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This is a Phase 4, prospective, open label, randomized, parallel controlled multicenter trial in which metformin extended release (XR) will be compared with metformin immediate release (IR) for the gastrointestinal tolerability and efficacy in the newly diagnosed subjects with Type 2 diabetes who have glycosylated hemoglobin (HbA1c) value between 7.0 to 10.0 percent (%).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Metformin IR | Active Comparator |
| |
| Metformin XR | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Metformin IR | Drug | Subjects will receive Metformin Immediate Release (IR) tablets, orally once daily at a dose of 500 milligram (mg) for 1 week, and then dose will increase with increments of 500 mg every week in first 2 weeks to 1500 mg. After that dose will increase up to maximum dose of 2000 mg for the next 2 weeks and will be maintained at 2000 mg until Week 16. |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 16 | Baseline, Week 16 | |
| Overall Gastrointestinal (GI) Tolerability Assessed as Percentage of Subjects With Gastrointestinal Adverse Events During Treatment Period | An adverse event (AE) was defined as any untoward medical occurrence in a subject which does not necessarily have a causal relationship with the treatment. An AE was any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with use of a medicinal product, whether or not considered related to the medicinal product. | Baseline up to Week 16 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Subjects With Pre-specified Gastrointestinal Adverse Events During Treatment Period | An adverse event (AE) was defined as any untoward medical occurrence in a subject which does not necessarily have a causal relationship with the treatment. An AE was any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with use of a medicinal product, whether or not considered related to the medicinal product. Number of subjects with pre-specified gastrointestinal adverse events (diarrhea, nausea, abdominal pain, bloating, constipation, dyspepsia and flatulence) were reported. |
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Inclusion criteria:
Exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Responsible | Merck Serono Co., Ltd., Beijing, China | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Please contact the Merck KGaA Communication Center | Darmstadt | Germany |
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| ID | Title | Description |
|---|---|---|
| FG000 | Metformin IR | Subjects received Metformin Immediate Release (IR) tablets, orally once daily (QD) at a dose of 500 milligram (mg) for 1 week, and then the dose was increased with increments of 500 mg every week in the first 2 weeks to 1500 mg. After that, the dose was increased up to a maximum dose of 2000 mg for the next two weeks and maintained at 2000 mg until Week 16. |
| FG001 | Metformin XR | Subjects received Metformin Extended Release (XR) tablets, orally QD at a dose of 500 mg for 1 week, and then the dose was increased with increments of 500 mg every week in the first 2 weeks to 1500 mg. After that, the dose was increased up to a maximum dose of 2000 mg for next 2 weeks and maintained at 2000 mg until Week 16. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Intent to Treat (ITT) population included all subjects who were randomly allocated to a treatment based on the intention to treat
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| ID | Title | Description |
|---|---|---|
| BG000 | Metformin IR | Subjects received Metformin IR tablets, orally QD at a dose of 500 milligram (mg) for 1 week, and then the dose was increased with increments of 500 mg every week in the first 2 weeks to 1500 mg. After that, the dose was increased up to a maximum dose of 2000 mg for the next two weeks and maintained at 2000 mg until Week 16. |
| 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 Week 16 | Per-protocol (PP) population included all subjects who were randomly allocated to a treatment based on intent to treat and were compliant with protocol (absence of any major protocol violations). Here "Number of Participants Analyzed" signifies those subjects who were evaluable for this outcome measure. | Posted | Least Squares Mean | Standard Error | Percentage of HbA1c | Baseline, Week 16 |
|
Baseline up to Week 18
