Safety and Efficacy of BI 10773 as add-on to Insulin Regimen in Patients With Type 2 Diabetes Mellitus

Obesity Clinical Trial

Official title:

A Phase III, Randomized, Double-blind, Placebo-controlled, Parallel Group Safety and Efficacy Study of BI 10773 (10 mg and 25 mg Administered Orally Once Daily) During 52 Weeks in Patients With Type 2 Diabetes Mellitus and Insufficient Glycemic Control on MDI Insulin Regimen Alone or With Metformin

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01306214
• Other study ID #: 1245.49
• Secondary ID: 2010-019968-37
• Status: Completed
• Phase: Phase 3
• First received: February 28, 2011
• Last updated: May 16, 2014
• Start date: February 2011
• Est. completion date: April 2013

Study information

• Verified date: May 2014
• Source: Boehringer Ingelheim
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Federal Agency for Medicinal and Health ProductsBulgaria: Bulgarian Drug AgencyColombia: Instituto Nacional de Vigilancia de Medicamentos y AlimentosCzech Republic: State Institute for Drug ControlFinland: Finnish Medicines AgencyFrance: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)Germany: Federal Institute for Drugs and Medical DevicesGuatemala:Mexico: Federal Commission for Protection Against Health RisksPeru: Ministry of HealthRussia: Pharmacological Committee, Ministry of HealthSpain: Spanish Agency of MedicinesUkraine: State Pharmacological Center - Ministry of HealthUnited States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

This trial will evaluate use of BI 10773 as add-on to insulin regimen alone or with metformin in patients with typr 2 diabetes. Both lowering glucose and HbA1c and reducing the use of insulin in this population would provide significant new information for the BI 10773 use and would offer a potential new therapeutic option in this population.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 566
• Est. completion date: April 2013
• Est. primary completion date: April 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion criteria:

1. Diagnosis of T2DM prior to informed consent

2. Male and female patients on diet and exercise regimen who are pre-treated with multiple daily injections (MDI) of insulin alone or in combination with immediate or extended release metformin

3. Stable metformin therapy: daily dose >=1500 mg/day or maximum tolerated dose

4. HbA1c >=7.5% and <=10% at screening

Exclusion criteria:

1. Uncontrolled hyperglycemia with a glucose level >240 mg/dl (>13.3 mmol/L) after an overnight fast during placebo run-in

2. Any contraindications to metformin according to the local label

3. Acute coronary syndrome, stroke or TIA within 3 months prior to informed consent

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Obesity

Intervention

Drug:
• Placebo
Placebo matching BI 10773 low dose
• Placebo
Placebo matching BI 10773 low dose
• Placebo
Placebo matching BI 10773 high dose
• Placebo
Placebo matching BI 10773 high dose
• BI 10773
BI 10773 low dose once daily
• BI 10773
BI 10773 high dose once daily

