A Sub-study to LMF237A2302 to Assess the Effect of 24 Weeks Treatment With Initial Combination of Vildagliptin Plus Metformin

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis
ClinicalTrials.gov Identifier:
NCT00468039
First received: April 27, 2007
Last updated: January 2, 2013
Last verified: January 2013
  Purpose

This study will evaluate the effects of treatment with vildagliptin and metformin as initial combination in newly diagnosed patients with type 2 diabetes who have very high levels of HbA1c and/or fasting plasma glucose.


Condition Intervention Phase
Diabetes Mellitus, Type 2
Drug: vildagliptin + metformin
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Multicenter, Open-label Sub-study to LMF237A2302 to Assess the Effect of 24 Weeks Treatment With Initial Combination of Vildagliptin 100mg qd Plus Metformin 1000mg Bid in Drug Naive Patients With Type 2 Diabetes With Very Poor Glycemic Control

Resource links provided by NLM:


Further study details as provided by Novartis:

Primary Outcome Measures:
  • glycosylated hemoglobin (HbA1c)at Baseline and week 24 [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • HbA1c at Baseline and week 12 [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Fasting plasma glucose test (FPG) at Baseline and week 24 [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • Weight at baseline and week 24 [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • Responder rates assessed by HbA1c absolute reduction from baseline to endpoint greater than or equal to 0.7% after 24 weeks [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • Safety assessed by monitoring and recording all adverse events, serious adverse events. [ Time Frame: 24 weeks ] [ Designated as safety issue: Yes ]

Enrollment: 94
Study Start Date: March 2007
Primary Completion Date: June 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: vildagliptin + metformin Drug: vildagliptin + metformin

  Eligibility

Ages Eligible for Study:   18 Years to 78 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male or female (non-fertile or of childbearing potential using a medically approved birth control method) patients with type 2 diabetes
  • Diagnosis of type 2 diabetes for at least 4 weeks prior to study entry
  • Body mass index 22-40 kg/meter squared
  • HbA1c > 11% and/or FPG >270 mg/dL

Exclusion Criteria:

  • Pregnant or lactating female
  • History of type 1 diabetes
  • Evidence of significant diabetic complications
  • Treatment with insulin or any other oral antidiabetic agent

Other protocol-defined inclusion/exclusion criteria may apply.

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00468039

Locations
United States, Texas
Diabetes and Glandular Disease Research Associates
San Antonio, Texas, United States, 78229
Sponsors and Collaborators
Novartis
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

No publications provided

Responsible Party: Novartis
ClinicalTrials.gov Identifier: NCT00468039     History of Changes
Other Study ID Numbers: CLMF237A2302S1
Study First Received: April 27, 2007
Last Updated: January 2, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Novartis:
metformin
vildagliptin
initial 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 April 17, 2014