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

This study is not yet open for participant recruitment.
Verified April 2013 by Novartis
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT01582243
First received: April 18, 2012
Last updated: April 2, 2013
Last verified: April 2013
History of Changes
  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:

U.S. FDA Resources

Further study details as provided by Novartis:

Primary Outcome Measures:
  • Change from baseline in glycosylated hemoglobin (HbA1c) at week 24 [ Time Frame: Baseline, Week 24 +/- 4 weeks ] [ Designated as safety issue: No ]
    HbA1c analysis will be performed on a blood sample obtained by study personnel at every visit.


Secondary Outcome Measures:
  • Change from baseline in glycosylated hemoglobin (HbA1c) at week 12 [ Time Frame: Baseline, week 12 +/- 4 weeks ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ 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.

  • Number of patients with adverse events, serious adverse events and hypoglycemic events [ Time Frame: 24 weeks (+/- 4 weeks) ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 40
Study Start Date: March 2013
Estimated Study Completion Date: September 2014
Estimated Primary Completion Date: September 2014 (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
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Outpatients who are 20 years of age or older with diagnosis of T2DM
  • Patients who have been treated with stable dose of metformin (≥1000 mg/day) monotherapy at least 4 weeks prior to Visit 1 and have failed to achieve the glucose control goal (defined as HbA1c ≤6.5%)

Exclusion Criteria:

  • Patients with renal dysfunction defined as creatinine clearance <50 ml/min at Visit 1
  • Patients with history of hepatic impairment but not limited to those with pretreatment AST or ALT >2.5x ULN at Visit 1

Other protocol-defined inclusion/exclusion criteria may apply.

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01582243

Contacts
Contact: Novartis Pharmaceuticals +41613241111
Contact: Novartis Pharmaceuticals

Locations
Taiwan
Novartis Investigative Site Not yet recruiting
Changhua, Taiwan, 500
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: NCT01582243     History of Changes
Other Study ID Numbers: CLAF237ATW03
Study First Received: April 18, 2012
Last Updated: April 2, 2013
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
Pharmacologic Actions
Dipeptidyl-Peptidase IV Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on June 17, 2013