Clinical Trial Details
| Trial ID: | L6215 |
| Source ID: | NCT00575588 |
| Associated Drug: | Metformin |
| Title: | 52-week add-on to Metformin Comparison of Saxagliptin and Sulphonylurea, With a 52-week Extension Period |
| Acronym: | |
| Status: | COMPLETED |
| Study Results: | YES |
| Results: | https://ClinicalTrials.gov/show/NCT00575588/results |
| Conditions: | Type 2 Diabetes |
| Interventions: | DRUG: Metformin|DRUG: Sulphonylurea|DRUG: Saxagliptin |
| Outcome Measures: | 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 | 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|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)|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 | Other: Hemoglobin A1c (HbA1c) Change From Baseline to Week 104, 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., Baseline, Week 104|Proportion of Participants Reporting at Least One Episode of Any Hypoglycaemic Event Over 104 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 104 weeks (Safety Analysis Set), Baseline, Week 104|Body Weight Change From Baseline to Week 104, 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., Baseline, Week 104|Mean Slope of the Regressions of Change From Week 24 to Week 104 in HbA1c, 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., Week 24 to Week 104 |
| Sponsor/Collaborators: | Sponsor: AstraZeneca | Collaborators: Bristol-Myers Squibb |
| Gender: | ALL |
| Age: | ADULT, OLDER_ADULT |
| Phases: | PHASE3 |
| Enrollment: | 891 |
| Study Type: | INTERVENTIONAL |
| Study Designs: | Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT |
| Start Date: | 2007-12 |
| Completion Date: | 2010-08 |
| Results First Posted: | 2010-09-06 |
| Last Update Posted: | 2012-03-21 |
| Locations: | 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, Finland|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, Germany|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, Hungary|Research Site, Bangalore, Karnataka, India|Research Site, Indore, Madhya Pradesh, India|Research Site, Mumbai, Mashatra, India|Research Site, Jaipur, Rajasthan, India|Research Site, Guri, Gyeonggi-do, Korea, Republic of|Research Site, Seongnam, Gyeonggi-do, Korea, Republic of|Research Site, Wonju, Kangwon-do, Korea, Republic of|Research Site, Incheon, Korea, Republic of|Research Site, Seoul, Korea, Republic of|Research Site, Uijeongbu-si, Korea, Republic of|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, Netherlands|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, Norway|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, Russian Federation|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, Slovakia|Research Site, Annan, Dumfries and Galloway, United Kingdom|Research Site, Whitstable, Kent, United Kingdom|Research Site, Hamilton, Lanarkshire, United Kingdom|Research Site, Salford, Manchester, United Kingdom|Research Site, Crawley, West Sussex, United Kingdom|Research Site, Bradford-on-avon, Wiltshire, United Kingdom|Research Site, Blackpool, United Kingdom|Research Site, Coatbridge, United Kingdom|Research Site, Coventry, United Kingdom|Research Site, Glasgow, United Kingdom|Research Site, Motherwell, United Kingdom|Research Site, Newcastle, United Kingdom|Research Site, Sheffield, United Kingdom|Research Site, Ho Chi Minh City, Vietnam|Research Site, Ho Chi Minh, Vietnam |
| URL: | https://clinicaltrials.gov/show/NCT00575588 |