Serious adverse events (SAEs) and Non-SAEs were presented separately for subjects who switched from Metformin IR to Metformin XR group due to intolerance to Metformin IR treatment.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Metformin IR | Subjects received Metformin IR tablets, orally QD at a dose of 500 mg for 1 week, and then the dose was increased with increments of 500 mg every week in the first 2 weeks to 1500 mg. After that, the dose was increased up to a maximum dose of 2000 mg for the next two weeks and maintained at 2000 mg until Week 16. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cardiac failure chronic | Cardiac disorders | MedDRA (18.1) | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Thrombocytosis | Blood and lymphatic system disorders | MedDRA (18.1) | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Merck KGaA Communication Center | Merck Healthcare, a business of Merck KGaA, Darmstadt, Germany | +49-6151-72-5200 | service@merckgroup.com |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D008687 | Metformin |
| ID | Term |
|---|---|
| D001645 | Biguanides |
| D006146 | Guanidines |
| D000578 | Amidines |
| D009930 | Organic Chemicals |
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|
|
| Metformin XR | Drug | Subjects will receive Metformin Extended Release (XR) tablets, orally once daily at a dose of 500 mg for 1 week, and then dose will increase with increments of 500 mg every week in first 2 weeks to 1500 mg. After that dose will increase up to maximum dose of 2000 mg for the next 2 weeks and will be maintained at 2000 mg until Week 16. |
|
|
| Baseline up to Week 16 |
| Change From Baseline in Fasting Plasma Glucose (FPG) Level at Week 1, 2, 4, 8, 12 and 16 | Baseline, Week 1, 2, 4, 8, 12,16 |
| Change From Baseline in 2-Hour Postprandial Plasma Glucose (PPG) Level at Weeks 8 and 16 | The 2-hour Postprandial plasma glucose (PPG) level refers to the plasma glucose concentrations after 2 hours of eating. | Baseline, Week 8 and 16 |
| Percentage of Subjects With Hypoglycemia | Hypoglycemia, also called as low blood glucose or low blood sugar, is defined as the blood glucose level of less than normal (that is less than 3.9 millimole per liter [mmol/L]). | Baseline up to Week 16 |
| Percentage of Subjects With Marked Hyperglycemia | Marked hyperglycemia was defined as the FPG level of greater than or equal to 11.1 mmol/L. | Baseline up to Week 16 |
| Percentage of Subjects With HbA1c Less Than (<) 7% | Baseline up to Week 16 |
| Percentage of Subjects Who Are Totally Intolerant to the Treatment | Subjects were considered to be totally intolerant if they experienced a Grade 3 or higher toxicity considered at least possibly related to the treatment. | Baseline up to Week 16 |
| Percentage of Subjects With HbA1c Less Than (<) 7% and With no Severe Gastrointestinal (GI) and Other Adverse Events (AEs) | Percentage of subjects with HbA1c <7% and with no severe GI and other AEs were reported. Severe adverse events were based on Common Terminology Criteria for Adverse Events (CTCAE), version 4.0 and were defined as those events which were medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self-care activities of daily living (ADL). Self-care ADL refer to bathing, dressing and undressing, feeding self, using the toilet, taking medications, and not bedridden. | Baseline up to Week 16 |
| Percentage of Subjects Who Are Compliant to Treatment | Compliance was defined as not skipping or forgetting dosing or not delaying the dosing time. Subjects who never missed a dose of medication were considered compliant. | Baseline up to Week 16 |
| Protocol Violation |
|
| Lack of Efficacy |
|
| Withdrawal by Subject |
|
| Other |
|
| BG001 |
| Metformin XR |
Subjects received Metformin XR tablets, orally QD at a dose of 500 mg for 1 week, and then the dose was increased with increments of 500 mg every week in the first 2 weeks to 1500 mg. After that, the dose was increased up to a maximum dose of 2000 mg for next 2 weeks and maintained at 2000 mg until Week 16. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Gender | Count of Participants | Participants |
|
| Metformin XR |
Subjects received Metformin XR tablets, orally QD at a dose of 500 mg for 1 week, and then the dose was increased with increments of 500 mg every week in the first 2 weeks to 1500 mg. After that, the dose was increased up to a maximum dose of 2000 mg for next 2 weeks and maintained at 2000 mg until Week 16. |
|
|
|
