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

Phase 3

Completed

• Conditions: Diabetes Mellitus, Type 2; Obesity
• Interventions: Drug: Placebo; Drug: BI 10773

• Registration Number: NCT01306214
• Lead Sponsor: Boehringer Ingelheim

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-02
• Study First Submitted: 2011-02-28
• Study First Submitted QC: 2011-02-28
• Study First Posted: 2011-03-01
• Primary Completion: 2013-04
• Study Completion: 2013-04
• Status Verified: 2014-05
• Results First Submitted: 2014-05-16
• Results First Submitted QC: 2014-05-16
• Last Update Submitted: 2014-05-16
• Results First Posted: 2014-06-17
• Last Update Posted: 2014-06-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 566

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
BI 10773 low dose	Placebo	BI 10773 low dose once daily
BI 10773 low dose	BI 10773	BI 10773 low dose once daily
BI 10773 high dose	Placebo	BI 10733 high dose once daily
BI 10773 high dose	BI 10773	BI 10733 high dose once daily
Placebo	Placebo	Placebo tablets matching BI 10773

Primary Outcome Measures

Name	Time	Method
Change From Baseline in HbA1c After 18 Weeks of Treatment	Baseline and 18 weeks	The primary endpoint was the change from baseline in HbA1c after 18 weeks of treatment.

Secondary Outcome Measures

Name	Time	Method
Change From Baseline in Insulin Dose After 52 Weeks of Treatment	Baseline and 52 weeks	The secondary endpoint is change from baseline in insulin dose after 52 weeks of treatment
Change From Baseline in Body Weight After 52 Weeks of Treatment	Baseline and 52 weeks	The secondary endpoint was the change from baseline in body weight after 52 weeks of treatment
Change From Baseline in HbA1c After 52 Weeks of Treatment	Baseline and 52 weeks	The secondary endpoint was the change from baseline in HbA1c after 52 weeks of treatment

Trial Locations

Locations (103)

1245.49.10005 Boehringer Ingelheim Investigational Site; 🇺🇸 Birmingham, Alabama, United States

1245.49.10011 Boehringer Ingelheim Investigational Site; 🇺🇸 Chandler, Arizona, United States

1245.49.10004 Boehringer Ingelheim Investigational Site; 🇺🇸 Tucson, Arizona, United States

1245.49.10002 Boehringer Ingelheim Investigational Site; 🇺🇸 Corona, California, United States

1245.49.10013 Boehringer Ingelheim Investigational Site; 🇺🇸 El Cajon, California, United States

1245.49.10030 Boehringer Ingelheim Investigational Site; 🇺🇸 Lomita, California, United States

1245.49.10014 Boehringer Ingelheim Investigational Site; 🇺🇸 Spring Valley, California, United States

1245.49.10019 Boehringer Ingelheim Investigational Site; 🇺🇸 Westlake Village, California, United States

1245.49.10024 Boehringer Ingelheim Investigational Site; 🇺🇸 Denver, Colorado, United States

1245.49.10018 Boehringer Ingelheim Investigational Site; 🇺🇸 Hialeah, Florida, United States

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