Efficacy and Safety of BI 10773 in Combination With Insulin in Patients With Type 2 Diabetes

Phase 2

Completed

• Conditions: Diabetes Mellitus, Type 2
• Interventions: Drug: BI 10773 placebo; Drug: BI 10773 low dose; Drug: BI 10773 high dose

• Registration Number: NCT01011868
• Lead Sponsor: Boehringer Ingelheim

Brief Summary

The objective of the current study is to investigate the efficacy, safety and tolerability of BI 10773 at two different doses compared to placebo during long term treatment (78 weeks) in combination with basal insulin in patients with type 2 diabetes mellitus with insufficient glycaemic control.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-11
• Study First Submitted: 2009-11-10
• Study First Submitted QC: 2009-11-10
• Study First Posted: 2009-11-11
• Primary Completion: 2012-05
• Results First Submitted: 2014-05-16
• Status Verified: 2014-09
• Results First Submitted QC: 2014-09-24
• Last Update Submitted: 2014-09-24
• Results First Posted: 2014-09-30
• Last Update Posted: 2014-09-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 494

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
placebo	BI 10773 placebo	Patients receive placebo to match BI 10773 daily
BI 10773 low dose	BI 10773 low dose	Patients receive BI 10773 low dose daily
BI 10773 high dose	BI 10773 high dose	Patients receive BI 10773 high dose daily
BI 10773 high dose	BI 10773 placebo	Patients receive BI 10773 high dose daily

Primary Outcome Measures

Name	Time	Method
Change From Baseline in Glycosylated Haemoglobin A1c (HbA1c) After 18 Weeks of Treatment	Baseline and 18 weeks	Change from baseline in Glycosylated haemoglobin A1c (HbA1c) after 18 weeks of treatment

Secondary Outcome Measures

Name	Time	Method
Change From Baseline in Basal Insulin Dose/Day After 54 and 78 Weeks of Treatment	Baseline, 54 and 78 weeks	Change from baseline in basal insulin dose/day after 54 and 78 weeks of treatment
Change From Baseline in Body Weight at Follow-up	Baseline and 82 weeks	Change from baseline in body weight at follow up (82 weeks)
Change From Baseline in Fasting Plasma Glucose (FPG) After 18, 54 and 78 Weeks of Treatment	Baseline, 18, 54 and 78 weeks	Change from baseline in fasting plasma glucose (FPG) after 18, 54 and 78 weeks of treatment
Change From Baseline in HbA1c After 54 and 78 Weeks of Treatment	Baseline, 54 and 78 weeks	Change from baseline in HbA1c after 54 and 78 weeks of treatment
The Occurrence of Treat to Target Efficacy Response, That is an HbA1c Under Treatment of <7.0% After 18, 54, and 78 Weeks of Treatment	Baseline, 18, 54 and 78 weeks	The occurrence of treat to target efficacy response, that is an HbA1c under treatment of \<7.0% After 18, 54, and 78 weeks of treatment
Occurrence of Relative Efficacy Response (HbA1c Lowering by at Least 0.5%) After 18, 54 and 78 Weeks of Treatment	Baseline and 18, 54 and 78 weeks	Patients that had a reduction in HbA1c of at least 0.5% from baseline to 18, 54 and 78 weeks of treatment
Percent Change From Baseline in Fasting Plasma Glucose (FPG) After 18, 54 and 78 Weeks of Treatment	Baseline, 18, 54 and 78 weeks	Percent change from baseline in fasting plasma glucose (FPG) after 18, 54 and 78 weeks of treatment
Change From Baseline in Body Weight After 18, 54 and 78 Weeks of Treatment	Baseline, 18, 54, 78 weeks	Change from baseline in body weight after 18, 54 and 78 weeks of treatment

Trial Locations

Locations (99)

1245.33.01014 Boehringer Ingelheim Investigational Site; 🇺🇸 Birmingham, Alabama, United States

1245.33.01047 Boehringer Ingelheim Investigational Site; 🇺🇸 Phoenix, Arizona, United States

1245.33.01060 Boehringer Ingelheim Investigational Site; 🇺🇸 Fresno, California, United States

1245.33.01013 Boehringer Ingelheim Investigational Site; 🇺🇸 Los Angeles, California, United States

1245.33.01008 Boehringer Ingelheim Investigational Site; 🇺🇸 Los Gatos, California, United States

1245.33.01019 Boehringer Ingelheim Investigational Site; 🇺🇸 National City, California, United States

1245.33.01055 Boehringer Ingelheim Investigational Site; 🇺🇸 Paramount, California, United States

1245.33.01012 Boehringer Ingelheim Investigational Site; 🇺🇸 Santa Ana, California, United States

1245.33.01054 Boehringer Ingelheim Investigational Site; 🇺🇸 Denver, Colorado, United States

1245.33.01046 Boehringer Ingelheim Investigational Site; 🇺🇸 Bradednton, Florida, United States

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