Back to results52-week add-on to Metformin Comparison of Saxagliptin and Sulphonylurea, With a 52-week Extension Period
Primary Purpose
Type 2 Diabetes
Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Metformin
Sulphonylurea
Saxagliptin
Sponsored by
About this trial
This is an interventional treatment trial for Type 2 Diabetes focused on measuring DPP-4 Inhibitors, HbA1c, incretins
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 prior to Visit 1,
- HbA1c >6.5% and ≤10.0%
Exclusion Criteria:
- Type 1 diabetes,
- history of diabetic ketoacidosis or hyperosmolar non-ketonic coma,
- Insulin therapy within one year of enrolment (with the exception of insulin therapy during a hospitalization or use in gestational diabetes)
Sites / Locations
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Saxagliptin
Glipizide
Arm Description
Outcomes
Primary Outcome Measures
Hemoglobin A1c (HbA1c) Change From Baseline to Week 52
Adjusted mean change from baseline in HbA1c achieved with saxagliptin added on to metformin versus glipizide added on to metformin at Week 52 (Per Protocol Analysis Set). HbA1c is a continuous measure, the change from baseline for each participant is calculated as the Week 52 value minus the baseline value.
Secondary Outcome Measures
Proportion of Participants Reporting at Least One Episode of Any Hypoglycaemic Event Over 52 Weeks
Proportion of participants reporting at least one episode of any hypoglycaemic event for saxagliptin added on to metformin versus glipizide added on to metformin over 52 weeks (Safety Analysis Set)
Body Weight Change From Baseline to Week 52
Adjusted mean change from baseline in Body Weight achieved with saxagliptin added on to metformin versus glipizide added on to metformin at Week 52 (Safety Analysis Set). Body Weight is a continuous measure, the change from baseline for each participant is calculated as the Week 52 (LOCF) value minus the baseline value.
Mean Slope of the Regressions of Change From Week 24 to Week 52 in HbA1c
Mean slopes of regression of change from Week 24 to Week 52 in HbA1c for saxagliptin added on to metformin versus glipizide added on to metformin (Per Protocol Analysis Set) achieved by fitting a mixed model with subject specific slopes for the time effect (weeks on randomized treatment was utilized). This analysis gives an assessment of the durability of the HbA1c effect.
Full Information
NCT ID
NCT00575588
First Posted
December 14, 2007
Last Updated
March 20, 2012
Sponsor
AstraZeneca
Collaborators
Bristol-Myers Squibb
1. Study Identification
Unique Protocol Identification Number
NCT00575588
Brief Title
52-week add-on to Metformin Comparison of Saxagliptin and Sulphonylurea, With a 52-week Extension Period
Official Title
A 52-Week International, Multi-centre, Randomized, Parallel-group, Double-blind, Active-controlled, Phase III Study With a 52-Week Extension Period to Evaluate the Safety and Efficacy of Saxagliptin in Combination With Metformin Compared With Sulphonylurea in Combination With Metformin in Adult Patients With Type 2 Diabetes Who Have Inadequate Glycaemic Control on Metformin Therapy Alone.
Study Type
Interventional
2. Study Status
Record Verification Date
March 2012
Overall Recruitment Status
Completed
Study Start Date
December 2007 (undefined)
Primary Completion Date
August 2009 (Actual)
Study Completion Date
August 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
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 sulphonylurea 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
DPP-4 Inhibitors, HbA1c, incretins
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
891 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Saxagliptin
Arm Type
Experimental
Arm Title
Glipizide
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Metformin
Intervention Description
open-label metformin
Intervention Type
Drug
Intervention Name(s)
Sulphonylurea
Intervention Description
Glipizide 5-20 mg capsules (titrated to optimal effect or highest tolerable dose during 18 weeks)
Intervention Type
Drug
Intervention Name(s)
Saxagliptin
Other Intervention Name(s)
Onglyza
Intervention Description
Saxagliptin 5 mg tablets
Primary Outcome Measure Information:
Title
Hemoglobin A1c (HbA1c) Change From Baseline to Week 52
Description
Adjusted mean change from baseline in HbA1c achieved with saxagliptin added on to metformin versus glipizide added on to metformin at Week 52 (Per Protocol Analysis Set). HbA1c is a continuous measure, the change from baseline for each participant is calculated as the Week 52 value minus the baseline value.
