12 Weeks Treatment With 3 Different Doses of BI 10773 in Type 2 Diabetic Patients
May 16, 2014 updated by: Boehringer Ingelheim
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
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
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
408
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Capital Federal, Argentina
- 1245.9.54001 Boehringer Ingelheim Investigational Site
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Capital Federal, Argentina
- 1245.9.54002 Boehringer Ingelheim Investigational Site
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Capital Federal, Argentina
- 1245.9.54007 Boehringer Ingelheim Investigational Site
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Capital Federal, Argentina
- 1245.9.54008 Boehringer Ingelheim Investigational Site
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Capital Federal, Argentina
- 1245.9.54009 Boehringer Ingelheim Investigational Site
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Capital Federal, Argentina
- 1245.9.54010 Boehringer Ingelheim Investigational Site
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Mar del Plata, Argentina
- 1245.9.54004 Boehringer Ingelheim Investigational Site
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Mendoza, Argentina
- 1245.9.54003 Boehringer Ingelheim Investigational Site
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Salta, Argentina
- 1245.9.54005 Boehringer Ingelheim Investigational Site
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Salta, Argentina
- 1245.9.54006 Boehringer Ingelheim Investigational Site
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Karlovac, Croatia
- 1245.9.38504 Boehringer Ingelheim Investigational Site
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Krapinske Toplice, Croatia
- 1245.9.38503 Boehringer Ingelheim Investigational Site
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Osijek, Croatia
- 1245.9.38506 Boehringer Ingelheim Investigational Site
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Varazdin, Croatia
- 1245.9.38505 Boehringer Ingelheim Investigational Site
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Zagreb, Croatia
- 1245.9.38501 Boehringer Ingelheim Investigational Site
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Tallin, Estonia
- 1245.9.37201 Boehringer Ingelheim Investigational Site
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Tallin, Estonia
- 1245.9.37202 Boehringer Ingelheim Investigational Site
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Tallin, Estonia
- 1245.9.37203 Boehringer Ingelheim Investigational Site
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Aschaffenburg, Germany
- 1245.9.49007 Boehringer Ingelheim Investigational Site
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Erlangen, Germany
- 1245.9.49001 Boehringer Ingelheim Investigational Site
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Hamburg, Germany
- 1245.9.49004 Boehringer Ingelheim Investigational Site
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Hamburg, Germany
- 1245.9.49005 Boehringer Ingelheim Investigational Site
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Melsungen, Germany
- 1245.9.49002 Boehringer Ingelheim Investigational Site
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Nürnberg, Germany
- 1245.9.49008 Boehringer Ingelheim Investigational Site
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St. Ingbert/Oberwürzbach, Germany
- 1245.9.49003 Boehringer Ingelheim Investigational Site
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Sulzbach-Rosenberg, Germany
- 1245.9.49006 Boehringer Ingelheim Investigational Site
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Genova, Italy
- 1245.9.39006 Boehringer Ingelheim Investigational Site
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Pisa, Italy
- 1245.9.39001 Boehringer Ingelheim Investigational Site
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Pisa, Italy
- 1245.9.39003 Boehringer Ingelheim Investigational Site
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Siena, Italy
- 1245.9.39004 Boehringer Ingelheim Investigational Site
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Treviso, Italy
- 1245.9.39005 Boehringer Ingelheim Investigational Site
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Goyang, Korea, Republic of
- 1245.9.82006 Boehringer Ingelheim Investigational Site
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Goyang, Korea, Republic of
- 1245.9.82008 Boehringer Ingelheim Investigational Site
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Incheon, Korea, Republic of
- 1245.9.82007 Boehringer Ingelheim Investigational Site
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Pucheon, Korea, Republic of
- 1245.9.82002 Boehringer Ingelheim Investigational Site
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Seoul, Korea, Republic of
- 1245.9.82001 Boehringer Ingelheim Investigational Site
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Seoul, Korea, Republic of
- 1245.9.82004 Boehringer Ingelheim Investigational Site
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Seoul, Korea, Republic of
- 1245.9.82005 Boehringer Ingelheim Investigational Site