| Primary | Overall Gastrointestinal (GI) Tolerability Assessed as Percentage of Subjects With Gastrointestinal Adverse Events During Treatment Period | An adverse event (AE) was defined as any untoward medical occurrence in a subject which does not necessarily have a causal relationship with the treatment. An AE was any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with use of a medicinal product, whether or not considered related to the medicinal product. | The safety population included all subjects who received at least 1 dose of trial treatment. | Posted | Number | 95% Confidence Interval | percentage of subjects | Baseline up to Week 16 |
|
|
|
|
| Secondary | Percentage of Subjects With Pre-specified Gastrointestinal Adverse Events During Treatment Period | An adverse event (AE) was defined as any untoward medical occurrence in a subject which does not necessarily have a causal relationship with the treatment. An AE was any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with use of a medicinal product, whether or not considered related to the medicinal product. Number of subjects with pre-specified gastrointestinal adverse events (diarrhea, nausea, abdominal pain, bloating, constipation, dyspepsia and flatulence) were reported. | The safety population included all subjects who received at least 1 dose of trial treatment. | Posted | Number | 95% Confidence Interval | percentage of subjects | Baseline up to Week 16 |
|
|
|
| Secondary | Change From Baseline in Fasting Plasma Glucose (FPG) Level at Week 1, 2, 4, 8, 12 and 16 | ITT population included all subjects who were randomly allocated to a treatment based on the intention to treat. Here "Number of Participants Analyzed" signifies those subjects who were evaluable for this outcome measure. Here "n" signifies those subjects who were evaluable for the specified time points for each arm, respectively. | Posted | Mean | Standard Deviation | Millimole Per Liter (mmol/L) | Baseline, Week 1, 2, 4, 8, 12,16 |
|
|
|
| Secondary | Change From Baseline in 2-Hour Postprandial Plasma Glucose (PPG) Level at Weeks 8 and 16 | The 2-hour Postprandial plasma glucose (PPG) level refers to the plasma glucose concentrations after 2 hours of eating. | ITT population included all subjects who were randomly allocated to a treatment based on the intention to treat. Here "Number of Participants Analyzed" signifies those subjects who were evaluable for this outcome measure. Here "n" signifies those subjects who were evaluable for the specified time points for each arm, respectively. | Posted | Mean | Standard Deviation | mmol/L | Baseline, Week 8 and 16 |
|
|
|
| Secondary | Percentage of Subjects With Hypoglycemia | Hypoglycemia, also called as low blood glucose or low blood sugar, is defined as the blood glucose level of less than normal (that is less than 3.9 millimole per liter [mmol/L]). | The safety population included all subjects who received at least 1 dose of trial treatment. | Posted | Number | 95% Confidence Interval | percentage of subjects | Baseline up to Week 16 |
|
|
|
| Secondary | Percentage of Subjects With Marked Hyperglycemia | Marked hyperglycemia was defined as the FPG level of greater than or equal to 11.1 mmol/L. | ITT population included all subjects who were randomly allocated to a treatment based on the intention to treat. | Posted | Number | 95% Confidence Interval | percentage of subjects | Baseline up to Week 16 |
|
|
|
| Secondary | Percentage of Subjects With HbA1c Less Than (<) 7% | ITT population included all subjects who were randomly allocated to a treatment based on the intention to treat. | Posted | Number | 95% Confidence Interval | percentage of subjects | Baseline up to Week 16 |
|
|
|
| Secondary | Percentage of Subjects Who Are Totally Intolerant to the Treatment | Subjects were considered to be totally intolerant if they experienced a Grade 3 or higher toxicity considered at least possibly related to the treatment. | The safety population included all subjects who received at least 1 dose of trial treatment. | Posted | Number | 95% Confidence Interval | percentage of subjects | Baseline up to Week 16 |
|
|
|
