18-week add-on to Metformin Comparison of Saxagliptin and Sitagliptin in Adult Patients With Type 2 Diabetes (T2D) - Full Text View

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 3

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment
Official Title:	18-wk, 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 T2D Who Have Inadequate Glycaemic Control on Metformin Alone

Resource links provided by NLM:

MedlinePlus related topics: Diabetes Diabetes Type 2

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

U.S. FDA Resources

Further study details as provided by AstraZeneca:

Primary Outcome Measures:

Hemoglobin A1c (HbA1c) Change From Baseline to Week 18 [ Time Frame: Baseline, Week 18 ] [ Designated as safety issue: No ]
Adjusted mean change from baseline in HbA1c achieved with saxagliptin added on to metformin versus sitagliptin added on to metformin at Week 18 (Per Protocol Analysis Set). HbA1c is a continuous measure, the change from baseline for each participant is calculated as the Week 18 value minus the baseline value.

Secondary Outcome Measures:

Proportion of Patients Achieving Therapeutic Glycaemic Response Defined as HbA1c <= 6.5% at Week 18 [ Time Frame: Week 18 (Last Observation Carried Forward) ] [ Designated as safety issue: No ]
Proportion of Patients Achieving Therapeutic Glycaemic Response Defined as HbA1c <= 6.5% at Week 18 (Full Analysis Set)
Fasting Plasma Glucose Change From Baseline to Week 18 (mg/dL) [ Time Frame: Baseline, Week 18 (Last Observation Carried Forward) ] [ Designated as safety issue: No ]
Adjusted mean change from baseline in Fasting Plasma Glucose achieved with saxagliptin added on to metformin versus sitagliptin added on to metformin at Week 18 (Full Analysis Set). Fasting Plasma Glucose is a continuous measure, the change from baseline for each participant is calculated as the Week 18 (LOCF) value minus the baseline value.
Fasting Plasma Glucose Change From Baseline to Week 18 (mmol/L) [ Time Frame: Baseline, Week 18 (Last Observation Carried Forward) ] [ Designated as safety issue: No ]
Adjusted mean change from baseline in Fasting Plasma Glucose achieved with saxagliptin added on to metformin versus sitagliptin added on to metformin at Week 18 (Full Analysis Set). Fasting Plasma Glucose is a continuous measure, the change from baseline for each participant is calculated as the Week 18 (LOCF) value minus the baseline value.

Enrollment:	822
Study Start Date:	April 2008
Study Completion Date:	March 2009
Primary Completion Date:	March 2009 (Final data collection date for primary outcome measure)

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

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 86 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:	Peter Öhman, Medical Science Director, AstraZeneca Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00666458 History of Changes
Other Study ID Numbers:	D1680C00002, EudraCT number 2007-006095-11
Study First Received:	April 23, 2008
Results First Received:	March 5, 2010
Last Updated:	March 5, 2010
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

Additional relevant MeSH terms:

Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Sitagliptin
Saxagliptin
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 16, 2013