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NCT00881530 Clinical Trial

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

Diabetes Mellitus, Type 2 Clinical Trial

Official title:
A 78 Week Open Label Extension to Trials Assessing the Safety and Efficacy of BI 10773 as Monotherapy or in Combination With Metformin in Type 2 Diabetic Patients

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00881530
Other study ID # 1245.24
Secondary ID 2008-007938-21
Status Completed
Phase Phase 2
First received April 14, 2009
Last updated May 16, 2014
Start date March 2009

Study information
Verified date May 2014
Source Boehringer Ingelheim
Contact n/a
Is FDA regulated No
Health authority Austria: Federal Office for Safety in Health CareCroatia: Agency for Medicinal Product and Medical DevicesCzech Republic: State Institute for Drug ControlEstonia: The State Agency of MedicineFinland: Finnish Medicines AgencyFrance: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)Germany: Federal Institute for Drugs and Medical DevicesHungary: National Institute of PharmacyItaly: Ethics CommitteeKorea: Food and Drug AdministrationLatvia: State Agency of MedicinesLithuania: State Medicine Control Agency - Ministry of HealthNorway: Norwegian Medicines AgencyRomania: National Medicines AgencyRussia: Pharmacological Committee, Ministry of HealthSlovakia: State Institute for Drug ControlSpain: Spanish Agency of MedicinesSweden: Medical Products AgencyTaiwan: Department of HealthUkraine: State Pharmacological Center - Ministry of HealthUnited States: Food and Drug Administration
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 660
Est. completion date
Est. primary completion date May 2011
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion criteria:

- patients completing one of double blind phase II trials 1245.9 or 1245.10

- informed consent

Exclusion criteria:

- 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• BI 10773
BI 10773 high dose once daily
• Metformin
open label comparator
• BI 10773
BI 10773 low dose once daily
• Sitagliptin
open label comparator

