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The purpose of this study is to assess the weight loss effect of lorcaserin during and at the end of 1 year of treatment in overweight and obese patients with Type II diabetes mellitus treated with metformin, sulfonylurea (SFU), or either agent in combination with other oral hypoglycemic agents.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lorcaserin 10 mg QD | Experimental | Lorcaserin 10 mg tablet each morning and placebo tablet each evening |
|
| Lorcaserin 10 mg BID | Experimental | Lorcaserin 10 mg tablet each morning and evening |
|
| Matching Placebo | Placebo Comparator | Matching placebo tablet each morning and evening |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lorcaserin 10 mg once daily (QD) | Drug | Lorcaserin 10 mg tablet each morning and placebo tablet each evening for a duration of 52 weeks. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Co-primary Endpoint- Percentage of Participants Achieving Greater Than or Equal to 5% Weight Loss From Baseline to Week 52 | The percentage of patients with a reduction from baseline body weight of 5% or more after 52 weeks. | Baseline and Week 52 |
| Measure | Description | Time Frame |
|---|---|---|
| Percent Change in Body Weight From Baseline to Week 52 | The percent change in body weight (kg) from baseline to week 52. | Baseline and Week 52 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Arena Pharmaceuticals, Inc. | San Diego | California | 92121 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28345809 | Derived | Magkos F, Nikonova E, Fain R, Zhou S, Ma T, Shanahan W. Effect of lorcaserin on glycemic parameters in patients with type 2 diabetes mellitus. Obesity (Silver Spring). 2017 May;25(5):842-849. doi: 10.1002/oby.21798. Epub 2017 Mar 27. | |
| 27888609 | Derived | Weissman NJ, Smith SR, Fain R, Hall N, Shanahan WR. Effects of lorcaserin on pre-existing valvulopathy: A pooled analysis of phase 3 trials. Obesity (Silver Spring). 2017 Jan;25(1):39-44. doi: 10.1002/oby.21695. Epub 2016 Nov 26. |
| Label | URL |
|---|---|
| Arena Pharmaceuticals, Inc. Home Page | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Lorcaserin 10 mg Once Daily (QD) | lorcaserin 10 mg QD tablets |
| FG001 | Lorcaserin 10 mg Twice a Day (BID) | lorcaserin 10 mg BID tablets |
| FG002 | Matching Placebo | matching placebo tablets |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Lorcaserin 10 mg QD | lorcaserin 10 mg QD tablets |
| BG001 | Lorcaserin 10 mg BID | lorcaserin 10 mg BID tablets |
| 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 | Co-primary Endpoint- Percentage of Participants Achieving Greater Than or Equal to 5% Weight Loss From Baseline to Week 52 | The percentage of patients with a reduction from baseline body weight of 5% or more after 52 weeks. | Modified Intent to Treat (MITT) with last observation carried forward (LOCF) | Posted | Number | percentage of participants | Baseline and Week 52 |
|
52 weeks
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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 | Lorcaserin 10 mg BID | lorcaserin 10 mg BID tablets |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Uterine leiomyoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (10.1) | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea | Gastrointestinal disorders | MedDRA (10.1) | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Eisai Medical Information | Eisai Inc. | +1-888-274-2378 | esi_medinfo@eisai.com |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| D015431 | Weight Loss |
| D006973 | Hypertension |
| D050171 | Dyslipidemias |
| D012891 | Sleep Apnea Syndromes |
| D002318 | Cardiovascular Diseases |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| C506658 | lorcaserin |
| C494814 | BID protein, human |
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| Lorcaserin 10 mg twice a day (BID) | Drug | Lorcaserin 10 mg tablet each morning and evening for a duration of 52 weeks. |
|
|
| Matching Placebo | Drug | Matching placebo tablet each morning and evening for a duration of 52 weeks. |
