage of participants that required >=1 rescue (blood glucose lowering) medications. |
| Baseline through Week 12 |
| Change From Baseline in Body Weight at 12-Week Endpoint | LS means were calculated using MMRM analysis adjusting for baseline HbA1c category, metformin use, washout of second OAM, treatment, visit, and treatment-by-visit interaction as fixed effects, baseline as a covariate, and participant as a random effect (excludes data after rescue therapy). | Baseline, Week 12 |
| Change From Baseline in 7-Point Blood Glucose Profile at 12-Week Endpoint | 7-Point Self-Monitored Blood Glucose profiles are measures of blood glucose concentration taken 7 times a day at morning pre-prandial, morning 2 hours postprandial, midday pre-prandial, midday 2 hours postprandial, evening pre-prandial, evening 2 hour postprandial, and bedtime. LS means were calculated using MMRM analysis adjusting for baseline HbA1c category, metformin use, washout of second OAM, treatment, visit, and treatment-by-visit interaction as fixed effects, baseline as a covariate, and participant as a random effect (excludes data after rescue therapy). | Baseline, Week 12 |
| Change From Baseline in Lipids at 12-Week Endpoint | Lipids includes: High Density Lipoprotein-Cholesterol (HDL-C), Low Density Lipoprotein-Cholesterol (LDL-C), Triglycerides, and Cholesterol. LS means were calculated using MMRM analysis adjusting for metformin use, washout of second OAM, baseline HbA1c category, treatment, visit, and treatment-by-visit interaction as fixed effects, baseline as a covariate, and participant as a random effect (excludes data after rescue therapy). | Baseline, Week 12 |
| Percentage of Participants With Anti-Drug Antibodies to LY3053102 | Percentage of participants with anti-LY3053102 antibody titre changes from baseline to the maximum postbaseline value. | Baseline through Study Completion (Up to 6 Months) |
| Percentage of Participants With Hypoglycemia | Hypoglycemia was defined as any event meeting the criteria for documented symptomatic hypoglycemia, asymptomatic hypoglycemia, or probable symptomatic hypoglycemia. | Baseline through Week 12 |
| Change From Baseline in Bone Metabolism at 12-Week Endpoint (Osteocalcin and Bone-Specific Alkaline Phosphatase [Bone-Specific ALP]) | LS means were calculated using MMRM analysis adjusting for metformin use, washout of second OAM, baseline HbA1c category, treatment, visit, and treatment-by-visit interaction as fixed effects, baseline as a covariate, and participant as a random effect (excludes data after rescue therapy). | Baseline, Week 12 |
| Change From Baseline in Bone Metabolism at 12-Week Endpoint (Beta-Crosslaps and Procollagen 1 N-Terminal Propeptide [P1NP]) | LS means were calculated using MMRM analysis adjusting for metformin use, washout of second OAM, baseline HbA1c category, treatment, visit, and treatment-by-visit interaction as fixed effects, baseline as a covariate, and participant as a random effect (excludes data after rescue therapy). | Baseline, Week 12 |
| Change From Baseline in Bone Mineral Density Markers at 12-Week Endpoint | LS means were calculated using MMRM analysis adjusting for metformin use, washout of second OAM, baseline HbA1c category, treatment, visit, and treatment-by-visit interaction as fixed effects, baseline as a covariate, and participant as a random effect (excludes data after rescue therapy). | Baseline, Week 12 |
| Pharmacokinetics: Area Under the Concentration Versus Time Curve During One Dosing Interval at Steady State (AUC [τ,ss]) of LY3053102 | AUC (τ,ss) = area under the concentration versus time curve during one dosing interval at steady state, where the dosing interval (τ) = 168 hours. | Predose, 0, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96, 168 hours post-dose |
| Miami |
| Florida |
| 33143 |
| United States |
| Compass Research | Orlando | Florida | 32806 | United States |
| Clinilabs, Inc (New York) | New York | New York | 10019 | United States |
| Dallas Diabetes Endocrine Center | Dallas | Texas | 75230 | United States |
| Physician Decision |
|
| Withdrawal by Subject |
|
| Lost to Follow-up |
|
| Early Termination Criteria Met |
|
| Randomized in Error |
|
| Lack of Efficacy |
|
| BG002 | 15 mg LY3053102 | 15 mg LY3053102 administered SC QW for 12 weeks |
| BG003 | 50 mg LY3053102 | 50 mg LY3053102 administered SC QW for 12 weeks |
| BG004 | 100 mg LY3053102 | 100 mg LY3053102 administered SC QW for 12 weeks |
| BG005 | 200 mg LY3053102 | 200 mg LY3053102 administered SC QW for 12 weeks |
| BG006 | 2 mg Exenatide ER | 2 mg Exenatide ER administered SC QW for 12 weeks |
| BG007 | Total | Total of all reporting groups |
| 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 | Count of Participants | Participants |
|
| Baseline Hemoglobin A1c (HbA1c) | Mean | Standard Deviation | Percent of HbA1c |
|
| Baseline Fasting Plasma Glucose | Mean | Standard Deviation | milligram/deciliter (mg/dL) |
|
| 7 mg LY3053102 |
7 mg LY3053102 administered SC Q1W for 12 weeks |
| OG002 | 15 mg LY3053102 | 15 mg LY3053102 administered SC Q1W for 12 weeks |
| OG003 | 50 mg LY3053102 | 50 mg LY3053102 administered SC Q1W for 12 weeks |
| OG004 | 100 mg LY3053102 | 100 mg LY3053102 administered SC Q1W for 12 weeks |
| OG005 | 200 mg LY3053102 | 200 mg LY3053102 administered SC Q1W for 12 weeks |
| OG006 | 2 mg Exenatide ER | 2 mg Exenatide ER administered SC Q1W for 12 weeks |
|
|
| Secondary | Percentage of Participants Achieving HbA1c <7.0% or HbA1c ≤6.5% at 12-Week Endpoint | HbA1c is a form of hemoglobin that is measured primarily to identify the average plasma glucose concentration over prolonged periods of time. | All randomized participants who received at least 1 dose of study drug, and who had baseline and post-baseline data. | Posted | Number | Percentage of Participants | Week 12 |
|
|
|
| Secondary | Percentage of Participants That Require Rescue Therapy | Percentage of participants that required >=1 rescue (blood glucose lowering) medications. | All randomized participants who took at least 1 dose of study drug, and who had a baseline and a post-baseline measurement for the time point. | Posted | Number | Percentage of Participants | Baseline through Week 12 |
|
|
|
| Secondary | Change From Baseline in Body Weight at 12-Week Endpoint | LS means were calculated using MMRM analysis adjusting for baseline HbA1c category, metformin use, washout of second OAM, treatment, visit, and treatment-by-visit interaction as fixed effects, baseline as a covariate, and participant as a random effect (excludes data after rescue therapy). | All randomized participants who received at least 1 dose of study drug, and who had baseline and post-baseline data. | Posted | Least Squares Mean | Standard Error | kilogram (kg) | Baseline, Week 12 |
|
|
|
| Secondary | Change From Baseline in 7-Point Blood Glucose Profile at 12-Week Endpoint | 7-Point Self-Monitored Blood Glucose profiles are measures of blood glucose concentration taken 7 times a day at morning pre-prandial, morning 2 hours postprandial, midday pre-prandial, midday 2 hours postprandial, evening pre-prandial, evening 2 hour postprandial, and bedtime. LS means were calculated using MMRM analysis adjusting for baseline HbA1c category, metformin use, washout of second OAM, treatment, visit, and treatment-by-visit interaction as fixed effects, baseline as a covariate, and participant as a random effect (excludes data after rescue therapy). | All randomized participants who received at least 1 dose of study drug, and who had baseline and post-baseline data. | Posted | Least Squares Mean | Standard Error | milligram/deciliter (mg/dL) | Baseline, Week 12 |
|
|
|
| Secondary | Change From Baseline in Lipids at 12-Week Endpoint | Lipids includes: High Density Lipoprotein-Cholesterol (HDL-C), Low Density Lipoprotein-Cholesterol (LDL-C), Triglycerides, and Cholesterol. LS means were calculated using MMRM analysis adjusting for metformin use, washout of second OAM, baseline HbA1c category, treatment, visit, and treatment-by-visit interaction as fixed effects, baseline as a covariate, and participant as a random effect (excludes data after rescue therapy). | All randomized participants who received at least 1 dose of study drug, and who had baseline and post-baseline data. | Posted | Least Squares Mean | Standard Error | mg/dL | Baseline, Week 12 |
|
|
|
| Secondary | Percentage of Participants With Anti-Drug Antibodies to LY3053102 | Percentage of participants with anti-LY3053102 antibody titre changes from baseline to the maximum postbaseline value. | All randomized participants who received at least 1 dose of study drug and had evaluable immunogenicity. | Posted | Number | Percentage of Participants | Baseline through Study Completion (Up to 6 Months) |
|
|
|
| Secondary | Percentage of Participants With Hypoglycemia | Hypoglycemia was defined as any event meeting the criteria for documented symptomatic hypoglycemia, asymptomatic hypoglycemia, or probable symptomatic hypoglycemia. | All randomized participants who received at least 1 dose of study drug. | Posted | Number | Percentage of Participants | Baseline through Week 12 |
|
|
|
| Secondary | Change From Baseline in Bone Metabolism at 12-Week Endpoint (Osteocalcin and Bone-Specific Alkaline Phosphatase [Bone-Specific ALP]) | LS means were calculated using MMRM analysis adjusting for metformin use, washout of second OAM, baseline HbA1c category, treatment, visit, and treatment-by-visit interaction as fixed effects, baseline as a covariate, and participant as a random effect (excludes data after rescue therapy). | All randomized participants who received at least 1 dose of study drug. | Posted | Least Squares Mean | Standard Error | microgram/liter (ug/L) | Baseline, Week 12 |
|
|
|
| Secondary | Change From Baseline in Bone Metabolism at 12-Week Endpoint (Beta-Crosslaps and Procollagen 1 N-Terminal Propeptide [P1NP]) | LS means were calculated using MMRM analysis adjusting for metformin use, washout of second OAM, baseline HbA1c category, treatment, visit, and treatment-by-visit interaction as fixed effects, baseline as a covariate, and participant as a random effect (excludes data after rescue therapy). | All randomized participants who received at least 1 dose of study drug. | Posted | Least Squares Mean | Standard Error | nanogram/milliliter (ng/mL) | Baseline, Week 12 |
|
|
|
| Secondary | Change From Baseline in Bone Mineral Density Markers at 12-Week Endpoint | LS means were calculated using MMRM analysis adjusting for metformin use, washout of second OAM, baseline HbA1c category, treatment, visit, and treatment-by-visit interaction as fixed effects, baseline as a covariate, and participant as a random effect (excludes data after rescue therapy). | All randomized participants who received at least 1 dose of study drug. | Posted | Least Squares Mean | Standard Error | milligram/square centimeter (mg/cm2) | Baseline, Week 12 |
|
|
|
| Secondary | Pharmacokinetics: Area Under the Concentration Versus Time Curve During One Dosing Interval at Steady State (AUC [τ,ss]) of LY3053102 | AUC (τ,ss) = area under the concentration versus time curve during one dosing interval at steady state, where the dosing interval (τ) = 168 hours. | All randomized participants who received at least 1 dose of study drug and had evaluable pharmacokinetics | Posted | Geometric Mean | Geometric Coefficient of Variation | microgram•hour/milliliter (µg•h/mL) | Predose, 0, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96, 168 hours post-dose |
|
|
|
| 1 |
| 10 |
| 6 |
| 10 |
| EG001 | 7 mg LY3053102 | 7 mg LY3053102 administered SC QW for 12 weeks | 0 | 8 | 4 | 8 |
| EG002 | 15 mg LY3053102 | 15 mg LY3053102 administered SC QW for 12 weeks | 0 | 8 | 4 | 8 |
| EG003 | 50 mg LY3053102 | 50 mg LY3053102 administered SC QW for 12 weeks | 0 | 7 | 4 | 7 |
| EG004 | 100 mg LY3053102 | 100 mg LY3053102 administered SC QW for 12 weeks | 1 | 8 | 7 | 8 |
| EG005 | 200 mg LY3053102 | 200 mg LY3053102 administered SC QW for 12 weeks | 0 | 8 | 7 | 8 |
| EG006 | 2 mg Exenatide ER | 2 mg exenatide ER administered SC QW for 12 weeks | 0 | 10 | 8 | 10 |
| Pneumonia | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
|
| Coronary artery disease | Cardiac disorders | MedDRA 16.0 | Systematic Assessment |
|
| Ear congestion | Ear and labyrinth disorders | MedDRA 16.0 | Systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
|
| Frequent bowel movements | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
|
| Gastrointestinal pain | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
|
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
|
| Hiatus hernia | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
|
| Large intestine polyp | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
|
| Oesophagitis | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
|
