12 Weeks Treatment With 3 Different Doses of BI 10773 in Type 2 Diabetic Patients
NCT ID: NCT00789035
Last Updated: 2014-06-18
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
408 participants
INTERVENTIONAL
2008-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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PARALLEL
TREATMENT
Interventions
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BI 10773
placebo
metformin
Eligibility Criteria
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Inclusion Criteria
* either treatment-naïve or on a maximum of 1 oral antidiabetic therapy on a stable dose for the10 weeks prior to screening
* HbA1c ≥6.5 to ≤9.0% and for treatment-naïve patients:HbA1c \>7.0 to ≤10.0%
* HbA1c \>7.0 to ≤10.0% at Visit 2 (start of run-in) for all patients
* Age between 18 and 80 years
* BMI less than 40 kg/m2
* Signed and dated informed consent prior to admission to the study in accordance with GCP and local legislation
Exclusion Criteria
2. Impaired hepatic function
3. Renal insufficiency or impaired renal function
4. Disease of central nervous system, or psychiatric disorders or clinically relevant neurologic disorders that may interfere with trial participation
5. Chronic or clinically relevant acute infections
6. Current or chronic urogenital tract infection determined by medical history
7. History of clinically relevant allergy/hypersensitivity
8. Treatment with glitazones, GLP-1 analogues or insulin within 3 months prior to informed consent
9. Treatment with anti obesity drugs
10. Current treatment with systemic steroids
11. Alcohol abuse
12. Treatment with an investigational drug within 2 months prior to informed consent
13. known intolerance to metformin
14. Dehydration
15. Unstable or acute CHF
16. Acute or chronic acidosis
17. Hereditary galactose intolerance
18. Woman of child bearing potential who are nursing or pregnant or not practicing an acceptable method of birth control
18 Years
80 Years
ALL
No
Sponsors
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Boehringer Ingelheim
INDUSTRY
Responsible Party
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Boehringer Ingelheim
Principal Investigators
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Boehringer Ingelheim
Role: STUDY_CHAIR
Boehringer Ingelheim
Locations
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1245.9.54001 Boehringer Ingelheim Investigational Site
Capital Federal, , Argentina
1245.9.54002 Boehringer Ingelheim Investigational Site
Capital Federal, , Argentina
1245.9.54007 Boehringer Ingelheim Investigational Site
Capital Federal, , Argentina
1245.9.54008 Boehringer Ingelheim Investigational Site
Capital Federal, , Argentina
1245.9.54009 Boehringer Ingelheim Investigational Site
Capital Federal, , Argentina
1245.9.54010 Boehringer Ingelheim Investigational Site
Capital Federal, , Argentina
1245.9.54004 Boehringer Ingelheim Investigational Site
Mar del Plata, , Argentina
1245.9.54003 Boehringer Ingelheim Investigational Site
Mendoza, , Argentina
1245.9.54005 Boehringer Ingelheim Investigational Site
Salta, , Argentina
1245.9.54006 Boehringer Ingelheim Investigational Site
Salta, , Argentina
1245.9.38504 Boehringer Ingelheim Investigational Site
Karlovac, , Croatia
1245.9.38503 Boehringer Ingelheim Investigational Site
Krapinske Toplice, , Croatia
1245.9.38506 Boehringer Ingelheim Investigational Site
Osijek, , Croatia
1245.9.38505 Boehringer Ingelheim Investigational Site
Varaždin, , Croatia
1245.9.38501 Boehringer Ingelheim Investigational Site
Zagreb, , Croatia
1245.9.37201 Boehringer Ingelheim Investigational Site
Tallinn, , Estonia
1245.9.37202 Boehringer Ingelheim Investigational Site
Tallinn, , Estonia
1245.9.37203 Boehringer Ingelheim Investigational Site
Tallinn, , Estonia
1245.9.49007 Boehringer Ingelheim Investigational Site
Aschaffenburg, , Germany
1245.9.49001 Boehringer Ingelheim Investigational Site
Erlangen, , Germany
1245.9.49004 Boehringer Ingelheim Investigational Site
Hamburg, , Germany
1245.9.49005 Boehringer Ingelheim Investigational Site
Hamburg, , Germany
1245.9.49002 Boehringer Ingelheim Investigational Site
Melsungen, , Germany
1245.9.49008 Boehringer Ingelheim Investigational Site
Nuremberg, , Germany
1245.9.49003 Boehringer Ingelheim Investigational Site
Saint Ingbert/Oberwürzbach, , Germany
1245.9.49006 Boehringer Ingelheim Investigational Site
Sulzbach-Rosenberg, , Germany
1245.9.39006 Boehringer Ingelheim Investigational Site
Genova, , Italy
1245.9.39001 Boehringer Ingelheim Investigational Site
