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| ID | Type | Description | Link |
|---|---|---|---|
| 28431754DIA4032 | Other Identifier | Johnson & Johnson Private Limited |
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The purpose of this study is to assess safety of canagliflozin + metformin hydrochloride immediate Release (IR) fixed-dose combination.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Canagliflozin + Metformin Hydrochloride Immediate Release (IR) | Experimental | Participants will receive canagliflozin + metformin hydrochloride IR fixed-dose combination, 50 milligram (mg) + 500 mg or 50 mg + 1000 mg, will be provided as tablets for oral administration. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Canagliflozin + Metformin hydrochloride (Fixed Dose Combination) | Drug | Participants will receive canagliflozin + metformin hydrochloride IR fixed-dose combination, 50 milligram (mg) + 500 mg or 50 mg + 1000 mg, will be provided as tablets for oral administration. The study Treatment duration will be of 24 weeks. |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs) | An adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Serious adverse event (SAE) was any untoward medical occurrence that at any dose resulted in death, was life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, was a suspected transmission of any infectious agent via a medicinal product. TEAEs were defined as events that started on or after the study medication start date and time. | Baseline (Day 1) up to 24 weeks |
| Percentage of Participants With Unexpected Adverse Events (AEs) | An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An adverse event was considered unexpected if the nature or severity was not consistent with the applicable product reference safety information. | Baseline (Day 1) up to 24 weeks |
| Percentage of Participants With Adverse Drug Reactions (ADRs) | ADRs were defined as the treatment related TEAEs. Treatment-related AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. TEAEs were defined as events that started on or after the study medication start date and time. | Baseline (Day 1) up to 24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Percent Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Weeks 12 and 24 | Percent change from baseline in HbA1c at Weeks 12 and 24 was reported. | Baseline, Weeks 12 and 24 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Johnson & Johnson Private Limited Clinical Trial | Johnson & Johnson Private Limited | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Lifecare Hospital and Research Centre | Bengaluru | 560092 | India | |||
| Post Graduate Institute of Medical Education And Research PGIMER |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39971605 | Derived | LaRoche JK, Lanier J, Alvarenga R, Collins M, Costelloe T, Chiau A, Whetherly H, De Soete W, Faludi J, Rens K. Climate footprint of industry-sponsored in-human clinical trials: life cycle assessments of clinical trials spanning multiple phases and disease areas. BMJ Open. 2025 Feb 19;15(2):e085364. doi: 10.1136/bmjopen-2024-085364. |
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The data sharing policy of the Janssen Pharmaceutical Companies of Johnson & Johnson is available at www.janssen.com/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu
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| ID | Title | Description |
|---|---|---|
| FG000 | Canagliflozin + Metformin Hydrochloride FDC | Participants received either (canagliflozin 50 milligram [mg] + metformin hydrochloride 500 mg) or (canagliflozin 50 mg + metformin hydrochloride 1000 mg) immediate release (IR) fixed-dose combination (FDC) tablets twice daily (BD) up to Week 24. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Feb 4, 2021 | Jul 25, 2023 |
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|
| Chandigarh |
| 160012 |
| India |
| Kovai Diabetes Specialty Centre & Hospital | Coimbatore | 641 009 | India |
| Excelcare Hospitals (A unit of Asclepius Hospitals and Health Care Pvt. Ltd.) | Guwahati | 781033 | India |
| Thumbay Hospital New life / Endocrinology | Hyderabad | 500024 | India |
| Fortis Hospital | Mohali | 160062 | India |
| Jehangir Clinical Development Center Pvt Ltd | Pune | 411001 | India |
| Chellaram Diabetes Institute | Pune | 411021 | India |
| Nirmal Hospital Pvt. Ltd. | Surat | 395002 | India |
| Jothydev's Diabetes Research Centre | Trivandrum | 695032 | India |
| Treated |
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| COMPLETED |
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| NOT COMPLETED |
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Safety analysis set included all participants who had taken at least 1 dose of study treatment.
