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Safety and Efficacy of Vildagliptin Plus Metformin (SPC) Treatment in Type 2 Diabetes Mellitus Patients

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ClinicalTrials.gov Identifier: NCT01582243
Recruitment Status : Completed
First Posted : April 20, 2012
Results First Posted : November 3, 2016
Last Update Posted : November 3, 2016
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Tracking Information
First Submitted Date  ICMJE April 18, 2012
First Posted Date  ICMJE April 20, 2012
Results First Submitted Date  ICMJE September 15, 2016
Results First Posted Date  ICMJE November 3, 2016
Last Update Posted Date November 3, 2016
Study Start Date  ICMJE April 2013
Actual Primary Completion Date September 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 15, 2016)
Mean Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 24 [ Time Frame: Baseline, Week 24 ]
HbA1c analysis will be performed on a blood sample obtained by study personnel.
Original Primary Outcome Measures  ICMJE
 (submitted: April 19, 2012)
Change from baseline in glycosylated hemoglobin (HbA1c) at week 24 [ Time Frame: Baseline, Week 24 +/- 4 weeks ]
HbA1c analysis will be performed on a blood sample obtained by study personnel at every visit.
Change History Complete list of historical versions of study NCT01582243 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: September 15, 2016)
  • Mean Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 12 [ Time Frame: Baseline, week 12 ]
    HbA1c analysis will be performed on a blood sample obtained by study personnel.
  • Mean Change From Baseline in Fasting Plasma Glucose(FPG) at Week 12 and 24 [ Time Frame: Baseline, week 12, week 24 ]
    FPG analysis will be performed on a blood sample obtained by study personnel.
  • Mean Change From Baseline in Postprandial Plasma Glucose(PPG) at Week 12 and 24 [ Time Frame: Baseline, week, week 24 ]
    PPG analysis will be performed on a blood sample obtained by study personnel.
  • Mean Change From Baseline in Mean Amplitude of Glycemic Excursions (MAGE) Detected by Continuous Glucose Monitoring System (CGMS) After 24-week [ Time Frame: Baseline, week 24 ]
    Mean amplitude of glycemic excursions (MAGE), which was used to quantify major swings of glycaemia and assess intra-day glycemic variability, was measured by inserting continuous glucose monitoring system (CGMS) in patients for 72 consecutive hours before Day 1 (Visit 2) and Week 24 (Visit 5). In order to unify the different initial time and time of completion in each patient, only the data recorded from Day 2 00:00 to Day 3 23:59 with total 48 hours were analyzed.
  • The Percentage of Patients Achieving the Two Glycemic Goals After 12- and 24-week Treatment [ Time Frame: week 12, week 24 ]
    Patients reaching glycemic goal of HbA1c ≤ 6.5% and ≤ 7.0% at week 12 and 24 will be calculated respectively.
Original Secondary Outcome Measures  ICMJE
 (submitted: April 19, 2012)
  • Change from baseline in glycosylated hemoglobin (HbA1c) at week 12 [ Time Frame: Baseline, week 12 +/- 4 weeks ]
    HbA1c analysis will be performed on a blood sample obtained by study personnel at every visit.
  • Change from baseline in fasting plasma glucose(FPG) at week 12 and 24 [ Time Frame: Baseline, week 12 +/- 4 weeks, week 24 +/- 4 weeks ]
    FPG analysis will be performed on a blood sample obtained by study personnel at every visit.
  • Change from baseline in postprandial plasma glucose(PPG) at week 12 and 24 [ Time Frame: Baseline, week 12 +/- 4, week 24 +/- 4 ]
    PPG analysis will be performed on a blood sample obtained by study personnel at every visit.
  • Change from baseline in mean amplitude of glycemic excursions (MAGE) by 72-hour continuous glucose monitoring system (CGMS) after 24-week [ Time Frame: Baseline, week 24 +/- 4 weeks ]
    CGMS sensor will be inserted 3 days prior to visit 2 and removed at visit 2 (day 1), and 3 days prior to Visit 5 (Week 24 ±4 weeks) and removed at Visit 5. 72-hr CGMS records before and after vildagliptin treatment will be collected.
  • Percentage of patients reaching the glycemic goal at week 12 and 24 [ Time Frame: week 12 +/- 4 weeks, week 24 + / - 4 weeks ]
    Patients reaching glycemic goal of HbA1c ≤ 6.5% and ≤ 7.0% at week 12 and 24 will be calculated respectively.
  • Number of patients with adverse events, serious adverse events and hypoglycemic events [ Time Frame: 24 weeks (+/- 4 weeks) ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Safety and Efficacy of Vildagliptin Plus Metformin (SPC) Treatment in Type 2 Diabetes Mellitus Patients
Official Title  ICMJE A Prospective, Open-label, Interventional Study to Assess the HbA1c Change an 24-hr Glucose Fluctuation After Vildagliptin Plus Metformain (SPC) Treatment in Metformin Monotherapy Uncontrolled Type 2 Diabetes Mellitus Patients
Brief Summary This study will assess the efficacy of vildagliptin plus metformin (SPC) treatment in type 2 diabetes mellitus patients uncontrolled by metformin monotherapy after 24 weeks treatment
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Diabetes Mellitus, Type 2
Intervention  ICMJE Drug: Vildagliptin
Vildagliptin 50 mg plus metformin 500 mg as Single Pill combination (SPC)
Other Name: LAF237, Galvus Met
Study Arms  ICMJE Experimental: Vildagliptin plus metformin (SPC)
Eligible participants received oral vildagliptin 50 mg plus metformin 500 mg (SPC) twice daily from week 1 to week 24.
Intervention: Drug: Vildagliptin
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 2, 2013)
40
Original Estimated Enrollment  ICMJE
 (submitted: April 19, 2012)
150
Actual Study Completion Date  ICMJE September 2015
Actual Primary Completion Date September 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion criteria

  1. Outpatients who were 20 years of age and older with diagnosis of T2DM.
  2. Patients who had been treated with stable dose of metformin (≥1000 mg/day) monotherapy at least 4 weeks prior to Visit 1 and had failed to achieve the glucose control goal. The glucose control goal was defined as HbA1c ≤ 6.5%.
  3. Male or female with child-bearing potential agreed to use an effective method of contraception approved by the investigator during the study.
  4. Understood the nature of the study, and had signed informed consent form.

Exclusion criteria

  1. Patients with contraindications mentioned in the Summary of Product Characteristics for vildagliptin or metformin.
  2. Patients with renal dysfunction defined as creatinine clearance < 60 ml/min at Visit 1.
  3. Patients with history of hepatic impairment, including but not limited to those with pretreatment AST or ALT > 3 ULN at Visit 1.
  4. Female patients who needed to lactate during the study.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 20 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Taiwan
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01582243
Other Study ID Numbers  ICMJE CLAF237ATW03
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Novartis ( Novartis Pharmaceuticals )
Study Sponsor  ICMJE Novartis Pharmaceuticals
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
PRS Account Novartis
Verification Date September 2016

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