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

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:
NCT01582243
First received: April 18, 2012
Last updated: April 15, 2014
Last verified: April 2014
  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:
  • 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: April 2013
Estimated Study Completion Date: June 2015
Estimated Primary Completion Date: June 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
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
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

Contacts
Contact: Novartis Pharmaceuticals +41613241111
Contact: Novartis Pharmaceuticals

Locations
Taiwan
Novartis Investigative Site 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 15, 2014
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
Endocrine System Diseases
Glucose Metabolism Disorders
Metabolic Diseases
Metformin
Vildagliptin
Dipeptidyl-Peptidase IV Inhibitors
Enzyme Inhibitors
Hypoglycemic Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Protease Inhibitors

ClinicalTrials.gov processed this record on October 23, 2014