Empagliflozin (BI 10773) in Type Two Diabetes (T2D) Patients, Open Label Extension

NCT00881530 | Completed Phase 2 Results

• 2 other identifiers: 1245.242008-007938-21
• Study Type: interventional
• Target: 660
• Locations: 20 countries
• Sites: 132

Brief Summary

The objective of the current study is to investigate the safety and efficacy of BI 10773 in 2 different doses compared to Metformin or to Sitagliptin given for 78 weeks in different modalities of treatment in patients with type 2 diabetes mellitus.

Conditions

Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (3)

• Hypoglycaemic Events

  Investigator defined Hypoglycaemic events. For documentation of hypoglycemic events, the following criteria were taken into consideration: * Asymptomatic hypoglycemia: the event was not accompanied by typical symptoms of hypoglycemia but with a measured plasma glucose of ≤70 mg/dL (≤3.9 mmol/L) * Documented symptomatic hypoglycemia with glucose of ≥54 mg/dL and ≤70 mg/dL (≥3.0 mmol/L and ≤3.9 mmol/L) * Documented symptomatic hypoglycemia with glucose of \<54 mg/dL (\<3.0 mmol/L): the event was accompanied by typical symptoms of hypoglycemia but in no need for external assistance * Severe hypoglycemic episode: the event required the assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions

  78 weeks plus 1 week of follow-up

• Change From Baseline to Week 78 in Lipid Parameters

  Change from baseline to week 78 in lipid parameters (Total cholesterol, High-density lipoprotein (HDL), Low-density lipoprotein (LDL) and Triglyceride)

  Weeks 1 and 78

• Clinical Relevant Abnormalities for Physical Examination, Vital Signs, ECG and Laboratory Measurements

  Clinical Relevant Abnormalities for Physical Examination, Vital Signs, ECG and Laboratory Measurements. New abnormal findings or worsening of baseline conditions were reported as treatment related Adverse Events.

  78 weeks plus 1 week of follow-up

Secondary Outcomes (5)

• Change From Baseline in HbA1c Over Time

  Weeks 1, 6, 18, 30, 42, 54, 66 and 78

• Occurence of a Treat-to-target Response (HbA1c < 7.0%)

  Weeks 1, 6, 18, 30, 42, 54, 66 and 78

• Occurrence of a Treat-to-target Response (HbA1c < 6.5%)

  Weeks 1, 6, 18, 30, 42, 54, 66 and 78

• Occurrence of a Relative Efficacy Response

  Weeks 1, 6, 18, 30, 42, 54, 66 and 78

• Change From Baseline in Fasting Plasma Glucose (FPG) Over Time

  Weeks 1, 6, 18, 30, 42, 54, 66 and 78

Study Arms (4)

Sitagliptin

ACTIVE COMPARATOR

100 mg

Drug: Sitagliptin

Metformin

ACTIVE COMPARATOR

2000 mg

Drug: Metformin

BI 10773 X mg

EXPERIMENTAL

lower dose

Drug: BI 10773

BI 10773 Y mg

EXPERIMENTAL

higher dose

Drug: BI 10773

Interventions

BI 10773 DRUG

BI 10773 high dose once daily

BI 10773 Y mg

Metformin DRUG

open label comparator

Metformin

Sitagliptin DRUG

open label comparator

Sitagliptin

Eligibility Criteria

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

You may qualify if:

• patients completing one of double blind phase II trials 1245.9 or 1245.10
• informed consent

You may not qualify if:

• patients meeting withdrawal criteria of preceding trial
• significant hepatic impairment
• significant renal impairment with creatinine clearance \< 50 ml/min
• contraindication to Metformin for all patients treated with Metformin
• premenopausal women that are nursing or pregnant or not practicing acceptable methods of birth control
• drug or alcohol abuse

Sponsors & Collaborators

• Boehringer Ingelheim: lead

Study Sites (137)

