Efficacy and Safety of Dapagliflozin in Combination With Glimepiride (a Sulphonylurea) in Type 2 Diabetes Patients
A 24-Week,Int.,Rand.,Double-blind,Parallel-group,Multi-centre, Plac.-Controlled Phase III Study With a 24-Wk Ext.Per.to Eval.the Efficacy and Safety of Dapagliflozin in Comb.With Glimepiride (a Sulphonylurea) in Subjects With Type2 Diab.Who Have Inadeq. Glycaemic Control on Glimepiride Therapy Alone
1 other identifier
interventional
597
7 countries
66
Brief Summary
This study is being carried out to see if dapagliflozin in addition to glimepiride (sulphonylurea) is effective and safe in treating patients with type 2 diabetes when compared to glimepiride alone.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3 type-2-diabetes
Started Apr 2008
Typical duration for phase_3 type-2-diabetes
66 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2008
CompletedFirst Submitted
Initial submission to the registry
May 16, 2008
CompletedFirst Posted
Study publicly available on registry
May 20, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2010
CompletedResults Posted
Study results publicly available
October 14, 2013
CompletedOctober 14, 2013
August 1, 2013
1.6 years
May 16, 2008
April 13, 2011
August 9, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Adjusted Mean Change in HbA1c Levels
To assess the efficacy of dapagliflozin compared to placebo as add-on therapy to glimepiride in improving glycemic control in participants with type 2 diabetes, as determined by the change in HbA1C levels from baseline to the end of the 24-week double-blind treatment period.
Baseline to Week 24
Secondary Outcomes (5)
Adjusted Mean Change in Body Weight
Baseline to Week 24
Adjusted Mean Change in 2-h Post-challenge Plasma Glucose Rise
Baseline to Week 24
Proportion of Participants Achieving Glycemic Response Defined as HbA1c <7%
At Week 24
Adjusted Mean Change in Body Weight for Participants With Baseline Body Mass Index (BMI)≥27 kg/m2
Baseline to Week 24
Adjusted Mean Change in Fasting Plasma Glucose (FPG)
Baseline to Week 24
Study Arms (4)
1
EXPERIMENTALdapagliflozin 2.5mg + Glimepiride
2
EXPERIMENTALdapagliflozin 5mg + Glimepiride
3
EXPERIMENTALdapagliflozin 10mg + Glimepiride
4
PLACEBO COMPARATORPlacebo + Glimepiride
Interventions
tablet oral 2.5, 5, or 10 mg total daily dose once daily 48 weeks
rescue medication oral dosing in accordance with the manufacturer's recommendations and clinical practice
rescue medication oral dosing in accordance with the manufacturer's recommendations and clinical practice
rescue medication oral dosing in accordance with the manufacturer's recommendations and clinical practice
Eligibility Criteria
You may qualify if:
- Type 2 Diabetes
- Treatment with a stable sulphonylurea monotherapy dose that is at least half the maximal recommended dose for a minimum of 8 weeks prior to study
- Inadequate glycaemic control, defined as A1C ≥ 7.0 % and ≤ 10%
You may not qualify if:
- Type 1 Diabetes
- Hepatic (liver) impairment
- Renal (kidney) failure or dysfunction
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
- Bristol-Myers Squibbcollaborator
Study Sites (66)
Research Site
Blansko, Czechia
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Bruntál, Czechia
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Břeclav, Czechia
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Hodonín, Czechia
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Ostrava - Belsky Les, Czechia
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Pilsen, Czechia
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Prague, Czechia
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Pribram VIII, Czechia
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Rakovník, Czechia
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Semily, Czechia
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Balatonfüred, Hungary
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Békéscsaba, Hungary
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Budapest, Hungary
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Csongrád, Hungary
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Eger, Hungary
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Gyöngyös, Hungary
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Kecskemét, Hungary
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Makó, Hungary
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Miskolc, Hungary
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Mosonmagyaróvár, Hungary
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Siófok, Hungary
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Szentes, Hungary
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Tát, Hungary
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Zalaegerszeg, Hungary
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Cebu City, Philippines
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Manila, Philippines
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Marikina City, Philippines
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Pasig, Philippines
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Bielsko-Biala, Poland
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Bydgoszcz, Poland
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Chojnice, Poland
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Chrzanów, Poland
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Ciechocinek, Poland
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Czechowice-Dziedzice, Poland
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Elblag, Poland
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Gdansk, Poland
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Gniewkowo, Poland
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Grudziądz, Poland
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Iława, Poland
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Krakow, Poland
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Mrągowo, Poland
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Poznan, Poland
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Płock, Poland
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Ruda Śląska, Poland
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Sopot, Poland
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Torun, Poland
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Wroclaw, Poland
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Zabrze, Poland
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Zielona Góra, Poland
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Żory, Poland
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Wŏnju, Gangwon-do, South Korea
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Suwon, Gyeonggi-do, South Korea
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Jeonju, Jeollabuk-do, South Korea
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Bucheon-si, South Korea
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Incheon, South Korea
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Seongnam, South Korea
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Seoul, South Korea
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Uljeongbu, South Korea
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Bangkok, Thailand
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Chiang Mai, Thailand
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Dnipropetrov'sk, Ukraine
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Donetsk, Ukraine
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Kharkiv, Ukraine
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Kiev, Ukraine
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Vinnytsia, Ukraine
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Zaporizhzhya, Ukraine
Related Publications (3)
Shah M, Stolbov L, Yakovleva T, Tang W, Sokolov V, Penland RC, Boulton D, Parkinson J. A model-based approach to investigating the relationship between glucose-insulin dynamics and dapagliflozin treatment effect in patients with type 2 diabetes. Diabetes Obes Metab. 2021 Apr;23(4):991-1000. doi: 10.1111/dom.14305. Epub 2021 Jan 25.
PMID: 33368935DERIVEDStrojek K, Yoon KH, Hruba V, Elze M, Langkilde AM, Parikh S. [Effect of dapagliflozin in patients with type 2 diabetes who have inadequate glycaemic control with glimepiride]. Dtsch Med Wochenschr. 2013 Apr;138 Suppl 1:S16-26. doi: 10.1055/s-0032-1305277. Epub 2013 Mar 25. German.
PMID: 23529567DERIVEDStrojek K, Yoon KH, Hruba V, Elze M, Langkilde AM, Parikh S. Effect of dapagliflozin in patients with type 2 diabetes who have inadequate glycaemic control with glimepiride: a randomized, 24-week, double-blind, placebo-controlled trial. Diabetes Obes Metab. 2011 Oct;13(10):928-38. doi: 10.1111/j.1463-1326.2011.01434.x.
PMID: 21672123DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
For participants who did not complete 24 weeks LOCF (last observation carried forward) was used. Only values prior to rescue medication were used.
Results Point of Contact
- Title
- Eva Johnsson
- Organization
- AstraZeneca
Study Officials
- PRINCIPAL INVESTIGATOR
Krzysztof Strojek, Prof. Dr.
Silesian Medical University3-Maja 13/15, 41-800 Zabrze; Poland
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 16, 2008
First Posted
May 20, 2008
Study Start
April 1, 2008
Primary Completion
November 1, 2009
Study Completion
May 1, 2010
Last Updated
October 14, 2013
Results First Posted
October 14, 2013
Record last verified: 2013-08