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Suwon, Korea, Republic of
- 1245.9.82009 Boehringer Ingelheim Investigational Site
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Uijeongbu, Korea, Republic of
- 1245.9.82003 Boehringer Ingelheim Investigational Site
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Klaipeda, Lithuania
- 1245.9.37002 Boehringer Ingelheim Investigational Site
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Vilnius, Lithuania
- 1245.9.37001 Boehringer Ingelheim Investigational Site
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Brasov, Romania
- 1245.9.40003 Boehringer Ingelheim Investigational Site
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Bucharest, Romania
- 1245.9.40002 Boehringer Ingelheim Investigational Site
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Galati, Romania
- 1245.9.40004 Boehringer Ingelheim Investigational Site
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Targu-Mures, Romania
- 1245.9.40005 Boehringer Ingelheim Investigational Site
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Ekaterinburg, Russian Federation
- 1245.9.70001 Boehringer Ingelheim Investigational Site
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Kazan, Russian Federation
- 1245.9.70002 Boehringer Ingelheim Investigational Site
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Nizhniy Novgorod, Russian Federation
- 1245.9.70003 Boehringer Ingelheim Investigational Site
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Petrozavodsk, Russian Federation
- 1245.9.70004 Boehringer Ingelheim Investigational Site
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Smolensk, Russian Federation
- 1245.9.70005 Boehringer Ingelheim Investigational Site
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Yaroslavl, Russian Federation
- 1245.9.70006 Boehringer Ingelheim Investigational Site
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Yaroslavl, Russian Federation
- 1245.9.70007 Boehringer Ingelheim Investigational Site
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Bratislava, Slovakia
- 1245.9.62002 Boehringer Ingelheim Investigational Site
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Lucenec, Slovakia
- 1245.9.62003 Boehringer Ingelheim Investigational Site
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Nove Mesto Nad Vahom, Slovakia
- 1245.9.62004 Boehringer Ingelheim Investigational Site
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Prievidza, Slovakia
- 1245.9.62001 Boehringer Ingelheim Investigational Site
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Göteborg, Sweden
- 1245.9.46003 Boehringer Ingelheim Investigational Site
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Härnösand, Sweden
- 1245.9.46004 Boehringer Ingelheim Investigational Site
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Lund, Sweden
- 1245.9.46005 Boehringer Ingelheim Investigational Site
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Stockholm, Sweden
- 1245.9.46001 Boehringer Ingelheim Investigational Site
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Västerås, Sweden
- 1245.9.46002 Boehringer Ingelheim Investigational Site
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Changhua, Taiwan
- 1245.9.88605 Boehringer Ingelheim Investigational Site
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Kaohsiung, Taiwan
- 1245.9.88607 Boehringer Ingelheim Investigational Site
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Taichung, Taiwan
- 1245.9.88604 Boehringer Ingelheim Investigational Site
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Tainan, Taiwan
- 1245.9.88606 Boehringer Ingelheim Investigational Site
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Taipei, Taiwan
- 1245.9.88601 Boehringer Ingelheim Investigational Site
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Taipei, Taiwan
- 1245.9.88603 Boehringer Ingelheim Investigational Site
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Taoyuan, Taiwan
- 1245.9.88602 Boehringer Ingelheim Investigational Site
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Kharkov, Ukraine
- 1245.9.38003 Boehringer Ingelheim Investigational Site
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Kiev, Ukraine
- 1245.9.38004 Boehringer Ingelheim Investigational Site
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Odessa, Ukraine
- 1245.9.38002 Boehringer Ingelheim Investigational Site
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Vinnytsya, Ukraine
- 1245.9.38001 Boehringer Ingelheim Investigational Site
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Vinnytsya, Ukraine
- 1245.9.38005 Boehringer Ingelheim Investigational Site
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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:
- Myocardial infarction, stroke or TIA within 6 months prior to informed consent
- Impaired hepatic function
- Renal insufficiency or impaired renal function
- Disease of central nervous system, or psychiatric disorders or clinically relevant neurologic disorders that may interfere with trial participation
- Chronic or clinically relevant acute infections
- Current or chronic urogenital tract infection determined by medical history
- History of clinically relevant allergy/hypersensitivity
