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

NCT00749190 | Completed Phase 2 Results

• 2 other identifiers: 1245.10EudraCT 2008-000641-54
• Study Type: interventional
• Target: 495
• Locations: 15 countries
• Sites: 109

Brief Summary

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.

Conditions

Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in HbA1c After 12 Weeks of Treatment

  Change from baseline in HbA1c after 12 weeks of treatment. In the measured values adjusted means are displayed. For means for the placebo and empagliflozin arms are from the model excluding the sitagliptin open label (OL) arm. The mean for the sitagliptin OL arm is from the model with just this treatment group and the placebo group.

  Baseline and 12 weeks

Secondary Outcomes (9)

• Change of FPG From Baseline After 12 Weeks of Treatment

  Baseline and 12 weeks

• Change of HbA1c From Baseline Over Time

  Baseline and weeks 4, 8 and 12

• Proportion of Patients Who Achieve an HbA1c ≤7.0% After 12 Weeks of Treatment

  Baseline and 12 weeks

• Proportion of Patients Who Achieve an HbA1c Lowering of at Least 0.5% After 12 Weeks of Treatment

  Baseline and 12 weeks

• Change From Baseline to Week 12 in Fasting Plasma Insulin (FPI)

  Baseline and 12 weeks

Interventions

BI 10773 DRUG

placebo DRUG

sitagliptin DRUG

Eligibility Criteria

• Age: 18 Years - 79 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• Stable metformin therapy of at least 1500 mg/day, or less if that is a maximum tolerated dose.
• 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
• HbA1c \>7.0% to 10.0% at Visit 2 (Start of Run-in)
• Age \>=18 and \<80years
• Body Mass Index (BMI) \<=40 kg/m2
• Signed and dated written informed consent prior to admission to the study in accordance with Good Clinical Practice (GCP) and local legislation

You may not qualify if:

• Myocardial infarction, stroke or transient ischemic attack (TIA) within 6 months prior to informed consent
• Impaired hepatic function
• Renal insufficiency or impaired renal function
• Diseases of the central nervous system or psychiatric disorders or clinically relevant neurological disorders that may interfere with participation in the trial
• Chronic or clinically relevant acute infections
• Current or chronic urogenital tract infection
• History of clinically relevant allergy/hypersensitivity
• Treatment with glitazones (e.g., rosiglitazone, pioglitazone), glucagon-like peptide (GLP-1) analogues, or insulin within 3 months prior to informed consent
• Treatment with anti-obesity drugs within 3 months prior to informed consent
• Treatment with systemic steroids or change in dosage of thyroid hormones within 6 weeks prior to informed consent
• Alcohol abuse or drug abuse
• Treatment with an investigational drug within 2 months prior to informed consent
• 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

Sponsors & Collaborators

• Boehringer Ingelheim: lead

Study Sites (116)

1245.10.10026 Boehringer Ingelheim Investigational Site

Chula Vista, California, United States

Location

1245.10.10001 Boehringer Ingelheim Investigational Site

Mission Viejo, California, United States

Location

1245.10.10011 Boehringer Ingelheim Investigational Site

Pasadena, California, United States

Location

1245.10.10028 Boehringer Ingelheim Investigational Site

Spring Valley, California, United States

Location

1245.10.10027 Boehringer Ingelheim Investigational Site

Walnut Creek, California, United States

Location

1245.10.10004 Boehringer Ingelheim Investigational Site

Clearwarter, Florida, United States

Location

1245.10.10021 Boehringer Ingelheim Investigational Site

Melbourne, Florida, United States

Location

1245.10.10005 Boehringer Ingelheim Investigational Site

Miami, Florida, United States

Location

1245.10.10019 Boehringer Ingelheim Investigational Site

Miami, Florida, United States

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1245.10.10024 Boehringer Ingelheim Investigational Site

Saint Cloud, Florida, United States

Location

1245.10.10014 Boehringer Ingelheim Investigational Site

Roswell, Georgia, United States

Location

1245.10.10016 Boehringer Ingelheim Investigational Site

Staten Island, New York, United States

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1245.10.10009 Boehringer Ingelheim Investigational Site

Shelby, North Carolina, United States

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1245.10.10006 Boehringer Ingelheim Investigational Site

Wadsworth, Ohio, United States

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1245.10.10023 Boehringer Ingelheim Investigational Site

Norristown, Pennsylvania, United States

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1245.10.10010 Boehringer Ingelheim Investigational Site

Clemson, South Carolina, United States

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1245.10.10015 Boehringer Ingelheim Investigational Site

Dallas, Texas, United States

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1245.10.10012 Boehringer Ingelheim Investigational Site

Temple, Texas, United States

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1245.10.10025 Boehringer Ingelheim Investigational Site

Federal Way, Washington, United States

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1245.10.54002 Boehringer Ingelheim Investigational Site

Capital Federal, Argentina

Location

1245.10.54004 Boehringer Ingelheim Investigational Site

Capital Federal, Argentina

Location

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

Location

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

Location

1245.10.43003 Boehringer Ingelheim Investigational Site

Vienna, Austria

Location

1245.10.42003 Boehringer Ingelheim Investigational Site

Brno, Czechia

Location

1245.10.42005 Boehringer Ingelheim Investigational Site

Brno, Czechia

Location

1245.10.42001 Boehringer Ingelheim Investigational Site

Břeclav, Czechia

Location

1245.10.42002 Boehringer Ingelheim Investigational Site

Hodonín, Czechia

Location

1245.10.37201 Boehringer Ingelheim Investigational Site

Tallinn, Estonia

Location

1245.10.37202 Boehringer Ingelheim Investigational Site

Tartu, Estonia

Location

1245.10.58006 Boehringer Ingelheim Investigational Site

Kerava, Finland

Location

1245.10.58003 Boehringer Ingelheim Investigational Site

Oulu, Finland

Location

1245.10.58004 Boehringer Ingelheim Investigational Site

Tampere, Finland

Location

1245.10.58001 Boehringer Ingelheim Investigational Site

Turku, Finland

Location

1245.10.3302A Boehringer Ingelheim Investigational Site

Bondy, France

Location

1245.10.3302B Boehringer Ingelheim Investigational Site

Bondy, France

Location

1245.10.3310A Boehringer Ingelheim Investigational Site

Caen, France

Location

1245.10.3310B Boehringer Ingelheim Investigational Site

Caen, France

Location

1245.10.3310C Boehringer Ingelheim Investigational Site

Caen, France

Location

1245.10.3301A Boehringer Ingelheim Investigational Site

Corbeil-Essonnes, France

Location

1245.10.3301B Boehringer Ingelheim Investigational Site

Corbeil-Essonnes, France

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1245.10.3303A Boehringer Ingelheim Investigational Site

