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Efficacy and Safety of Vildagliptin 50mg Bid as an add-on Therapy to Insulin With or Without Metformin, in Patients With Type 2 Diabetes Mellitus

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT01582230
First received: April 18, 2012
Last updated: August 29, 2013
Last verified: August 2013

April 18, 2012
August 29, 2013
April 2012
May 2013   (final data collection date for primary outcome measure)
  • Change from baseline in glycosylated hemoglobin (HbA1c) at study endpoint, assessed in overall study population [ Time Frame: Baseline and every study visit up to 24 weeks ] [ Designated as safety issue: No ]
    HbA1c analysis will be performed on a blood sample obtained by study personnel at every visit and measured by ion exchange HPLC. Study endpoint is defined as final available post- randomization assessment obtained at any visit prior to or at the start of major change in insulin use, up to final scheduled study visit (week 24 visit) inclusive.
  • Change from baseline in glycosylated hemoglobin (HbA1c) at study endpoint, assessed in Chinese study population [ Time Frame: Baseline and every study visit up to 24 weeks ] [ Designated as safety issue: No ]
    HbA1c analysis will be performed on a blood sample obtained by study personnel at every visit and measured by ion exchange HPLC. Study endpoint is defined as final available post- randomization assessment obtained at any visit prior to or at the start of major change in insulin use, up to final scheduled study visit (week 24 visit) inclusive.
Same as current
Complete list of historical versions of study NCT01582230 on ClinicalTrials.gov Archive Site
  • Number of patients with adverse events, serious adverse events and death on over all population [ Time Frame: 24 weeks ] [ Designated as safety issue: Yes ]
    Adverse events are defined as any unfavorable and unintended diagnosis, symptom, sign (including an abnormal laboratory finding), syndrome or disease which either occurs during study, having been absent at baseline, or, if present at baseline, appears to worsen. 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.
  • Change from baseline after 24 weeks of treatment in fasting plasma glucose (FPG)on overall population [ Time Frame: Baseline, week 24 ] [ Designated as safety issue: No ]
    FPG will be performed on the blood samples collected at all every study visits from baseline to week 24.
  • Percentage of patients meeting responder criteria after 24 weeks treatment on overall population [ Time Frame: After 24 weeks ] [ Designated as safety issue: No ]

    Responder rate will be analyzed in the following categories:

    • Endpoint HbA1c ≤ 6.5%
    • Endpoint HbA1c < 7%
    • Endpoint HbA1c <7% in patients with baseline HbA1c ≤ 8% The percentage of patients meeting each of the responder criteria as described, as well as the percentage of patients meeting any of these criteria in each treatment group will be computed
  • Number of patients with adverse events, serious adverse events and death on Chinese population [ Time Frame: 24 weeks ] [ Designated as safety issue: Yes ]
    Adverse events are defined as any unfavorable and unintended diagnosis, symptom, sign (including an abnormal laboratory finding), syndrome or disease which either occurs during study, having been absent at baseline, or, if present at baseline, appears to worsen. 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.
  • Change from baseline after 24 weeks of treatment in fasting plasma glucose (FPG) on Chinese population [ Time Frame: Baseline, week 24 ] [ Designated as safety issue: No ]
    FPG will be performed on the blood samples collected at all every study visits from baseline to week 24.
  • Percentage of patients meeting responder criteria after 24 weeks treatment on Chinese population [ Time Frame: After 24 weeks ] [ Designated as safety issue: No ]
    Responder rate will be analyzed in the following categories: • Endpoint HbA1c ≤ 6.5% • Endpoint HbA1c < 7% • Endpoint HbA1c <7% in patients with baseline HbA1c ≤ 8% The percentage of patients meeting each of the responder criteria as described, as well as the percentage of patients meeting any of these criteria in each treatment group will be computed
Same as current
Not Provided
Not Provided
 
Efficacy and Safety of Vildagliptin 50mg Bid as an add-on Therapy to Insulin With or Without Metformin, in Patients With Type 2 Diabetes Mellitus
A 24-week, Multi-center, Double-blind, Randomized, Placebo-controlled, Parallel-group Study to Assess the Efficacy and Safety of Vildagliptin 50mg Bid as an add-on Therapy to Insulin, With or Without Metformin, in Patients With Type 2 Diabetes Mellitus

The purpose of this study is to assess the efficacy and safety of vildagliptin 50mg bid add-on therapy to improve overall glycemic control in patients with type 2 diabetes mellitus inadequately controlled on insulin with or without metformin treatment.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Type 2 Diabetes Mellitus
  • Drug: Vildagliptin
    Patient will receive vildagliptin 50mg twice daily (bid) in addition to their stable dose of insulin with or without metformin for 24 weeks
    Other Name: Galvus, LAF237
  • Drug: Placebo
    Patient will receive matching placebo to vildagliptin in addition to their stable dose of insulin with or without metformin for 24 weeks
  • Experimental: Vildagliptin
    Eligible patients will receive vildagliptin 50 mg in addition to their stable dose of insulin with or without metformin. One tablet should be taken twice daily as one tablet before breakfast meal and one tablet before the evening meal for 24 weeks.
    Intervention: Drug: Vildagliptin
  • Placebo Comparator: Placebo
    Eligible patients will receive matching placebo in addition to their stable dose of insulin with or without metformin. One tablet should be taken twice daily as one tablet before breakfast meal and one tablet before the evening meal for 24 weeks.
    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
293
May 2013
May 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Patients with confirmed diagnosis of Type2 diabetes mellitus (T2DM) by standard criteria
  • C-peptide >0.6 ng/ml (>0.20 nmol/L).
  • HbA1c ≥7.5 to ≤11% at Visit 1
  • Treatment with stable, once or twice daily doses (maximum dose of < 1 unit/kg/day) of basal (long-acting, intermediate-acting) insulin alone or pre-mixed insulin for at least 12 weeks prior to Visit 1. Stable is defined as ±10% of the Visit 1 dose during the previous 12 weeks
  • Patients receiving metformin must be on a stable dose of metformin (at least 1500 mg daily or a maximally tolerated dose) for at least 12 weeks prior to Visit 1
  • Body Mass Index (BMI) ≥20 to ≤40 kg/m2 at Visit

Exclusion Criteria:

Patients fulfilling any of the following criteria are not eligible for participation in the study

  • Fasting plasma glucose (FPG) ≥240 mg/dl (13.3 mmol/L) at Visit 1
  • Pregnant or lactating women
  • Acute metabolic diabetes complications such as ketoacidosis or hyperosmolar state (coma) within the past 6 months
  • Current diagnosis of congestive heart failure (NYHA III or IV).
  • Myocardial infarction (MI) within the past 6 months
  • Liver disease such as cirrhosis or chronic active hepatitis

Other protocol defined inclusion/excusion criteria may apply

Both
18 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
China,   Philippines,   Singapore,   Thailand
 
NCT01582230
CLAF237A23155
Not Provided
Novartis ( Novartis Pharmaceuticals )
Novartis Pharmaceuticals
Not Provided
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
Novartis
August 2013

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