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NCT00300287
A 56-Week Extension to a Clinical Study to Assess the Efficacy and Safety of Vildagliptin Compared to Placebo in Drug Naive Patients With Type 2 Diabetes and Mild Hyperglycemia
Phase 3 trial testing Vildagliptin in Diabetes Mellitus, Type 2 in 150 participants. Completed in 26 June 2007.
26 June 2007
Quick facts
| Lead sponsor | Novartis |
|---|---|
| Phase | Phase 3 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | double |
| Primary purpose | treatment |
| Enrollment | 150 |
| Start date | 20 February 2006 |
| Primary completion | 26 June 2007 |
| Estimated completion | 26 June 2007 |
| Sites | 1 location across Germany |
Drugs / interventions tested
- Vildagliptin (VILDAGLIPTIN) — full drug profile →
Conditions studied
- Diabetes Mellitus, Type 2 — all drugs for Diabetes Mellitus, Type 2 →
Sponsor
Novartis — full company profile →
Who can join
19 and older, any sex, with Diabetes Mellitus, Type 2. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This study is not being conducted in the United States. Key long-term clinical studies have shown that people with type 2 diabetes should try to achieve overall blood glucose levels as close to normal as possible. The purpose of this study is to gather data on the long-term safety and effectiveness of vildagliptin, an unapproved drug, compared to placebo in lowering overall blood glucose levels in people with type 2 diabetes who have not been previously treated with drug therapy to lower their blood sugar and whose blood glucose levels are close to normal.
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 NCT00300287
- 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 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 Novartis trials
Trials by the same sponsor.
- NCT06595069 — A Real-world Study to Assess the Characteristics and Long-term Effectiveness of Inclisiran in Chinese Adult Patients · completed
- NCT06632730 — Therapeutic Management and Use of Resources and Costs of Spinal Muscular Atrophy in Spain · completed
- NCT06395909 — A Study to Assess the Effectiveness and Safety of Mayzent in Chinese Patients With Relapsing Forms of Multiple Sclerosis · completed
- NCT06516029 — Real-World Evaluation of Patient Characteristics and Treatment Patterns Among Patients With CML-CP Treated With Ascimini · completed
- NCT06644638 — Real-World Persistence and Adherence of Ofatumumab Compared to Self-Injectable and Oral DMTs in Patients With Multiple S · completed
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 NCT00300287 (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
- Last refreshed: 2 August 2017
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/NCT00300287.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing