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
  Purpose

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.


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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Novartis:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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


Enrollment: 293
Study Start Date: April 2012
Study Completion Date: May 2013
Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
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
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.
Drug: Placebo
Patient will receive matching placebo to vildagliptin in addition to their stable dose of insulin with or without metformin for 24 weeks

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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

  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: NCT01582230

Locations
China, Beijing
Novartis Investigative Site
Beijing, Beijing, China, 100730
China, Hunan
Novartis Investigative Site
Changsha, Hunan, China, 410003
Novartis Investigative Site
Changsha City, Hunan, China, 410011
China, Jiangsu
Novartis Investigative Site
Nanjing, Jiangsu, China, 210006
Novartis Investigative Site
Wu Xi, Jiangsu, China, 214023
China, Jiangxi
Novartis Investigative Site
Nanchang, Jiangxi, China, 330006
China, Liaoning
Novartis Investigative Site
Shenyang, Liaoning, China, 110003
China, Shandong
Novartis Investigative Site
Jinan, Shandong, China, 250031
China, Shanxi
Novartis Investigative Site
Xi'an, Shanxi, China, 710032
China, Sichuan
Novartis Investigative Site
Chengdu, Sichuan, China, 610072
China
Novartis Investigative Site
Beijing, China
Novartis Investigative Site
Shanghai, China, 200025
Novartis Investigative Site
Tianjin, China, 300052
Philippines
Novartis Investigative Site
Metro Manila, Philippines, 1500
Novartis Investigative Site
Pasay City, Philippines, 1300
Novartis Investigative Site
Quezon City, Philippines, 1102
Singapore
Novartis Investigative Site
Singapore, Singapore, 169608
Novartis Investigative Site
Singapore, Singapore, 768825
Thailand
Novartis Investigative Site
Bangkok, Thailand, 10400
Novartis Investigative Site
Bangkok, Thailand, 10330
Novartis Investigative Site
Khon Kaen, Thailand, 40002
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: NCT01582230     History of Changes
Other Study ID Numbers: CLAF237A23155
Study First Received: April 18, 2012
Last Updated: August 29, 2013
Health Authority: China: States Food and Drug Administration
Philippines: Department of Health; Bureau of Food and Drugs
Singapore: Health Products Regulation Group (HPRG), Health Sciences Authority
Thailand: Food and Drug Administration

Keywords provided by Novartis:
Type 2 diabetes mellitus
Vildagliptin

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Insulin, Globin Zinc
Vildagliptin
Metformin
Insulin
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 September 18, 2014