NCT00468039 is a Phase 3 clinical trial of vildagliptin + metformin in Diabetes Mellitus, Type 2, sponsored by Novartis.

Who is sponsoring NCT00468039?

NCT00468039 is sponsored by Novartis.

What drugs are being tested in NCT00468039?

Interventions in NCT00468039: vildagliptin + metformin.

What condition does NCT00468039 study?

NCT00468039 studies Diabetes Mellitus, Type 2.

Is NCT00468039 still recruiting?

NCT00468039 is currently completed. Last updated 19 December 2020.

Last reviewed 2020-12-19 · How we verify

NCT00468039

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

A Sub-study to LMF237A2302 to Assess the Effect of 24 Weeks Treatment With Initial Combination of Vildagliptin Plus Metformin

Completed Phase 3 Last updated 19 December 2020

What this trial tests

Phase 3 trial testing vildagliptin + metformin in Diabetes Mellitus, Type 2 in 94 participants. Completed in 6 June 2008.

Timeline

6 March 2007

Primary endpoint
6 June 2008

6 June 2008

Quick facts

Lead sponsor	Novartis
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	94
Start date	6 March 2007
Primary completion	6 June 2008
Estimated completion	6 June 2008
Sites	1 location across United States

Drugs / interventions tested

vildagliptin + metformin

Conditions studied

Diabetes Mellitus, Type 2 — all drugs for Diabetes Mellitus, Type 2 →

Sponsor

Novartis — full company profile →

Who can join

Adults 18 to 78, any sex, with Diabetes Mellitus, Type 2. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This study will evaluate the effects of treatment with vildagliptin and metformin as initial combination in newly diagnosed patients with type 2 diabetes who have very high levels of HbA1c and/or fasting plasma glucose.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

Dipeptidyl peptidase-4 inhibitors and fracture risk: an updated meta-analysis of randomized clinical trials.
Fu J, Zhu J, Hao Y, Guo C, et al · · 2016 · cited 41× · PMID 27384445 · DOI 10.1038/srep29104
Risk of Fractures Associated with Dipeptidyl Peptidase-4 Inhibitor Treatment: A Systematic Review and Meta-Analysis of Randomized Controlled Trials.
Chen Q, Liu T, Zhou H, Peng H, et al · · 2019 · cited 16× · PMID 31347093 · DOI 10.1007/s13300-019-0668-5
New Hypoglycemic Drugs: Combination Drugs and Targets Discovery.
Ni X, Zhang L, Feng X, Tang L. · · 2022 · cited 11× · PMID 35865956 · DOI 10.3389/fphar.2022.877797

Verify or expand the search:

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)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT00468039 (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 Novartis
Last refreshed: 19 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/NCT00468039.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing