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

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:

MedlinePlus related topics: Diabetes Medicines Diabetes Type 2

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

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 Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Vildagliptin Dipeptidyl-Peptidase IV Inhibitors	Enzyme Inhibitors Hypoglycemic Agents Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Physiological Effects of Drugs Protease Inhibitors

ClinicalTrials.gov processed this record on February 27, 2015