1245.24.101001 Boehringer Ingelheim Investigational Site

Mission Viejo, California, United States

Location

1245.24.101028 Boehringer Ingelheim Investigational Site

Spring Valley, California, United States

Location

1245.24.101027 Boehringer Ingelheim Investigational Site

Walnut Creek, California, United States

Location

1245.24.101004 Boehringer Ingelheim Investigational Site

Clearwarter, Florida, United States

Location

1245.24.101005 Boehringer Ingelheim Investigational Site

Miami, Florida, United States

Location

1245.24.101024 Boehringer Ingelheim Investigational Site

Saint Cloud, Florida, United States

Location

1245.24.101014 Boehringer Ingelheim Investigational Site

Roswell, Georgia, United States

Location

1245.24.101016 Boehringer Ingelheim Investigational Site

Staten Island, New York, United States

Location

1245.24.101006 Boehringer Ingelheim Investigational Site

Wadsworth, Ohio, United States

Location

1245.24.101023 Boehringer Ingelheim Investigational Site

Norristown, Pennsylvania, United States

Location

1245.24.101015 Boehringer Ingelheim Investigational Site

Dallas, Texas, United States

Location

1245.24.101025 Boehringer Ingelheim Investigational Site

Federal Way, Washington, United States

Location

1245.24.431002 Boehringer Ingelheim Investigational Site

Graz, Austria

Location

1245.24.431001 Boehringer Ingelheim Investigational Site

Vienna, Austria

Location

1245.24.431003 Boehringer Ingelheim Investigational Site

Vienna, Austria

Location

1245.24.385104 Boehringer Ingelheim Investigational Site

Karlovac, Croatia

Location

1245.24.385103 Boehringer Ingelheim Investigational Site

Krapinske Toplice, Croatia

Location

1245.24.385106 Boehringer Ingelheim Investigational Site

Osijek, Croatia

Location

1245.24.385101 Boehringer Ingelheim Investigational Site

Zagreb, Croatia

Location

1245.24.420103 Boehringer Ingelheim Investigational Site

Brno, Czechia

Location

1245.24.420105 Boehringer Ingelheim Investigational Site

Brno, Czechia

Location

1245.24.420101 Boehringer Ingelheim Investigational Site

Břeclav, Czechia

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1245.24.420102 Boehringer Ingelheim Investigational Site

Hodonín, Czechia

Location

1245.24.372101 Boehringer Ingelheim Investigational Site

Tallinn, Estonia

Location

1245.24.372102 Boehringer Ingelheim Investigational Site

Tallinn, Estonia

Location

1245.24.372103 Boehringer Ingelheim Investigational Site

Tallinn, Estonia

Location

1245.24.372104 Boehringer Ingelheim Investigational Site

Tallinn, Estonia

Location

1245.24.372105 Boehringer Ingelheim Investigational Site

Tartu, Estonia

Location

1245.24.581006 Boehringer Ingelheim Investigational Site

Kerava, Finland

Location

1245.24.581003 Boehringer Ingelheim Investigational Site

Oulu, Finland

Location

1245.24.581004 Boehringer Ingelheim Investigational Site

Tampere, Finland

Location

1245.24.581001 Boehringer Ingelheim Investigational Site

Turku, Finland

Location

1245.24.3302A Boehringer Ingelheim Investigational Site

Bondy, France

Location

1245.24.3302B Boehringer Ingelheim Investigational Site

Bondy, France

Location

1245.24.3310A Boehringer Ingelheim Investigational Site

Caen, France

Location

1245.24.3310C Boehringer Ingelheim Investigational Site

Caen, France

Location

1245.24.3301A Boehringer Ingelheim Investigational Site

Corbeil-Essonnes, France

Location

1245.24.3303A Boehringer Ingelheim Investigational Site

La Rochelle, France

Location

1245.24.3303B Boehringer Ingelheim Investigational Site

La Rochelle, France

Location

1245.24.3309A Boehringer Ingelheim Investigational Site

Nanterre, France

Location

1245.24.3306A Boehringer Ingelheim Investigational Site

Narbonne, France

Location

1245.24.3304A Boehringer Ingelheim Investigational Site

Reims, France

Location

1245.24.3311B Boehringer Ingelheim Investigational Site

Saint-Mandé, France

Location

1245.24.3305A Boehringer Ingelheim Investigational Site

Valenciennes, France

Location

1245.24.3305B Boehringer Ingelheim Investigational Site

Valenciennes, France

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1245.24.491011 Boehringer Ingelheim Investigational Site

Aschaffenburg, Germany

Location

1245.24.491007 Boehringer Ingelheim Investigational Site

Frankfurt am Main, Germany

Location

1245.24.491004 Boehringer Ingelheim Investigational Site

Hamburg, Germany

Location

1245.24.491005 Boehringer Ingelheim Investigational Site

Hamburg, Germany

Location

1245.24.491002 Boehringer Ingelheim Investigational Site

Melsungen, Germany

Location

1245.24.491012 Boehringer Ingelheim Investigational Site

Nuremberg, Germany

Location

1245.24.491008 Boehringer Ingelheim Investigational Site

Rehlingen-Siersburg, Germany

Location

1245.24.491003 Boehringer Ingelheim Investigational Site

Saint Ingbert/Oberwürzbach, Germany

Location

1245.24.491010 Boehringer Ingelheim Investigational Site

Sulzbach-Rosenberg, Germany

Location

1245.24.361001 Boehringer Ingelheim Investigational Site

Budapest, Hungary

Location

1245.24.361003 Boehringer Ingelheim Investigational Site

Budapest, Hungary

Location

1245.24.361004 Boehringer Ingelheim Investigational Site

Budapest, Hungary

Location

1245.24.361005 Boehringer Ingelheim Investigational Site

Győr, Hungary

Location

1245.24.361002 Boehringer Ingelheim Investigational Site

Szombathely, Hungary

Location

1245.24.391006 Boehringer Ingelheim Investigational Site

Genova, Italy

Location

1245.24.391003 Boehringer Ingelheim Investigational Site

Pisa, Italy

Location

1245.24.391005 Boehringer Ingelheim Investigational Site

Treviso, Italy

Location

1245.24.371101 Boehringer Ingelheim Investigational Site

Daugavpils, Latvia

Location

1245.24.371105 Boehringer Ingelheim Investigational Site

Kuldīga, Latvia

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1245.24.371106 Boehringer Ingelheim Investigational Site

Ogre, Latvia

Location

1245.24.371103 Boehringer Ingelheim Investigational Site

Riga, Latvia

Location

1245.24.371107 Boehringer Ingelheim Investigational Site

Riga, Latvia

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1245.24.371102 Boehringer Ingelheim Investigational Site

Talsi, Latvia

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1245.24.371104 Boehringer Ingelheim Investigational Site

Valmiera, Latvia

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1245.24.370102 Boehringer Ingelheim Investigational Site

Klaipėda, Lithuania

Location

1245.24.370101 Boehringer Ingelheim Investigational Site

Vilnius, Lithuania

Location

1245.24.471004 Boehringer Ingelheim Investigational Site

Ålesund, Norway

Location

1245.24.471003 Boehringer Ingelheim Investigational Site

Hamar, Norway

Location

1245.24.471005 Boehringer Ingelheim Investigational Site

Oslo, Norway

Location

1245.24.471001 Boehringer Ingelheim Investigational Site

Stavanger, Norway

Location

1245.24.401005 Boehringer Ingelheim Investigational Site

Alba Iulia, Romania

Location

1245.24.401006 Boehringer Ingelheim Investigational Site

Baia Mare Maramures, Romania

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1245.24.401002 Boehringer Ingelheim Investigational Site

