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BI 10773 add-on to Metformin in Patients With Type 2 Diabetes

NCT ID: NCT00749190

Last Updated: 2014-06-13

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

495 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-08-31

Brief Summary

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The objective of the current study is to investigate the efficacy, safety and pharmacokinetics of five doses of BI 10773 compared to placebo given for 12 weeks as add-on therapy to on going metformin therapy in patients with T2DM with insufficient glycemic control. In addition, there will be an open-label treatment arm with sitagliptin (JanuviaTM) as add-on therapy to metformin.

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Detailed Description

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Conditions

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Diabetes Mellitus, Type 2

Study Design

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Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Interventions

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BI 10773

Intervention Type DRUG

placebo

Intervention Type DRUG

sitagliptin

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1. Male and female patients with a diagnosis of type 2 diabetes mellitus and previously treated with metformin alone or with metformin and one other oral antidiabetic drug
2. Stable metformin therapy of at least 1500 mg/day, or less if that is a maximum tolerated dose.
3. HbA1c at screening 6.5% to 9.0% for patients on metformin and one other antidiabetic drug, and HbA1c \>7.0% to 10% for patients on metformin only
4. HbA1c \>7.0% to 10.0% at Visit 2 (Start of Run-in)
5. Age \>=18 and \<80years
6. Body Mass Index (BMI) \<=40 kg/m2
7. Signed and dated written informed consent prior to admission to the study in accordance with Good Clinical Practice (GCP) and local legislation

Exclusion Criteria

1. Myocardial infarction, stroke or transient ischemic attack (TIA) within 6 months prior to informed consent
2. Impaired hepatic function
3. Renal insufficiency or impaired renal function
4. Diseases of the central nervous system or psychiatric disorders or clinically relevant neurological disorders that may interfere with participation in the trial
5. Chronic or clinically relevant acute infections
6. Current or chronic urogenital tract infection
7. History of clinically relevant allergy/hypersensitivity
8. Treatment with glitazones (e.g., rosiglitazone, pioglitazone), glucagon-like peptide (GLP-1) analogues, or insulin within 3 months prior to informed consent
9. Treatment with anti-obesity drugs within 3 months prior to informed consent
10. Treatment with systemic steroids or change in dosage of thyroid hormones within 6 weeks prior to informed consent
11. Alcohol abuse or drug abuse
12. Treatment with an investigational drug within 2 months prior to informed consent
13. Women of child-bearing potential who are nursing or pregnant, or who are not practicing an acceptable method of birth control, or do not plan to continue using this method throughout the study and do not agree to periodic pregnancy testing during participation in the trial
Minimum Eligible Age

18 Years

Maximum Eligible Age

79 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Boehringer Ingelheim

INDUSTRY

Sponsor Role lead

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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1245.10.10026 Boehringer Ingelheim Investigational Site

Chula Vista, California, United States

Site Status

1245.10.10001 Boehringer Ingelheim Investigational Site

Mission Viejo, California, United States

Site Status

1245.10.10011 Boehringer Ingelheim Investigational Site

Pasadena, California, United States

Site Status

1245.10.10028 Boehringer Ingelheim Investigational Site

Spring Valley, California, United States

Site Status

1245.10.10027 Boehringer Ingelheim Investigational Site

Walnut Creek, California, United States

Site Status

1245.10.10004 Boehringer Ingelheim Investigational Site

Clearwarter, Florida, United States

Site Status

1245.10.10021 Boehringer Ingelheim Investigational Site

Melbourne, Florida, United States

Site Status

1245.10.10005 Boehringer Ingelheim Investigational Site

Miami, Florida, United States

Site Status

1245.10.10019 Boehringer Ingelheim Investigational Site

Miami, Florida, United States

Site Status

1245.10.10024 Boehringer Ingelheim Investigational Site

Saint Cloud, Florida, United States

Site Status

1245.10.10014 Boehringer Ingelheim Investigational Site

Roswell, Georgia, United States

Site Status

1245.10.10016 Boehringer Ingelheim Investigational Site

Staten Island, New York, United States

Site Status

1245.10.10009 Boehringer Ingelheim Investigational Site

Shelby, North Carolina, United States

Site Status

1245.10.10006 Boehringer Ingelheim Investigational Site

Wadsworth, Ohio, United States

Site Status

1245.10.10023 Boehringer Ingelheim Investigational Site

Norristown, Pennsylvania, United States

Site Status

1245.10.10010 Boehringer Ingelheim Investigational Site

Clemson, South Carolina, United States

Site Status

1245.10.10015 Boehringer Ingelheim Investigational Site

Dallas, Texas, United States

Site Status

1245.10.10012 Boehringer Ingelheim Investigational Site

Temple, Texas, United States

Site Status

1245.10.10025 Boehringer Ingelheim Investigational Site

Federal Way, Washington, United States

Site Status

1245.10.54002 Boehringer Ingelheim Investigational Site

Capital Federal, , Argentina

Site Status

1245.10.54004 Boehringer Ingelheim Investigational Site

Capital Federal, , Argentina

Site Status

1245.10.54008 Boehringer Ingelheim Investigational Site

Capital Federal, , Argentina

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1245.10.54006 Boehringer Ingelheim Investigational Site

