18-Week Add-on to Metformin Comparison of Saxagliptin and Sitagliptin - Full Text View

Sponsors and Collaborators:	AstraZeneca Bristol-Myers Squibb
Information provided by:	AstraZeneca
ClinicalTrials.gov Identifier:	NCT00666458

Purpose

Saxagliptin is a new investigational medication being developed for treatment of type 2 diabetes. This study is designed to assess the efficacy and tolerability of saxagliptin in addition to metformin and compare to sitagliptin in addition with metformin.

Condition	Intervention	Phase
Type 2 Diabetes	Drug: saxagliptin Drug: sitagliptin	Phase III

MedlinePlus related topics: Diabetes

Drug Information available for: Saxagliptin Sitagliptin Sitagliptin phosphate Metformin Metformin hydrochloride

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment, Safety/Efficacy Study
Official Title:	An 18-Week, International, Multi-Centre, Randomized, Parallel-Group, Double-Blind, Active-Controlled Phase IIIb Study to Evaluate the Efficacy and Safety of Saxagliptin in Combination With Metformin in Comparison With Sitagliptin in Combination With Metformin in Adult Patients With Type 2 Diabetes W

Further study details as provided by AstraZeneca:

Primary Outcome Measures:

HbA1c change from baseline [ Time Frame: 18 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Change from baseline in FPG, insulin, C-peptide, glucagon and proinsulin [ Time Frame: 18 weeks ] [ Designated as safety issue: Yes ]
Proportion of patients with HbA1c ≤6.5% [ Time Frame: 18 weeks ] [ Designated as safety issue: Yes ]
Change in baseline HbA1c in patients with baseline HbA1c ³7.0% [ Time Frame: 18 weeks ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	710
Study Start Date:	April 2008
Estimated Study Completion Date:	March 2009
Estimated Primary Completion Date:	November 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental saxagliptin add-on to metformin	Drug: saxagliptin tablet, per oral, once daily
2: Active Comparator sitagliptin add-on to metformin	Drug: sitagliptin capsule, per oral, once daily

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Diagnosed with type 2 diabetes
Treatment with metformin alone on stable doses of 1500 mg or higher per day for at least 8 weeks

Exclusion Criteria:

Type 1 diabetes, history of diabetic ketoacidosis or hyperosmolar non-ketotic coma
Insulin therapy within one year
Previous treatment with DPP-4 inhibitor

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00666458

Show 92 Study Locations

Sponsors and Collaborators

AstraZeneca

Bristol-Myers Squibb

Investigators

Principal Investigator:	André Scheen, Professor	Clinical Pharmacology Unit, Liege, Belgium
Study Director:	Peter Öhman, MD, PhD	AstraZeneca, Wilmington, USA
Study Chair:	Deborah Price, MSc	AstraZeneca, Wilmington, USA

More Information

No publications provided

Responsible Party:	AstraZeneca Pharmaceuticals ( Peter Öhman, Medical Science Director )
Study ID Numbers:	D1680C00002, EudraCT number 2007-006095-11
Study First Received:	April 23, 2008
Last Updated:	March 24, 2009
ClinicalTrials.gov Identifier:	NCT00666458 History of Changes
Health Authority:	Sweden: The National Board of Health and Welfare; Norway: Norwegian Institute of Public Health; Denmark: National Board of Health; Italy: National Institute of Health; France: Direction Générale de la Santé; South Africa: Department of Health; Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica; Brazil: Ministry of Health; Mexico: Ministry of Health; Belgium: Directorate general for the protection of Public health: Medicines

Keywords provided by AstraZeneca:

Type 2 diabetes
metformin

Study placed in the following topic categories:

Dipeptidyl-Peptidase IV Inhibitors
Hypoglycemic Agents
Metabolic Diseases
Metformin
Diabetes Mellitus, Type 2
Diabetes Mellitus

Endocrine System Diseases
Endocrinopathy
Glucose Metabolism Disorders
Metabolic Disorder
Protease Inhibitors
Sitagliptin

Additional relevant MeSH terms:

Metabolic Diseases
Molecular Mechanisms of Pharmacological Action
Metformin
Physiological Effects of Drugs
Diabetes Mellitus
Endocrine System Diseases
Enzyme Inhibitors

Pharmacologic Actions
Sitagliptin
Protease Inhibitors
Dipeptidyl-Peptidase IV Inhibitors
Hypoglycemic Agents
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders

ClinicalTrials.gov processed this record on May 07, 2009