Locations
Country Name City State
Austria 1245.24.431002 Boehringer Ingelheim Investigational Site Graz
Austria 1245.24.431001 Boehringer Ingelheim Investigational Site Wien
Austria 1245.24.431003 Boehringer Ingelheim Investigational Site Wien
Croatia 1245.24.385104 Boehringer Ingelheim Investigational Site Karlovac
Croatia 1245.24.385103 Boehringer Ingelheim Investigational Site Krapinske Toplice
Croatia 1245.24.385106 Boehringer Ingelheim Investigational Site Osijek
Croatia 1245.24.385101 Boehringer Ingelheim Investigational Site Zagreb
Czech Republic 1245.24.420101 Boehringer Ingelheim Investigational Site Breclav
Czech Republic 1245.24.420103 Boehringer Ingelheim Investigational Site Brno
Czech Republic 1245.24.420105 Boehringer Ingelheim Investigational Site Brno
Czech Republic 1245.24.420102 Boehringer Ingelheim Investigational Site Hodonin
Estonia 1245.24.372101 Boehringer Ingelheim Investigational Site Tallinn
Estonia 1245.24.372102 Boehringer Ingelheim Investigational Site Tallinn
Estonia 1245.24.372103 Boehringer Ingelheim Investigational Site Tallinn
Estonia 1245.24.372104 Boehringer Ingelheim Investigational Site Tallinn
Estonia 1245.24.372105 Boehringer Ingelheim Investigational Site Tartu
Finland 1245.24.581006 Boehringer Ingelheim Investigational Site Kerava
Finland 1245.24.581003 Boehringer Ingelheim Investigational Site Oulu
Finland 1245.24.581004 Boehringer Ingelheim Investigational Site Tampere
Finland 1245.24.581001 Boehringer Ingelheim Investigational Site Turku
France 1245.24.3302A Boehringer Ingelheim Investigational Site Bondy Cedex
France 1245.24.3302B Boehringer Ingelheim Investigational Site Bondy Cedex
France 1245.24.3310A Boehringer Ingelheim Investigational Site Caen Cedex 5
France 1245.24.3310C Boehringer Ingelheim Investigational Site Caen Cedex 5
France 1245.24.3301A Boehringer Ingelheim Investigational Site Corbeil Essonnes
France 1245.24.3303A Boehringer Ingelheim Investigational Site La Rochelle Cedex 1
France 1245.24.3303B Boehringer Ingelheim Investigational Site La Rochelle Cedex 1
France 1245.24.3309A Boehringer Ingelheim Investigational Site Nanterre Cedex
France 1245.24.3306A Boehringer Ingelheim Investigational Site Narbonne Cedex
France 1245.24.3304A Boehringer Ingelheim Investigational Site Reims Cedex
France 1245.24.3311B Boehringer Ingelheim Investigational Site Saint Mandé
France 1245.24.3305A Boehringer Ingelheim Investigational Site Valenciennes
France 1245.24.3305B Boehringer Ingelheim Investigational Site Valenciennes
Germany 1245.24.491011 Boehringer Ingelheim Investigational Site Aschaffenburg
Germany 1245.24.491007 Boehringer Ingelheim Investigational Site Frankfurt am Main
Germany 1245.24.491004 Boehringer Ingelheim Investigational Site Hamburg
Germany 1245.24.491005 Boehringer Ingelheim Investigational Site Hamburg
Germany 1245.24.491002 Boehringer Ingelheim Investigational Site Melsungen
Germany 1245.24.491012 Boehringer Ingelheim Investigational Site Nürnberg
Germany 1245.24.491008 Boehringer Ingelheim Investigational Site Rehlingen-Siersburg
Germany 1245.24.491003 Boehringer Ingelheim Investigational Site St. Ingbert/Oberwürzbach
Germany 1245.24.491010 Boehringer Ingelheim Investigational Site Sulzbach-Rosenberg
Hungary 1245.24.361001 Boehringer Ingelheim Investigational Site Budapest
Hungary 1245.24.361003 Boehringer Ingelheim Investigational Site Budapest
Hungary 1245.24.361004 Boehringer Ingelheim Investigational Site Budapest
Hungary 1245.24.361005 Boehringer Ingelheim Investigational Site Gyor
Hungary 1245.24.361002 Boehringer Ingelheim Investigational Site Szombathely
Italy 1245.24.391006 Boehringer Ingelheim Investigational Site Genova
Italy 1245.24.391003 Boehringer Ingelheim Investigational Site Pisa
Italy 1245.24.391005 Boehringer Ingelheim Investigational Site Treviso
Korea, Republic of 1245.24.821006 Boehringer Ingelheim Investigational Site Goyang
Korea, Republic of 1245.24.821008 Boehringer Ingelheim Investigational Site Goyang
Korea, Republic of 1245.24.821007 Boehringer Ingelheim Investigational Site Incheon
Korea, Republic of 1245.24.821002 Boehringer Ingelheim Investigational Site Pucheon
Korea, Republic of 1245.24.821001 Boehringer Ingelheim Investigational Site Seoul
Korea, Republic of 1245.24.821004 Boehringer Ingelheim Investigational Site Seoul
Korea, Republic of 1245.24.821009 Boehringer Ingelheim Investigational Site Suwon
Korea, Republic of 1245.24.821003 Boehringer Ingelheim Investigational Site Uijeongbu
Latvia 1245.24.371101 Boehringer Ingelheim Investigational Site Daugavpils
Latvia 1245.24.371105 Boehringer Ingelheim Investigational Site Kuldiga
Latvia 1245.24.371106 Boehringer Ingelheim Investigational Site Ogre
Latvia 1245.24.371103 Boehringer Ingelheim Investigational Site Riga
Latvia 1245.24.371107 Boehringer Ingelheim Investigational Site Riga
Latvia 1245.24.371102 Boehringer Ingelheim Investigational Site Talsi
Latvia 1245.24.371104 Boehringer Ingelheim Investigational Site Valmiera
Lithuania 1245.24.370102 Boehringer Ingelheim Investigational Site Klaipeda
Lithuania 1245.24.370101 Boehringer Ingelheim Investigational Site Vilnius
Norway 1245.24.471004 Boehringer Ingelheim Investigational Site Ålesund
Norway 1245.24.471003 Boehringer Ingelheim Investigational Site Hamar
Norway 1245.24.471005 Boehringer Ingelheim Investigational Site Oslo