Time Frame
Baseline to 52 Weeks
Secondary Outcome Measure Information:
Title
Proportion of Participants Reporting at Least One Episode of Any Hypoglycaemic Event Over 52 Weeks
Description
Proportion of participants reporting at least one episode of any hypoglycaemic event for saxagliptin added on to metformin versus glipizide added on to metformin over 52 weeks (Safety Analysis Set)
Time Frame
From Baseline to Week 52
Title
Body Weight Change From Baseline to Week 52
Description
Adjusted mean change from baseline in Body Weight achieved with saxagliptin added on to metformin versus glipizide added on to metformin at Week 52 (Safety Analysis Set). Body Weight is a continuous measure, the change from baseline for each participant is calculated as the Week 52 (LOCF) value minus the baseline value.
Time Frame
Baseline, Week 52 (Last Observation Carried Forward)
Title
Mean Slope of the Regressions of Change From Week 24 to Week 52 in HbA1c
Description
Mean slopes of regression of change from Week 24 to Week 52 in HbA1c for saxagliptin added on to metformin versus glipizide added on to metformin (Per Protocol Analysis Set) achieved by fitting a mixed model with subject specific slopes for the time effect (weeks on randomized treatment was utilized). This analysis gives an assessment of the durability of the HbA1c effect.
Time Frame
Week 24 to Week 52
Other Pre-specified Outcome Measures:
Title
Hemoglobin A1c (HbA1c) Change From Baseline to Week 104
Description
Adjusted mean change from baseline in HbA1c achieved with saxagliptin added on to metformin versus glipizide added on to metformin at Week 104 (Full Analysis Set). HbA1c is a continuous measure, the change from baseline for each participant is calculated as the Week 104 value minus the baseline value.
Time Frame
Baseline, Week 104
Title
Proportion of Participants Reporting at Least One Episode of Any Hypoglycaemic Event Over 104 Weeks
Description
Proportion of participants reporting at least one episode of any hypoglycaemic event for saxagliptin added on to metformin versus glipizide added on to metformin over 104 weeks (Safety Analysis Set)
Time Frame
Baseline, Week 104
Title
Body Weight Change From Baseline to Week 104
Description
Adjusted mean change from baseline in Body Weight achieved with saxagliptin added on to metformin versus glipizide added on to metformin at Week 104. Body Weight is a continuous measure, the change from baseline for each participant is calculated as the Week 104 value minus the baseline value.
Time Frame
Baseline, Week 104
Title
Mean Slope of the Regressions of Change From Week 24 to Week 104 in HbA1c
Description
Mean slopes of regression of change from Week 24 to Week 104 in HbA1c for saxagliptin added on to metformin versus glipizide added on to metformin (Full Analysis Set) achieved by fitting a mixed model with subject specific slopes for the time effect (weeks on randomized treatment was utilized). This analysis gives an assessment of the durability of the HbA1c effect.
