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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.
Information provided by (Responsible Party):
Novartis Identifier:
First received: June 29, 2007
Last updated: February 23, 2017
Last verified: February 2017
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
Intervention Model: Parallel Assignment
Masking: Double
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
Study Completion Date: July 2008
Primary Completion Date: July 2008 (Final data collection date for primary outcome measure)

Ages Eligible for Study:   18 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All

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
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 identifier: NCT00494884

Novartis Investigative Site
Bochum, Germany
Sponsors and Collaborators
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

Additional Information:
Responsible Party: Novartis Identifier: NCT00494884     History of Changes
Other Study ID Numbers: CLAF237ADE02
Study First Received: June 29, 2007
Last Updated: February 23, 2017

Keywords provided by Novartis:
Type 2 diabetes
metformin combination

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Hypoglycemic Agents
Physiological Effects of Drugs
Dipeptidyl-Peptidase IV Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action processed this record on August 18, 2017