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

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:

MedlinePlus related topics: Diabetes Diabetes Type 2

Drug Information available for: Metformin Metformin hydrochloride

U.S. FDA Resources

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

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 May 23, 2013