Efficacy and Safety of Vildagliptin Compared to Metformin in Elderly Drug Naive Patients With Type 2 Diabetes

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT00383578
First received: September 29, 2006
Last updated: January 2, 2013
Last verified: January 2013
  Purpose

This study is designed to demonstrate the efficacy and safety of vildagliptin compared to metformin in elderly drug naive patients with type 2 diabetes


Condition Intervention Phase
Diabetes Mellitus, Type 2
Drug: Vildagliptin 100 mg qd
Drug: Metformin 1500 mg daily
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Multicenter, Randomized, Double-Blind, Active Controlled Study to Compare the Effect of 24 Weeks Treatment With Vildagliptin 100 mg qd or Metformin 1500 mg Daily in Elderly Drug Naive Patients With Type 2 Diabetes

Resource links provided by NLM:


Further study details as provided by Novartis:

Primary Outcome Measures:
  • Change from baseline in HbA1c [ Time Frame: after 24 weeks of treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Adverse event profile [ Time Frame: after 24 weeks of treatment ] [ Designated as safety issue: Yes ]
  • Gastrointestinal tolerability [ Time Frame: after 24 weeks of treatment ] [ Designated as safety issue: No ]
  • Patients with endpoint HbA1c <7% and patients with reduction in HbA1c > 0.7% [ Time Frame: after 24 weeks of treatment ] [ Designated as safety issue: No ]
  • Change from baseline in fasting plasma glucose [ Time Frame: after 24 weeks of treatment ] [ Designated as safety issue: No ]
  • Change from baseline in body weight [ Time Frame: after 24 weeks of treatment ] [ Designated as safety issue: No ]

Enrollment: 335
Study Start Date: September 2006
Primary Completion Date: May 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Vildagliptin Drug: Vildagliptin 100 mg qd
Active Comparator: Metformin Drug: Metformin 1500 mg daily

  Eligibility

Ages Eligible for Study:   65 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age from 65 years to the upper age limit recommended by local prescribing information for metformin
  • Drug naive patients with type 2 diabetes.
  • Body mass index (BMI) in the range of 22-40 kg/m2.
  • HbA1c in the range of 7 to 9% inclusive
  • FPG <270 mg/dL (15 mmol/L)

Exclusion Criteria:

  • A history of type 1 diabetes
  • Evidence of significant diabetic complications
  • Treatment with insulin or any other oral antidiabetic agents

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: NCT00383578

Locations
Germany
Investigative Centers
Nurnberg, Germany
Switzerland
Novartis Pharmaceuticals
Basel, Switzerland
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

Additional Information:
No publications provided

Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT00383578     History of Changes
Other Study ID Numbers: CLAF237A2398
Study First Received: September 29, 2006
Last Updated: January 2, 2013
Health Authority: Estonia: The State Agency of Medicine
United States: Food and Drug Administration

Keywords provided by Novartis:
Type 2 diabetes
vildagliptin
hemoglobin A1c
metformin

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

ClinicalTrials.gov processed this record on October 20, 2014