NCT01193296 (OPTIMA) is a Phase 4 clinical trial of Vildagliptin in Type 2 Diabetes Mellitus, sponsored by Novartis.

Who is sponsoring NCT01193296?

NCT01193296 is sponsored by Novartis.

What drugs are being tested in NCT01193296?

Interventions in NCT01193296: Vildagliptin, Sitagliptin.

What condition does NCT01193296 study?

NCT01193296 studies Type 2 Diabetes Mellitus.

Is NCT01193296 still recruiting?

NCT01193296 is currently completed. Last updated 3 May 2012.

Last reviewed 2012-05-03 · How we verify

NCT01193296: OPTIMA

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

Prospective, Randomized, Open-label Study With Blinded Endpoint (PROBE Design) to Compare the 72 hr Glycemic Profiles Obtained by Continuous Subcutaneous Glucose Monitoring (CSGM) in Type 2 Diabetic Patients at Baseline With Metformin Monotherapy and After an 8-week Period With the Addition of Either Vildagliptin or Sitagliptin in Patients Insufficiently Controlled by Metformin After at Least 3 Months of Monotherapy

Completed Phase 4 Last updated 3 May 2012

What this trial tests

Phase 4 trial testing Vildagliptin in Type 2 Diabetes Mellitus in 36 participants. Completed in 1 June 2011.

Timeline

1 June 2010

Primary endpoint
1 June 2011

1 June 2011

Quick facts

Lead sponsor	Novartis
Phase	Phase 4
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	36
Start date	1 June 2010
Primary completion	1 June 2011
Estimated completion	1 June 2011
Sites	7 locations across France

Drugs / interventions tested

Vildagliptin (VILDAGLIPTIN) — full drug profile →
Sitagliptin (SITAGLIPTIN) — full drug profile →

Conditions studied

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

Sponsor

Novartis — full company profile →

Who can join

Adults 18 to 79, any sex, with Type 2 Diabetes Mellitus. 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.

Glycemic variability assessed by MAGE (Mean Amplitude of Glycemic Excursion)
Time frame: 8 weeks

Sponsor's own description

The study will assess glycemic variability and optimized glycemic control in T2DM patients treated with a DPP-4 inhibitor as add-on therapy to metformin.

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:

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 Mellitus

Currently open trials in the same condition.

NCT07351058 — A Clinical Study to Evaluate the Effects of RO7795068 in Participants With Obesity or Overweight and Type 2 Diabetes · Phase 3 · recruiting
NCT07373938 — Carotid Wall Texture as a Cardiovascular Risk Biomarker in Type 2 Diabetes Mellitus · recruiting
NCT07433062 — A Study to Evaluate the Effect of AZD6793 on the Pharmacokinetics and Pharmacodynamics of Metformin in Participants With · Phase 1 · recruiting
NCT07276776 — An Evaluation of the Omnipod® M System in Adults With Type 2 Diabetes · NA · active not recruiting
NCT07232537 — An Observational Study Called FINE-REAL Korea to Learn More About the Use of the Drug Finerenone in People With Chronic · 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 NCT01193296 (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: 3 May 2012

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/NCT01193296.

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