Safety and Efficacy of Galvus in Elderly Type 2 Diabetes Patients

Phase 3

Completed

• Conditions: Type 2 Diabetes Mellitus
• Interventions: Drug: Vildagliptin; Drug: Placebo

• Registration Number: NCT01257451
• Lead Sponsor: 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).

Detailed Description

Not available

Study Timeline

• Study Start: 2010-12
• Study First Submitted: 2010-12-06
• Study First Submitted QC: 2010-12-08
• Study First Posted: 2010-12-09
• Primary Completion: 2012-03
• Study Completion: 2012-03
• Status Verified: 2012-12
• Last Update Submitted: 2012-12-14
• Last Update Posted: 2012-12-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 431

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Vildagliptin	Vildagliptin	-
Placebo	Placebo	-

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Novartis Investigative Site; 🇬🇧 Wiltshire, United Kingdom