Back to results18-week add-on to Metformin Comparison of Saxagliptin and Sitagliptin in Adult Patients With Type 2 Diabetes (T2D)
Primary Purpose
Type 2 Diabetes
Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
saxagliptin
sitagliptin
Sponsored by
About this trial
This is an interventional treatment trial for Type 2 Diabetes focused on measuring Type 2 diabetes, metformin
Eligibility 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
Sites / Locations
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Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
1
2
Arm Description
saxagliptin add-on to metformin
sitagliptin add-on to metformin
Outcomes
Primary Outcome Measures
Hemoglobin A1c (HbA1c) Change From Baseline to Week 18
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
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)
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)
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.
Full Information
NCT ID
NCT00666458
First Posted
April 23, 2008
Last Updated
March 5, 2010
Sponsor
AstraZeneca
Collaborators
Bristol-Myers Squibb
1. Study Identification
Unique Protocol Identification Number
NCT00666458
Brief Title
18-week add-on to Metformin Comparison of Saxagliptin and Sitagliptin in Adult Patients With Type 2 Diabetes (T2D)
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
Study Type
Interventional
2. Study Status
Record Verification Date
March 2010
Overall Recruitment Status
Completed
Study Start Date
April 2008 (undefined)
Primary Completion Date
March 2009 (Actual)
Study Completion Date
March 2009 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
AstraZeneca
Collaborators
Bristol-Myers Squibb
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes
Keywords
Type 2 diabetes, metformin
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
822 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
saxagliptin add-on to metformin
Arm Title
2
Arm Type
Active Comparator
Arm Description
sitagliptin add-on to metformin
Intervention Type
Drug
Intervention Name(s)
saxagliptin
Other Intervention Name(s)
Onglyza
Intervention Description
tablet, per oral, once daily
Intervention Type
Drug
Intervention Name(s)
sitagliptin
Other Intervention Name(s)
Januvia
Intervention Description
capsule, per oral, once daily
Primary Outcome Measure Information:
Title
Hemoglobin A1c (HbA1c) Change From Baseline to Week 18
Description
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.
Time Frame
Baseline, Week 18
Secondary Outcome Measure Information:
Title
Proportion of Patients Achieving Therapeutic Glycaemic Response Defined as HbA1c <= 6.5% at Week 18
Description
Proportion of Patients Achieving Therapeutic Glycaemic Response Defined as HbA1c <= 6.5% at Week 18 (Full Analysis Set)
Time Frame
Week 18 (Last Observation Carried Forward)
Title
Fasting Plasma Glucose Change From Baseline to Week 18 (mg/dL)
Description
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.
Time Frame
Baseline, Week 18 (Last Observation Carried Forward)
Title
Fasting Plasma Glucose Change From Baseline to Week 18 (mmol/L)
Description
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.
