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

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

Overview[ - collapse ][ - ]

Purpose	The purpose of this study is to observe change of HbA1c over time from baseline to month 12. The ultimate goal of this study is 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.
Condition	Type-2 Diabetes Mellitus
Intervention	Drug: Vildagliptin Drug: Metformin
Phase	Phase 4
Sponsor	Novartis Pharmaceuticals
Responsible Party	Novartis
ClinicalTrials.gov Identifier	NCT01766778
First Received	January 9, 2013
Last Updated	June 11, 2013
Last verified	June 2013

Tracking Information[ + expand ][ + ]

First Received Date	January 9, 2013
Last Updated Date	June 11, 2013
Start Date	May 2013
Estimated Primary Completion Date	January 2015
Current Primary Outcome Measures	Mean change of HbA1c from Baseline to Month 12 [Time Frame: Baseline, Month 12 (weeK 52)] [Designated as safety issue: No]To examine the change in HbA1c from baseline to month12 for patients administered with Vildagliptin (50mg once daily or 50 mg twice daily) add-on regimen
Current Secondary Outcome Measures	Mean change in fasting plasma glucose (FPG) from Baseline to Month 12 [Time Frame: Baseline, Month 12 (week 52)] [Designated as safety issue: No]To examine the change in FPG from baseline to Month 12 Percentage of patients with HbA1c <7.0% [Time Frame: Month 12] [Designated as safety issue: No]Determine percentage of patients achieving HbA1c <7.0% at month 12 between the treatment arms Percentage of overall drug compliance in 12 months [Time Frame: Month 12] [Designated as safety issue: No]Determine percentage of overall drug compliance in 12 months between treatment arms Percentage patients with adverse events, serious adverse events and death as an assessment of overall safety and tolerability [Time Frame: Month 12] [Designated as safety issue: Yes]This analysis will report percentage patients with adverse events and patient discontinued from the study due to adverse events. Aslo, percentage of patients with serious adverse events and death will be reported.

Descriptive Information[ + expand ][ + ]

Brief Title	Early add-on Vildagliptin in Patients With Type 2 Diabetes Inadequately Controlled by Metformin
Official Title	A Local Phase IV, Multicenter, Open-label Study to Evaluate Early add-on Vildagliptin in Patients With Type 2 Diabetes Inadequately Controlled by Metformin
Brief Summary	The purpose of this study is to observe change of HbA1c over time from baseline to month 12. The ultimate goal of this study is 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.
Detailed Description	Not Provided
Study Type	Interventional
Study Phase	Phase 4
Study Design	Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Condition	Type-2 Diabetes Mellitus
Intervention	Drug: Vildagliptin Vildagliptin 50mg capsule Other Names: Galvus LAF237 Drug: Metformin Metformin maximum tolerance dose
Study Arm (s)	Active Comparator: Vildagliptin 50mg once daily (QD) Vildagliptin 50mg QD plus stabilized or maximum tolerated dose of Metformin Active Comparator: Vildagliptin 50mg twice daily (BID) Vildagliptin 50mg BID plus stabilized or maximum tolerated dose of Metformin

Recruitment Information[ + expand ][ + ]

Recruitment Status	Recruiting
Estimated Enrollment	170
Estimated Completion Date	January 2015
Estimated Primary Completion Date	January 2015
Eligibility 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 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 Other protocol defined inclusion/exclusion criteria may apply
Gender	Both
Ages	18 Years
Accepts Healthy Volunteers	No
Contacts	Contact: Novartis Pharmaceuticals +41613241111
Location Countries	Hong Kong

Administrative Information[ + expand ][ + ]

NCT Number	NCT01766778
Other Study ID Numbers	CLAF237AHK01
Has Data Monitoring Committee	No
Information Provided By	Novartis
Study Sponsor	Novartis Pharmaceuticals
Collaborators	Not Provided
Investigators	Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
Verification Date	June 2013

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