Safety and Efficacy of Galvus as add-on Therapy to Metformin Plus Glimepiride

Type 2 Diabetes Mellitus Clinical Trial

— Vildagliptin  

Official title:

A Multi-center, Randomized, Double-blind Placebo Controlled Study to Evaluate the Efficacy and Safety of 24 Weeks Treatment With Vildagliptin 50 mg Bid as add-on Therapy to Metformin Plus Glimepiride in Patients With Type 2 Diabetes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01233622
• Other study ID #: CLAF237A23152
• Secondary ID: EudraCT 2010-021
• Status: Completed
• Phase: Phase 3
• First received: November 1, 2010
• Last updated: February 21, 2017
• Start date: October 2010
• Est. completion date: November 2011

Study information

• Verified date: February 2017
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study will evaluate the efficacy and safety of vildagliptin 50 mg bid as add-on therapy to metformin plus glimepiride in patients with Type 2 Diabetes (T2D).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 317
• Est. completion date: November 2011
• Est. primary completion date: November 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion criteria

• Confirmed diagnosis of T2DM by standard criteria.

• Treatment with oral anti-diabetic therapy, on stable dose for at least 12 weeks prior to the screening visit. Acceptable background anti-diabetic therapy includes: metformin (= 1500 mg) as monotherapy or in combination with SU, TZDs, or glinides

• Age: =18 to = 80 years

• HbA1c of = 7.5 and = 11.0%

• Body Mass Index (BMI) =22 to =45 kg/m2

Exclusion criteria:

• FPG = 270 mg/dL (= 15.0 mmol/L)

• Acute metabolic diabetes complications such as ketoacidosis or hyperosmolar state (coma) within the past 6 months

• Any of following within past 6 months: Myocardial infarction, TIA or stroke, coronary artery bypass surgery or percutaneous coronary intervention

• History of hypersensitivity to any of the study drugs or to drugs of similar chemical classes

• Acute infections which may affect blood glucose control within 4 weeks prior to screening Other protocol-defined inclusion/exclusion criteria may apply

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type 2 Diabetes Mellitus

Intervention

Drug:
• Vildagliptin

• Placebo

Locations

Country	Name	City	State
Australia	Novartis Investigative Site	Box Hill
Australia	Novartis Investigative Site	Heidelberg
Australia	Novartis Investigative Site	Parkville
Australia	Novartis Investigative Site	St. Leonards
Germany	Novartis Investigative Site	Anderbeck
Germany	Novartis Investigative Site #1	Berlin
Germany	Novartis Investigative Site #2	Berlin
Germany	Novartis Investigative Site #3	Berlin
Germany	Novartis Investigative Site #4	Berlin
Germany	Novartis Investigative Site	Hamburg
Germany	Novartis Investigative Site	Hildesheim
Germany	Novartis Investigative Site	Sangerhausen
Hungary	Novartis Investigative Site	Budapest
Hungary	Novartis Investigative Site	Erd
Hungary	Novartis Investigative Site	Torokbalint
Italy	Novartis Investigative Site	Bergamo
Italy	Novartis Investigative Site	Cosenza
Italy	Novartis Investigative Site	Milano
Italy	Novartis Investigative Site	Padova
Italy	Novartis Investigative Site	Pisa
Italy	Novartis Investigative Site #1	Roma
Italy	Novartis Investigative Site #2	Roma
Italy	Novartis Investigative Site	Torino
Korea, Republic of	Novartis Investigative Site	Bundang
Korea, Republic of	Novartis Investigative Site #1	Seoul
Korea, Republic of	Novartis Investigative Site #2	Seoul
Korea, Republic of	Novartis Investigative Site #3	Seoul
Korea, Republic of	Novartis Investigative Site	Suwon
Mexico	Novartis Investigative Site #1	Aguascalientes
Mexico	Novartis Investigative Site #2	Aguascalientes
Mexico	Novartis Investigative Site #3	Aguascalientes
Mexico	Novartis Investigative Site #1	Durango
Mexico	Novartis Investigative Site #2	Durango
Mexico	Novartis Investigative Site #3	Durango
Mexico	Novartis Investigative Site #1	Guadalajara
Mexico	Novartis Investigative Site #2	Guadalajara
Mexico	Novartis Investigative Site #3	Guadalajara
Mexico	Novartis Investigative Site #4	Guadalajara
Mexico	Novartis Investigative Site #5	Guadalajara
Mexico	Novartis Investigative Site	Mexico
Mexico	Novartis Investigative Site #1	Pachuca
Mexico	Novartis Investigative Site #2	Pachuca
Mexico	Novartis Investigative Site #3	Pachuca
Philippines	Novartis Investigative Site	Manila
Philippines	Novartis Investigative Site #1	Quezon City
Philippines	Novartis Investigative Site #2	Quezon City
Romania	Novartis Investigative Site	Alba-Iulia
Romania	Novartis Investigative Site	Bucharest
Romania	Novartis Investigative Site #1	Oradea
Romania	Novartis Investigative Site #2	Oradea
Romania	Novartis Investigative Site	Targu-Mures
Taiwan	Novartis Investigative Site	Changhua
Taiwan	Novartis Investigative Site	Taichung
Taiwan	Novartis Investigative Site	Taipei
Taiwan	Novartis Investigative Site	Yongkang

Sponsors (1)

Lead Sponsor	Collaborator
Novartis

Countries where clinical trial is conducted

Australia,  Germany,  Hungary,  Italy,  Korea, Republic of,  Mexico,  Philippines,  Romania,  Taiwan, 

References & Publications (1)

Lukashevich V, Del Prato S, Araga M, Kothny W. Efficacy and safety of vildagliptin in patients with type 2 diabetes mellitus inadequately controlled with dual combination of metformin and sulphonylurea. Diabetes Obes Metab. 2014 May;16(5):403-9. doi: 10.1 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	HbA1c Reduction		24 weeks
Secondary	FPG reduction		24 weeks
Secondary	Safety and tolerability-frequency of treatment emergent adverse events (incl. overall Aes, SAEs, death, Aes leading ot study discontinuation or study drug interruption, pre-specified potential AEs)		24 weeks
Secondary	Responder Rate		24 weeks

External Links

•   Results for CLAF237A23152 from the Novartis Clinical Trials website