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NCT01106625
A Randomized, Double-Blind, Placebo-Controlled, 3-Arm, Parallel-Group, Multicenter Study to Evaluate the Efficacy, Safety, and Tolerability of Canagliflozin in the Treatment of Subjects With Type 2 Diabetes Mellitus With Inadequate Glycemic Control on Metformin and Sulphonylurea Therapy
Phase 3 trial testing Canagliflozin in Diabetes Mellitus, Type 2 in 469 participants. Completed in 1 April 2012.
1 September 2011
Quick facts
| Lead sponsor | Janssen Research & Development, LLC |
|---|---|
| Phase | Phase 3 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | triple |
| Primary purpose | treatment |
| Enrollment | 469 |
| Start date | 1 May 2010 |
| Primary completion | 1 September 2011 |
| Estimated completion | 1 April 2012 |
| Sites | 76 locations across United States, Australia, Belgium, France, Guatemala, Hungary, Israel, Mexico |
Drugs / interventions tested
- Canagliflozin (CANAGLIFLOZIN) — full drug profile →
- Placebo
- Metformin (metformin) — full drug profile →
- Sulphonylruea — full drug profile →
Conditions studied
- Diabetes Mellitus, Type 2 — all drugs for Diabetes Mellitus, Type 2 →
Sponsor
Janssen Research & Development, LLC — full company profile →
Who can join
Adults 18 to 80, any sex, with Diabetes Mellitus, Type 2. Patients with the condition only — healthy volunteers not accepted.
What's being measured
Primary outcomes are the specific endpoints the trial is designed to prove or disprove.
-
Change in HbA1c From Baseline to Week 26
Time frame: Day 1 (Baseline) and Week 26
The table below shows the least-squares (LS) mean change in HbA1c from Baseline to Week 26 for each treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin group minus placebo) in the LS mean change.
Sponsor's own description
The purpose of this study is to evaluate the efficacy and safety of 2 different doses of canagliflozin compared with placebo in patients with type 2 diabetes mellitus who are receiving treatment with metformin and sulphonylurea and have inadequate glycemic (blood sugar) control.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
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Effects of Canagliflozin on Fracture Risk in Patients With Type 2 Diabetes Mellitus.
Watts NB, Bilezikian JP, Usiskin K, Edwards R, et al · · 2016 · cited 304× · PMID 26580237 · DOI 10.1210/jc.2015-3167 -
Efficacy and safety of canagliflozin in patients with type 2 diabetes mellitus inadequately controlled with metformin and sulphonylurea: a randomised trial.
Wilding JP, Charpentier G, Hollander P, González-Gálvez G, et al · · 2013 · cited 266× · PMID 24118688 · DOI 10.1111/ijcp.12322 -
Update on developments with SGLT2 inhibitors in the management of type 2 diabetes.
Nauck MA. · · 2014 · cited 227× · PMID 25246775 · DOI 10.2147/dddt.s50773 -
Sodium-glucose cotransporter 2 inhibitors (SGLT2i) and cardiac arrhythmias: a systematic review and meta-analysis.
Li HL, Lip GYH, Feng Q, Fei Y, et al · · 2021 · cited 127× · PMID 33962654 · DOI 10.1186/s12933-021-01293-8 -
Genital mycotic infections with canagliflozin, a sodium glucose co-transporter 2 inhibitor, in patients with type 2 diabetes mellitus: a pooled analysis of clinical studies.
Nyirjesy P, Sobel JD, Fung A, Mayer C, et al · · 2014 · cited 112× · PMID 24517339 · DOI 10.1185/03007995.2014.890925 -
Effects of canagliflozin on body weight and relationship to HbA1c and blood pressure changes in patients with type 2 diabetes.
Cefalu WT, Stenlöf K, Leiter LA, Wilding JP, et al · · 2015 · cited 103× · PMID 25813214 · DOI 10.1007/s00125-015-3547-2 -
Sodium-Glucose Co-Transporter Inhibitors and Atrial Fibrillation: A Systematic Review and Meta-Analysis of Randomized Controlled Trials.
Pandey AK, Okaj I, Kaur H, Belley-Cote EP, et al · · 2021 · cited 100× · PMID 34459238 · DOI 10.1161/jaha.121.022222 -
SGLT2 inhibitors and atrial fibrillation in type 2 diabetes: a systematic review with meta-analysis of 16 randomized controlled trials.
Li WJ, Chen XQ, Xu LL, Li YQ, et al · · 2020 · cited 100× · PMID 32847602 · DOI 10.1186/s12933-020-01105-5
Verify or expand the search:
- PubMed search for NCT01106625
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Canagliflozin
Trials testing the same drug.
- NCT07076823 — Safety and Efficacy of Canagliflozin in Patients With Metastatic High Microsatellite Instability (MSI-H) Colorectal Canc · Phase 1 · recruiting
- NCT06851962 — Impact of Pharmacogenetic-Guided Treatment on Type 2 Diabetes. · Phase 4 · active not recruiting
- NCT05513729 — Effect of Canagliflozin on Liver Inflammation Damage in Type 2 Diabetes Patients With Nonalcoholic Fatty Liver Disease · unknown
- NCT05364190 — Canagliflozin in Patients With Acute Decompansted Heart Failure · Phase 3 · completed
- NCT05856578 — Comparing the Efficacy of Mulberry Twig Alkaloid Tablet and Canagliflozin in Patients With Type 2 Diabetes · Phase 4 · unknown
Other recruiting trials for Diabetes Mellitus, Type 2
Currently open trials in the same condition.
- NCT07415954 — A Research Study Comparing How Well Different Doses of the Medicine NNC0662-0419 Lower Blood Sugar in People With Type 2 · Phase 2 · recruiting
- NCT07532863 — A Real-world Study to Investigate Cardiovascular Risk Profile Among Newly Diagnosed Type 2 Diabetes Mellitus (T2DM) Part · recruiting
- NCT07336329 — Continuous Glucose Monitoring in Non-Insulin Treated Type 2 Diabetes: Continuous vs. Periodic Use · NA · recruiting
- NCT07242469 — A Clinical Trial of MK-1403 in Participants With Type 2 Diabetes Mellitus (MK-1403-006) · Phase 1 · recruiting
- NCT07444203 — Transformative Research in Diabetic Nephropathy 2.0 · recruiting
Other Janssen Research & Development, LLC trials
Trials by the same sponsor.
- NCT07518186 — A Study Comparing JNJ-79635322 and Teclistamab in Participants With Relapsed or Refractory Multiple Myeloma · Phase 3 · not yet recruiting
- NCT07309445 — A Study to Assess Real-World Use and Outcomes of TAR-200 for Participants With Non-Muscle Invasive Bladder Cancer (NMIBC · recruiting
- NCT07499232 — A Study of Guselkumab Versus Risankizumab in Participants With Moderately to Severely Active Crohn's Disease · Phase 3 · not yet recruiting
- NCT07438496 — A Study of Nipocalimab in Adults With Moderate to Severe Systemic Lupus Erythematosus · Phase 3 · recruiting
- NCT07227025 — A Study of Amivantamab and Olomorasib Combination Therapy in Participants With Metastatic Non-Small Cell Lung Cancer · Phase 1, PHASE2 · recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT01106625 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Janssen Research & Development, LLC
- Last refreshed: 12 June 2013
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01106625.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing