Efficacy and Safety of Vildagliptin Compared to Metformin in Elderly Drug Naive Patients With Type 2 Diabetes

NCT ID: NCT00383578

Last Updated: 2020-12-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

335 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-09-30

Brief Summary

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This study is designed to demonstrate the efficacy and safety of vildagliptin compared to metformin in elderly drug naive patients with type 2 diabetes

Detailed Description

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Conditions

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Diabetes Mellitus, Type 2

Keywords

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Type 2 diabetes vildagliptin hemoglobin A1c metformin

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Vildagliptin

Group Type EXPERIMENTAL

Vildagliptin 100 mg qd

Intervention Type DRUG

Metformin

Group Type ACTIVE_COMPARATOR

Metformin 1500 mg daily

Intervention Type DRUG

Interventions

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Vildagliptin 100 mg qd

Intervention Type DRUG

Metformin 1500 mg daily

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Age from 65 years to the upper age limit recommended by local prescribing information for metformin
* Drug naive patients with type 2 diabetes.
* Body mass index (BMI) in the range of 22-40 kg/m2.
* HbA1c in the range of 7 to 9% inclusive
* FPG \<270 mg/dL (15 mmol/L)

Exclusion Criteria

* A history of type 1 diabetes
* Evidence of significant diabetic complications
* Treatment with insulin or any other oral antidiabetic agents
Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Novartis Pharmaceuticals

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Novartis Pharmaceuticals

Role: STUDY_DIRECTOR

Novartis Pharmaceuticals

Locations

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Investigative Centers

Nuremberg, , Germany

Site Status

Novartis Pharmaceuticals

Basel, , Switzerland

Site Status

Countries

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Germany Switzerland

Related Links

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https://www.novctrd.com/ctrdweb/trialresult/trialresults/pdf?trialResultId=2652

Resutls for CLAF237A2398 on the Novartis clinical trials website

Other Identifiers

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CLAF237A2398

Identifier Type: -

Identifier Source: org_study_id