|
| 27659698 | Derived | Handelsman Y, Fain R, Wang Z, Li X, Fujioka K, Shanahan W. Lorcaserin treatment allows for decreased number needed to treat for weight and glycemic parameters in week 12 responders with >/=5% weight loss. Postgrad Med. 2016 Nov;128(8):740-746. doi: 10.1080/00325481.2016.1240591. Epub 2016 Oct 19. |
| 27389084 | Derived | Pi-Sunyer X, Shanahan W, Fain R, Ma T, Garvey WT. Impact of lorcaserin on glycemic control in overweight and obese patients with type 2 diabetes: analysis of week 52 responders and nonresponders. Postgrad Med. 2016 Aug;128(6):591-7. doi: 10.1080/00325481.2016.1208618. Epub 2016 Jul 18. |
| 27206567 | Derived | Nguyen CT, Zhou S, Shanahan W, Fain R. Lorcaserin in Obese and Overweight Patients Taking Prohibited Serotonergic Agents: A Retrospective Analysis. Clin Ther. 2016 Jun;38(6):1498-1509. doi: 10.1016/j.clinthera.2016.04.004. Epub 2016 May 17. |
| 23661689 | Derived | Weissman NJ, Sanchez M, Koch GG, Smith SR, Shanahan WR, Anderson CM. Echocardiographic assessment of cardiac valvular regurgitation with lorcaserin from analysis of 3 phase 3 clinical trials. Circ Cardiovasc Imaging. 2013 Jul;6(4):560-7. doi: 10.1161/CIRCIMAGING.112.000128. Epub 2013 May 9. |
| 22421927 | Derived | O'Neil PM, Smith SR, Weissman NJ, Fidler MC, Sanchez M, Zhang J, Raether B, Anderson CM, Shanahan WR. Randomized placebo-controlled clinical trial of lorcaserin for weight loss in type 2 diabetes mellitus: the BLOOM-DM study. Obesity (Silver Spring). 2012 Jul;20(7):1426-36. doi: 10.1038/oby.2012.66. Epub 2012 Mar 16. |
| BG002 |
| Matching Placebo |
matching placebo tablets |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Matching Placebo |
matching placebo tablets |
|
|
|
| Secondary | Percent Change in Body Weight From Baseline to Week 52 | The percent change in body weight (kg) from baseline to week 52. | MITT with LOCF | Posted | Least Squares Mean | Standard Error | % change from baseline: body wt (kg) | Baseline and Week 52 |
|
|
|
|
| 16 |
| 256 |
| 236 |
| 256 |
| EG001 | Lorcaserin 10 mg QD | lorcaserin 10 mg QD tablets | 8 | 95 | 89 | 95 |
| EG002 | Matching Placebo | matching placebo tablets | 17 | 252 | 213 | 252 |
| Thymoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (10.1) | Non-systematic Assessment |
|
| Abdominal abscess | Infections and infestations | MedDRA (10.1) | Non-systematic Assessment |
|
| Non-cardiac chest pain | General disorders | MedDRA (10.1) | Non-systematic Assessment |
|
| Coronary artery occlusion | Cardiac disorders | MedDRA (10.1) | Non-systematic Assessment |
|
| Hypotension | Vascular disorders | MedDRA (10.1) | Non-systematic Assessment |
|
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA (10.1) | Non-systematic Assessment |
|
| Gastroenteritis | Infections and infestations | MedDRA (10.1) | Non-systematic Assessment |
|
| Conversion disorder | Psychiatric disorders | MedDRA (10.1) | Non-systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (10.1) | Non-systematic Assessment |
|
| Intervertebral disc protrusion | Musculoskeletal and connective tissue disorders | MedDRA (10.1) | Non-systematic Assessment |
|
| Anaphylactic shock | Immune system disorders | MedDRA (10.1) | Non-systematic Assessment |
|
| Dehydration | Metabolism and nutrition disorders | MedDRA (10.1) | Non-systematic Assessment |
|
| Cholecystitis | Hepatobiliary disorders | MedDRA (10.1) | Non-systematic Assessment |
|
| Adverse drug reaction | General disorders | MedDRA (10.1) | Non-systematic Assessment |
|
| Coronary artery disease | Cardiac disorders | MedDRA (10.1) | Non-systematic Assessment |
|
| Infected skin ulcer | Infections and infestations | MedDRA (10.1) | Non-systematic Assessment |
|
| Anaemia | Blood and lymphatic system disorders | MedDRA (10.1) | Non-systematic Assessment |
|
| Prostate cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (10.1) | Non-systematic Assessment |
|
| Angina pectoris | Cardiac disorders | MedDRA (10.1) | Non-systematic Assessment |
|
| Depression | Psychiatric disorders | MedDRA (10.1) | Non-systematic Assessment |
