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)

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01257451

Enrollment

431

Registered

2010-12-09

Start date

2010-12-31

Completion date

2012-03-31

Last updated

2012-12-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 2 Diabetes Mellitus

Keywords

Type 2 Diabetes Mellitus, Vildagliptin, Elderly Patients

Brief summary

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

Interventions

DRUGVildagliptin

vildagliptin 50mg bid

DRUGPlacebo

Placebo 50mg bid

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

70 Years to No maximum

Healthy volunteers

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/

Design outcomes

Primary

Measure	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

Measure	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

Countries

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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 23, 2026