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Safety and Efficacy of Galvus as add-on Therapy to Metformin Plus Glimepiride (Vildagliptin)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis
ClinicalTrials.gov Identifier:
NCT01233622
First received: November 1, 2010
Last updated: September 4, 2012
Last verified: September 2012
History of Changes
  Purpose

This study will evaluate the efficacy and safety of vildagliptin 50 mg bid as add-on therapy to metformin plus glimepiride in patients with Type 2 Diabetes (T2D).


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, Investigator)
Primary Purpose: Treatment
Official Title: A Multi-center, Randomized, Double-blind Placebo Controlled Study to Evaluate the Efficacy and Safety of 24 Weeks Treatment With Vildagliptin 50 mg Bid as add-on Therapy to Metformin Plus Glimepiride in Patients With Type 2 Diabetes

Resource links provided by NLM:

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:
  • FPG reduction [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • Safety and tolerability-frequency of treatment emergent adverse events (incl. overall Aes, SAEs, death, Aes leading ot study discontinuation or study drug interruption, pre-specified potential AEs) [ Time Frame: 24 weeks ] [ Designated as safety issue: Yes ]
  • Responder Rate [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]

Enrollment: 317
Study Start Date: October 2010
Study Completion Date: November 2011
Primary Completion Date: November 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Vildagliptin (metformin + glimepiride) Drug: Vildagliptin
Placebo Comparator: Placebo (metformin + glimepiride) 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 by standard criteria.
  • Treatment with oral anti-diabetic therapy, on stable dose for at least 12 weeks prior to the screening visit. Acceptable background anti-diabetic therapy includes: metformin (≥ 1500 mg) as monotherapy or in combination with SU, TZDs, or glinides
  • Age: ≥18 to ≤ 80 years
  • HbA1c of ≥ 7.5 and ≤ 11.0%
  • Body Mass Index (BMI) ≥22 to ≤45 kg/m2

Exclusion criteria:

  • FPG ≥ 270 mg/dL (≥ 15.0 mmol/L)
  • Acute metabolic diabetes complications such as ketoacidosis or hyperosmolar state (coma) within the past 6 months
  • Any of following within past 6 months: Myocardial infarction, TIA or stroke, coronary artery bypass surgery or percutaneous coronary intervention
  • History of hypersensitivity to any of the study drugs or to drugs of similar chemical classes
  • Acute infections which may affect blood glucose control within 4 weeks prior to screening Other protocol-defined inclusion/exclusion criteria may apply
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01233622

  Show 55 Study Locations
Sponsors and Collaborators
Novartis
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

No publications provided

Responsible Party: Novartis
ClinicalTrials.gov Identifier: NCT01233622     History of Changes
Other Study ID Numbers: CLAF237A23152, EudraCT 2010-021097-11
Study First Received: November 1, 2010
Last Updated: September 4, 2012
Health Authority: Australia: Department of Health and Ageing Therapeutic Goods Administration
Germany: Federal Institute for Drugs and Medical Devices
Hungary: National Institute of Pharmacy
India: Drugs Controller General of India
Italy: The Italian Medicines Agency
Korea: Food and Drug Administration
Mexico: Ministry of Health
Philippines: Bureau of Food and Drugs
Romania: National Medicines Agency
Taiwan: Center for Drug Evaluation

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Glimepiride
Vildagliptin
Metformin
Hypoglycemic Agents
Physiological Effects of Drugs
 Pharmacologic Actions
Immunosuppressive Agents
Immunologic Factors
Anti-Arrhythmia Agents
Cardiovascular Agents
Therapeutic Uses
Dipeptidyl-Peptidase IV Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 23, 2013