Locations

Country	Name	City	State
Belgium	1245.49.32010 Boehringer Ingelheim Investigational Site	Bonheiden
Belgium	1245.49.32002 Boehringer Ingelheim Investigational Site	Edegem
Belgium	1245.49.32007 Boehringer Ingelheim Investigational Site	Huy
Belgium	1245.49.32014 Boehringer Ingelheim Investigational Site	Jette
Belgium	1245.49.32013 Boehringer Ingelheim Investigational Site	La Louvière
Belgium	1245.49.32012 Boehringer Ingelheim Investigational Site	Leuven
Bulgaria	1245.49.59003 Boehringer Ingelheim Investigational Site	Pleven
Bulgaria	1245.49.59004 Boehringer Ingelheim Investigational Site	Sofia
Bulgaria	1245.49.59001 Boehringer Ingelheim Investigational Site	Stara Zagora
Colombia	1245.49.57003 Boehringer Ingelheim Investigational Site	Barranquilla
Colombia	1245.49.57005 Boehringer Ingelheim Investigational Site	Bogota
Colombia	1245.49.57006 Boehringer Ingelheim Investigational Site	Bogota
Colombia	1245.49.57004 Boehringer Ingelheim Investigational Site	Bogotá
Colombia	1245.49.57002 Boehringer Ingelheim Investigational Site	Medellín
Czech Republic	1245.49.42013 Boehringer Ingelheim Investigational Site	Breclav
Czech Republic	1245.49.42003 Boehringer Ingelheim Investigational Site	Brno
Czech Republic	1245.49.42010 Boehringer Ingelheim Investigational Site	Brno
Czech Republic	1245.49.42011 Boehringer Ingelheim Investigational Site	Chrudim
Czech Republic	1245.49.42009 Boehringer Ingelheim Investigational Site	Hodonin
Czech Republic	1245.49.42012 Boehringer Ingelheim Investigational Site	Svitavy56802
Finland	1245.49.72001 Boehringer Ingelheim Investigational Site	Kuopio
Finland	1245.49.72002 Boehringer Ingelheim Investigational Site	Oulu
Finland	1245.49.72003 Boehringer Ingelheim Investigational Site	Turku
France	1245.49.33001 Boehringer Ingelheim Investigational Site	Grenoble Cedex
France	1245.49.33011 Boehringer Ingelheim Investigational Site	Le Creusot
France	1245.49.33012 Boehringer Ingelheim Investigational Site	Marseille
France	1245.49.33003 Boehringer Ingelheim Investigational Site	Nantes cedex 1
France	1245.49.33010 Boehringer Ingelheim Investigational Site	Narbonne Cedex
France	1245.49.33004 Boehringer Ingelheim Investigational Site	Pierre Benite
France	1245.49.33007 Boehringer Ingelheim Investigational Site	Point-à-Pitre Cedex
France	1245.49.33008 Boehringer Ingelheim Investigational Site	Saint Priest en Jarez
France	1245.49.33009 Boehringer Ingelheim Investigational Site	Vénissieux Cedex
Germany	1245.49.49104 Boehringer Ingelheim Investigational Site	Bosenheim
Germany	1245.49.49013 Boehringer Ingelheim Investigational Site	Dresden
Germany	1245.49.49101 Boehringer Ingelheim Investigational Site	Mainz
Germany	1245.49.49002 Boehringer Ingelheim Investigational Site	Neuwied
Germany	1245.49.49005 Boehringer Ingelheim Investigational Site	Saarbrücken
Germany	1245.49.49102 Boehringer Ingelheim Investigational Site	Wangen
Guatemala	1245.49.50201 Boehringer Ingelheim Investigational Site	Guatemala
Guatemala	1245.49.50202 Boehringer Ingelheim Investigational Site	Guatemala
Guatemala	1245.49.50203 Boehringer Ingelheim Investigational Site	Guatemala
Guatemala	1245.49.50204 Boehringer Ingelheim Investigational Site	Guatemala
Guatemala	1245.49.50205 Boehringer Ingelheim Investigational Site	Quetzaltenango
Mexico	1245.49.52011 Boehringer Ingelheim Investigational Site	Aguascalientes
Mexico	1245.49.52012 Boehringer Ingelheim Investigational Site	Cuautla
Mexico	1245.49.52003 Boehringer Ingelheim Investigational Site	Durango
Mexico	1245.49.52005 Boehringer Ingelheim Investigational Site	Durango
Mexico	1245.49.52004 Boehringer Ingelheim Investigational Site	Guadalajara
Mexico	1245.49.52006 Boehringer Ingelheim Investigational Site	Guadalajara
Mexico	1245.49.52008 Boehringer Ingelheim Investigational Site	Guadalajara
Mexico	1245.49.52001 Boehringer Ingelheim Investigational Site	México, D.F.
Mexico	1245.49.52002 Boehringer Ingelheim Investigational Site	Monterrey
Mexico	1245.49.52009 Boehringer Ingelheim Investigational Site	Monterrey
Mexico	1245.49.52010 Boehringer Ingelheim Investigational Site	Monterrey
Peru	1245.49.51002 Boehringer Ingelheim Investigational Site	Arequipa
Peru	1245.49.51006 Boehringer Ingelheim Investigational Site	Arequipa
Peru	1245.49.51010 Boehringer Ingelheim Investigational Site	Jesus Maria
Peru	1245.49.51001 Boehringer Ingelheim Investigational Site	Lima
Peru	1245.49.51008 Boehringer Ingelheim Investigational Site	Lima
Peru	1245.49.51009 Boehringer Ingelheim Investigational Site	Lima
Russian Federation	1245.49.70008 Boehringer Ingelheim Investigational Site	Moscow
