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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01766778
First Posted: January 11, 2013
Last Update Posted: May 15, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
January 9, 2013
January 11, 2013
February 23, 2017
April 10, 2017
May 15, 2017
May 13, 2013
October 22, 2015   (Final data collection date for primary outcome measure)
Change of Glycosylated Hemoglobin A1c (HbA1c) From Baseline to Month 12 [ Time Frame: Baseline, Month 12 (weeK 52) ]
HbA1c is an integrated measure of average glucose concentration in plasma in the last 2-3 months. Blood samples were collected to analyze HbA1c
Mean change of HbA1c from Baseline to Month 12 [ Time Frame: Baseline, Month 12 (weeK 52) ]
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
  • Change of Glycosylated Hemoglobin A1c (HbA1c) From Baseline to Month 3, 6, 9 and 12 (Based on MMRM Analysis) [ Time Frame: Baseline, Month 3, 6, 9 and 12 ]
    HbA1c is an integrated measure of average glucose concentration in plasma in the last 2-3 months. Blood samples were collected to analyze HbA1c. Mixed Model of Repeated Measures (MMRM) was used to analyze this outcome. For the MMRM analysis, the model includes terms for treatment, period, treatment-by-period interaction and baseline value, and further adjusted by age, pre-existing hypertension and microvascular and macrovascular complications for diabetes mellitus. The variables selected for baseline adjustment were based on the lowest AIC.
  • Change in Fasting Plasma Glucose (FPG) From Baseline to Month 3, 6, 9 and 12 (Based on MMRM Analysis) [ Time Frame: Baseline, Month 3, 6, 9 and 12 ]
    Blood samples were collected to analyze fasting plasma glucose. Mixed Model of Repeated Measures (MMRM) was used to analyze this outcome. For the MMRM analysis, the model included terms for treatment, period, treatment-by-period interaction and baseline value, and further adjusted by pre-existing hypertension. The variable selected for baseline adjustment was based on the lowest AIC.
  • Percentage of Patients Achieving Good Glycemic Control [ Time Frame: Month 3, 6, 9, 12 ]
    Blood samples were collected to analyze HbA1c. Good glycemic control is defined as patient achieving Hb1Ac < 7.0%. Percentage of patients who achieved HbA1c less than 7.0% at month 3, 6, 9 and 12 were reported for this endpoint.
  • Percentage of Overall Drug Compliance in 12 Months [ Time Frame: Month 12 ]
    The overall drug compliance (%) = (Observed Consumption / Expected Consumption) x 100% Where (Observed Consumption / Expected Consumption) = [1- (Number of missing tablets from all visits/(sum of Allocated Daily Dosage (in tablets) from all visits × No. of Days between the Date Dispensed and the Date Returned))]
  • Number of Patients With Adverse Events, Serious Adverse Events and Death as an Assessment of Overall Safety and Tolerability [ Time Frame: Month 12 ]
    This analysis reported 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 was reported.
  • Mean change in FPG from Baseline to Month 12 [ Time Frame: Baseline, Month 12 (week 52) ]
    To examine the change in FBG from baseline to Month 12
  • Percentage of patients with HbA1c <7.0% [ Time Frame: Month 12 ]
    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 ]
    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 ]
    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 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.
Not Provided
Interventional
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Type-2 Diabetes Mellitus
  • Drug: LAF237 (vildagliptin)
    Vildagliptin 50mg capsule
    Other Name: LAF237
  • Drug: Metformin
    Metformin maximum tolerance dose
  • Active Comparator: LAF237 (vildagliptin) 50mg once daily (QD)
    Vildagliptin 50mg QD plus stabilized or maximum tolerated dose of Metformin
    Interventions:
    • Drug: LAF237 (vildagliptin)
    • Drug: Metformin
  • Active Comparator: LAF237 (vildagliptin) 50mg twice daily (BID)
    Vildagliptin 50mg BID plus stabilized or maximum tolerated dose of Metformin
    Interventions:
    • Drug: LAF237 (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.
 
Completed
117
October 22, 2015
October 22, 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

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Hong Kong
 
 
NCT01766778
CLAF237AHK01
No
Not Provided
Not Provided
Novartis ( Novartis Pharmaceuticals )
Novartis Pharmaceuticals
Not Provided
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
Novartis
April 2017

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