Time Frame
Baseline, Week 18 (Last Observation Carried Forward)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
André Scheen, Professor
Organizational Affiliation
Clinical Pharmacology Unit, Liege, Belgium
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Peter Öhman, MD, PhD
Organizational Affiliation
AstraZeneca, Wilmington, USA
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Deborah Price, MSc
Organizational Affiliation
AstraZeneca, Wilmington, USA
Official's Role
Study Chair
Facility Information:
Facility Name
Research Site
City
Lanus
State/Province
Buenos Aires
Country
Argentina
Facility Name
Research Site
City
Mar Del Plata
State/Province
Buenos Aires
Country
Argentina
Facility Name
Research Site
City
Buenos Aires
Country
Argentina
Facility Name
Research Site
City
Caba
Country
Argentina
Facility Name
Research Site
City
Capital Federal
Country
Argentina
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Research Site
City
Ciudad de Buenos Aires
Country
Argentina
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City
Cordoba
Country
Argentina
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City
Rosario
Country
Argentina
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City
Santa Fe
Country
Argentina
Facility Name
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City
Aalst
Country
Belgium
Facility Name
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City
Bonheiden
Country
Belgium
Facility Name
Research Site
City
Brugge
Country
Belgium
Facility Name
Research Site
City
Genk
Country
Belgium
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Research Site
City
Gozee
Country
Belgium
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City
Hasselt
Country
Belgium
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City
Liege
Country
Belgium
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City
Saint-medard
Country
Belgium
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City
Sint-gillis-waas
Country
Belgium
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City
Tessenderlo
Country
Belgium
Facility Name
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City
Thuillies
Country
Belgium
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City
Aalborg
Country
Denmark
Facility Name
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City
Arhus
Country
Denmark
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City
Christiansfeld
Country
Denmark
Facility Name
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City
Farso
Country
Denmark
Facility Name
Research Site
City
Gentofte
Country
Denmark
Facility Name
Research Site
City
Hobro
Country
Denmark
Facility Name
Research Site
City
Kolding
Country
Denmark
Facility Name
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City
Rodovre
Country
Denmark
Facility Name
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City
Viborg
Country
Denmark
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City
Angers
Country
France
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Chateau Gontier
Country
France
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Corbeil Essonnes
Country
France
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La Seyne Sur Mer
Country
France
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Laval
Country
France
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Le Lavandou
Country
France
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Montrevault
Country
France
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Saint Cyr
Country
France
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Tierce
Country
France
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Toulon
Country
France
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Witry Les Reims
Country
France
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City
Bergamo
State/Province
BG
Country
Italy
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City
Foggia
State/Province
FG
Country
Italy
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City
Chiavari
State/Province
GE
Country
Italy
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City
Genova
State/Province
GE
Country
Italy
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City
Rozzano
State/Province
MI
Country
Italy
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City
Olbia
State/Province
OT
Country
Italy
Facility Name
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City
Padova
State/Province
PD
Country
Italy
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Research Site
City
Pordenone
State/Province
PN
Country
Italy
Facility Name
Research Site
City
Mercato San Severino
State/Province
SA
Country
Italy
Facility Name
Research Site
City
Siena
State/Province
SI
Country
Italy
Facility Name
Research Site
City
Mexico
State/Province
D.f.
Country
Mexico
Facility Name
Research Site
City
Guadalajara
State/Province
Jalisco
Country
Mexico
Facility Name
Research Site
City
Monterrey
Country
Mexico
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City
Alesund
Country
Norway
Facility Name
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City
Elverum
Country
Norway
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City
Halden
Country
Norway
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City
Hamar
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Norway
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Lierskogen
Country
Norway
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Lillehammer
Country
Norway
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Oslo
Country
Norway
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Sandvika
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Norway
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Strommen
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Norway
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Svelvik
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Norway
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Benoni
State/Province
Gauteng
Country
South Africa
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Johannesburg
State/Province
Gauteng
Country
South Africa
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Cape Town
State/Province
Western Cape
Country
South Africa
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City
Bloemfontein
Country
South Africa
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Cape Town
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South Africa
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Durban
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South Africa
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Johannesburg
Country
South Africa
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Kwa Zulu Natal
Country
South Africa
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Pretoria
Country
South Africa
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City
Boras
Country
Sweden
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City
Degeberga
Country
Sweden
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City
Finspang
Country
Sweden
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Goteborg
Country
Sweden
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Jonkoping
Country
Sweden
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Odeshog
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Sweden
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Orebro
Country
Sweden
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Pitea
Country
Sweden
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Rattvik
Country
Sweden
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Skanor
Country
Sweden
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Timra
Country
Sweden
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City
Trollhattan
Country
Sweden
Facility Name
Research Site
City
Uddevalla
Country
Sweden
Facility Name
Research Site
City
Umea
Country
Sweden
12. IPD Sharing Statement
Learn more about this trial
18-week add-on to Metformin Comparison of Saxagliptin and Sitagliptin in Adult Patients With Type 2 Diabetes (T2D)
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