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| ID | Title | Description |
|---|---|---|
| BG000 | Canagliflozin + Metformin Hydrochloride FDC | Participants received either (canagliflozin 50 milligram [mg] + metformin hydrochloride 500 mg) or (canagliflozin 50 mg + metformin hydrochloride 1000 mg) immediate release (IR) fixed-dose combination (FDC) tablets twice daily (BD) up to Week 24. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Race/Ethnicity, Customized | Count of Participants | Participants |
| ||||||||||||||||||
| Region of Enrollment | Count of Participants | Participants |
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| 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 | Percentage of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs) | An adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Serious adverse event (SAE) was any untoward medical occurrence that at any dose resulted in death, was life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, was a suspected transmission of any infectious agent via a medicinal product. TEAEs were defined as events that started on or after the study medication start date and time. | Safety analysis set included all participants who had taken at least 1 dose of study treatment. | Posted | Number | Percentage of participants | Baseline (Day 1) up to 24 weeks |
|
|
| |||||||||||||||||||||||||||||||||
| Primary | Percentage of Participants With Unexpected Adverse Events (AEs) | An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An adverse event was considered unexpected if the nature or severity was not consistent with the applicable product reference safety information. | Safety analysis set included all participants who had taken at least 1 dose of study treatment. | Posted | Number | Percentage of participants | Baseline (Day 1) up to 24 weeks |
|
| ||||||||||||||||||||||||||||||||||
| Secondary | Percent Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Weeks 12 and 24 | Percent change from baseline in HbA1c at Weeks 12 and 24 was reported. | Efficacy analysis set included all participants who had taken at least 1 dose of study treatment and had both baseline and at least 1 post-baseline efficacy assessment. Here, 'N' (number of participants analyzed) signifies number of participants evaluable for this outcome measure and 'n' (number analyzed) represents number of participants evaluable at the specified timepoints. | Posted | Mean | Standard Deviation | Percent change | Baseline, Weeks 12 and 24 |
|
| |||||||||||||||||||||||||||||||||
| Primary | Percentage of Participants With Adverse Drug Reactions (ADRs) | ADRs were defined as the treatment related TEAEs. Treatment-related AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. TEAEs were defined as events that started on or after the study medication start date and time. | Safety analysis set included all participants who had taken at least 1 dose of study treatment. | Posted | Number | Percentage of participants | Baseline (Day 1) up to 24 weeks |
|
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Baseline (Day 1) up to end of study (28 weeks)
Safety analysis set included all participants who had taken at least 1 dose of study 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 | Canagliflozin + Metformin Hydrochloride FDC | Participants received either (canagliflozin 50 milligram [mg] + metformin hydrochloride 500 mg) or (canagliflozin 50 mg + metformin hydrochloride 1000 mg) immediate release (IR) fixed-dose combination (FDC) tablets twice daily (BD) up to Week 24. | 0 | 274 | 3 | 274 | 114 | 274 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| COVID-19 | Infections and infestations | MedDRA Version 25.0 | Non-systematic Assessment |
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| Urinary Tract Infection | Infections and infestations | MedDRA Version 25.0 | Non-systematic Assessment |
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| Diabetic Ketoacidosis | Metabolism and nutrition disorders | MedDRA Version 25.0 | Non-systematic Assessment |
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| Prostatomegaly | Reproductive system and breast disorders | MedDRA Version 25.0 | Non-systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA Version 25.0 | Non-systematic Assessment |
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| Lymphopenia | Blood and lymphatic system disorders | MedDRA Version 25.0 | Non-systematic Assessment |
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| Palpitations | Cardiac disorders | MedDRA Version 25.0 | Non-systematic Assessment |
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| Sinus Bradycardia | Cardiac disorders | MedDRA Version 25.0 | Non-systematic Assessment |
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| Sinus Tachycardia | Cardiac disorders | MedDRA Version 25.0 | Non-systematic Assessment |
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| Hydrocele | Congenital, familial and genetic disorders | MedDRA Version 25.0 | Non-systematic Assessment |
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| Cataract | Eye disorders | MedDRA Version 25.0 | Non-systematic Assessment |
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| Diabetic Retinal Oedema | Eye disorders | MedDRA Version 25.0 | Non-systematic Assessment |
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| Constipation | Gastrointestinal disorders | MedDRA Version 25.0 | Non-systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | MedDRA Version 25.0 | Non-systematic Assessment |
