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
  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:


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
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: 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, Type 2
Diabetes Mellitus
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 September 16, 2014