- Treatment with glitazones, GLP-1 analogues or insulin within 3 months prior to informed consent
- Treatment with anti obesity drugs
- Current treatment with systemic steroids
- Alcohol abuse
- Treatment with an investigational drug within 2 months prior to informed consent
- known intolerance to metformin
- Dehydration
- Unstable or acute CHF
- Acute or chronic acidosis
- Hereditary galactose intolerance
- Woman of child bearing potential who are nursing or pregnant or not practicing an acceptable method of birth control
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Interventional Model: Parallel Assignment
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Change of Glycosilated Haemoglobin A1c (HbA1c) From Baseline After 12 Weeks of Treatment
Time Frame: Baseline and 12 weeks
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Change of HbA1c from baseline after 12 weeks of treatment. Note, adjusted means are presented. For the placebo and empa groups, measured values presented are for the model including only these treatment groups, for the metformin group the measured values presented are for the model including only placebo and metformin groups. |
Baseline and 12 weeks
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Change of FPG From Baseline After 12 Weeks of Treatment
Time Frame: Baseline and 12 weeks
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Change of Fasting Plasma Glucose (FPG) from baseline after 12 weeks of treatment. Results presented stem from a repeated measures analysis. Note, adjusted means are presented. For the placebo and empa groups, measured values presented are for the model including only these treatment groups, for the metformin group the measured values presented are for the model including only placebo and metformin groups. |
Baseline and 12 weeks
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Change of HbA1c From Baseline Over Time
Time Frame: Baseline and weeks 4, 8 and 12
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Change of HbA1c from baseline over time.
Results presented stem from a repeated measures analysis.
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Baseline and weeks 4, 8 and 12
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Proportion of Patients Who Achieve an HbA1c ≤7.0% After 12 Weeks of Treatment
Time Frame: 12 weeks
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Results for HbA1c categories at week 12 (Proportion of patients with HbA1c less than equal to 7%).
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12 weeks
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Proportion of Patients Who Achieve an HbA1c Lowering of at Least 0.5% After 12 Weeks of Treatment
Time Frame: 12 weeks
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Results for HbA1c categories at week 12 (Proportion of patients with HbA1c lowered at least 0.5%).
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12 weeks
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Change From Baseline to Week 12 in Fasting Plasma Insulin (FPI)
Time Frame: Baseline and 12 weeks
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Results for change of FPI from baseline at week 12 based on ANCOVA.
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Baseline and 12 weeks
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Change in Homeostasis Model Assessment Index for Insulin Resistance (HOMA-IR)
Time Frame: Baseline and 12 weeks
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HOMA-IR (to assess insulin resistance) is defined as (FPI x FPG)/22.5.
Results based on ANCOVA.
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Baseline and 12 weeks
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Change in Homeostasis Model Assessment Index for Beta Cell Function (HOMA-%B)
Time Frame: Baseline and 12 weeks
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HOMA-%B (to assess insulin beta cell function) is defined as (20 x FPI)/(FPG-3.5).
Results are based on ANCOVA.
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Baseline and 12 weeks
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Change of Body Weight After 12 Weeks of Treatment
Time Frame: Baseline and 12 weeks
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Results for change of body weight after 12 weeks of treatment based on ANCOVA.
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Baseline and 12 weeks
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Trough Concentrations of Empagliflozin in Plasma
Time Frame: Days 28, 56 and 84
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Pre-dose (within 30 minutes before dosing) trough concentrations of Empagliflozin in plasma
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Days 28, 56 and 84
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2008
Primary Completion (Actual)
October 1, 2009
Study Registration Dates
First Submitted
October 13, 2008
First Submitted That Met QC Criteria
November 10, 2008
First Posted (Estimate)
November 11, 2008
Study Record Updates
Last Update Posted (Estimate)
June 18, 2014
Last Update Submitted That Met QC Criteria
May 16, 2014
Last Verified
May 1, 2014
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1245.9
- EudraCT No 2008-000640-14
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.