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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

December 20, 2011
March 11, 2013
December 2011
February 2013   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01497522 on ClinicalTrials.gov Archive Site
  • 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.
Same as current
Not Provided
Not Provided
 
Efficacy and Safety of Vildagliptin as add-on Therapy to Metformin in Patients With Type 2 Diabetes
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

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.

Not Provided
Interventional
Phase 3
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Diabetes Mellitus, Type 2
  • Drug: Vildagliptin
    vildagliptin 50 mg twice daily
    Other Name: LAF237
  • Drug: Placebo
    Matching Placebo of vildagliptin 50 mg twice daily
  • Experimental: Vildagliptin
    In addition to their stable dose of metformin monotherapy, patients should take vildagliptin 50 mg twice daily.
    Intervention: Drug: Vildagliptin
  • Placebo Comparator: Placebo
    In addition to their stable dose of metformin monotherapy, patients should take vildagliptin matching placebo.
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
183
February 2013
February 2013   (final data collection date for primary outcome measure)

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

Both
20 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Japan
 
NCT01497522
CLMF237A1301
Not Provided
Novartis ( Novartis Pharmaceuticals )
Novartis Pharmaceuticals
Not Provided
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
Novartis
March 2013

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