Time Frame
Week 24 to Week 104
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 prior to Visit 1,
HbA1c >6.5% and ≤10.0%
Exclusion Criteria:
Type 1 diabetes,
history of diabetic ketoacidosis or hyperosmolar non-ketonic coma,
Insulin therapy within one year of enrolment (with the exception of insulin therapy during a hospitalization or use in gestational diabetes)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Burkhard Goke
Organizational Affiliation
University of Munich, Germany
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Peter Ohman, MD
Organizational Affiliation
AstraZeneca
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Deborah Price, MSc
Organizational Affiliation
AstraZeneca
Official's Role
Study Chair
Facility Information:
Facility Name
Research Site
City
Hanko
Country
Finland
Facility Name
Research Site
City
Helsinki
Country
Finland
Facility Name
Research Site
City
Kuopio
Country
Finland
Facility Name
Research Site
City
Kuusankoski
Country
Finland
Facility Name
Research Site
City
Mikkeli
Country
Finland
Facility Name
Research Site
City
Oulu
Country
Finland
Facility Name
Research Site
City
Tampere
Country
Finland
Facility Name
Research Site
City
Aschaffenburg
Country
Germany
Facility Name
Research Site
City
Berlin
Country
Germany
Facility Name
Research Site
City
Dortmund
Country
Germany
Facility Name
Research Site
City
Frankfurt
Country
Germany
Facility Name
Research Site
City
Hamburg
Country
Germany
Facility Name
Research Site
City
Hannover
Country
Germany
Facility Name
Research Site
City
Mainz
Country
Germany
Facility Name
Research Site
City
Mannheim
Country
Germany
Facility Name
Research Site
City
Mulheim
Country
Germany
Facility Name
Research Site
City
Pirna
Country
Germany
Facility Name
Research Site
City
Ratzeburg
Country
Germany
Facility Name
Research Site
City
Reinfeld
Country
Germany
Facility Name
Research Site
City
Rhaunen
Country
Germany
Facility Name
Research Site
City
Schmiedeberg
Country
Germany
Facility Name
Research Site
City
Tubingen
Country
Germany
Facility Name
Research Site
City
Wahlstedt
Country
Germany
Facility Name
Research Site
City
Weinheim
Country
Germany
Facility Name
Research Site
City
Balatonfured
Country
Hungary
Facility Name
Research Site
City
Bekescsaba
Country
Hungary
Facility Name
Research Site
City
Budapest
Country
Hungary
Facility Name
Research Site
City
Debrecen
Country
Hungary
Facility Name
Research Site
City
Gyula
Country
Hungary
Facility Name
Research Site
City
Kalocsa
Country
Hungary
Facility Name
Research Site
City
Kaposvar
Country
Hungary
Facility Name
Research Site
City
Kecskemet
Country
Hungary
Facility Name
Research Site
City
Miskolc
Country
Hungary
Facility Name
Research Site
City
Mosonmagyarovar
Country
Hungary
Facility Name
Research Site
City
Nyiregyhaza
Country
Hungary
Facility Name
Research Site
City
Szekesfehervar
Country
Hungary
Facility Name
Research Site
City
Bangalore
State/Province
Karnataka
Country
India
Facility Name
Research Site
City
Indore
State/Province
Madhya Pradesh
Country
India
Facility Name
Research Site
City
Mumbai
State/Province
Mashatra
Country
India
Facility Name
Research Site
City
Jaipur
State/Province
Rajasthan
Country
India
Facility Name
Research Site
City
Guri
State/Province
Gyeonggi-do
Country
Korea, Republic of
Facility Name
Research Site
City
Seongnam
State/Province
Gyeonggi-do
Country
Korea, Republic of
Facility Name
Research Site
City
Wonju
State/Province
Kangwon-do
Country
Korea, Republic of
Facility Name
Research Site
City
Incheon
Country
Korea, Republic of
Facility Name
Research Site
City
Seoul
Country
Korea, Republic of
Facility Name
Research Site
City
Uijeongbu-si
Country
Korea, Republic of
Facility Name
Research Site
City
Beek En Donk
Country
Netherlands
Facility Name
Research Site
City
Den Bosch
Country
Netherlands
Facility Name
Research Site
City
Den Haag
Country
Netherlands
Facility Name
Research Site
City
Deurne
Country
Netherlands
Facility Name
Research Site
City
Dordrecht
Country
Netherlands
Facility Name
Research Site
City
Losser
Country
Netherlands
Facility Name
Research Site
City
