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
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: 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
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 21, 2014