Brasov, Romania

Location

1245.24.401001 Boehringer Ingelheim Investigational Site

Bucharest, Romania

Location

1245.24.401008 Boehringer Ingelheim Investigational Site

Bucharest, Romania

Location

1245.24.401003 Boehringer Ingelheim Investigational Site

Galati, Romania

Location

1245.24.401007 Boehringer Ingelheim Investigational Site

Satu Mare, Romania

Location

1245.24.401004 Boehringer Ingelheim Investigational Site

Târgu Mureş, Romania

Location

1245.24.701002 Boehringer Ingelheim Investigational Site

Kazan', Russia

Location

1245.24.701008 Boehringer Ingelheim Investigational Site

Moscow, Russia

Location

1245.24.701009 Boehringer Ingelheim Investigational Site

Moscow, Russia

Location

1245.24.701010 Boehringer Ingelheim Investigational Site

Moscow, Russia

Location

1245.24.701004 Boehringer Ingelheim Investigational Site

Petrozavodsk, Russia

Location

1245.24.701012 Boehringer Ingelheim Investigational Site

Saint Petersburg, Russia

Location

1245.24.701013 Boehringer Ingelheim Investigational Site

Saint Petersburg, Russia

Location

1245.24.701014 Boehringer Ingelheim Investigational Site

Saratov, Russia

Location

1245.24.701005 Boehringer Ingelheim Investigational Site

Smolensk, Russia

Location

1245.24.701006 Boehringer Ingelheim Investigational Site

Yaroslavl, Russia

Location

1245.24.701007 Boehringer Ingelheim Investigational Site

Yaroslavl, Russia

Location

1245.24.701001 Boehringer Ingelheim Investigational Site

Yekaterinburg, Russia

Location

1245.24.421102 Boehringer Ingelheim Investigational Site

Bratislava, Slovakia

Location

1245.24.421107 Boehringer Ingelheim Investigational Site

Bratislava, Slovakia

Location

1245.24.421103 Boehringer Ingelheim Investigational Site

Lučenec, Slovakia

Location

1245.24.421105 Boehringer Ingelheim Investigational Site

Nitra, Slovakia

Location

1245.24.421106 Boehringer Ingelheim Investigational Site

Nitra, Slovakia

Location

1245.24.421104 Boehringer Ingelheim Investigational Site

Nové Mesto nad Váhom, Slovakia

Location

1245.24.421108 Boehringer Ingelheim Investigational Site

Prešov, Slovakia

Location

1245.24.421101 Boehringer Ingelheim Investigational Site

Prievidza, Slovakia

Location

1245.24.821006 Boehringer Ingelheim Investigational Site

Goyang, South Korea

Location

1245.24.821008 Boehringer Ingelheim Investigational Site

Goyang, South Korea

Location

1245.24.821007 Boehringer Ingelheim Investigational Site

Incheon, South Korea

Location

1245.24.821002 Boehringer Ingelheim Investigational Site

Pucheon, South Korea

Location

1245.24.821001 Boehringer Ingelheim Investigational Site

Seoul, South Korea

Location

1245.24.821004 Boehringer Ingelheim Investigational Site

Seoul, South Korea

Location

1245.24.821009 Boehringer Ingelheim Investigational Site

Suwon, South Korea

Location

1245.24.821003 Boehringer Ingelheim Investigational Site

Uijeongbu-si, South Korea

Location

1245.24.341002 Boehringer Ingelheim Investigational Site

Barcelona, Spain

Location

1245.24.341001 Boehringer Ingelheim Investigational Site

Girona, Spain

Location

1245.24.341010 Boehringer Ingelheim Investigational Site

L'Hospitalet de Llobregat (Barcelona), Spain

Location

1245.24.341004 Boehringer Ingelheim Investigational Site

Málaga, Spain

Location

1245.24.341005 Boehringer Ingelheim Investigational Site

Palma Mallorca, Spain

Location

1245.24.341006 Boehringer Ingelheim Investigational Site

Palma Mallorca, Spain

Location

1245.24.341008 Boehringer Ingelheim Investigational Site

Santander, Spain

Location

1245.24.461004 Boehringer Ingelheim Investigational Site

Härnösand, Sweden

Location

1245.24.461005 Boehringer Ingelheim Investigational Site

Lund, Sweden

Location

1245.24.461001 Boehringer Ingelheim Investigational Site

Stockholm, Sweden

Location

1245.24.886105 Boehringer Ingelheim Investigational Site

Changhua, Taiwan

Location

1245.24.886107 Boehringer Ingelheim Investigational Site

Kaohsiung City, Taiwan

Location

1245.24.886104 Boehringer Ingelheim Investigational Site

Taichun, Taiwan

Location

1245.24.886106 Boehringer Ingelheim Investigational Site

Tainan, Taiwan

Location

1245.24.886101 Boehringer Ingelheim Investigational Site

Taipei, Taiwan

Location

1245.24.886103 Boehringer Ingelheim Investigational Site

Taipei, Taiwan

Location

1245.24.886102 Boehringer Ingelheim Investigational Site

Taoyuan District, Taiwan

Location

1245.24.381007 Boehringer Ingelheim Investigational Site

Dnipro, Ukraine

Location

1245.24.381003 Boehringer Ingelheim Investigational Site

Kharkiv, Ukraine

Location

1245.24.381009 Boehringer Ingelheim Investigational Site

Kharkiv, Ukraine

Location

1245.24.381010 Boehringer Ingelheim Investigational Site

Kharkiv, Ukraine

Location

1245.24.381008 Boehringer Ingelheim Investigational Site

Kiev, Ukraine

Location

1245.24.381002 Boehringer Ingelheim Investigational Site

Odesa, Ukraine

Location

1245.24.381006 Boehringer Ingelheim Investigational Site

Vinnitsa, Ukraine

Location

1245.24.381001 Boehringer Ingelheim Investigational Site

Vinnytsia, Ukraine

Location

1245.24.381005 Boehringer Ingelheim Investigational Site

Vinnytsia, Ukraine

Location

Related Publications (1)

• Ferrannini E, Berk A, Hantel S, Pinnetti S, Hach T, Woerle HJ, Broedl UC. Long-term safety and efficacy of empagliflozin, sitagliptin, and metformin: an active-controlled, parallel-group, randomized, 78-week open-label extension study in patients with type 2 diabetes. Diabetes Care. 2013 Dec;36(12):4015-21. doi: 10.2337/dc13-0663. Epub 2013 Nov 1.

  PMID: 24186878 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

empagliflozin; Metformin; Sitagliptin Phosphate

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Biguanides; Guanidines; Amidines; Organic Chemicals; 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
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 14, 2009
• First Posted: April 15, 2009
• Study Start: March 1, 2009
• Primary Completion: May 1, 2011
• Last Updated: June 16, 2014
• Results First Posted: June 16, 2014

Record last verified: 2014-05

Locations

CZ (4); RU (12); SE (3); AU (3); ES (7); IT (3); FI (4); TW (7); US (12); FR (13); LA (7); HU (5); RO (8); LI (2); KR (8); NO (4); CR (4); DE (9); SL (8); UA (9)