| Secondary | Percentage of Subjects With HbA1c Less Than (<) 7% and With no Severe Gastrointestinal (GI) and Other Adverse Events (AEs) | Percentage of subjects with HbA1c <7% and with no severe GI and other AEs were reported. Severe adverse events were based on Common Terminology Criteria for Adverse Events (CTCAE), version 4.0 and were defined as those events which were medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self-care activities of daily living (ADL). Self-care ADL refer to bathing, dressing and undressing, feeding self, using the toilet, taking medications, and not bedridden. | ITT population included all subjects who were randomly allocated to a treatment based on the intention to treat. | Posted | Number | 95% Confidence Interval | percentage of subjects | Baseline up to Week 16 |
|
|
|
| Secondary | Percentage of Subjects Who Are Compliant to Treatment | Compliance was defined as not skipping or forgetting dosing or not delaying the dosing time. Subjects who never missed a dose of medication were considered compliant. | The safety population included all subjects who received at least 1 dose of trial treatment. | Posted | Number | percentage of subjects | Baseline up to Week 16 |
|
|
|
| 6 |
| 249 |
| 96 |
| 249 |
| EG001 | Metformin XR | Subjects received Metformin XR tablets, orally QD at a dose of 500 mg for 1 week, and then the dose was increased with increments of 500 mg every week in the first 2 weeks to 1500 mg. After that, the dose was increased up to a maximum dose of 2000 mg for next 2 weeks and maintained at 2000 mg until Week 16. | 2 | 264 | 136 | 264 |
| EG002 | Metformin IR to XR | Subjects who received Metformin IR tablets initially, but were shifted to Metformin XR group due to intolerance to Metformin IR. | 0 | 12 | 12 | 12 |
| Retinal detachment | Eye disorders | MedDRA (18.1) | Non-systematic Assessment |
|
| Liver injury | Hepatobiliary disorders | MedDRA (18.1) | Non-systematic Assessment |
|
| Foot fracture | Injury, poisoning and procedural complications | MedDRA (18.1) | Non-systematic Assessment |
|
| Blood glucose increased | Investigations | MedDRA (18.1) | Non-systematic Assessment |
|
| Blood ketone body increased | Investigations | MedDRA (18.1) | Non-systematic Assessment |
|
| Adrenal adenoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (18.1) | Non-systematic Assessment |
|
| Brain neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (18.1) | Non-systematic Assessment |
|
| Haemangioma of liver | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (18.1) | Non-systematic Assessment |
|
| Angina pectoris | Cardiac disorders | MedDRA (18.1) | Non-systematic Assessment |
|
| Cardiac Discomfort | Cardiac disorders | MedDRA (18.1) | Non-systematic Assessment |
|
| Palpitations | Cardiac disorders | MedDRA (18.1) | Non-systematic Assessment |
|
| Right Ventricular Hypertrophy | Cardiac disorders | MedDRA (18.1) | Non-systematic Assessment |
|
| Sinus bradycardia | Cardiac disorders | MedDRA (18.1) | Non-systematic Assessment |
|
| Tachycardia | Cardiac disorders | MedDRA (18.1) | Non-systematic Assessment |
|
| Inner Ear Disorder | Ear and labyrinth disorders | MedDRA (18.1) | Non-systematic Assessment |
|
| Thyroiditis | Endocrine disorders | MedDRA (18.1) | Non-systematic Assessment |
|
| Cataract | Eye disorders | MedDRA (18.1) | Non-systematic Assessment |
|
| Eye Ulcer | Eye disorders | MedDRA (18.1) | Non-systematic Assessment |
|
| Visual Acuity Reduced | Eye disorders | MedDRA (18.1) | Non-systematic Assessment |
|
| Abdominal Discomfort | Gastrointestinal disorders | MedDRA (18.1) | Non-systematic Assessment |
|
| Abdominal Distension | Gastrointestinal disorders | MedDRA (18.1) | Non-systematic Assessment |
|
| Abdominal Pain | Gastrointestinal disorders | MedDRA (18.1) | Non-systematic Assessment |
|
| Abdominal Pain Upper | Gastrointestinal disorders | MedDRA (18.1) | Non-systematic Assessment |
|
| Abnormal Faeces | Gastrointestinal disorders | MedDRA (18.1) | Non-systematic Assessment |
|
| Bowel Movement Irregularity | Gastrointestinal disorders | MedDRA (18.1) | Non-systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA (18.1) | Non-systematic Assessment |
|
| Defaecation urgency | Gastrointestinal disorders | MedDRA (18.1) | Non-systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA (18.1) | Non-systematic Assessment |
|
| Dry mouth | Gastrointestinal disorders | MedDRA (18.1) | Non-systematic Assessment |
|
| Dyspepsia | Gastrointestinal disorders | MedDRA (18.1) | Non-systematic Assessment |
|
| Eructation | Gastrointestinal disorders | MedDRA (18.1) | Non-systematic Assessment |
|
| Faeces Discoloured | Gastrointestinal disorders | MedDRA (18.1) | Non-systematic Assessment |
|
| Faeces Hard | Gastrointestinal disorders | MedDRA (18.1) | Non-systematic Assessment |
|
