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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT01582243
First received: April 18, 2012
Last updated: September 15, 2016
Last verified: September 2016
  Purpose
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

Condition Intervention Phase
Diabetes Mellitus, Type 2
Drug: Vildagliptin
Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Novartis:

Primary Outcome Measures:
  • Mean Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 24 [ Time Frame: Baseline, Week 24 ] [ Designated as safety issue: No ]
    HbA1c analysis will be performed on a blood sample obtained by study personnel.


Secondary Outcome Measures:
  • Mean Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 12 [ Time Frame: Baseline, week 12 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Patients reaching glycemic goal of HbA1c ≤ 6.5% and ≤ 7.0% at week 12 and 24 will be calculated respectively.


Enrollment: 40
Study Start Date: April 2013
Study Completion Date: September 2015
Primary Completion Date: September 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Drug: Vildagliptin
Vildagliptin 50 mg plus metformin 500 mg as Single Pill combination (SPC)
Other Name: LAF237, Galvus Met

  Eligibility

Ages Eligible for Study:   20 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  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: NCT01582243

Locations
Taiwan
Novartis Investigative Site
Changhua, Taiwan, 500
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01582243     History of Changes
Other Study ID Numbers: CLAF237ATW03 
Study First Received: April 18, 2012
Results First Received: September 15, 2016
Last Updated: September 15, 2016
Health Authority: Taiwan: Department of Health

Keywords provided by Novartis:
Diabetes Mellitus, type 2
vildagliptin

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
Dipeptidyl-Peptidase IV Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on December 02, 2016