Norway 1245.24.471001 Boehringer Ingelheim Investigational Site Stavanger
Romania 1245.24.401005 Boehringer Ingelheim Investigational Site Alba Iulia
Romania 1245.24.401006 Boehringer Ingelheim Investigational Site Baia Mare Maramures
Romania 1245.24.401002 Boehringer Ingelheim Investigational Site Brasov
Romania 1245.24.401001 Boehringer Ingelheim Investigational Site Bucharest
Romania 1245.24.401008 Boehringer Ingelheim Investigational Site Bucharest
Romania 1245.24.401003 Boehringer Ingelheim Investigational Site Galati
Romania 1245.24.401007 Boehringer Ingelheim Investigational Site Satu Mare
Romania 1245.24.401004 Boehringer Ingelheim Investigational Site Targu-Mures
Russian Federation 1245.24.701001 Boehringer Ingelheim Investigational Site Ekaterinburg
Russian Federation 1245.24.701002 Boehringer Ingelheim Investigational Site Kazan
Russian Federation 1245.24.701008 Boehringer Ingelheim Investigational Site Moscow
Russian Federation 1245.24.701009 Boehringer Ingelheim Investigational Site Moscow
Russian Federation 1245.24.701010 Boehringer Ingelheim Investigational Site Moscow
Russian Federation 1245.24.701004 Boehringer Ingelheim Investigational Site Petrozavodsk
Russian Federation 1245.24.701014 Boehringer Ingelheim Investigational Site Saratov
Russian Federation 1245.24.701005 Boehringer Ingelheim Investigational Site Smolensk
Russian Federation 1245.24.701012 Boehringer Ingelheim Investigational Site St. Petersburg
Russian Federation 1245.24.701013 Boehringer Ingelheim Investigational Site St. Petersburg
Russian Federation 1245.24.701006 Boehringer Ingelheim Investigational Site Yaroslavl
Russian Federation 1245.24.701007 Boehringer Ingelheim Investigational Site Yaroslavl
Slovakia 1245.24.421102 Boehringer Ingelheim Investigational Site Bratislava
Slovakia 1245.24.421107 Boehringer Ingelheim Investigational Site Bratislava
Slovakia 1245.24.421103 Boehringer Ingelheim Investigational Site Lucenec
Slovakia 1245.24.421105 Boehringer Ingelheim Investigational Site Nitra
Slovakia 1245.24.421106 Boehringer Ingelheim Investigational Site Nitra
Slovakia 1245.24.421104 Boehringer Ingelheim Investigational Site Nove Mesto Nad Vahom
Slovakia 1245.24.421108 Boehringer Ingelheim Investigational Site Presov
Slovakia 1245.24.421101 Boehringer Ingelheim Investigational Site Prievidza
Spain 1245.24.341002 Boehringer Ingelheim Investigational Site Barcelona
Spain 1245.24.341001 Boehringer Ingelheim Investigational Site Girona
Spain 1245.24.341010 Boehringer Ingelheim Investigational Site L'Hospitalet de Llobregat (Barcelona)
Spain 1245.24.341004 Boehringer Ingelheim Investigational Site Málaga
Spain 1245.24.341005 Boehringer Ingelheim Investigational Site Palma Mallorca
Spain 1245.24.341006 Boehringer Ingelheim Investigational Site Palma Mallorca
Spain 1245.24.341008 Boehringer Ingelheim Investigational Site Santander
Sweden 1245.24.461004 Boehringer Ingelheim Investigational Site Härnösand
Sweden 1245.24.461005 Boehringer Ingelheim Investigational Site Lund
Sweden 1245.24.461001 Boehringer Ingelheim Investigational Site Stockholm
Taiwan 1245.24.886105 Boehringer Ingelheim Investigational Site Changhua
Taiwan 1245.24.886107 Boehringer Ingelheim Investigational Site Kaohsiung
Taiwan 1245.24.886104 Boehringer Ingelheim Investigational Site Taichun
Taiwan 1245.24.886106 Boehringer Ingelheim Investigational Site Tainan
Taiwan 1245.24.886101 Boehringer Ingelheim Investigational Site Taipei
Taiwan 1245.24.886103 Boehringer Ingelheim Investigational Site Taipei
Taiwan 1245.24.886102 Boehringer Ingelheim Investigational Site Taoyuan
Ukraine 1245.24.381007 Boehringer Ingelheim Investigational Site Dnepropetrovsk
Ukraine 1245.24.381010 Boehringer Ingelheim Investigational Site Kharkiv
Ukraine 1245.24.381003 Boehringer Ingelheim Investigational Site Kharkov
Ukraine 1245.24.381009 Boehringer Ingelheim Investigational Site Kharkov
Ukraine 1245.24.381008 Boehringer Ingelheim Investigational Site Kiev
Ukraine 1245.24.381002 Boehringer Ingelheim Investigational Site Odessa
Ukraine 1245.24.381006 Boehringer Ingelheim Investigational Site Vinnitsa
Ukraine 1245.24.381001 Boehringer Ingelheim Investigational Site Vinnytsya
Ukraine 1245.24.381005 Boehringer Ingelheim Investigational Site Vinnytsya
United States 1245.24.101004 Boehringer Ingelheim Investigational Site Clearwarter Florida
United States 1245.24.101015 Boehringer Ingelheim Investigational Site Dallas Texas
United States 1245.24.101025 Boehringer Ingelheim Investigational Site Federal Way Washington
United States 1245.24.101005 Boehringer Ingelheim Investigational Site Miami Florida
United States 1245.24.101001 Boehringer Ingelheim Investigational Site Mission Viejo California
United States 1245.24.101023 Boehringer Ingelheim Investigational Site Norristown Pennsylvania
United States 1245.24.101014 Boehringer Ingelheim Investigational Site Roswell Georgia
United States 1245.24.101028 Boehringer Ingelheim Investigational Site Spring Valley California
United States 1245.24.101024 Boehringer Ingelheim Investigational Site St. Cloud Florida
United States 1245.24.101016 Boehringer Ingelheim Investigational Site Staten Island New York
United States 1245.24.101006 Boehringer Ingelheim Investigational Site Wadsworth Ohio
United States 1245.24.101027 Boehringer Ingelheim Investigational Site Walnut Creek California