| Flatulence | Gastrointestinal disorders | MedDRA (18.1) | Non-systematic Assessment |
|
| Food Poisoning | Gastrointestinal disorders | MedDRA (18.1) | Non-systematic Assessment |
|
| Frequent Bowel Movements | Gastrointestinal disorders | MedDRA (18.1) | Non-systematic Assessment |
|
| Gastritis | Gastrointestinal disorders | MedDRA (18.1) | Non-systematic Assessment |
|
| Gastrooesophageal Reflux Disease | Gastrointestinal disorders | MedDRA (18.1) | Non-systematic Assessment |
|
| Haemorrhoids | Gastrointestinal disorders | MedDRA (18.1) | Non-systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA (18.1) | Non-systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA (18.1) | Non-systematic Assessment |
|
| Asthenia | General disorders | MedDRA (18.1) | Non-systematic Assessment |
|
| Chest Disconfort | General disorders | MedDRA (18.1) | Non-systematic Assessment |
|
| Chest pain | General disorders | MedDRA (18.1) | Non-systematic Assessment |
|
| Fatigue | General disorders | MedDRA (18.1) | Non-systematic Assessment |
|
| Hangover | General disorders | MedDRA (18.1) | Non-systematic Assessment |
|
| Non-Cardiac Chest Pain | General disorders | MedDRA (18.1) | Non-systematic Assessment |
|
| Oedema Peripheral | General disorders | MedDRA (18.1) | Non-systematic Assessment |
|
| Pyrexia | General disorders | MedDRA (18.1) | Non-systematic Assessment |
|
| Cholecystitis Chronic | Hepatobiliary disorders | MedDRA (18.1) | Non-systematic Assessment |
|
| Cholelithiasis | Hepatobiliary disorders | MedDRA (18.1) | Non-systematic Assessment |
|
| Hepatic Function Abnormal | Hepatobiliary disorders | MedDRA (18.1) | Non-systematic Assessment |
|
| Hepatic Steatosis | Hepatobiliary disorders | MedDRA (18.1) | Non-systematic Assessment |
|
| Periphatic Discomfort | Hepatobiliary disorders | MedDRA (18.1) | Non-systematic Assessment |
|
| Drug Hypersensitivity | Immune system disorders | MedDRA (18.1) | Non-systematic Assessment |
|
| Hypersensitivity | Immune system disorders | MedDRA (18.1) | Non-systematic Assessment |
|
| Chronic Hepatitis B | Infections and infestations | MedDRA (18.1) | Non-systematic Assessment |
|
| Gastroenteritis | Infections and infestations | MedDRA (18.1) | Non-systematic Assessment |
|
| Herpes Zoster | Infections and infestations | MedDRA (18.1) | Non-systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA (18.1) | Non-systematic Assessment |
|
| Upper Respiratory Tract Infection | Infections and infestations | MedDRA (18.1) | Non-systematic Assessment |
|
| Urinary tract Infection | Infections and infestations | MedDRA (18.1) | Non-systematic Assessment |
|
| Muscle Injury | Injury, poisoning and procedural complications | MedDRA (18.1) | Non-systematic Assessment |
|
| Muscle Strain | Injury, poisoning and procedural complications | MedDRA (18.1) | Non-systematic Assessment |
|
| Alanine Aminotransferase Increased | Investigations | MedDRA (18.1) | Non-systematic Assessment |
|
| Aspartate Aminotransferase Increased | Investigations | MedDRA (18.1) | Non-systematic Assessment |
|
| Blood Bilirubin increased | Investigations | MedDRA (18.1) | Non-systematic Assessment |
|
| Blood Glucose Decreased | Investigations | MedDRA (18.1) | Non-systematic Assessment |
|
| Blood Potassium Decreased | Investigations | MedDRA (18.1) | Non-systematic Assessment |
|
| Blood Potassium Increased | Investigations | MedDRA (18.1) | Non-systematic Assessment |
|
| Blood pressure Decreased | Investigations | MedDRA (18.1) | Non-systematic Assessment |
|
| Blood Sodium Increased | Investigations | MedDRA (18.1) | Non-systematic Assessment |
|
| Blood Triglycerides Increased | Investigations | MedDRA (18.1) | Non-systematic Assessment |
|
| Blood uric Acid Increased | Investigations | MedDRA (18.1) | Non-systematic Assessment |
|
| Electrocardiogram Abnormal | Investigations | MedDRA (18.1) | Non-systematic Assessment |
|
| Electrocardiogram ST Segment Depression | Investigations | MedDRA (18.1) | Non-systematic Assessment |
|
| Electrocardiogram ST Segment Elevation | Investigations | MedDRA (18.1) | Non-systematic Assessment |
|
| Electrocardiogram T Wave Abnormal | Investigations | MedDRA (18.1) | Non-systematic Assessment |
|
| Electrocardiogram T Wave Amplitude Decreased | Investigations | MedDRA (18.1) | Non-systematic Assessment |
|
| Gastric PH Decreased | Investigations | MedDRA (18.1) | Non-systematic Assessment |
|
| Liver Function Test Abnormal | Investigations | MedDRA (18.1) | Non-systematic Assessment |
|
