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
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: 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 July 23, 2014