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Safety and Efficacy of Vildagliptin Plus Metformin (SPC) Treatment in Type 2 Diabetes Mellitus Patients

NCT ID: NCT01582243

Last Updated: 2016-11-03

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-04-30

Study Completion Date

2015-09-30

Brief Summary

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This study will assess the efficacy of vildagliptin plus metformin (SPC) treatment in type 2 diabetes mellitus patients uncontrolled by metformin monotherapy after 24 weeks treatment

Detailed Description

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Conditions

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Diabetes Mellitus, Type 2

Keywords

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Diabetes Mellitus, type 2 vildagliptin

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Vildagliptin plus metformin (SPC)

Eligible participants received oral vildagliptin 50 mg plus metformin 500 mg (SPC) twice daily from week 1 to week 24.

Group Type EXPERIMENTAL

Vildagliptin

Intervention Type DRUG

Vildagliptin 50 mg plus metformin 500 mg as Single Pill combination (SPC)

Interventions

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Vildagliptin

Vildagliptin 50 mg plus metformin 500 mg as Single Pill combination (SPC)

Intervention Type DRUG

Other Intervention Names

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LAF237, Galvus Met

Eligibility Criteria

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Inclusion Criteria

1. Outpatients who were 20 years of age and older with diagnosis of T2DM.
2. Patients who had been treated with stable dose of metformin (≥1000 mg/day) monotherapy at least 4 weeks prior to Visit 1 and had failed to achieve the glucose control goal. The glucose control goal was defined as HbA1c ≤ 6.5%.
3. Male or female with child-bearing potential agreed to use an effective method of contraception approved by the investigator during the study.
4. Understood the nature of the study, and had signed informed consent form.

Exclusion Criteria

1. Patients with contraindications mentioned in the Summary of Product Characteristics for vildagliptin or metformin.
2. Patients with renal dysfunction defined as creatinine clearance \< 60 ml/min at Visit 1.
3. Patients with history of hepatic impairment, including but not limited to those with pretreatment AST or ALT \> 3 ULN at Visit 1.
4. Female patients who needed to lactate during the study.
Minimum Eligible Age

20 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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Novartis Investigative Site

Changhua, , Taiwan

Site Status

Countries

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Taiwan

Other Identifiers

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CLAF237ATW03

Identifier Type: -

Identifier Source: org_study_id