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

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ClinicalTrials.gov Identifier: NCT01224366
Recruitment Status : Completed
First Posted : October 20, 2010
Last Update Posted : February 23, 2017
Sponsor:
Information provided by (Responsible Party):
Novartis

Study Description
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
To assess the efficacy and safety of vildagliptin add-on therapy to reduce HbA1c in patients with T2DM inadequately controlled by insulin, with or without concurrent metformin therapy.

Condition or disease Intervention/treatment Phase
Type 2 Diabetes Mellitus Drug: Vildagliptin Drug: Placebo Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 448 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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.
Study Start Date : September 2010
Actual Primary Completion Date : October 2011
Actual Study Completion Date : October 2011

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U.S. FDA Resources

Arms and Interventions
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Arm Intervention/treatment
Experimental: Vildagliptin Drug: Vildagliptin
Placebo Comparator: Placebo Drug: Placebo


Outcome Measures
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Primary Outcome Measures :
  1. HbA1c reduction [ Time Frame: 24 weeks ]

Secondary Outcome Measures :
  1. HbA1c reduction in subpopulation treated with insulin and with metformin [ Time Frame: 24 weeks ]
  2. HbA1c reduction in subpopulation treated with insulin and without metformin [ Time Frame: 24 weeks ]
  3. Reduction in FPG (overall and subpopulations) [ Time Frame: 24 weeks ]
  4. Responder rates (overall and subpopulations) [ Time Frame: 24 weeks ]
  5. Incidence of hypoglycemia and severe hypoglycemia (overall and subpopulations) [ Time Frame: 24 weeks ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Confirmed diagnosis of T2DM
  • On a stable dose of insulin as defined by the protocol
  • On a stable does of metformin (if applicable) as defined by the protocol
  • Age 18 to 80 years
  • HbA1c of 7.5 to 11.0%
  • Body Mass Index (BMI) 22 to 40 kg/m2

Exclusion Criteria:

  • Type 1 diabetes
  • Short-acting or rapid-acting insulin
  • Pregnancy or lactation
  • Evidence of serious diabetic complications
  • Evidence of serious cardiovascular complications
  • Laboratory value abnormalities as defined by the protocol
  • Other protocol-defined inclusion/exclusion criteria may apply
Contacts and Locations
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01224366


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Sponsors and Collaborators
Novartis
Investigators
Study Chair: Novartis Pharmaceuticals Novartis Pharmaceuticals
More Information
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Additional Information:
Results for CLAF237A23135 from the Novartis Clinical Trials website  This link exits the ClinicalTrials.gov site

Publications of Results:

Responsible Party: Novartis
ClinicalTrials.gov Identifier: NCT01224366     History of Changes
Other Study ID Numbers: CLAF237A23135
First Posted: October 20, 2010    Key Record Dates
Last Update Posted: February 23, 2017
Last Verified: February 2017

Keywords provided by Novartis:
Add-on to insulin

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Vildagliptin
Insulin
 Hypoglycemic Agents
Physiological Effects of Drugs
Dipeptidyl-Peptidase IV Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action