Mar del Plata, , Argentina

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1245.10.54005 Boehringer Ingelheim Investigational Site

Mendoza, , Argentina

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1245.10.43002 Boehringer Ingelheim Investigational Site

Graz, , Austria

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1245.10.43004 Boehringer Ingelheim Investigational Site

Innsbruck, , Austria

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1245.10.43001 Boehringer Ingelheim Investigational Site

Vienna, , Austria

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1245.10.43003 Boehringer Ingelheim Investigational Site

Vienna, , Austria

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1245.10.42003 Boehringer Ingelheim Investigational Site

Brno, , Czechia

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1245.10.42005 Boehringer Ingelheim Investigational Site

Brno, , Czechia

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1245.10.42001 Boehringer Ingelheim Investigational Site

Břeclav, , Czechia

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1245.10.42002 Boehringer Ingelheim Investigational Site

Hodonín, , Czechia

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1245.10.37201 Boehringer Ingelheim Investigational Site

Tallinn, , Estonia

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1245.10.37202 Boehringer Ingelheim Investigational Site

Tartu, , Estonia

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1245.10.58006 Boehringer Ingelheim Investigational Site

Kerava, , Finland

Site Status

1245.10.58003 Boehringer Ingelheim Investigational Site

Oulu, , Finland

Site Status

1245.10.58004 Boehringer Ingelheim Investigational Site

Tampere, , Finland

Site Status

1245.10.58001 Boehringer Ingelheim Investigational Site

Turku, , Finland

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1245.10.3302A Boehringer Ingelheim Investigational Site

Bondy, , France

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1245.10.3302B Boehringer Ingelheim Investigational Site

Bondy, , France

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1245.10.3310A Boehringer Ingelheim Investigational Site

Caen, , France

Site Status

1245.10.3310B Boehringer Ingelheim Investigational Site

Caen, , France

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1245.10.3310C Boehringer Ingelheim Investigational Site

Caen, , France

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1245.10.3301A Boehringer Ingelheim Investigational Site

Corbeil-Essonnes, , France

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1245.10.3301B Boehringer Ingelheim Investigational Site

Corbeil-Essonnes, , France

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1245.10.3303A Boehringer Ingelheim Investigational Site

La Rochelle, , France

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1245.10.3303B Boehringer Ingelheim Investigational Site

La Rochelle, , France

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1245.10.3303C Boehringer Ingelheim Investigational Site

La Rochelle, , France

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1245.10.3303D Boehringer Ingelheim Investigational Site

La Rochelle, , France

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1245.10.3308A Boehringer Ingelheim Investigational Site

Le Grau-du-Roi, , France

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1245.10.3308B Boehringer Ingelheim Investigational Site

Le Grau-du-Roi, , France

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1245.10.3309A Boehringer Ingelheim Investigational Site

Nanterre, , France

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1245.10.3306A Boehringer Ingelheim Investigational Site

Narbonne, , France

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1245.10.3306B Boehringer Ingelheim Investigational Site

Narbonne, , France

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1245.10.3307A Boehringer Ingelheim Investigational Site

Quimper, , France

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1245.10.3304A Boehringer Ingelheim Investigational Site

Reims, , France

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1245.10.3304B Boehringer Ingelheim Investigational Site

Reims, , France

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1245.10.3304C Boehringer Ingelheim Investigational Site

Reims, , France

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1245.10.3311A Boehringer Ingelheim Investigational Site

Saint-Mandé, , France

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1245.10.3311B Boehringer Ingelheim Investigational Site

Saint-Mandé, , France

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1245.10.3311C Boehringer Ingelheim Investigational Site

Saint-Mandé, , France

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1245.10.3311D Boehringer Ingelheim Investigational Site

Saint-Mandé, , France

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1245.10.3305A Boehringer Ingelheim Investigational Site

Valenciennes, , France

Site Status

1245.10.3305B Boehringer Ingelheim Investigational Site

Valenciennes, , France

Site Status

1245.10.3305C Boehringer Ingelheim Investigational Site

Valenciennes, , France

Site Status

1245.10.3305D Boehringer Ingelheim Investigational Site

Valenciennes, , France

Site Status

1245.10.49001 Boehringer Ingelheim Investigational Site

Erlangen, , Germany

Site Status

1245.10.49003 Boehringer Ingelheim Investigational Site

Frankfurt, , Germany

Site Status

1245.10.49002 Boehringer Ingelheim Investigational Site

Hamburg, , Germany

Site Status

1245.10.49004 Boehringer Ingelheim Investigational Site

Rehlingen-Siersburg, , Germany

Site Status

1245.10.36001 Boehringer Ingelheim Investigational Site

Budapest, , Hungary

Site Status

1245.10.36003 Boehringer Ingelheim Investigational Site

Budapest, , Hungary

Site Status

1245.10.36004 Boehringer Ingelheim Investigational Site

Budapest, , Hungary

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1245.10.36005 Boehringer Ingelheim Investigational Site

