Vildagliptin 100 mg Once Daily vs. Placebo as Add-on Therapy in Patients With Type 2 Diabetes Inadequately Controlled With Metformin - Full Text View

Sponsored by:	Novartis
Information provided by:	Novartis
ClinicalTrials.gov Identifier:	NCT00494884

Purpose

This study will investigate efficacy and safety of vildagliptin in patients with low baseline levels starting at an HbA1C level of 6.5% to support convenient early intervention with combination therapies. In parallel, morning and evening dosing will be evaluated in this patient population for the first time.

Condition	Intervention	Phase
Diabetes Mellitus, Type 2	Drug: vildagliptin	Phase III

MedlinePlus related topics: Diabetes

Drug Information available for: Metformin Metformin hydrochloride Dextrose Vildagliptin

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	A Multicenter, Randomized, Double-Blind, Parallel-Group Study to Investigate the Glucose Lowering Effect, Safety and Tolerability of 24 Weeks Treatment With Vildagliptin 100 mg o.d. Versus Placebo Followed by a 12 Weeks Treatment Period With Open-Label Vildagliptin 100 mg o.d. as Add-on Therapy in Patients With Type 2 Diabetes Inadequately Controlled With Metformin

Further study details as provided by Novartis:

Primary Outcome Measures:

Change from baseline in HbA1c [ Time Frame: 24 weeks ]

Secondary Outcome Measures:

Change from baseline in fasting plasma glucose [ Time Frame: 24 weeks ]
Adverse event profiles including gastrointestinal tolerability and hypoglycemia [ Time Frame: 24 weeks ]
Responder rates [ Time Frame: 24 weeks ]
Change from baseline in insulin and proinsulin in a subgroup of patients [ Time Frame: 24 weeks ]
Change in systolic and diastolic blood pressure [ Time Frame: 24 weeks ]

Study Start Date:

June 2007

Eligibility

Ages Eligible for Study:	18 Years to 85 Years
Genders Eligible for Study:	Both

Criteria

Inclusion Criteria:

Male, non-fertile female or female of childbearing potential using a medically approved birth control method
Patients who have received metformin for at least three months prior to visit 1 and have been on a stable dose for a minimum of 8 weeks prior to visit 1
Agreement to maintain the same dose of metformin throughout the study
Age in the range of 18-85 years inclusive.
HbA1c in the range of 6.5 - 8.0% (inclusive) at visit 1
Agreement to maintain prior diet and exercise habits during the full course of the study
Ability to comply with all study requirements and signed informed consent to participate in the study.

Exclusion Criteria:

Pregnant or lactating female

A history of:

type 1 diabetes, diabetes that is a result of pancreatic injury, or secondary forms of diabetes, e.g. Cushing's syndrome and acromegaly.
acute metabolic diabetic complications such as ketoacidosis or hyperosmolar state (coma) within the past 6 months.

Any of the following significant laboratory abnormalities:

ALT, AST greater than 2 times the upper limit of the normal range at visit 1.
Direct bilirubin greater than the upper limit of the normal range at visit 1.
Serum creatinine levels equal to or greater than 1.5 mg/dL (132 umol/L) males, equal to or greater than 1.4 mg/dL (123 umol/L) females, or a history of abnormal creatinine clearance at visit 1.
Clinically significant TSH values outside of normal range at visit 1.
Clinically significant laboratory abnormalities, confirmed by repeat measurement, other than hyperglycemia, hyperinsulinemia, and glycosuria at visit 1 Treatment with any oral anti-diabetic other than metformin within 3 months prior to visit 1

Other protocol-defined inclusion/exclusion criteria may apply

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00494884

Locations

Germany
Novartis Investigative Site
Bochum, Germany

Sponsors and Collaborators

Novartis

Investigators

Study Director:

Prof. Dr. W. E. Schmidt

Ruhr-Universitat Bochum, Medizinische Klinik, St. Josef Hospital, Gudrunstr. 56, D-44791 Bochum, Telefon: 0234-509-2311, Telefax: 0234-509-2309

More Information

Study ID Numbers:	CLAF237ADE02
Study First Received:	June 29, 2007
Last Updated:	December 17, 2007
ClinicalTrials.gov Identifier:	NCT00494884
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Novartis:

Type 2 diabetes
vildagliptin
metformin combination

Study placed in the following topic categories:

Metabolic Diseases
Metformin
Diabetes Mellitus, Type 2
Diabetes Mellitus
Endocrine System Diseases

Endocrinopathy
Metabolic disorder
Glucose Metabolism Disorders
Vildagliptin

Additional relevant MeSH terms:

Dipeptidyl-Peptidase IV Inhibitors
Hypoglycemic Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs

Enzyme Inhibitors
Pharmacologic Actions
Protease Inhibitors

ClinicalTrials.gov processed this record on January 16, 2009