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| Dyspepsia | Gastrointestinal disorders | MedDRA Version 25.0 | Non-systematic Assessment |
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| Frequent Bowel Movements | Gastrointestinal disorders | MedDRA Version 25.0 | Non-systematic Assessment |
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| Gastritis | Gastrointestinal disorders | MedDRA Version 25.0 | Non-systematic Assessment |
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| Hyperchlorhydria | Gastrointestinal disorders | MedDRA Version 25.0 | Non-systematic Assessment |
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| Stomatitis | Gastrointestinal disorders | MedDRA Version 25.0 | Non-systematic Assessment |
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| Toothache | Gastrointestinal disorders | MedDRA Version 25.0 | Non-systematic Assessment |
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| Asthenia | General disorders | MedDRA Version 25.0 | Non-systematic Assessment |
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| Chest Pain | General disorders | MedDRA Version 25.0 | Non-systematic Assessment |
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| Fatigue | General disorders | MedDRA Version 25.0 | Non-systematic Assessment |
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| Pain | General disorders | MedDRA Version 25.0 | Non-systematic Assessment |
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| Pyrexia | General disorders | MedDRA Version 25.0 | Non-systematic Assessment |
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| Bronchitis | Infections and infestations | MedDRA Version 25.0 | Non-systematic Assessment |
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| COVID-19 | Infections and infestations | MedDRA Version 25.0 | Non-systematic Assessment |
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| Carbuncle | Infections and infestations | MedDRA Version 25.0 | Non-systematic Assessment |
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| Dengue Fever | Infections and infestations | MedDRA Version 25.0 | Non-systematic Assessment |
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| Dysentery | Infections and infestations | MedDRA Version 25.0 | Non-systematic Assessment |
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| Fungal Infection | Infections and infestations | MedDRA Version 25.0 | Non-systematic Assessment |
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| Fungal Skin Infection | Infections and infestations | MedDRA Version 25.0 | Non-systematic Assessment |
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| Gastroenteritis | Infections and infestations | MedDRA Version 25.0 | Non-systematic Assessment |
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| Genital Infection | Infections and infestations | MedDRA Version 25.0 | Non-systematic Assessment |
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| Nasopharyngitis | Infections and infestations | MedDRA Version 25.0 | Non-systematic Assessment |
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| Orchitis | Infections and infestations | MedDRA Version 25.0 | Non-systematic Assessment |
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| Tinea Cruris | Infections and infestations | MedDRA Version 25.0 | Non-systematic Assessment |
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| Urinary Tract Infection | Infections and infestations | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Vaginal Infection | Infections and infestations | MedDRA Version 25.0 | Non-systematic Assessment |
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| Vulvovaginitis | Infections and infestations | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Limb Injury | Injury, poisoning and procedural complications | MedDRA Version 25.0 | Non-systematic Assessment |
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| Albumin Urine Present | Investigations | MedDRA Version 25.0 | Non-systematic Assessment |
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| Blood Creatinine Increased | Investigations | MedDRA Version 25.0 | Non-systematic Assessment |
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| Blood Pressure Increased | Investigations | MedDRA Version 25.0 | Non-systematic Assessment |
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| Blood Triglycerides Increased | Investigations | MedDRA Version 25.0 | Non-systematic Assessment |
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| Urine Albumin/Creatinine Ratio Increased | Investigations | MedDRA Version 25.0 | Non-systematic Assessment |
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| Weight Decreased | Investigations | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Decreased Appetite | Metabolism and nutrition disorders | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Diabetes Mellitus Inadequate Control | Metabolism and nutrition disorders | MedDRA Version 25.0 | Non-systematic Assessment |
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| Diabetic Ketoacidosis | Metabolism and nutrition disorders | MedDRA Version 25.0 | Non-systematic Assessment |
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| Dyslipidaemia | Metabolism and nutrition disorders | MedDRA Version 25.0 | Non-systematic Assessment |
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| Hyperlipidaemia | Metabolism and nutrition disorders | MedDRA Version 25.0 | Non-systematic Assessment |
