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Efficacy and Safety of Vildagliptin as add-on Therapy to Metformin in Patients With Type 2 Diabetes

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT01497522
First received: December 20, 2011
Last updated: March 11, 2013
Last verified: March 2013
History of Changes
  Purpose

The purpose of the study is to evaluate the efficacy and safety of vildagliptin 50 mg bid as an add-on therapy to metformin in Japanese patients with T2DM. This study is being conducted to support registration of the fixed-dose combination of vildagliptin and metformin for the treatment of Type 2 diabetes mellitus (T2DM) in Japan.


Condition Intervention Phase
Diabetes Mellitus, Type 2
 Drug: Vildagliptin
Drug: Placebo
 Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Multicenter, Double-Blind, Randomized, Parallel-Group Study to Compare the Effect of 12 Weeks Treatment With LAF237 50 mg Bid to Placebo as Add-On Therapy in Patients With Type 2 Diabetes Inadequately Controlled With Metformin Monotherapy

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 12 weeks between treatment groups [ Time Frame: Baseline to 12 weeks ] [ Designated as safety issue: No ]
    HbA1c will be performed on a blood sample obtained by study personnel and measured by high-performance liquid chromatography (HPLC) performed at a central laboratory.


Secondary Outcome Measures:
  • Change from baseline in HbA1c at 12 weeks within subgroups of metformin doses [ Time Frame: Baseline to 12 weeks ] [ Designated as safety issue: No ]
    HbA1c will be performed on a blood sample obtained by study personnel and measured by high-performance liquid chromatography (HPLC) performed at a central laboratory.

  • Change from baseline in Fasting plasma glucose (FPG) at 12 weeks [ Time Frame: Baseline to 12 weeks ] [ Designated as safety issue: No ]
    FPG will be performed on a blood sample obtained by study personnel and analyzed at a central laboratory.

  • Percentage of patients meeting Responder rates in HbA1c [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

    Responder rates will be categorized by predefined HbA1c value at 12 weeks :

    • Endpoint HbA1c ≤ 6.5%
    • Endpoint HbA1c ≤ 7%
    • Endpoint HbA1c ≤ 7% in patients with baseline HbA1c ≤ 8%

  • Number of patients with adverse events (including hypoglycemia), serious adverse events and death [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
    The occurrence of adverse events will be sought by non-directive questioning of the patient at each visit. Adverse events are defined as appearance or worsening of any undesirable symptom, sign (including an abnormal laboratory finding), or medical conditions. Serious adverse events are any untoward medical occurrences that result in death, are life threatening, require (or prolong) hospitalization, cause persistent or significant disability/incapacity, result in congenital anomalies or birth defects, or are other conditions which in judgment of investigators represent significant hazards.


Enrollment: 183
Study Start Date: December 2011
Study Completion Date: February 2013
Primary Completion Date: February 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Vildagliptin
In addition to their stable dose of metformin monotherapy, patients should take vildagliptin 50 mg twice daily.
 Drug: Vildagliptin
vildagliptin 50 mg twice daily
Other Name: LAF237
Placebo Comparator: Placebo
In addition to their stable dose of metformin monotherapy, patients should take vildagliptin matching placebo.
 Drug: Placebo
Matching Placebo of vildagliptin 50 mg twice daily

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with type 2 diabetes inadequately controlled with diet, exercise and oral anti-diabetic therapy.
  • HbA1c in the range of 7.0-10.0%
  • Body mass index in the range 20-35 kg/m2

Exclusion Criteria:

  • Type 1 diabetes, diabetes resulting from pancreatic injury, or secondary forms of diabetes
  • Significant heart diseases

Other protocol-defined inclusion/exclusion criteria may apply

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01497522

Locations
Japan
Novartis Investigative Site
Kitakyushu, Fukuoka, Japan, 800-0296
Novartis Investigative Site
Kurume, Fukuoka, Japan, 830-8543
Novartis Investigative Site
Ohkawa-city, Fukuoka, Japan, 831-0016
Novartis Investigative Site
Kawasaki-city, Kanagawa, Japan, 210-0014
Novartis Investigative Site
Yokohama, Kanagawa, Japan, 221-0802
Novartis Investigative Site
Kyoto-city, Kyoto, Japan, 615-0035
Novartis Investigative Site
Takatsuki, Osaka, Japan, 569-1096
Novartis Investigative Site
Ageo-city, Saitama, Japan, 362-8588
Novartis Investigative Site
Bunkyo-ku, Tokyo, Japan, 113-0031
Novartis Investigative Site
Edogawa-ku, Tokyo, Japan, 134-0084
Novartis Investigative Site
Hachioji, Tokyo, Japan, 192-0046
Novartis Investigative Site
Kiyose, Tokyo, Japan, 204-0021
Novartis Investigative Site
Minato-ku, Tokyo, Japan, 105-7390
Novartis Investigative Site
Minato-ku, Tokyo, Japan, 108-0075
Novartis Investigative Site
Nerima-ku, Tokyo, Japan, 177-0051
Novartis Investigative Site
Shinagawa-ku, Tokyo, Japan, 141-0032
Novartis Investigative Site
Toshima-ku, Tokyo, Japan, 171-0021
Novartis Investigative Site
Fukuoka, Japan, 819-0168
Novartis Investigative Site
Fukuoka, Japan, 810-0001
Novartis Investigative Site
Kyoto, Japan, 607-8062
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: NCT01497522     History of Changes
Other Study ID Numbers: CLMF237A1301
Study First Received: December 20, 2011
Last Updated: March 11, 2013
Health Authority: United States: Food and Drug Administration
Pharmaceuticals and Medical Devices Agency (PMDA): Japan

Keywords provided by Novartis:
Vildagliptin
Type 2 diabetes
HbA1c
Fasting plasma glucose

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 May 21, 2013