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

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2014 by Novartis
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT01766778
First received: January 9, 2013
Last updated: April 28, 2014
Last verified: April 2014
  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 Intervention Phase
Type-2 Diabetes Mellitus
Drug: Vildagliptin
Drug: Metformin
Phase 4

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

Resource links provided by NLM:


Further study details as provided by Novartis:

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


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.


Estimated Enrollment: 170
Study Start Date: May 2013
Estimated Study Completion Date: April 2015
Estimated Primary Completion Date: April 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Vildagliptin 50mg once daily (QD)
Vildagliptin 50mg QD plus stabilized or maximum tolerated dose of Metformin
Drug: Vildagliptin
Vildagliptin 50mg capsule
Other Names:
  • Galvus
  • LAF237
Drug: Metformin
Metformin maximum tolerance dose
Active Comparator: Vildagliptin 50mg twice daily (BID)
Vildagliptin 50mg BID plus stabilized or maximum tolerated dose of Metformin
Drug: Vildagliptin
Vildagliptin 50mg capsule
Other Names:
  • Galvus
  • LAF237
Drug: Metformin
Metformin maximum tolerance dose

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01766778

Contacts
Contact: Novartis Pharmaceuticals +41613241111
Contact: Novartis Pharmaceuticals

Locations
Hong Kong
Novartis Investigative Site Recruiting
Hong Kong, Hong Kong
Novartis Investigative Site Recruiting
Hong Kong SAR, Hong Kong
Novartis Investigative Site Recruiting
HongKong, Hong Kong
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

No publications provided

Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT01766778     History of Changes
Other Study ID Numbers: CLAF237AHK01
Study First Received: January 9, 2013
Last Updated: April 28, 2014
Health Authority: Hong Kong: Department of Health

Keywords provided by Novartis:
type-2 diabetes mellitus, inadequately controlled Metformin

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Vildagliptin
Metformin
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions
Dipeptidyl-Peptidase IV Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on July 22, 2014