Safety and Efficacy of Galvus in Elderly Type 2 Diabetes Patients
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)
2 other identifiers
interventional
431
7 countries
46
Brief Summary
This study will evaluate the efficacy and safety of vildagliptin 50 mg bid in elderly patients with Type 2 Diabetes Mellitus (T2DM).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3 type-2-diabetes-mellitus
Started Dec 2010
Shorter than P25 for phase_3 type-2-diabetes-mellitus
46 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2010
CompletedFirst Submitted
Initial submission to the registry
December 6, 2010
CompletedFirst Posted
Study publicly available on registry
December 9, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2012
CompletedDecember 18, 2012
December 1, 2012
1.2 years
December 6, 2010
December 14, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
To evaluate the proportion of vildagliptin treated patients achieving HbA1c reduction and/or proportion reaching investigator defined target HbA1c relative to placebo
24 weeks
Secondary Outcomes (3)
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
To evaluate the proportion of vildagliptin treated patients achieving fasting plasma glucose (FPG) reduction relative to placebo
24 weeks
To assess the responder rates of patients treated with vildagliptin as compared to placebo
24 weeks
Study Arms (2)
Vildagliptin
EXPERIMENTALPlacebo
PLACEBO COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (46)
Novartis Investigative Site
Wichelen, Belgium, 9260, Belgium
Novartis Investigative Site
Buizingen, 1501, Belgium
Novartis Investigative Site
De Pinte, 9840, Belgium
Novartis Investigative Site
Genk, 3600, Belgium
Novartis Investigative Site
Mouscron, 7700, Belgium
Novartis Investigative Site
Nazareth, 9810, Belgium
Novartis Investigative Site
Oostham, 3945, Belgium
Novartis Investigative Site
Blagoevgrad, Bulgaria, 2700, Bulgaria
Novartis Investigative Site
Dimitrovgrad, Bulgaria, 6400, Bulgaria
Novartis Investigative Site
Plovdiv, Bulgaria, 4001, Bulgaria
Novartis Investigative Site
Sofia, Bulgaria, 1431, Bulgaria
Novartis Investigative Site
Varna, Bulgaria, 9002, Bulgaria
Novartis Investigative Site
Pleven, 5800, Bulgaria
Novartis Investigative Site
Sofia, 1431, Bulgaria
Novartis Investigative Site
Lahti, Suomi, 15110, Finland
Novartis Investigative Site
Helsinki, 00180, Finland
Novartis Investigative Site
Oulu, FIN-90100, Finland
Novartis Investigative Site
Münster, Germany, 48143, Germany
Novartis Investigative Site
Völlkingen, Germany, 66333, Germany
Novartis Investigative Site
Bamberg, 96050, Germany
Novartis Investigative Site
Beckum, 59269, Germany
Novartis Investigative Site
Berlin, 10115, Germany
Novartis Investigative Site
Eisleben Lutherstadt, 06295, Germany
Novartis Investigative Site
Falkensee, 14612, Germany
Novartis Investigative Site
Lichtenfels, 96215, Germany
Novartis Investigative Site
Magdeburg, 39112, Germany
Novartis Investigative Site
Mammendorf, 82291, Germany
Novartis Investigative Site
Potsdam, 14469, Germany
Novartis Investigative Site
Sulzbach-Rosenberg, 92237, Germany
Novartis Investigative Site
Wetter, 58300, Germany
Novartis Investigative Site
Bratislava, Slovak Republic, 811 02, Slovakia
Novartis Investigative Site
Ľubochňa, Slovak Republic, 03491, Slovakia
Novartis Investigative Site
Levice, Slovakia, 934 01, Slovakia
Novartis Investigative Site
Nové Zámky, Slovakia, 940 01, Slovakia
Novartis Investigative Site
Pie¿¿any, Slovakia, 92101, Slovakia
Novartis Investigative Site
Košice, 040 22, Slovakia
Novartis Investigative Site
Ružomberok, 034 01, Slovakia
Novartis Investigative Site
Alicante, Alicante, 03114, Spain
Novartis Investigative Site
Sanlúcar de Barrameda, Andalusia, 11540, Spain
Novartis Investigative Site
Centelles, Barcelona, 08540, Spain
Novartis Investigative Site
Alzira, Valencia, 46600, Spain
Novartis Investigative Site
Truro, Cornwall, TR1 3LJ, United Kingdom
Novartis Investigative Site
Birmingham, B9 5SS, United Kingdom
Novartis Investigative Site
Exeter, EX2 5DW, United Kingdom
Novartis Investigative Site
Stevenage, SG1 4AB, United Kingdom
Novartis Investigative Site
Wiltshire, SN15 2SB, United Kingdom
Related Publications (1)
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.
PMID: 23706759DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Novartis Pharmaceuticals
Novartis Pharmaceuticals
- STUDY DIRECTOR
Novartis Pharmaceuticals Corporation
Novartis Pharmaceuticals
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 6, 2010
First Posted
December 9, 2010
Study Start
December 1, 2010
Primary Completion
March 1, 2012
Study Completion
March 1, 2012
Last Updated
December 18, 2012
Record last verified: 2012-12