Sponsors (1)
Lead Sponsor Collaborator
Boehringer Ingelheim

Countries where clinical trial is conducted

United States,  Austria,  Croatia,  Czech Republic,  Estonia,  Finland,  France,  Germany,  Hungary,  Italy,  Korea, Republic of,  Latvia,  Lithuania,  Norway,  Romania,  Russian Federation,  Slovakia,  Spain,  Sweden,  Taiwan,  Ukraine, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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 No
Primary 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 No
Primary 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 No
Secondary Change From Baseline in HbA1c Over Time Baseline source: before first intake of active treatment (preceding trial or Open label extension) Weeks 1, 6, 18, 30, 42, 54, 66 and 78 No
Secondary Occurence of a Treat-to-target Response (HbA1c < 7.0%) Occurence of a treat-to-target response, defined as HbA1c < 7.0% over time Weeks 1, 6, 18, 30, 42, 54, 66 and 78 No
Secondary Occurrence of a Treat-to-target Response (HbA1c < 6.5%) Occurrence of a Treat-to-target Response, defined as HbA1c < 6.5% over time Weeks 1, 6, 18, 30, 42, 54, 66 and 78 No
Secondary Occurrence of a Relative Efficacy Response Occurrence of a Relative Efficacy Response (HbA1c Lowered by at least >=0.5% over time) Weeks 1, 6, 18, 30, 42, 54, 66 and 78 No
Secondary Change From Baseline in Fasting Plasma Glucose (FPG) Over Time Baseline source: before first intake of active treatment (preceding trial or Open label extension) Weeks 1, 6, 18, 30, 42, 54, 66 and 78 No
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