La Rochelle, France

Location

1245.10.3303B Boehringer Ingelheim Investigational Site

La Rochelle, France

Location

1245.10.3303C Boehringer Ingelheim Investigational Site

La Rochelle, France

Location

1245.10.3303D Boehringer Ingelheim Investigational Site

La Rochelle, France

Location

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

Location

1245.10.3304A Boehringer Ingelheim Investigational Site

Reims, France

Location

1245.10.3304B Boehringer Ingelheim Investigational Site

Reims, France

Location

1245.10.3304C Boehringer Ingelheim Investigational Site

Reims, France

Location

1245.10.3311A Boehringer Ingelheim Investigational Site

Saint-Mandé, France

Location

1245.10.3311B Boehringer Ingelheim Investigational Site

Saint-Mandé, France

Location

1245.10.3311C Boehringer Ingelheim Investigational Site

Saint-Mandé, France

Location

1245.10.3311D Boehringer Ingelheim Investigational Site

Saint-Mandé, France

Location

1245.10.3305A Boehringer Ingelheim Investigational Site

Valenciennes, France

Location

1245.10.3305B Boehringer Ingelheim Investigational Site

Valenciennes, France

Location

1245.10.3305C Boehringer Ingelheim Investigational Site

Valenciennes, France

Location

1245.10.3305D Boehringer Ingelheim Investigational Site

Valenciennes, France

Location

1245.10.49001 Boehringer Ingelheim Investigational Site

Erlangen, Germany

Location

1245.10.49003 Boehringer Ingelheim Investigational Site

Frankfurt, Germany

Location

1245.10.49002 Boehringer Ingelheim Investigational Site

Hamburg, Germany

Location

1245.10.49004 Boehringer Ingelheim Investigational Site

Rehlingen-Siersburg, Germany

Location

1245.10.36001 Boehringer Ingelheim Investigational Site

Budapest, Hungary

Location

1245.10.36003 Boehringer Ingelheim Investigational Site

Budapest, Hungary

Location

1245.10.36004 Boehringer Ingelheim Investigational Site

Budapest, Hungary

Location

1245.10.36005 Boehringer Ingelheim Investigational Site

Győr, Hungary

Location

1245.10.36002 Boehringer Ingelheim Investigational Site

Szombathely, Hungary

Location

1245.10.37101 Boehringer Ingelheim Investigational Site

Daugavpils, Latvia

Location

1245.10.37105 Boehringer Ingelheim Investigational Site

Kuldīga, Latvia

Location

1245.10.37106 Boehringer Ingelheim Investigational Site

Ogre, Latvia

Location

1245.10.37103 Boehringer Ingelheim Investigational Site

Riga, Latvia

Location

1245.10.37107 Boehringer Ingelheim Investigational Site

Riga, Latvia

Location

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

Location

1245.10.47003 Boehringer Ingelheim Investigational Site

Hamar, Norway

Location

1245.10.47005 Boehringer Ingelheim Investigational Site

Oslo, Norway

Location

1245.10.47001 Boehringer Ingelheim Investigational Site

Stavanger, Norway

Location

1245.10.40001 Boehringer Ingelheim Investigational Site

Alba Iulia, Romania

Location

1245.10.40005 Boehringer Ingelheim Investigational Site

Baia Mare Maramures, Romania

Location

1245.10.40003 Boehringer Ingelheim Investigational Site

Brasov, Romania

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1245.10.40002 Boehringer Ingelheim Investigational Site

Bucharest, Romania

Location

1245.10.40007 Boehringer Ingelheim Investigational Site

Bucharest, Romania

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1245.10.40004 Boehringer Ingelheim Investigational Site

Galati, Romania

Location

1245.10.40006 Boehringer Ingelheim Investigational Site

Satu Mare, Romania

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1245.10.70001 Boehringer Ingelheim Investigational Site

Moscow, Russia

Location

1245.10.70002 Boehringer Ingelheim Investigational Site

Moscow, Russia

Location

1245.10.70003 Boehringer Ingelheim Investigational Site

Moscow, Russia

Location

1245.10.70004 Boehringer Ingelheim Investigational Site

Saint Petersburg, Russia

Location

1245.10.70005 Boehringer Ingelheim Investigational Site

Saint Petersburg, Russia

Location

1245.10.70006 Boehringer Ingelheim Investigational Site

Saint Petersburg, Russia

Location

1245.10.70007 Boehringer Ingelheim Investigational Site

Saratov, Russia

Location

1245.10.62003 Boehringer Ingelheim Investigational Site

Bratislava, Slovakia

Location

1245.10.62001 Boehringer Ingelheim Investigational Site

Nitra, Slovakia

Location

1245.10.62002 Boehringer Ingelheim Investigational Site

Nitra, Slovakia

Location

1245.10.62004 Boehringer Ingelheim Investigational Site

Prešov, Slovakia

Location

1245.10.34002 Boehringer Ingelheim Investigational Site

Barcelona, Spain

Location

1245.10.34001 Boehringer Ingelheim Investigational Site

Girona, Spain

Location

1245.10.34010 Boehringer Ingelheim Investigational Site

L'Hospitalet de Llobregat (Barcelona), Spain

Location

1245.10.34004 Boehringer Ingelheim Investigational Site

Málaga, Spain

Location

1245.10.34005 Boehringer Ingelheim Investigational Site

Palma (Mallorca), Spain

Location

1245.10.34006 Boehringer Ingelheim Investigational Site

Palma de Mallorca, Spain

Location

1245.10.34008 Boehringer Ingelheim Investigational Site

Santander, Spain

Location

1245.10.38002 Boehringer Ingelheim Investigational Site

Dnipro, Ukraine

Location

1245.10.38004 Boehringer Ingelheim Investigational Site

Kharkiv, Ukraine

Location

1245.10.38005 Boehringer Ingelheim Investigational Site

Kharkiv, Ukraine

Location

1245.10.38003 Boehringer Ingelheim Investigational Site

Kiev, Ukraine

Location

1245.10.38001 Boehringer Ingelheim Investigational Site

Vinnitsa, Ukraine

Location

Related Publications (2)

• 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.

  PMID: 35472672 DERIVED

• 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.

  PMID: 23940010 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

empagliflozin; Sitagliptin Phosphate

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Triazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pyrazines

Results Point of Contact

• Title: Boehringer Ingelheim Call Center
• Organization: Boehringer Ingelheim Pharmaceuticals

clintriage.rdg@boehringer-ingelheim.com

1-800-243-0127

Study Officials

• Boehringer Ingelheim

  Boehringer Ingelheim

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: September 8, 2008
• First Posted: September 9, 2008
• Study Start: August 1, 2008
• Primary Completion: October 1, 2009
• Last Updated: June 13, 2014
• Results First Posted: June 13, 2014

Record last verified: 2014-05

Locations

UA (5); ES (2); LA (7); RO (7); RU (7); AR (5); US (19); SL (4); CZ (4); FR (28); NO (4); FI (4); HU (5); AU (4); DE (4)