Safety and Efficacy of Galvus in Elderly Type 2 Diabetes Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01257451
Recruitment Status : Completed
First Posted : December 9, 2010
Last Update Posted : December 18, 2012
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

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

Condition or disease Intervention/treatment Phase
Type 2 Diabetes Mellitus Drug: Vildagliptin Drug: Placebo Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 431 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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 Start Date : December 2010
Actual Primary Completion Date : March 2012
Actual Study Completion Date : March 2012

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: Vildagliptin Drug: Vildagliptin
vildagliptin 50mg bid
Placebo Comparator: Placebo Drug: Placebo
Placebo 50mg bid

Primary Outcome Measures :
  1. To evaluate the proportion of vildagliptin treated patients achieving HbA1c reduction and/or proportion reaching investigator defined target HbA1c relative to placebo [ Time Frame: 24 weeks ]

Secondary Outcome Measures :
  1. 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. [ Time Frame: 24 weeks ]
  2. To evaluate the proportion of vildagliptin treated patients achieving fasting plasma glucose (FPG) reduction relative to placebo [ Time Frame: 24 weeks ]
  3. To assess the responder rates of patients treated with vildagliptin as compared to placebo [ Time Frame: 24 weeks ]

Information from the National Library of Medicine

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Ages Eligible for Study:   70 Years and older   (Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01257451

  Hide Study Locations
Novartis Investigative Site
Buizingen, Belgium, 1501
Novartis Investigative Site
De Pinte, Belgium, 9840
Novartis Investigative Site
Genk, Belgium, 3600
Novartis Investigative Site
Mouscron, Belgium, 7700
Novartis Investigative Site
Nazareth, Belgium, 9810
Novartis Investigative Site
Oostham, Belgium, 3945
Novartis Investigative Site
Wichelen, Belgium, 9260
Novartis Investigative Site
Blagoevgrad, Bulgaria, 2700
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Dimitrovgrad, Bulgaria, 6400
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Pleven, Bulgaria, 5800
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Plovdiv, Bulgaria, 4001
Novartis Investigative Site
Sofia, Bulgaria, 1431
Novartis Investigative Site
Varna, Bulgaria, 9002
Novartis Investigative Site
Lahti, Suomi, Finland, 15110
Novartis Investigative Site
Helsinki, Finland, 00180
Novartis Investigative Site
Oulu, Finland, FIN-90100
Novartis Investigative Site
Bamberg, Germany, 96050
Novartis Investigative Site
Beckum, Germany, 59269
Novartis Investigative Site
Berlin, Germany, 10115
Novartis Investigative Site
Falkensee, Germany, 14612
Novartis Investigative Site
Lichtenfels, Germany, 96215
Novartis Investigative Site
Lutherstadt Eisleben, Germany, 06295
Novartis Investigative Site
Magdeburg, Germany, 39112
Novartis Investigative Site
Mammendorf, Germany, 82291
Novartis Investigative Site
Münster, Germany, 48143
Novartis Investigative Site
Potsdam, Germany, 14469
Novartis Investigative Site
Sulzbach-Rosenberg, Germany, 92237
Novartis Investigative Site
Völlkingen, Germany, 66333
Novartis Investigative Site
Wetter, Germany, 58300
Novartis Investigative Site
Bratislava, Slovak Republic, Slovakia, 811 02
Novartis Investigative Site
Lubochna, Slovak Republic, Slovakia, 03491
Novartis Investigative Site
Kosice, Slovakia, 040 22
Novartis Investigative Site
Levice, Slovakia, 934 01
Novartis Investigative Site
Nové Zámky, Slovakia, 940 01
Novartis Investigative Site
Pie¿¿any, Slovakia, 92101
Novartis Investigative Site
Ruzomberok, Slovakia, 034 01
Novartis Investigative Site
Sanlúcar de Barrameda, Andalucía, Spain, 11540
Novartis Investigative Site
Centelles, Barcelona, Spain, 08540
Novartis Investigative Site
Alzira, Comunidad Valenciana, Spain, 46600
Novartis Investigative Site
Alicante, Spain, 03114
United Kingdom
Novartis Investigative Site
Truro, Cornwall, United Kingdom, TR1 3LJ
Novartis Investigative Site
Birmingham, United Kingdom, B9 5SS
Novartis Investigative Site
Exeter, United Kingdom, EX2 5DW
Novartis Investigative Site
Stevenage, United Kingdom, SG1 4AB
Novartis Investigative Site
Wiltshire, United Kingdom, SN15 2SB
Sponsors and Collaborators
Novartis Pharmaceuticals
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
Study Director: Novartis Pharmaceuticals Corporation Novartis Pharmaceuticals

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Novartis Pharmaceuticals Identifier: NCT01257451     History of Changes
Other Study ID Numbers: CLAF237A23150
First Posted: December 9, 2010    Key Record Dates
Last Update Posted: December 18, 2012
Last Verified: December 2012

Keywords provided by Novartis ( Novartis Pharmaceuticals ):
Type 2 Diabetes Mellitus, Vildagliptin, Elderly Patients

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Dipeptidyl-Peptidase IV Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Hypoglycemic Agents
Physiological Effects of Drugs