| Toothache | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
|
| Asthenia | General disorders | MedDRA 16.0 | Systematic Assessment |
|
| Chills | General disorders | MedDRA 16.0 | Systematic Assessment |
|
| Fatigue | General disorders | MedDRA 16.0 | Systematic Assessment |
|
| Injection site discolouration | General disorders | MedDRA 16.0 | Systematic Assessment |
|
| Injection site erosion | General disorders | MedDRA 16.0 | Systematic Assessment |
|
| Injection site erythema | General disorders | MedDRA 16.0 | Systematic Assessment |
|
| Injection site haematoma | General disorders | MedDRA 16.0 | Systematic Assessment |
|
| Injection site haemorrhage | General disorders | MedDRA 16.0 | Systematic Assessment |
|
| Injection site induration | General disorders | MedDRA 16.0 | Systematic Assessment |
|
| Injection site nodule | General disorders | MedDRA 16.0 | Systematic Assessment |
|
| Injection site pain | General disorders | MedDRA 16.0 | Systematic Assessment |
|
| Injection site pruritus | General disorders | MedDRA 16.0 | Systematic Assessment |
|
| Injection site reaction | General disorders | MedDRA 16.0 | Systematic Assessment |
|
| Injection site urticaria | General disorders | MedDRA 16.0 | Systematic Assessment |
|
| Malaise | General disorders | MedDRA 16.0 | Systematic Assessment |
|
| Oedema peripheral | General disorders | MedDRA 16.0 | Systematic Assessment |
|
| Thirst | General disorders | MedDRA 16.0 | Systematic Assessment |
|
| Hepatic steatosis | Hepatobiliary disorders | MedDRA 16.0 | Systematic Assessment |
|
| Seasonal allergy | Immune system disorders | MedDRA 16.0 | Systematic Assessment |
|
| Cystitis | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
|
| Contusion | Injury, poisoning and procedural complications | MedDRA 16.0 | Systematic Assessment |
|
| Blood glucose increased | Investigations | MedDRA 16.0 | Systematic Assessment |
|
| Blood pressure systolic increased | Investigations | MedDRA 16.0 | Systematic Assessment |
|
| Cardiac stress test abnormal | Investigations | MedDRA 16.0 | Systematic Assessment |
|
| Lipase increased | Investigations | MedDRA 16.0 | Systematic Assessment |
|
| Platelet count decreased | Investigations | MedDRA 16.0 | Systematic Assessment |
|
| Weight increased | Investigations | MedDRA 16.0 | Systematic Assessment |
|
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 16.0 | Systematic Assessment |
|
| Fluid retention | Metabolism and nutrition disorders | MedDRA 16.0 | Systematic Assessment |
|
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA 16.0 | Systematic Assessment |
|
| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA 16.0 | Systematic Assessment |
|
| Increased appetite | Metabolism and nutrition disorders | MedDRA 16.0 | Systematic Assessment |
|
| Joint stiffness | Musculoskeletal and connective tissue disorders | MedDRA 16.0 | Systematic Assessment |
|
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA 16.0 | Systematic Assessment |
|
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA 16.0 | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA 16.0 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 16.0 | Systematic Assessment |
|
| Hypogeusia | Nervous system disorders | MedDRA 16.0 | Systematic Assessment |
|
| Paraesthesia | Nervous system disorders | MedDRA 16.0 | Systematic Assessment |
|
| Nephrolithiasis | Renal and urinary disorders | MedDRA 16.0 | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 | Systematic Assessment |
|
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 | Systematic Assessment |
|
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 | Systematic Assessment |
|
| Rhinitis allergic | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 | Systematic Assessment |
|
| Sinus congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 | Systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 16.0 | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA 16.0 | Systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA 16.0 | Systematic Assessment |
|
Not provided
| D004700 | Endocrine System Diseases |
|
| HbA1c ≤6.5% |
|
|
| Midday Meal (Post- minus Pre-prandial) |
|
| Evening Meal (Post- minus Pre-prandial) |
|
| Bedtime |
|
|
| LDL-C |
|
|
|
| Bone-Specific ALP |
|
|
|
| P1NP |
|
|
|
| Neck of Femur |
|
|
| Total Hip |
|
|