Safety and Efficacy of Galvus in Elderly Type 2 Diabetes Patients

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

Official Title
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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)

Conditions
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Type 2 Diabetes Mellitus

Intervention / Treatment
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* Drug: Vildagliptin
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Vildagliptin<br> | Drug: Vildagliptin<br>* vildagliptin 50mg bid<br>|
| Placebo Comparator: Placebo<br> | Drug: Placebo<br>* Placebo 50mg bid<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Type 2 Diabetes Mellitus, Vildagliptin, Elderly Patients