Safety and Efficacy of Galvus in Elderly Type 2 Diabetes Patients

Type 2 Diabetes Mellitus Clinical Trial

Official title:

A Multi-center, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of 24 Weeks Treatment With Vildagliptin in Type 2 Diabetes Mellitus Patients ≥ 70 Years (Drug-naive or Inadequately Controlled on Oral Agents)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01257451
• Other study ID #: CLAF237A23150
• Secondary ID: 2010-022658-18
• Status: Completed
• Phase: Phase 3
• First received: December 6, 2010
• Last updated: December 14, 2012
• Start date: December 2010
• Est. completion date: March 2012

Study information

• Verified date: December 2012
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationBelgium: Federal Agency for Medicinal Products and Health ProductsBulgaria: Ministry of HealthFrance: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)Germany: Federal Ministry of Education and ResearchSlovakia: State Institute for Drug ControlSpain: Ministry of HealthUnited Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Interventional

Clinical Trial Summary

This study will evaluate the efficacy and safety of vildagliptin 50 mg bid in elderly patients with Type 2 Diabetes Mellitus (T2DM).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 431
• Est. completion date: March 2012
• Est. primary completion date: March 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 70 Years and older

Eligibility

Inclusion Criteria:

• age: = 70 years inclusive at Visit 1.

• patients with a confirmed diagnosis of T2DM

• HbA1c of = 7% and =10.0% by central laboratory at Visit 1 and assessed by the investigator to be inadequately controlled

• body mass index (BMI) in the range of 19-45kg/m2

Exclusion Criteria:

• FPG = 270 mg/dL (= 15.0 mmol/L)

• previous or current participation in any vildagliptin clinical study.

• history of hypersensitivity to DPP-4 inhibitors.

• concurrent medical condition that may interfere with the interpretation of efficacy and safety data during the study.

• donation of blood or significant blood loss equaling to at least one unit of blood within the past 2 weeks of start of study or a blood transfusion within the past 12 weeks or planned regular transfusions during the study period Other protocol-defined inclusion/exclusion criteria may apply

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

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

Intervention

Drug:
• Vildagliptin
vildagliptin 50mg bid
• Placebo
Placebo 50mg bid

Locations

Country	Name	City	State
Belgium	Novartis Investigative Site	Buizingen
Belgium	Novartis Investigative Site	De Pinte
Belgium	Novartis Investigative Site	Genk
Belgium	Novartis Investigative Site	Mouscron
Belgium	Novartis Investigative Site	Nazareth
Belgium	Novartis Investigative Site	Oostham
Belgium	Novartis Investigative Site	Wichelen
Bulgaria	Novartis Investigative Site	Blagoevgrad
Bulgaria	Novartis Investigative Site	Dimitrovgrad
Bulgaria	Novartis Investigative Site	Pleven
Bulgaria	Novartis Investigative Site	Plovdiv
Bulgaria	Novartis Investigative Site	Sofia
Bulgaria	Novartis Investigative Site	Varna
Finland	Novartis Investigative Site	Helsinki
Finland	Novartis Investigative Site	Lahti	Suomi
Finland	Novartis Investigative Site	Oulu
Germany	Novartis Investigative Site	Bamberg
Germany	Novartis Investigative Site	Beckum
Germany	Novartis Investigative Site	Berlin
Germany	Novartis Investigative Site	Falkensee
Germany	Novartis Investigative Site	Lichtenfels
Germany	Novartis Investigative Site	Lutherstadt Eisleben
Germany	Novartis Investigative Site	Magdeburg
Germany	Novartis Investigative Site	Mammendorf
Germany	Novartis Investigative Site	Münster
Germany	Novartis Investigative Site	Potsdam
Germany	Novartis Investigative Site	Sulzbach-Rosenberg
Germany	Novartis Investigative Site	Völlkingen
Germany	Novartis Investigative Site	Wetter
Slovakia	Novartis Investigative Site	Bratislava	Slovak Republic
Slovakia	Novartis Investigative Site	Kosice
Slovakia	Novartis Investigative Site	Levice
Slovakia	Novartis Investigative Site	Lubochna	Slovak Republic
Slovakia	Novartis Investigative Site	Nové Zámky
Slovakia	Novartis Investigative Site	Pie¿¿any
Slovakia	Novartis Investigative Site	Ruzomberok
Spain	Novartis Investigative Site	Alicante
Spain	Novartis Investigative Site	Alzira	Comunidad Valenciana
Spain	Novartis Investigative Site	Centelles	Barcelona
Spain	Novartis Investigative Site	Sanlúcar de Barrameda	Andalucía
United Kingdom	Novartis Investigative Site	Birmingham
United Kingdom	Novartis Investigative Site	Exeter
United Kingdom	Novartis Investigative Site	Stevenage
United Kingdom	Novartis Investigative Site	Truro	Cornwall
United Kingdom	Novartis Investigative Site	Wiltshire

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Countries where clinical trial is conducted

Belgium,  Bulgaria,  Finland,  Germany,  Slovakia,  Spain,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To evaluate the proportion of vildagliptin treated patients achieving HbA1c reduction and/or proportion reaching investigator defined target HbA1c relative to placebo		24 weeks	No
Secondary	To evaluate the safety and tolerability of vildagliptin in elderly patients with T2DM who are drug-naive or inadequately controlled with oral antidiabetic drugs (OADs) including physical exam, vital sign, hematology, chemistry and electrocardiogram.		24 weeks	Yes
Secondary	To evaluate the proportion of vildagliptin treated patients achieving fasting plasma glucose (FPG) reduction relative to placebo		24 weeks	No
Secondary	To assess the responder rates of patients treated with vildagliptin as compared to placebo		24 weeks	No