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

Novartis

Status and phase: Completed; Phase 4

Conditions: Type-2 Diabetes Mellitus

Treatments: Drug: LAF237 (vildagliptin); Drug: Metformin

Study type: Interventional

Funder types: Industry

Identifiers

NCT01766778

CLAF237AHK01

Details and patient eligibility

About

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.

Enrollment: 117 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Key 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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117 participants in 2 patient groups

LAF237 (vildagliptin) 50mg once daily (QD)

Active Comparator group

Description:

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

Treatment:

Drug: Metformin

Drug: LAF237 (vildagliptin)

LAF237 (vildagliptin) 50mg twice daily (BID)

Active Comparator group

Description:

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

Treatment:

Drug: Metformin

Drug: LAF237 (vildagliptin)