Safety and Efficacy of Galvus in Elderly Type 2 Diabetes Patients

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT01257451
• Date of registration: 06/12/2010
• Prospective Registration: No
• Primary sponsor: Novartis Pharmaceuticals
• Public title: Safety and Efficacy of Galvus in Elderly Type 2 Diabetes Patients
• Scientific 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)
• Date of first enrolment: December 2010
• Target sample size: 431
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT01257451
• Study type: Interventional
• Study design: Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
• Phase: Phase 3

Countries of recruitment

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

Contacts

• Name: Novartis Pharmaceuticals
• Affiliation: Novartis Pharmaceuticals

• Name: Novartis Pharmaceuticals Corporation
• Affiliation: Novartis Pharmaceuticals

Key inclusion & exclusion 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



Age minimum: 70 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Type 2 Diabetes Mellitus

Intervention(s)

Drug: Placebo

Drug: Vildagliptin

Primary Outcome(s)

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(s)

To evaluate the proportion of vildagliptin treated patients achieving fasting plasma glucose (FPG) reduction relative to placebo [Time Frame: 24 weeks]

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]

To assess the responder rates of patients treated with vildagliptin as compared to placebo [Time Frame: 24 weeks]

Secondary ID(s)

2010-022658-18

CLAF237A23150

Source(s) of Monetary Support

Please refer to primary and secondary sponsors