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

Type-2 Diabetes Mellitus Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01766778
• Other study ID #: CLAF237AHK01
• Status: Completed
• Phase: Phase 4
• First received: January 9, 2013
• Last updated: February 23, 2016
• Start date: May 2013
• Est. completion date: October 2015

Study information

• Verified date: February 2016
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Health authority: Hong Kong: Department of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 125
• Est. completion date: October 2015
• Est. primary completion date: October 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type-2 Diabetes Mellitus

Intervention

Drug:
• Vildagliptin
Vildagliptin 50mg capsule
• Metformin
Metformin maximum tolerance dose

Locations

Country	Name	City	State
Hong Kong	Novartis Investigative Site	Hong Kong SAR
Hong Kong	Novartis Investigative Site	HongKong
Hong Kong	Novartis Investigative Site	Tuen Mun

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Country where clinical trial is conducted

Hong Kong, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean change of HbA1c from Baseline to Month 12	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	Baseline, Month 12 (weeK 52)	No
Secondary	Mean change in fasting plasma glucose (FPG) from Baseline to Month 12	To examine the change in FPG from baseline to Month 12	Baseline, Month 12 (week 52)	No
Secondary	Percentage of patients with HbA1c <7.0%	Determine percentage of patients achieving HbA1c <7.0% at month 12 between the treatment arms	Month 12	No
Secondary	Percentage of overall drug compliance in 12 months	Determine percentage of overall drug compliance in 12 months between treatment arms	Month 12	No
Secondary	Percentage patients with adverse events, serious adverse events and death as an assessment of overall safety and tolerability	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.	Month 12	Yes