Győr, , Hungary

Site Status

1245.10.36002 Boehringer Ingelheim Investigational Site

Szombathely, , Hungary

Site Status

1245.10.37101 Boehringer Ingelheim Investigational Site

Daugavpils, , Latvia

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1245.10.37105 Boehringer Ingelheim Investigational Site

Kuldīga, , Latvia

Site Status

1245.10.37106 Boehringer Ingelheim Investigational Site

Ogre, , Latvia

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1245.10.37103 Boehringer Ingelheim Investigational Site

Riga, , Latvia

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1245.10.37107 Boehringer Ingelheim Investigational Site

Riga, , Latvia

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1245.10.37102 Boehringer Ingelheim Investigational Site

Talsi, , Latvia

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1245.10.37104 Boehringer Ingelheim Investigational Site

Valmiera, , Latvia

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1245.10.47004 Boehringer Ingelheim Investigational Site

Ålesund, , Norway

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1245.10.47003 Boehringer Ingelheim Investigational Site

Hamar, , Norway

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1245.10.47005 Boehringer Ingelheim Investigational Site

Oslo, , Norway

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1245.10.47001 Boehringer Ingelheim Investigational Site

Stavanger, , Norway

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1245.10.40001 Boehringer Ingelheim Investigational Site

Alba Iulia, , Romania

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1245.10.40005 Boehringer Ingelheim Investigational Site

Baia Mare Maramures, , Romania

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1245.10.40003 Boehringer Ingelheim Investigational Site

Brasov, , Romania

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1245.10.40002 Boehringer Ingelheim Investigational Site

Bucharest, , Romania

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1245.10.40007 Boehringer Ingelheim Investigational Site

Bucharest, , Romania

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1245.10.40004 Boehringer Ingelheim Investigational Site

Galati, , Romania

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1245.10.40006 Boehringer Ingelheim Investigational Site

Satu Mare, , Romania

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1245.10.70001 Boehringer Ingelheim Investigational Site

Moscow, , Russia

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1245.10.70002 Boehringer Ingelheim Investigational Site

Moscow, , Russia

Site Status

1245.10.70003 Boehringer Ingelheim Investigational Site

Moscow, , Russia

Site Status

1245.10.70004 Boehringer Ingelheim Investigational Site

Saint Petersburg, , Russia

Site Status

1245.10.70005 Boehringer Ingelheim Investigational Site

Saint Petersburg, , Russia

Site Status

1245.10.70006 Boehringer Ingelheim Investigational Site

Saint Petersburg, , Russia

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1245.10.70007 Boehringer Ingelheim Investigational Site

Saratov, , Russia

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1245.10.62003 Boehringer Ingelheim Investigational Site

Bratislava, , Slovakia

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1245.10.62001 Boehringer Ingelheim Investigational Site

Nitra, , Slovakia

Site Status

1245.10.62002 Boehringer Ingelheim Investigational Site

Nitra, , Slovakia

Site Status

1245.10.62004 Boehringer Ingelheim Investigational Site

Prešov, , Slovakia

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1245.10.34002 Boehringer Ingelheim Investigational Site

Barcelona, , Spain

Site Status

1245.10.34001 Boehringer Ingelheim Investigational Site

Girona, , Spain

Site Status

1245.10.34010 Boehringer Ingelheim Investigational Site

L'Hospitalet de Llobregat (Barcelona), , Spain

Site Status

1245.10.34004 Boehringer Ingelheim Investigational Site

Málaga, , Spain

Site Status

1245.10.34005 Boehringer Ingelheim Investigational Site

Palma (Mallorca), , Spain

Site Status

1245.10.34006 Boehringer Ingelheim Investigational Site

Palma de Mallorca, , Spain

Site Status

1245.10.34008 Boehringer Ingelheim Investigational Site

Santander, , Spain

Site Status

1245.10.38002 Boehringer Ingelheim Investigational Site

Dnipro, , Ukraine

Site Status

1245.10.38004 Boehringer Ingelheim Investigational Site

Kharkiv, , Ukraine

Site Status

1245.10.38005 Boehringer Ingelheim Investigational Site

Kharkiv, , Ukraine

Site Status

1245.10.38003 Boehringer Ingelheim Investigational Site

Kiev, , Ukraine

Site Status

1245.10.38001 Boehringer Ingelheim Investigational Site

Vinnitsa, , Ukraine

Site Status

Countries

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United States Argentina Austria Czechia Estonia Finland France Germany Hungary Latvia Norway Romania Russia Slovakia Spain Ukraine

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.

Reference Type DERIVED
PMID: 35472672 (View on PubMed)

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.

Reference Type DERIVED
PMID: 23940010 (View on PubMed)

Other Identifiers

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EudraCT 2008-000641-54

Identifier Type: -

Identifier Source: secondary_id

1245.10

Identifier Type: -

Identifier Source: org_study_id

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