Pisa, , Italy
1245.9.39003 Boehringer Ingelheim Investigational Site
Pisa, , Italy
1245.9.39004 Boehringer Ingelheim Investigational Site
Siena, , Italy
1245.9.39005 Boehringer Ingelheim Investigational Site
Treviso, , Italy
1245.9.37002 Boehringer Ingelheim Investigational Site
Klaipėda, , Lithuania
1245.9.37001 Boehringer Ingelheim Investigational Site
Vilnius, , Lithuania
1245.9.40003 Boehringer Ingelheim Investigational Site
Brasov, , Romania
1245.9.40002 Boehringer Ingelheim Investigational Site
Bucharest, , Romania
1245.9.40004 Boehringer Ingelheim Investigational Site
Galati, , Romania
1245.9.40005 Boehringer Ingelheim Investigational Site
Târgu Mureş, , Romania
1245.9.70002 Boehringer Ingelheim Investigational Site
Kazan', , Russia
1245.9.70003 Boehringer Ingelheim Investigational Site
Nizhny Novgorod, , Russia
1245.9.70004 Boehringer Ingelheim Investigational Site
Petrozavodsk, , Russia
1245.9.70005 Boehringer Ingelheim Investigational Site
Smolensk, , Russia
1245.9.70006 Boehringer Ingelheim Investigational Site
Yaroslavl, , Russia
1245.9.70007 Boehringer Ingelheim Investigational Site
Yaroslavl, , Russia
1245.9.70001 Boehringer Ingelheim Investigational Site
Yekaterinburg, , Russia
1245.9.62002 Boehringer Ingelheim Investigational Site
Bratislava, , Slovakia
1245.9.62003 Boehringer Ingelheim Investigational Site
Lučenec, , Slovakia
1245.9.62004 Boehringer Ingelheim Investigational Site
Nové Mesto nad Váhom, , Slovakia
1245.9.62001 Boehringer Ingelheim Investigational Site
Prievidza, , Slovakia
1245.9.82006 Boehringer Ingelheim Investigational Site
Goyang, , South Korea
1245.9.82008 Boehringer Ingelheim Investigational Site
Goyang, , South Korea
1245.9.82007 Boehringer Ingelheim Investigational Site
Incheon, , South Korea
1245.9.82002 Boehringer Ingelheim Investigational Site
Pucheon, , South Korea
1245.9.82001 Boehringer Ingelheim Investigational Site
Seoul, , South Korea
1245.9.82004 Boehringer Ingelheim Investigational Site
Seoul, , South Korea
1245.9.82005 Boehringer Ingelheim Investigational Site
Seoul, , South Korea
1245.9.82009 Boehringer Ingelheim Investigational Site
Suwon, , South Korea
1245.9.82003 Boehringer Ingelheim Investigational Site
Uijeongbu-si, , South Korea
1245.9.46003 Boehringer Ingelheim Investigational Site
Gothenburg, , Sweden
1245.9.46004 Boehringer Ingelheim Investigational Site
Härnösand, , Sweden
1245.9.46005 Boehringer Ingelheim Investigational Site
Lund, , Sweden
1245.9.46001 Boehringer Ingelheim Investigational Site
Stockholm, , Sweden
1245.9.46002 Boehringer Ingelheim Investigational Site
Västerås, , Sweden
1245.9.88605 Boehringer Ingelheim Investigational Site
Changhua, , Taiwan
1245.9.88607 Boehringer Ingelheim Investigational Site
Kaohsiung City, , Taiwan
1245.9.88604 Boehringer Ingelheim Investigational Site
Taichung, , Taiwan
1245.9.88606 Boehringer Ingelheim Investigational Site
Tainan City, , Taiwan
1245.9.88601 Boehringer Ingelheim Investigational Site
Taipei, , Taiwan
1245.9.88603 Boehringer Ingelheim Investigational Site
Taipei, , Taiwan
1245.9.88602 Boehringer Ingelheim Investigational Site
Taoyuan District, , Taiwan
1245.9.38003 Boehringer Ingelheim Investigational Site
Kharkiv, , Ukraine
1245.9.38004 Boehringer Ingelheim Investigational Site
Kiev, , Ukraine
1245.9.38002 Boehringer Ingelheim Investigational Site
Odesa, , Ukraine
1245.9.38001 Boehringer Ingelheim Investigational Site
Vinnytsia, , Ukraine
1245.9.38005 Boehringer Ingelheim Investigational Site
Vinnytsia, , Ukraine
Countries
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References
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Tuttle KR, Levin A, Nangaku M, Kadowaki T, Agarwal R, Hauske SJ, Elsasser A, Ritter I, Steubl D, Wanner C, Wheeler DC. Safety of Empagliflozin in Patients With Type 2 Diabetes and Chronic Kidney Disease: Pooled Analysis of Placebo-Controlled Clinical Trials. Diabetes Care. 2022 Jun 2;45(6):1445-1452. doi: 10.2337/dc21-2034.
Riggs MM, Staab A, Seman L, MacGregor TR, Bergsma TT, Gastonguay MR, Macha S. Population pharmacokinetics of empagliflozin, a sodium glucose cotransporter 2 inhibitor, in patients with type 2 diabetes. J Clin Pharmacol. 2013 Oct;53(10):1028-38. doi: 10.1002/jcph.147. Epub 2013 Aug 13.
Other Identifiers
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EudraCT No 2008-000640-14
Identifier Type: -
Identifier Source: secondary_id
1245.9
Identifier Type: -
Identifier Source: org_study_id
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