Evaluate Efficacy and Safety of Saxagliptin in Adult Patients With Type 2 Diabetes Inadequate Glycemic Control - Full Text View

Purpose

Saxagliptin is a new investigational medication being developed for treatment of type 2 diabetes. This study is designed to evaluate the efficacy and safety in adult patients with inadequate glycaemic control with diet and exercise.

Condition	Intervention	Phase
Type 2 Diabetes	Drug: Saxagliptin Drug: Placebo	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:	A 24-Week International, Multi-centre, Randomized, Parallel-group, Double-blind, Placebo-controlled, Phase III Study to Evaluate the Efficacy and Safety of Saxagliptin in Adult Patients With Type 2 Diabetes Who Have Inadequate Glycaemic Control With Diet and Exercise.

Resource links provided by NLM:

MedlinePlus related topics: Diabetes Diabetes Type 2 Exercise and Physical Fitness

Drug Information available for: Saxagliptin

U.S. FDA Resources

Further study details as provided by AstraZeneca:

Primary Outcome Measures:

Absolute Change From Baseline to Week 24 in Glycosylated Haemoglobin A1c (HbA1c) [ Time Frame: Baseline , Week 24 ] [ Designated as safety issue: No ]
Adjusted* mean change from baseline in HbA1c achieved with saxagliptin 5 mg versus placebo at week 24 (LOCF, Full Analysis set). HbA1c is a continuous measure, the change from baseline for each subject is calculated as the week 24 values minus the baseline value. HbA1c data were excluded on and after rescue medication.

Secondary Outcome Measures:

Absolute Change (mmol/L) From Baseline to Week 24 in Fasting Plasma Glucose (FPG) [ Time Frame: Baseline, Week 24 ] [ Designated as safety issue: No ]
Adjusted* mean change from baseline in fasting plasma glucose (FPG) achieved with saxagliptin 5 mg versus placebo at week 24 (Last Observation Carried Forward (LOCF), Full Analysis set). FPG is a continuous measure, the change from baseline for each subject is calculated as the week 24 values minus the baseline value. FPG data were excluded on and after rescue medication.
Absolute Change (mg/dL) From Baseline to Week 24 in Fasting Plasma Glucose (FPG) [ Time Frame: Baseline, Week 24 ] [ Designated as safety issue: No ]
Adjusted* mean change from baseline in fasting plasma glucose (FPG) achieved with saxagliptin 5 mg versus placebo at week 24 (LOCF, Full Analysis set). FPG is a continuous measure, the change from baseline for each subject is calculated as the week 24 values minus the baseline value. FPG data were excluded on and after rescue medication.
Absolute Change (mmol*Min/L) From Baseline to Week 24 in Area Under the Curve (AUC) From 0 to 180 Minutes for Postprandial Glucose (PPG) During Mixed Meal (Instant Noodles) Tolerance Tests (MMTT) in All MMTT Participants [ Time Frame: Baseline , Week 24 ] [ Designated as safety issue: No ]
Adjusted* mean change from baseline in PPG AUC achieved with saxagliptin 5 mg versus placebo at week 24 (LOCF, Full Analysis set). Trapezoidal method was used to compute AUC under the 3 hour PPG curve. Change from baseline for each subject is computed as the week 24 value minus the baseline value.PPG data were excluded on and after rescue medication
Absolute Change (mg*Min/dL) From Baseline to Week 24 in Area Under the Curve (AUC) From 0 to 180 Minutes for Postprandial Glucose (PPG) During Mixed Meal (Instant Noodles) Tolerance Tests (MMTT) in All MMTT Participants [ Time Frame: Baseline , Week 24 ] [ Designated as safety issue: No ]
Adjusted* mean change from baseline in PPG AUC achieved with saxagliptin 5 mg versus placebo at week 24 (LOCF, Full Analysis set). Trapezoidal method was used to compute AUC under the 3 hour PPG curve. Change from baseline for each subject is computed as the week 24 value minus the baseline value.PPG data were excluded on and after rescue medication
Proportion of Patients Achieving a Therapeutic Glycemic Response Defined as HbA1c <7.0% at Week 24 [ Time Frame: Baseline, Week 24 ] [ Designated as safety issue: No ]
Proportion of participants (expressed in percentage of total participants) achieving HbA1c < 7.0% for saxagliptin versus placebo at week 24. HbA1c Data were excluded on and after rescue medication

Enrollment:	568
Study Start Date:	June 2008
Study Completion Date:	October 2009
Primary Completion Date:	October 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Saxagliptin 5mg	Drug: Saxagliptin 5mg, oral tablet, once daily for 24 weeks Other Name: Onglyza
Placebo Comparator: Placebo	Drug: Placebo oral tablet, once daily for 24 weeks

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
Patients should be drug naïve ie, not received medical treatment for diabetes,
HbA1c ≥ 7.2% and ≤10.0% (at enrolment), HbA1c ≥ 7.0% and ≤10.0% (at randomization)

Exclusion Criteria:

Insulin therapy within one year of enrolment (with the exception of insulin therapy during a hospitalization or use in gestational diabetes),
Type 1 diabetes,history of ketoacidosis or hyperosmolar non-ketonic koma

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00698932

Show 30 Study Locations

Sponsors and Collaborators

AstraZeneca

Bristol-Myers Squibb

Investigators

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, MD, PhD, Medical Science Director, AstraZeneca Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00698932 History of Changes
Other Study ID Numbers:	D1680C00005
Study First Received:	June 16, 2008
Results First Received:	September 20, 2010
Last Updated:	August 17, 2011
Health Authority:	China: Food and Drug Administration India: Drugs Controller General of India Philippines: Bureau of Food and Drugs South Korea: Korea Food and Drug Administration (KFDA)

Keywords provided by AstraZeneca:

DPP-4 inhibitors
HBA1c
Incretins

Additional relevant MeSH terms:

Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Saxagliptin
Dipeptidyl-Peptidase IV Inhibitors

Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Hypoglycemic Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 22, 2013