|
| Cerebrovascular accident | Nervous system disorders | MedDRA (10.1) | Non-systematic Assessment |
|
| Phlebitis | Vascular disorders | MedDRA (10.1) | Non-systematic Assessment |
|
| Chest pain | General disorders | MedDRA (10.1) | Non-systematic Assessment |
|
| Nephrolithiasis | Renal and urinary disorders | MedDRA (10.1) | Non-systematic Assessment |
|
| Convulsion | Nervous system disorders | MedDRA (10.1) | Non-systematic Assessment |
|
| Hypersensitivity | Immune system disorders | MedDRA (10.1) | Non-systematic Assessment |
|
| Myocardial infarction | Cardiac disorders | MedDRA (10.1) | Non-systematic Assessment |
|
| Cellulitis of male external genital organ | Infections and infestations | MedDRA (10.1) | Non-systematic Assessment |
|
| Urethral cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (10.1) | Non-systematic Assessment |
|
| Spinal column stenosis | Musculoskeletal and connective tissue disorders | MedDRA (10.1) | Non-systematic Assessment |
|
| Atrial fibrillation | Cardiac disorders | MedDRA (10.1) | Non-systematic Assessment |
|
| Cellulitis | Infections and infestations | MedDRA (10.1) | Non-systematic Assessment |
|
| Gastrointestinal ulcer haemorrhage | Gastrointestinal disorders | MedDRA (10.1) | Non-systematic Assessment |
|
| Oesophageal carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (10.1) | Non-systematic Assessment |
|
| Endometrial cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (10.1) | Non-systematic Assessment |
|
| Colitis | Gastrointestinal disorders | MedDRA (10.1) | Non-systematic Assessment |
|
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA (10.1) | Non-systematic Assessment |
|
| Acute prerenal failure | Renal and urinary disorders | MedDRA (10.1) | Non-systematic Assessment |
|
| Pancreatitis acute | Gastrointestinal disorders | MedDRA (10.1) | Non-systematic Assessment |
|
| Bursitis infective | Infections and infestations | MedDRA (10.1) | Non-systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA (10.1) | Non-systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA (10.1) | Non-systematic Assessment |
|
| Fatigue | General disorders | MedDRA (10.1) | Non-systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA (10.1) | Non-systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA (10.1) | Non-systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA (10.1) | Non-systematic Assessment |
|
| Gastroenteritis viral | Infections and infestations | MedDRA (10.1) | Non-systematic Assessment |
|
| Influenza | Infections and infestations | MedDRA (10.1) | Non-systematic Assessment |
|
| Sinusitis | Infections and infestations | MedDRA (10.1) | Non-systematic Assessment |
|
| Bronchitis | Infections and infestations | MedDRA (10.1) | Non-systematic Assessment |
|
| Gastroenteritis | Infections and infestations | MedDRA (10.1) | Non-systematic Assessment |
|
| Procedural pain | Injury, poisoning and procedural complications | MedDRA (10.1) | Non-systematic Assessment |
|
| Hypoglycemia | Metabolism and nutrition disorders | MedDRA (10.1) | Non-systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (10.1) | Non-systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA (10.1) | Non-systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA (10.1) | Non-systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA (10.1) | Non-systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (10.1) | Non-systematic Assessment |
|
| Sinus congestion | Respiratory, thoracic and mediastinal disorders | MedDRA (10.1) | Non-systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA (10.1) | Non-systematic Assessment |
|
| Depression | Psychiatric disorders | MedDRA (10.1) | Non-systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (10.1) | Non-systematic Assessment |
|
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| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001836 | Body Weight Changes |
| D014652 | Vascular Diseases |
| D052439 | Lipid Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D001049 | Apnea |
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |