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NCT01159249
A Multicenter, Open Label, Long-Term Safety Study of 52 Weeks Treatment With Vildagliptin in Patients With Type 2 Diabetes
Phase 3 trial testing Vildagliptin in Type 2 Diabetes in 245 participants. Completed in 1 January 2012.
1 January 2012
Quick facts
| Lead sponsor | Novartis Pharmaceuticals |
|---|---|
| Phase | Phase 3 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | non randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 245 |
| Start date | 1 June 2010 |
| Primary completion | 1 January 2012 |
| Estimated completion | 1 January 2012 |
| Sites | 24 locations across Japan |
Drugs / interventions tested
- Vildagliptin (VILDAGLIPTIN) — full drug profile →
Conditions studied
- Type 2 Diabetes — all drugs for Type 2 Diabetes →
Sponsor
Novartis Pharmaceuticals — full company profile →
Who can join
20 and older, any sex, with Type 2 Diabetes. 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.
-
Measure AEs, vital signs, laboratory evaluations
Time frame: 52 weeks
Sponsor's own description
This study is designed to demonstrate the long-term safety of vildagliptin in patients with type 2 diabetes. This study will study vildagliptin as add-on therapy with metformin, thiazolidinedione, α-glucosidase inhibitor (α-GI), rapid-acting insulin secretagogues in the treatment of type 2 diabetes in Japan.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT01159249
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Vildagliptin
Trials testing the same drug.
- NCT05366868 — Durable Effect of Imeglimin on the Glycemic Control in Patients With Type 2 Diabetes Mellitus · Phase 4 · active not recruiting
- NCT04300790 — Study to Evaluate the Effect of Metformin in the Prevention of HG in HR[+]/HER2[-] PIK3CA-mut Advanced BC Patients · Phase 2 · completed
- NCT05359432 — Comparison of Empaglifozin and Vildagliptin in Type 2 Diabetes Mellitus · Phase 4 · completed
- NCT04485845 — Metformin Versus Vildagliptin in Reducing Risk of Metabolic Syndrome Complications Progression · Phase 4 · unknown
- NCT04654676 — DPP4 Inhibitor on Glycemic Variability · Phase 4 · completed
Other recruiting trials for Type 2 Diabetes
Currently open trials in the same condition.
- NCT07053319 — SGLT2i, Pioglitazone, and Ketone Production in T2D · Phase 1 · recruiting
- NCT07272837 — Impact of Semaglutide (Ozempic/Wegovy®) on Heart and Muscle Mass · recruiting
- NCT07463859 — Effects of Periodontal Treatment Associated With Antimicrobial Photodynamic Therapy on Halitosis in Patients With Diabet · NA · recruiting
- NCT07254689 — The Food for Health Study · NA · recruiting
- NCT07558863 — Effect of GLP-1RA on Cardiac Autonomic Neuropathy in Type 2 Diabetes · Phase 4 · recruiting
Other Novartis Pharmaceuticals trials
Trials by the same sponsor.
- NCT07498335 — Study to Assess the Efficacy, Pharmacokinetics, Safety and Tolerability of Atrasentan in Pediatric Patients With Primary · Phase 3 · not yet recruiting
- NCT07489573 — Study of Efficacy and Safety of Secukinumab in Chinese Adult Patients With Moderate to Severe Hidradenitis Suppurativa · Phase 4 · not yet recruiting
- NCT07484269 — PULSE Registry: for Patients Receiving Lutetium (177Lu) Vipivotide Tetraxetan · not yet recruiting
- NCT07416162 — A Study of Iptacopan in Korean Patients With Paroxysmal Nocturnal Hemoglobinuria or C3 Glomerulopathy · not yet recruiting
- NCT07387926 — Safety and Efficacy of Asciminib in Pediatrics and Young Adults With Relapse/Refractory (r/r) Philadelphia Positive (Ph+ · Phase 1, PHASE2 · not yet 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 NCT01159249 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Novartis Pharmaceuticals
- Last refreshed: 11 December 2020
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/NCT01159249.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing