Early add-on Vildagliptin in Patients With Type 2 Diabetes Inadequately Controlled by Metformin

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

117 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-05-13

Study Completion Date

2015-10-22

Brief Summary

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The purpose of this study was to observe change of HbA1c over time from baseline to month 12. The ultimate goal of this study was to provide a local reference value to the physicians \& patients in the future when they consider initiating Vildagliptin and taking balance between efficacy, compliance, risk factors, convenience and medication cost.

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Detailed Description

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Conditions

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Type-2 Diabetes Mellitus

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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LAF237 (vildagliptin) 50mg once daily (QD)

Vildagliptin 50mg QD plus stabilized or maximum tolerated dose of Metformin

Group Type ACTIVE_COMPARATOR

LAF237 (vildagliptin)

Intervention Type DRUG

Vildagliptin 50mg capsule

Metformin

Intervention Type DRUG

Metformin maximum tolerance dose

LAF237 (vildagliptin) 50mg twice daily (BID)

Vildagliptin 50mg BID plus stabilized or maximum tolerated dose of Metformin

Group Type ACTIVE_COMPARATOR

LAF237 (vildagliptin)

Intervention Type DRUG

Vildagliptin 50mg capsule

Metformin

Intervention Type DRUG

Metformin maximum tolerance dose

Interventions

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LAF237 (vildagliptin)

Vildagliptin 50mg capsule

Intervention Type DRUG

Metformin

Metformin maximum tolerance dose

Intervention Type DRUG

Other Intervention Names

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LAF237

Eligibility Criteria

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Inclusion Criteria

1. Male or Female in age ≥18 at Visit 1
2. Type 2 diabetes mellitus (T2DM) patients on their maximum tolerated dose of Metformin for more than 3 months
3. HbA1c (glycosylated hemoglobin) at Visit 1 greater than 7.0%
4. With nearest documented record of HbA1c before Visit 1 greater than 7.0% after patient reached his/her maximum tolerated dose of Metformin

Exclusion Criteria

1. Patients with hepatic impairment, including patients with a pre-treatment alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \> 2.5 X the upper limit of normal at Visit 1
2. Patients with moderate or severe renal impairment or end-stage-renal-disease (ESRD) on haemodialysis at the time of enrolment
3. Patients with hereditary problems of galactose intolerance, the Lapp lactose deficiency or glucose-galactose malabsorption
4. Pregnant women or breastfeeding women at the time of enrolment
5. Use of insulin or other oral anti-diabetic drug (OAD) apart from Metformin in the past for T2DM treatment

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No