A Sub-study to LMF237A2302 to Assess the Effect of 24 Weeks Treatment With Initial Combination of Vildagliptin Plus Metformin
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
1 other identifier
interventional
94
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3 diabetes-mellitus-type-2
Started Mar 2007
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 6, 2007
CompletedFirst Submitted
Initial submission to the registry
April 27, 2007
CompletedFirst Posted
Study publicly available on registry
May 1, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 6, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
June 6, 2008
CompletedDecember 19, 2020
August 1, 2017
1.3 years
April 27, 2007
December 11, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
glycosylated hemoglobin (HbA1c)at Baseline and week 24
24 weeks
Secondary Outcomes (5)
HbA1c at Baseline and week 12
12 weeks
Fasting plasma glucose test (FPG) at Baseline and week 24
24 weeks
Weight at baseline and week 24
24 weeks
Responder rates assessed by HbA1c absolute reduction from baseline to endpoint greater than or equal to 0.7% after 24 weeks
24 weeks
Safety assessed by monitoring and recording all adverse events, serious adverse events.
24 weeks
Study Arms (1)
vildagliptin + metformin
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Pregnant or lactating female
- History of type 1 diabetes
- Evidence of significant diabetic complications
- Treatment with insulin or any other oral antidiabetic agent
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Novartislead
Study Sites (1)
Diabetes and Glandular Disease Research Associates
San Antonio, Texas, 78229, United States
Related Publications (1)
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.
PMID: 19320662RESULT
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Novartis Pharmaceuticals
Novartis Pharmaceuticals
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 27, 2007
First Posted
May 1, 2007
Study Start
March 6, 2007
Primary Completion
June 6, 2008
Study Completion
June 6, 2008
Last Updated
December 19, 2020
Record last verified: 2017-08