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

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

Overview[ - collapse ][ - ]

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	Diabetes Mellitus, Type 2
Intervention	Drug: vildagliptin + metformin
Phase	Phase 3
Sponsor	Novartis
Responsible Party	Novartis
ClinicalTrials.gov Identifier	NCT00468039
First Received	April 27, 2007
Last Updated	January 2, 2013
Last verified	January 2013

Tracking Information[ + expand ][ + ]

First Received Date	April 27, 2007
Last Updated Date	January 2, 2013
Start Date	March 2007
Estimated Primary Completion Date	Not Provided
Current Primary Outcome Measures	glycosylated hemoglobin (HbA1c)at Baseline and week 24 [Time Frame: 24 weeks] [Designated as safety issue: No]
Current 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]

Descriptive Information[ + expand ][ + ]

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
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.
Detailed Description	Not Provided
Study Type	Interventional
Study Phase	Phase 3
Study Design	Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Condition	Diabetes Mellitus, Type 2
Intervention	Drug: vildagliptin + metformin
Study Arm (s)	Experimental: vildagliptin + metformin

Recruitment Information[ + expand ][ + ]

Recruitment Status	Completed
Estimated Enrollment	94
Estimated Completion Date	Not Provided
Estimated Primary Completion Date	June 2008
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.
Gender	Both
Ages	18 Years
Accepts Healthy Volunteers	No
Contacts	Not Provided
Location Countries	United States

Administrative Information[ + expand ][ + ]

NCT Number	NCT00468039
Other Study ID Numbers	CLMF237A2302S1
Has Data Monitoring Committee	Not Provided
Information Provided By	Novartis
Study Sponsor	Novartis
Collaborators	Not Provided
Investigators	Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
Verification Date	January 2013

Locations[ + expand ][ + ]