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
  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:


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
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: 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
Anti-Arrhythmia Agents
Cardiovascular Agents
Therapeutic Uses
Immunosuppressive Agents
Immunologic Factors
Dipeptidyl-Peptidase IV Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on August 19, 2014