Nijverdal
Country
Netherlands
Facility Name
Research Site
City
Rijswijk
Country
Netherlands
Facility Name
Research Site
City
Roelofarendsveen
Country
Netherlands
Facility Name
Research Site
City
Rotterdam
Country
Netherlands
Facility Name
Research Site
City
Volendam
Country
Netherlands
Facility Name
Research Site
City
Bergen
Country
Norway
Facility Name
Research Site
City
Elverum
Country
Norway
Facility Name
Research Site
City
Flatasen
Country
Norway
Facility Name
Research Site
City
Hamar
Country
Norway
Facility Name
Research Site
City
Honefoss
Country
Norway
Facility Name
Research Site
City
Inderoy
Country
Norway
Facility Name
Research Site
City
Oslo
Country
Norway
Facility Name
Research Site
City
Radal
Country
Norway
Facility Name
Research Site
City
Skedsmokorset
Country
Norway
Facility Name
Research Site
City
Sogndal
Country
Norway
Facility Name
Research Site
City
Spikkestad
Country
Norway
Facility Name
Research Site
City
Trollasen
Country
Norway
Facility Name
Research Site
City
Kazan
Country
Russian Federation
Facility Name
Research Site
City
Moscow
Country
Russian Federation
Facility Name
Research Site
City
Nizhnii Novgorod
Country
Russian Federation
Facility Name
Research Site
City
St. Petersburg
Country
Russian Federation
Facility Name
Research Site
City
Yaroslavl
Country
Russian Federation
Facility Name
Research Site
City
Dolny Kubin
Country
Slovakia
Facility Name
Research Site
City
Kosice - Tahanovce
Country
Slovakia
Facility Name
Research Site
City
Moldava Nad Bodvou
Country
Slovakia
Facility Name
Research Site
City
Ruzomberok
Country
Slovakia
Facility Name
Research Site
City
Trnava
Country
Slovakia
Facility Name
Research Site
City
Zilina
Country
Slovakia
Facility Name
Research Site
City
Annan
State/Province
Dumfries and Galloway
Country
United Kingdom
Facility Name
Research Site
City
Whitstable
State/Province
Kent
Country
United Kingdom
Facility Name
Research Site
City
Hamilton
State/Province
Lanarkshire
Country
United Kingdom
Facility Name
Research Site
City
Salford
State/Province
Manchester
Country
United Kingdom
Facility Name
Research Site
City
Crawley
State/Province
West Sussex
Country
United Kingdom
Facility Name
Research Site
City
Bradford-on-avon
State/Province
Wiltshire
Country
United Kingdom
Facility Name
Research Site
City
Blackpool
Country
United Kingdom
Facility Name
Research Site
City
Coatbridge
Country
United Kingdom
Facility Name
Research Site
City
Coventry
Country
United Kingdom
Facility Name
Research Site
City
Glasgow
Country
United Kingdom
Facility Name
Research Site
City
Motherwell
Country
United Kingdom
Facility Name
Research Site
City
Newcastle
Country
United Kingdom
Facility Name
Research Site
City
Sheffield
Country
United Kingdom
Facility Name
Research Site
City
Ho Chi Minh City
Country
Vietnam
Facility Name
Research Site
City
Ho Chi Minh
Country
Vietnam
12. IPD Sharing Statement
Citations:
PubMed Identifier
25414932
Citation
Cook W, Minervini G, Bryzinski B, Hirshberg B. Saxagliptin efficacy and safety in patients with type 2 diabetes mellitus stratified by cardiovascular disease history and cardiovascular risk factors: analysis of 3 clinical trials. Postgrad Med. 2014 Oct;126(6):19-32. doi: 10.3810/pgm.2014.10.2818.
Results Reference
derived
PubMed Identifier
24397584
Citation
Mintz ML, Minervini G. Saxagliptin versus glipizide as add-on therapy to metformin: assessment of hypoglycemia. Curr Med Res Opin. 2014 May;30(5):761-70. doi: 10.1185/03007995.2014.880674. Epub 2014 Jan 30.
Results Reference
derived
PubMed Identifier
23638466
Citation
Goke B, Gallwitz B, Eriksson JG, Hellqvist A, Gause-Nilsson I. Saxagliptin vs. glipizide as add-on therapy in patients with type 2 diabetes mellitus inadequately controlled on metformin alone: long-term (52-week) extension of a 52-week randomised controlled trial. Int J Clin Pract. 2013 Apr;67(4):307-16. doi: 10.1111/ijcp.12119.
Results Reference
derived
Learn more about this trial
52-week add-on to Metformin Comparison of Saxagliptin and Sulphonylurea, With a 52-week Extension Period
We'll reach out to this number within 24 hrs