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

January 9, 2013
April 28, 2014
May 2013
April 2015   (final data collection date for primary outcome measure)
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
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 Vildapliptin (50mg once daily or 50 mg twice daily) add-on regimen
Complete list of historical versions of study NCT01766778 on ClinicalTrials.gov Archive Site
  • 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.
  • Mean change in FPG from Baseline to Month 12 [ Time Frame: Baseline, Month 12 (week 52) ] [ Designated as safety issue: No ]
    To examine the change in FBG 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.
Not Provided
Not Provided
 
Early add-on Vildagliptin in Patients With Type 2 Diabetes Inadequately Controlled by Metformin
A Local Phase IV, Multicenter, Open-label Study to Evaluate Early add-on Vildagliptin in Patients With Type 2 Diabetes Inadequately Controlled by Metformin

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.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Type-2 Diabetes Mellitus
  • Drug: Vildagliptin
    Vildagliptin 50mg capsule
    Other Names:
    • Galvus
    • LAF237
  • Drug: Metformin
    Metformin maximum tolerance dose
  • Active Comparator: Vildagliptin 50mg once daily (QD)
    Vildagliptin 50mg QD plus stabilized or maximum tolerated dose of Metformin
    Interventions:
    • Drug: Vildagliptin
    • Drug: Metformin
  • Active Comparator: Vildagliptin 50mg twice daily (BID)
    Vildagliptin 50mg BID plus stabilized or maximum tolerated dose of Metformin
    Interventions:
    • Drug: Vildagliptin
    • Drug: Metformin
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
170
April 2015
April 2015   (final data collection date for primary outcome measure)

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

Both
18 Years and older
No
Contact: Novartis Pharmaceuticals +41613241111
Contact: Novartis Pharmaceuticals
Hong Kong
 
NCT01766778
CLAF237AHK01
No
Novartis ( Novartis Pharmaceuticals )
Novartis Pharmaceuticals
Not Provided
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
Novartis
April 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP