Clinical trial NCT00789035: 12 Weeks Treatment With 3 Different Doses of BI 10773 in Type 2 Diabetic Patients
Official title: A Phase IIb, Randomized, Parallel Group Safety, Efficacy, and Pharmacokinetics Study of BI 10773 (5 mg, 10 mg and 25 mg) Administered Orally Once Daily Over 12 Weeks Compared Double Blind to Placebo, as Monotherapy, With an Additional Open-label Metformin Arm in Type 2 Diabetic Patients With Insufficient Glycemic Control
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Diabetes Mellitus, Type 2
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2008-11-11
Enrollment: 408
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The objective is to investigate the efficacy, safety and pharmacokinetics of three different doses of BI 10773 compared to placebo given for 12 weeks in patients with type 2 diabetes mellitus with insufficient glycemic control. In addition an open-label metformin arm will be assessed


Eligibility criteria: Inclusion Criteria:

* Male and female patients with a diagnosis of type 2 diabetes mellitus
* 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:

1. Myocardial infarction, stroke or TIA within 6 months prior to informed consent
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

Primary outcomes:
measure: Change of Glycosilated Haemoglobin A1c (HbA1c) From Baseline After 12 Weeks of Treatment
timeFrame: Baseline and 12 weeks
Secondary outcomes:
measure: Change of FPG From Baseline After 12 Weeks of Treatment
timeFrame: Baseline and 12 weeks
measure: Change of HbA1c From Baseline Over Time
timeFrame: Baseline and weeks 4, 8 and 12
measure: Proportion of Patients Who Achieve an HbA1c ≤7.0% After 12 Weeks of Treatment
timeFrame: 12 weeks
measure: Proportion of Patients Who Achieve an HbA1c Lowering of at Least 0.5% After 12 Weeks of Treatment
timeFrame: 12 weeks
measure: Change From Baseline to Week 12 in Fasting Plasma Insulin (FPI)
timeFrame: Baseline and 12 weeks
measure: Change in Homeostasis Model Assessment Index for Insulin Resistance (HOMA-IR)
timeFrame: Baseline and 12 weeks
measure: Change in Homeostasis Model Assessment Index for Beta Cell Function (HOMA-%B)
timeFrame: Baseline and 12 weeks
measure: Change of Body Weight After 12 Weeks of Treatment
timeFrame: Baseline and 12 weeks
measure: Trough Concentrations of Empagliflozin in Plasma
timeFrame: Days 28, 56 and 84
Other outcomes:
Locations:
city: Capital Federal
country: Argentina
facility: 1245.9.54001 Boehringer Ingelheim Investigational Site
city: Capital Federal
country: Argentina
facility: 1245.9.54002 Boehringer Ingelheim Investigational Site
city: Capital Federal
country: Argentina
facility: 1245.9.54007 Boehringer Ingelheim Investigational Site
city: Capital Federal
country: Argentina
facility: 1245.9.54008 Boehringer Ingelheim Investigational Site
city: Capital Federal
country: Argentina
facility: 1245.9.54009 Boehringer Ingelheim Investigational Site
city: Capital Federal
country: Argentina
facility: 1245.9.54010 Boehringer Ingelheim Investigational Site
city: Mar del Plata
country: Argentina
facility: 1245.9.54004 Boehringer Ingelheim Investigational Site
city: Mendoza
country: Argentina
facility: 1245.9.54003 Boehringer Ingelheim Investigational Site
city: Salta
country: Argentina
facility: 1245.9.54005 Boehringer Ingelheim Investigational Site
city: Salta
country: Argentina
facility: 1245.9.54006 Boehringer Ingelheim Investigational Site
city: Karlovac
country: Croatia
facility: 1245.9.38504 Boehringer Ingelheim Investigational Site
city: Krapinske Toplice
country: Croatia
facility: 1245.9.38503 Boehringer Ingelheim Investigational Site
city: Osijek
country: Croatia
facility: 1245.9.38506 Boehringer Ingelheim Investigational Site
city: Varazdin
country: Croatia
facility: 1245.9.38505 Boehringer Ingelheim Investigational Site
city: Zagreb
country: Croatia
facility: 1245.9.38501 Boehringer Ingelheim Investigational Site
city: Tallin
country: Estonia
facility: 1245.9.37201 Boehringer Ingelheim Investigational Site
city: Tallin
country: Estonia
facility: 1245.9.37202 Boehringer Ingelheim Investigational Site
city: Tallin
country: Estonia
facility: 1245.9.37203 Boehringer Ingelheim Investigational Site
city: Aschaffenburg
country: Germany
facility: 1245.9.49007 Boehringer Ingelheim Investigational Site
city: Erlangen
country: Germany
facility: 1245.9.49001 Boehringer Ingelheim Investigational Site
city: Hamburg
country: Germany
facility: 1245.9.49004 Boehringer Ingelheim Investigational Site
city: Hamburg
country: Germany
facility: 1245.9.49005 Boehringer Ingelheim Investigational Site
city: Melsungen
country: Germany
facility: 1245.9.49002 Boehringer Ingelheim Investigational Site
city: Nürnberg
country: Germany
facility: 1245.9.49008 Boehringer Ingelheim Investigational Site
city: St. Ingbert/Oberwürzbach
country: Germany
facility: 1245.9.49003 Boehringer Ingelheim Investigational Site
city: Sulzbach-Rosenberg
country: Germany
facility: 1245.9.49006 Boehringer Ingelheim Investigational Site
city: Genova
country: Italy
facility: 1245.9.39006 Boehringer Ingelheim Investigational Site
city: Pisa
country: Italy
facility: 1245.9.39001 Boehringer Ingelheim Investigational Site
city: Pisa
country: Italy
facility: 1245.9.39003 Boehringer Ingelheim Investigational Site
city: Siena
country: Italy
facility: 1245.9.39004 Boehringer Ingelheim Investigational Site
city: Treviso
country: Italy
facility: 1245.9.39005 Boehringer Ingelheim Investigational Site
city: Goyang
country: Korea, Republic of
facility: 1245.9.82006 Boehringer Ingelheim Investigational Site
city: Goyang
country: Korea, Republic of
facility: 1245.9.82008 Boehringer Ingelheim Investigational Site
city: Incheon
country: Korea, Republic of
facility: 1245.9.82007 Boehringer Ingelheim Investigational Site
city: Pucheon
country: Korea, Republic of
facility: 1245.9.82002 Boehringer Ingelheim Investigational Site
city: Seoul
country: Korea, Republic of
facility: 1245.9.82001 Boehringer Ingelheim Investigational Site
city: Seoul
country: Korea, Republic of
facility: 1245.9.82004 Boehringer Ingelheim Investigational Site
city: Seoul
country: Korea, Republic of
facility: 1245.9.82005 Boehringer Ingelheim Investigational Site
city: Suwon
country: Korea, Republic of
facility: 1245.9.82009 Boehringer Ingelheim Investigational Site
city: Uijeongbu
country: Korea, Republic of
facility: 1245.9.82003 Boehringer Ingelheim Investigational Site
city: Klaipeda
country: Lithuania
facility: 1245.9.37002 Boehringer Ingelheim Investigational Site
city: Vilnius
country: Lithuania
facility: 1245.9.37001 Boehringer Ingelheim Investigational Site
city: Brasov
country: Romania
facility: 1245.9.40003 Boehringer Ingelheim Investigational Site
city: Bucharest
country: Romania
facility: 1245.9.40002 Boehringer Ingelheim Investigational Site
city: Galati
country: Romania
facility: 1245.9.40004 Boehringer Ingelheim Investigational Site
city: Targu-Mures
country: Romania
facility: 1245.9.40005 Boehringer Ingelheim Investigational Site
city: Ekaterinburg
country: Russian Federation
facility: 1245.9.70001 Boehringer Ingelheim Investigational Site
city: Kazan
country: Russian Federation
facility: 1245.9.70002 Boehringer Ingelheim Investigational Site
city: Nizhniy Novgorod
country: Russian Federation
facility: 1245.9.70003 Boehringer Ingelheim Investigational Site
city: Petrozavodsk
country: Russian Federation
facility: 1245.9.70004 Boehringer Ingelheim Investigational Site
city: Smolensk
country: Russian Federation
facility: 1245.9.70005 Boehringer Ingelheim Investigational Site
city: Yaroslavl
country: Russian Federation
facility: 1245.9.70006 Boehringer Ingelheim Investigational Site
city: Yaroslavl
country: Russian Federation
facility: 1245.9.70007 Boehringer Ingelheim Investigational Site
city: Bratislava
country: Slovakia
facility: 1245.9.62002 Boehringer Ingelheim Investigational Site
city: Lucenec
country: Slovakia
facility: 1245.9.62003 Boehringer Ingelheim Investigational Site
city: Nove Mesto Nad Vahom
country: Slovakia
facility: 1245.9.62004 Boehringer Ingelheim Investigational Site
city: Prievidza
country: Slovakia
facility: 1245.9.62001 Boehringer Ingelheim Investigational Site
city: Göteborg
country: Sweden
facility: 1245.9.46003 Boehringer Ingelheim Investigational Site
city: Härnösand
country: Sweden
facility: 1245.9.46004 Boehringer Ingelheim Investigational Site
city: Lund
country: Sweden
facility: 1245.9.46005 Boehringer Ingelheim Investigational Site
city: Stockholm
country: Sweden
facility: 1245.9.46001 Boehringer Ingelheim Investigational Site
city: Västerås
country: Sweden
facility: 1245.9.46002 Boehringer Ingelheim Investigational Site
city: Changhua
country: Taiwan
facility: 1245.9.88605 Boehringer Ingelheim Investigational Site
city: Kaohsiung
country: Taiwan
facility: 1245.9.88607 Boehringer Ingelheim Investigational Site
city: Taichung
country: Taiwan
facility: 1245.9.88604 Boehringer Ingelheim Investigational Site
city: Tainan
country: Taiwan
facility: 1245.9.88606 Boehringer Ingelheim Investigational Site
city: Taipei
country: Taiwan
facility: 1245.9.88601 Boehringer Ingelheim Investigational Site
city: Taipei
country: Taiwan
facility: 1245.9.88603 Boehringer Ingelheim Investigational Site
city: Taoyuan
country: Taiwan
facility: 1245.9.88602 Boehringer Ingelheim Investigational Site
city: Kharkov
country: Ukraine
facility: 1245.9.38003 Boehringer Ingelheim Investigational Site
city: Kiev
country: Ukraine
facility: 1245.9.38004 Boehringer Ingelheim Investigational Site
city: Odessa
country: Ukraine
facility: 1245.9.38002 Boehringer Ingelheim Investigational Site
city: Vinnytsya
country: Ukraine
facility: 1245.9.38001 Boehringer Ingelheim Investigational Site
city: Vinnytsya
country: Ukraine
facility: 1245.9.38005 Boehringer Ingelheim Investigational Site
Study officials:
affiliation: Boehringer Ingelheim
name: Boehringer Ingelheim
role: STUDY_CHAIR
References:
citation: 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.
citation: 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.