52-week add-on to Metformin Comparison of Saxagliptin and Sulphonylurea, With a 52-week Extension Period

Type 2 Diabetes Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00575588
• Other study ID #: D1680C00001
• Secondary ID: EudraCT number 2
• Status: Completed
• Phase: Phase 3
• First received: December 14, 2007
• Last updated: March 20, 2012
• Start date: December 2007
• Est. completion date: August 2010

Study information

• Verified date: March 2012
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 891
• Est. completion date: August 2010
• Est. primary completion date: August 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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)

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Type 2 Diabetes

Intervention

Drug:
• Metformin
open-label metformin
• Sulphonylurea
Glipizide 5-20 mg capsules (titrated to optimal effect or highest tolerable dose during 18 weeks)
• Saxagliptin
Saxagliptin 5 mg tablets

Locations

Country	Name	City	State
Finland	Research Site	Hanko
Finland	Research Site	Helsinki
Finland	Research Site	Kuopio
Finland	Research Site	Kuusankoski
Finland	Research Site	Mikkeli
Finland	Research Site	Oulu
Finland	Research Site	Tampere
Germany	Research Site	Aschaffenburg
Germany	Research Site	Berlin
Germany	Research Site	Dortmund
Germany	Research Site	Frankfurt
Germany	Research Site	Hamburg
Germany	Research Site	Hannover
Germany	Research Site	Mainz
Germany	Research Site	Mannheim
Germany	Research Site	Mulheim
Germany	Research Site	Pirna
Germany	Research Site	Ratzeburg
Germany	Research Site	Reinfeld
Germany	Research Site	Rhaunen
Germany	Research Site	Schmiedeberg
Germany	Research Site	Tubingen
Germany	Research Site	Wahlstedt
Germany	Research Site	Weinheim
Hungary	Research Site	Balatonfured
Hungary	Research Site	Bekescsaba
Hungary	Research Site	Budapest
Hungary	Research Site	Debrecen
Hungary	Research Site	Gyula
Hungary	Research Site	Kalocsa
Hungary	Research Site	Kaposvar
Hungary	Research Site	Kecskemet
Hungary	Research Site	Miskolc
Hungary	Research Site	Mosonmagyarovar
Hungary	Research Site	Nyiregyhaza
Hungary	Research Site	Szekesfehervar
India	Research Site	Bangalore	Karnataka
India	Research Site	Indore	Madhya Pradesh
India	Research Site	Jaipur	Rajasthan
India	Research Site	Mumbai	Mashatra
Korea, Republic of	Research Site	Guri	Gyeonggi-do
Korea, Republic of	Research Site	Incheon
Korea, Republic of	Research Site	Seongnam	Gyeonggi-do
Korea, Republic of	Research Site	Seoul
Korea, Republic of	Research Site	Uijeongbu-si
Korea, Republic of	Research Site	Wonju	Kangwon-do
Netherlands	Research Site	Beek En Donk
Netherlands	Research Site	Den Bosch
Netherlands	Research Site	Den Haag
Netherlands	Research Site	Deurne
Netherlands	Research Site	Dordrecht
Netherlands	Research Site	Losser
Netherlands	Research Site	Nijverdal
Netherlands	Research Site	Rijswijk
Netherlands	Research Site	Roelofarendsveen
Netherlands	Research Site	Rotterdam
Netherlands	Research Site	Volendam
Norway	Research Site	Bergen
Norway	Research Site	Elverum
Norway	Research Site	Flatasen
Norway	Research Site	Hamar
Norway	Research Site	Honefoss
Norway	Research Site	Inderoy
Norway	Research Site	Oslo
Norway	Research Site	Radal
Norway	Research Site	Skedsmokorset
Norway	Research Site	Sogndal
Norway	Research Site	Spikkestad
Norway	Research Site	Trollasen
Russian Federation	Research Site	Kazan
Russian Federation	Research Site	Moscow
Russian Federation	Research Site	Nizhnii Novgorod
Russian Federation	Research Site	St. Petersburg
Russian Federation	Research Site	Yaroslavl
Slovakia	Research Site	Dolny Kubin
Slovakia	Research Site	Kosice - Tahanovce
Slovakia	Research Site	Moldava Nad Bodvou
Slovakia	Research Site	Ruzomberok
Slovakia	Research Site	Trnava
Slovakia	Research Site	Zilina
United Kingdom	Research Site	Annan	Dumfries and Galloway
United Kingdom	Research Site	Blackpool
United Kingdom	Research Site	Bradford-on-avon	Wiltshire
United Kingdom	Research Site	Coatbridge
United Kingdom	Research Site	Coventry
United Kingdom	Research Site	Crawley	West Sussex
United Kingdom	Research Site	Glasgow
United Kingdom	Research Site	Hamilton	Lanarkshire
United Kingdom	Research Site	Motherwell
United Kingdom	Research Site	Newcastle
United Kingdom	Research Site	Salford	Manchester
United Kingdom	Research Site	Sheffield
United Kingdom	Research Site	Whitstable	Kent
Vietnam	Research Site	Ho Chi Minh
Vietnam	Research Site	Ho Chi Minh City

Sponsors (2)

Lead Sponsor	Collaborator
AstraZeneca	Bristol-Myers Squibb

Countries where clinical trial is conducted

Finland,  Germany,  Hungary,  India,  Korea, Republic of,  Netherlands,  Norway,  Russian Federation,  Slovakia,  United Kingdom,  Vietnam, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Baseline to 52 Weeks	No
Secondary	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)	From Baseline to Week 52	Yes
Secondary	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.	Baseline, Week 52 (Last Observation Carried Forward)	Yes
Secondary	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.	Week 24 to Week 52	No