| Low Density Lipoprotein Increased | Investigations | MedDRA (18.1) | Non-systematic Assessment |
|
| Platelet Count Decreased | Investigations | MedDRA (18.1) | Non-systematic Assessment |
|
| Protein Urine Present | Investigations | MedDRA (18.1) | Non-systematic Assessment |
|
| Urine Ketone Body Present | Investigations | MedDRA (18.1) | Non-systematic Assessment |
|
| Weight Decreased | Investigations | MedDRA (18.1) | Non-systematic Assessment |
|
| White Blood Cell Count Decreased | Investigations | MedDRA (18.1) | Non-systematic Assessment |
|
| White Blood Cell Count Increased | Investigations | MedDRA (18.1) | Non-systematic Assessment |
|
| Decreased Appetite | Metabolism and nutrition disorders | MedDRA (18.1) | Non-systematic Assessment |
|
| Dyslipidaemia | Metabolism and nutrition disorders | MedDRA (18.1) | Non-systematic Assessment |
|
| Electrolyte Imbalance | Metabolism and nutrition disorders | MedDRA (18.1) | Non-systematic Assessment |
|
| Hyperlipidaemia | Metabolism and nutrition disorders | MedDRA (18.1) | Non-systematic Assessment |
|
| Hyperuricaemia | Metabolism and nutrition disorders | MedDRA (18.1) | Non-systematic Assessment |
|
| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA (18.1) | Non-systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (18.1) | Non-systematic Assessment |
|
| Muscular Weakness | Musculoskeletal and connective tissue disorders | MedDRA (18.1) | Non-systematic Assessment |
|
| Musculoskeletal Pain | Musculoskeletal and connective tissue disorders | MedDRA (18.1) | Non-systematic Assessment |
|
| Pain in Extremity | Musculoskeletal and connective tissue disorders | MedDRA (18.1) | Non-systematic Assessment |
|
| Periarthritis | Musculoskeletal and connective tissue disorders | MedDRA (18.1) | Non-systematic Assessment |
|
| Spinal Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA (18.1) | Non-systematic Assessment |
|
| Cerebral Ischaemia | Nervous system disorders | MedDRA (18.1) | Non-systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA (18.1) | Non-systematic Assessment |
|
| Dysgeusia | Nervous system disorders | MedDRA (18.1) | Non-systematic Assessment |
|
| Head Discomfort | Nervous system disorders | MedDRA (18.1) | Non-systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA (18.1) | Non-systematic Assessment |
|
| Paraesthesia | Nervous system disorders | MedDRA (18.1) | Non-systematic Assessment |
|
| Initial Insomnia | Psychiatric disorders | MedDRA (18.1) | Non-systematic Assessment |
|
| Libido Decreased | Psychiatric disorders | MedDRA (18.1) | Non-systematic Assessment |
|
| Listless | Psychiatric disorders | MedDRA (18.1) | Non-systematic Assessment |
|
| Nephrolithiasis | Renal and urinary disorders | MedDRA (18.1) | Non-systematic Assessment |
|
| Renal Cyst | Renal and urinary disorders | MedDRA (18.1) | Non-systematic Assessment |
|
| Renal Impairment | Renal and urinary disorders | MedDRA (18.1) | Non-systematic Assessment |
|
| Benign Prostatic Hyperplasia | Reproductive system and breast disorders | MedDRA (18.1) | Non-systematic Assessment |
|
| Prostatic Calcification | Reproductive system and breast disorders | MedDRA (18.1) | Non-systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (18.1) | Non-systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (18.1) | Non-systematic Assessment |
|
| Hiccups | Respiratory, thoracic and mediastinal disorders | MedDRA (18.1) | Non-systematic Assessment |
|
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA (18.1) | Non-systematic Assessment |
|
| Erythema | Skin and subcutaneous tissue disorders | MedDRA (18.1) | Non-systematic Assessment |
|
| Generalized Erythema | Skin and subcutaneous tissue disorders | MedDRA (18.1) | Non-systematic Assessment |
|
| Hyperhidrosis | Skin and subcutaneous tissue disorders | MedDRA (18.1) | Non-systematic Assessment |
|
| Pigmentation Disorder | Skin and subcutaneous tissue disorders | MedDRA (18.1) | Non-systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA (18.1) | Non-systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA (18.1) | Non-systematic Assessment |
|
Not provided
Not provided
| D004700 | Endocrine System Diseases |
| Nausea |
|
| Abdominal Pain |
|
| Constipation |
|
| Dyspepsia |
|
| Flatulence |
|
| Change at Week 2 (n= 243, 244) |
|
| Change at Week 4 (n= 240, 239) |
|
| Change at Week 8 (n= 219, 230) |
|
| Change at Week 12 (n= 216, 221) |
|
| Change at Week 16 (n= 214, 218) |
|
| Change at Week 16 (n= 213, 215) |
|