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

This study has been completed.
Sponsor:
Information provided by:
Novartis
ClinicalTrials.gov Identifier:
NCT00494884
First received: June 29, 2007
Last updated: July 13, 2009
Last verified: July 2009
  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 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
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

Resource links provided by NLM:


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
Primary Completion Date: July 2008 (Final data collection date for primary outcome measure)
  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

No publications provided

ClinicalTrials.gov Identifier: NCT00494884     History of Changes
Other Study ID Numbers: CLAF237ADE02
Study First Received: June 29, 2007
Last Updated: July 13, 2009
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Novartis:
Type 2 diabetes
vildagliptin
metformin combination

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Vildagliptin
Metformin
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 April 15, 2014