Clinical trial NCT01257451: Safety and Efficacy of Galvus in Elderly Type 2 Diabetes Patients
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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Type 2 Diabetes Mellitus
Keywords: Type 2 Diabetes Mellitus, Vildagliptin, Elderly Patients
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2010-12-09
Enrollment: 431
Sex: ALL
Minimum age (years): 70
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility criteria: 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

Primary outcomes:
measure: To evaluate the proportion of vildagliptin treated patients achieving HbA1c reduction and/or proportion reaching investigator defined target HbA1c relative to placebo
timeFrame: 24 weeks
Secondary outcomes:
measure: 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.
timeFrame: 24 weeks
measure: To evaluate the proportion of vildagliptin treated patients achieving fasting plasma glucose (FPG) reduction relative to placebo
timeFrame: 24 weeks
measure: To assess the responder rates of patients treated with vildagliptin as compared to placebo
timeFrame: 24 weeks
Other outcomes:
Locations:
city: Buizingen
country: Belgium
facility: Novartis Investigative Site
city: De Pinte
country: Belgium
facility: Novartis Investigative Site
city: Genk
country: Belgium
facility: Novartis Investigative Site
city: Mouscron
country: Belgium
facility: Novartis Investigative Site
city: Nazareth
country: Belgium
facility: Novartis Investigative Site
city: Oostham
country: Belgium
facility: Novartis Investigative Site
city: Wichelen
country: Belgium
facility: Novartis Investigative Site
city: Blagoevgrad
country: Bulgaria
facility: Novartis Investigative Site
city: Dimitrovgrad
country: Bulgaria
facility: Novartis Investigative Site
city: Pleven
country: Bulgaria
facility: Novartis Investigative Site
city: Plovdiv
country: Bulgaria
facility: Novartis Investigative Site
city: Sofia
country: Bulgaria
facility: Novartis Investigative Site
city: Varna
country: Bulgaria
facility: Novartis Investigative Site
city: Lahti
country: Finland
facility: Novartis Investigative Site
state: Suomi
city: Helsinki
country: Finland
facility: Novartis Investigative Site
city: Oulu
country: Finland
facility: Novartis Investigative Site
city: Bamberg
country: Germany
facility: Novartis Investigative Site
city: Beckum
country: Germany
facility: Novartis Investigative Site
city: Berlin
country: Germany
facility: Novartis Investigative Site
city: Falkensee
country: Germany
facility: Novartis Investigative Site
city: Lichtenfels
country: Germany
facility: Novartis Investigative Site
city: Lutherstadt Eisleben
country: Germany
facility: Novartis Investigative Site
city: Magdeburg
country: Germany
facility: Novartis Investigative Site
city: Mammendorf
country: Germany
facility: Novartis Investigative Site
city: Münster
country: Germany
facility: Novartis Investigative Site
city: Potsdam
country: Germany
facility: Novartis Investigative Site
city: Sulzbach-Rosenberg
country: Germany
facility: Novartis Investigative Site
city: Völlkingen
country: Germany
facility: Novartis Investigative Site
city: Wetter
country: Germany
facility: Novartis Investigative Site
city: Bratislava
country: Slovakia
facility: Novartis Investigative Site
state: Slovak Republic
city: Lubochna
country: Slovakia
facility: Novartis Investigative Site
state: Slovak Republic
city: Kosice
country: Slovakia
facility: Novartis Investigative Site
city: Levice
country: Slovakia
facility: Novartis Investigative Site
city: Nové Zámky
country: Slovakia
facility: Novartis Investigative Site
city: Pie¿¿any
country: Slovakia
facility: Novartis Investigative Site
city: Ruzomberok
country: Slovakia
facility: Novartis Investigative Site
city: Sanlúcar de Barrameda
country: Spain
facility: Novartis Investigative Site
state: Andalucía
city: Centelles
country: Spain
facility: Novartis Investigative Site
state: Barcelona
city: Alzira
country: Spain
facility: Novartis Investigative Site
state: Comunidad Valenciana
city: Alicante
country: Spain
facility: Novartis Investigative Site
city: Truro
country: United Kingdom
facility: Novartis Investigative Site
state: Cornwall
city: Birmingham
country: United Kingdom
facility: Novartis Investigative Site
city: Exeter
country: United Kingdom
facility: Novartis Investigative Site
city: Stevenage
country: United Kingdom
facility: Novartis Investigative Site
city: Wiltshire
country: United Kingdom
facility: Novartis Investigative Site
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals Corporation
role: STUDY_DIRECTOR
References:
citation: Strain WD, Lukashevich V, Kothny W, Hoellinger MJ, Paldanius PM. Individualised treatment targets for elderly patients with type 2 diabetes using vildagliptin add-on or lone therapy (INTERVAL): a 24 week, randomised, double-blind, placebo-controlled study. Lancet. 2013 Aug 3;382(9890):409-416. doi: 10.1016/S0140-6736(13)60995-2. Epub 2013 May 23.