Russian Federation	1245.49.70009 Boehringer Ingelheim Investigational Site	Moscow
Russian Federation	1245.49.70006 Boehringer Ingelheim Investigational Site	St. Petersburg
Russian Federation	1245.49.70010 Boehringer Ingelheim Investigational Site	St. Petersburg
Spain	1245.49.34039 Boehringer Ingelheim Investigational Site	Avila
Spain	1245.49.34038 Boehringer Ingelheim Investigational Site	Madrid
Spain	1245.49.34044 Boehringer Ingelheim Investigational Site	Madrid
Spain	1245.49.34043 Boehringer Ingelheim Investigational Site	MBoadilla del Monte (Madrid)
Spain	1245.49.34047 Boehringer Ingelheim Investigational Site	Palma de Mallorca
Spain	1245.49.34045 Boehringer Ingelheim Investigational Site	pozuelo de Alarcon
Spain	1245.49.34016 Boehringer Ingelheim Investigational Site	Santiago de Compostela (La Coruña)
Spain	1245.49.34041 Boehringer Ingelheim Investigational Site	Valencia
Ukraine	1245.49.75016 Boehringer Ingelheim Investigational Site	Kharkov
Ukraine	1245.49.75007 Boehringer Ingelheim Investigational Site	Kiev
Ukraine	1245.49.75014 Boehringer Ingelheim Investigational Site	Kiev
Ukraine	1245.49.75015 Boehringer Ingelheim Investigational Site	Kiev
Ukraine	1245.49.75013 Boehringer Ingelheim Investigational Site	Kyiv
United States	1245.49.10003 Boehringer Ingelheim Investigational Site	Austin	Texas
United States	1245.49.10005 Boehringer Ingelheim Investigational Site	Birmingham	Alabama
United States	1245.49.10021 Boehringer Ingelheim Investigational Site	Blue Ridge	Georgia
United States	1245.49.10033 Boehringer Ingelheim Investigational Site	Bountiful	Utah
United States	1245.49.10011 Boehringer Ingelheim Investigational Site	Chandler	Arizona
United States	1245.49.10009 Boehringer Ingelheim Investigational Site	Chicago	Illinois
United States	1245.49.10006 Boehringer Ingelheim Investigational Site	Columbus	Ohio
United States	1245.49.10002 Boehringer Ingelheim Investigational Site	Corona	California
United States	1245.49.10001 Boehringer Ingelheim Investigational Site	Dallas	Texas
United States	1245.49.10024 Boehringer Ingelheim Investigational Site	Denver	Colorado
United States	1245.49.10013 Boehringer Ingelheim Investigational Site	El Cajon	California
United States	1245.49.10015 Boehringer Ingelheim Investigational Site	Evansville	Indiana
United States	1245.49.10007 Boehringer Ingelheim Investigational Site	Fargo	North Dakota
United States	1245.49.10023 Boehringer Ingelheim Investigational Site	Greenville	North Carolina
United States	1245.49.10025 Boehringer Ingelheim Investigational Site	Greer	South Carolina
United States	1245.49.10018 Boehringer Ingelheim Investigational Site	Hialeah	Florida
United States	1245.49.10031 Boehringer Ingelheim Investigational Site	Houston	Texas
United States	1245.49.10030 Boehringer Ingelheim Investigational Site	Lomita	California
United States	1245.49.10022 Boehringer Ingelheim Investigational Site	Memphis	Tennessee
United States	1245.49.10016 Boehringer Ingelheim Investigational Site	Miami	Florida
United States	1245.49.10026 Boehringer Ingelheim Investigational Site	Norfolk	Virginia
United States	1245.49.10020 Boehringer Ingelheim Investigational Site	Renton	Washington
United States	1245.49.10032 Boehringer Ingelheim Investigational Site	Salt Lake City	Utah
United States	1245.49.10014 Boehringer Ingelheim Investigational Site	Spring Valley	California
United States	1245.49.10004 Boehringer Ingelheim Investigational Site	Tucson	Arizona
United States	1245.49.10019 Boehringer Ingelheim Investigational Site	Westlake Village	California

Sponsors (2)

Lead Sponsor	Collaborator
Boehringer Ingelheim	Eli Lilly and Company

Countries where clinical trial is conducted

United States,  Belgium,  Bulgaria,  Colombia,  Czech Republic,  Finland,  France,  Germany,  Guatemala,  Mexico,  Peru,  Russian Federation,  Spain,  Ukraine, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change From Baseline in HbA1c After 18 Weeks of Treatment	The primary endpoint was the change from baseline in HbA1c after 18 weeks of treatment.	Baseline and 18 weeks	No
Secondary	Change From Baseline in Insulin Dose After 52 Weeks of Treatment	The secondary endpoint is change from baseline in insulin dose after 52 weeks of treatment	Baseline and 52 weeks	No
Secondary	Change From Baseline in Body Weight After 52 Weeks of Treatment	The secondary endpoint was the change from baseline in body weight after 52 weeks of treatment	Baseline and 52 weeks	No
Secondary	Change From Baseline in HbA1c After 52 Weeks of Treatment	The secondary endpoint was the change from baseline in HbA1c after 52 weeks of treatment	Baseline and 52 weeks	No