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| Hypertriglyceridaemia | Metabolism and nutrition disorders | MedDRA Version 25.0 | Non-systematic Assessment |
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| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA Version 25.0 | Non-systematic Assessment |
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| Type 2 Diabetes Mellitus | Metabolism and nutrition disorders | MedDRA Version 25.0 | Non-systematic Assessment |
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| Vitamin B12 Deficiency | Metabolism and nutrition disorders | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA Version 25.0 | Non-systematic Assessment |
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| Back Pain | Musculoskeletal and connective tissue disorders | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Fibromyalgia | Musculoskeletal and connective tissue disorders | MedDRA Version 25.0 | Non-systematic Assessment |
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| Joint Swelling | Musculoskeletal and connective tissue disorders | MedDRA Version 25.0 | Non-systematic Assessment |
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| Muscle Spasms | Musculoskeletal and connective tissue disorders | MedDRA Version 25.0 | Non-systematic Assessment |
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| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Neck Pain | Musculoskeletal and connective tissue disorders | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Pain in Extremity | Musculoskeletal and connective tissue disorders | MedDRA Version 25.0 | Non-systematic Assessment |
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| Dizziness | Nervous system disorders | MedDRA Version 25.0 | Non-systematic Assessment |
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| Dizziness Exertional | Nervous system disorders | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Head Discomfort | Nervous system disorders | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Hypoaesthesia | Nervous system disorders | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Lethargy | Nervous system disorders | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Paraesthesia | Nervous system disorders | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Albuminuria | Renal and urinary disorders | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Dysuria | Renal and urinary disorders | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Microalbuminuria | Renal and urinary disorders | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Micturition Urgency | Renal and urinary disorders | MedDRA Version 25.0 | Non-systematic Assessment |
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| Nephrolithiasis | Renal and urinary disorders | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Proteinuria | Renal and urinary disorders | MedDRA Version 25.0 | Non-systematic Assessment |
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| Adenomyosis | Reproductive system and breast disorders | MedDRA Version 25.0 | Non-systematic Assessment |
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| Balanoposthitis | Reproductive system and breast disorders | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Prostatomegaly | Reproductive system and breast disorders | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Pruritus Genital | Reproductive system and breast disorders | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Smegma Accumulation | Reproductive system and breast disorders | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Vulvovaginal Pruritus | Reproductive system and breast disorders | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Dyspnoea Exertional | Respiratory, thoracic and mediastinal disorders | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Nasal Pruritus | Respiratory, thoracic and mediastinal disorders | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Upper Respiratory Tract Congestion | Respiratory, thoracic and mediastinal disorders | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Dermatitis Allergic | Skin and subcutaneous tissue disorders | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Hyperhidrosis | Skin and subcutaneous tissue disorders | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA Version 25.0 | Non-systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA Version 25.0 | Non-systematic Assessment |
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If an investigator wishes to publish information from the study, a copy of the manuscript must be provided to the sponsor for review at least 60 days before submission for publication or presentation. If requested by the sponsor in writing, the investigator will withhold such publication for up to an additional 60 days.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Advisor | Janssen Research & Development, LLC | 844-434-4210 | ClinicalTrialDisclosure@its.jnj.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Mar 10, 2022 | Jul 25, 2023 | SAP_001.pdf |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| D000068896 | Canagliflozin |
| D008687 | Metformin |
| ID | Term |
|---|---|
| D013876 | Thiophenes |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D005960 | Glucosides |
| D006027 | Glycosides |
| D002241 | Carbohydrates |
| D001645 | Biguanides |
| D006146 | Guanidines |
| D000578 | Amidines |
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