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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis
ClinicalTrials.gov Identifier:
NCT01224366
First received: October 18, 2010
Last updated: September 4, 2012
Last verified: September 2012
History of Changes
  Purpose

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

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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.

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Novartis:

Primary Outcome Measures:
  • HbA1c reduction [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • HbA1c reduction in subpopulation treated with insulin and with metformin [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • HbA1c reduction in subpopulation treated with insulin and without metformin [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • Reduction in FPG (overall and subpopulations) [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • Responder rates (overall and subpopulations) [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • Incidence of hypoglycemia and severe hypoglycemia (overall and subpopulations) [ Time Frame: 24 weeks ] [ Designated as safety issue: Yes ]

Enrollment: 448
Study Start Date: September 2010
Study Completion Date: October 2011
Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Vildagliptin Drug: Vildagliptin
Placebo Comparator: Placebo Drug: Placebo

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01224366

  Show 66 Study Locations
Sponsors and Collaborators
Novartis
Investigators
Study Chair: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

No publications provided

Responsible Party: Novartis
ClinicalTrials.gov Identifier: NCT01224366     History of Changes
Other Study ID Numbers: CLAF237A23135
Study First Received: October 18, 2010
Last Updated: September 4, 2012
Health Authority: Australia: Department of Health and Ageing Therapeutic Goods Administration
Belgium: Federal Agency for Medicinal Products and Health Products
Czech Republic: State Institute for Drug Control
Germany: Federal Institute for Drugs and Medical Devices
Guatemala: Ministry of Public Health and Social Assistance
Hong Kong: Department of Health
Hungary: National Institute of Pharmacy
India: Central Drugs Standard Control Organization
Romania: National Medicines Agency
Slovakia: State Institute for Drug Control
United Kingdom: Medicines and Healthcare Products Regulatory Agency

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
Pharmacologic Actions
Dipeptidyl-Peptidase IV Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 19, 2013