Back to resultsA Sub-study to LMF237A2302 to Assess the Effect of 24 Weeks Treatment With Initial Combination of Vildagliptin Plus Metformin
Primary Purpose
Diabetes Mellitus, Type 2
Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
vildagliptin + metformin
Sponsored by
About this trial
This is an interventional treatment trial for Diabetes Mellitus, Type 2 focused on measuring metformin, vildagliptin, initial combination
Eligibility 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.
Sites / Locations
- Diabetes and Glandular Disease Research Associates
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
vildagliptin + metformin
Arm Description
Outcomes
Primary Outcome Measures
glycosylated hemoglobin (HbA1c)at Baseline and week 24
Secondary Outcome Measures
HbA1c at Baseline and week 12
Fasting plasma glucose test (FPG) at Baseline and week 24
Weight at baseline and week 24
Responder rates assessed by HbA1c absolute reduction from baseline to endpoint greater than or equal to 0.7% after 24 weeks
Safety assessed by monitoring and recording all adverse events, serious adverse events.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00468039
Brief Title
A Sub-study to LMF237A2302 to Assess the Effect of 24 Weeks Treatment With Initial Combination of Vildagliptin Plus Metformin
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
Study Type
Interventional
2. Study Status
Record Verification Date
August 2017
Overall Recruitment Status
Completed
Study Start Date
March 6, 2007 (Actual)
Primary Completion Date
June 6, 2008 (Actual)
Study Completion Date
June 6, 2008 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novartis
4. Oversight
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type 2
Keywords
metformin, vildagliptin, initial combination
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
94 (Actual)
8. Arms, Groups, and Interventions
Arm Title
vildagliptin + metformin
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
vildagliptin + metformin
Primary Outcome Measure Information:
Title
glycosylated hemoglobin (HbA1c)at Baseline and week 24
Time Frame
24 weeks
Secondary Outcome Measure Information:
Title
HbA1c at Baseline and week 12
Time Frame
12 weeks
Title
Fasting plasma glucose test (FPG) at Baseline and week 24
Time Frame
24 weeks
Title
Weight at baseline and week 24
Time Frame
24 weeks
Title
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
Title
Safety assessed by monitoring and recording all adverse events, serious adverse events.
Time Frame
24 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
78 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Novartis Pharmaceuticals
Organizational Affiliation
Novartis Pharmaceuticals
Official's Role
Study Director
Facility Information:
Facility Name
Diabetes and Glandular Disease Research Associates
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
19320662
Citation
Bosi E, Dotta F, Jia Y, Goodman M. Vildagliptin plus metformin combination therapy provides superior glycaemic control to individual monotherapy in treatment-naive patients with type 2 diabetes mellitus. Diabetes Obes Metab. 2009 May;11(5):506-15. doi: 10.1111/j.1463-1326.2009.01040.x. Epub 2009 Mar 23.
Results Reference
result
Links:
URL
https://www.novctrd.com/ctrdweb/trialresult/trialresults/pdf?trialResultId=2651
Description
Results for CLMF237A2302S1 from the Novartis Clinical Trials website
Learn more about this trial
A Sub-study to LMF237A2302 to Assess the Effect of 24 Weeks Treatment With Initial Combination of Vildagliptin Plus Metformin
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