12 Week Efficacy and Safety Study of Empagliflozin (BI 10773) in Hypertensive Patients With Type 2 Diabetes Mellitus

Phase 3

Completed

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

• Registration Number: NCT01370005
• Lead Sponsor: Boehringer Ingelheim

Brief Summary

This trial will evaluate safety and efficacy of BI 10773 in hypertensive patients with type 2 diabetes. Since hyperglycaemia and hypertension are key risk factors for both micro- and macrovascular complications, assessment of both glucose and blood pressure lowering effects of BI 10773 in hypertensive patients with type 2 diabetes could provide clinically highly relevant, new information for the use of BI 10773

Detailed Description

Not available

Study Timeline

• Study Start: 2011-06
• Study First Submitted: 2011-06-08
• Study First Submitted QC: 2011-06-08
• Study First Posted: 2011-06-09
• Primary Completion: 2012-07
• Study Completion: 2012-07
• Results First Submitted: 2014-05-16
• Results First Submitted QC: 2014-05-16
• Results First Posted: 2014-06-17
• Status Verified: 2016-01
• Last Update Submitted: 2016-01-22
• Last Update Posted: 2016-02-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 825

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
HbA1c Change From Baseline	Baseline and 12 weeks	Change from baseline in HbA1c after 12 weeks of treatment.
Mean 24-hour Systolic Blood Pressure Change From Baseline	Baseline and 12 weeks	Change from baseline of mean 24-hour systolic blood pressure (SBP).

Secondary Outcome Measures

Name	Time	Method
Mean 24-hour Diastolic Blood Pressure Change From Baseline	Baseline and 12 weeks	Change from baseline in mean 24-hour diastolic blood pressure (DBP) after 12 weeks.
Proportion of Patients With HbA1c <7%	Baseline and 12 weeks	Proportion of patients with HbA1c \<7% after 12 weeks.
Fasting Plasma Glucose (FPG) Change From Baseline	Baseline and 12 weeks	Change from baseline in FPG after 12 weeks of treatment.
Body Weight Change From Baseline	Baseline and 12 weeks	Change from baseline in body weight after 12 weeks of treatment.
Daytime Mean Systolic Blood Pressure (SBP) Change From Baseline	Baseline and 12 weeks	Change from baseline in daytime mean SBP after 12 weeks of treatment.
Daytime Mean Diastolic Blood Pressure (DBP) Change From Baseline	Baseline and 12 weeks	Change from baseline in daytime mean DBP after 12 weeks of treatment.
Nighttime Mean Systolic Blood Pressure (SBP) Change From Baseline	Baseline and 12 weeks	Change from baseline in nighttime mean SBP after 12 weeks of treatment.
Nighttime Mean Diastolic Blood Pressure (DBP) Change From Baseline	Baseline and 12 weeks	Change from baseline in nighttime mean DBP after 12 weeks of treatment.
Trough Mean Seated Systolic Blood Pressure (SBP) Change From Baseline	Baseline and 12 weeks	Change from baseline in Trough Mean Seated SBP after 12 weeks of treatment.
Trough Mean Seated Diastolic Blood Pressure (DBP) Change From Baseline	Baseline and 12 weeks	Change from baseline in trough mean seated DBP after 12 weeks of treatment.
Proportion of Patients Reaching Blood Pressure <130/80 mmHg	Baseline and 12 weeks	Proportion of patients reaching blood pressure \<130/80 mmHg after 12 weeks of treatment
Composite Endpoint of Change From Baseline of HbA1c, Systolic Blood Pressure and Body Weight	Baseline and 12 weeks	A composite endpoint of the following conditions at week 12 compared to baseline (all 3 fulfilled): reduction of HbA1c from baseline of at least 0.5%, reduction of systolic blood pressure \> 3 mmHg from baseline and reduction of weight from baseline \> 2%
Orthostatic Blood Pressure	Baseline and 12 weeks	Orthostatic blood pressure (BP) at baseline and after 12 weeks of treatment.

Trial Locations

Locations (120)

1245.48.10024 Boehringer Ingelheim Investigational Site; 🇺🇸 Huntsville, Alabama, United States

1245.48.10002 Boehringer Ingelheim Investigational Site; 🇺🇸 Phoenix, Arizona, United States

1245.48.10014 Boehringer Ingelheim Investigational Site; 🇺🇸 Lincoln, California, United States

1245.48.10030 Boehringer Ingelheim Investigational Site; 🇺🇸 Long Beach, California, United States

1245.48.10033 Boehringer Ingelheim Investigational Site; 🇺🇸 Long Beach, California, United States

1245.48.10027 Boehringer Ingelheim Investigational Site; 🇺🇸 Los Angeles, California, United States

1245.48.10041 Boehringer Ingelheim Investigational Site; 🇺🇸 Tustin, California, United States

1245.48.10039 Boehringer Ingelheim Investigational Site; 🇺🇸 West Hills, California, United States

1245.48.10008 Boehringer Ingelheim Investigational Site; 🇺🇸 Davie, Florida, United States

1245.48.10025 Boehringer Ingelheim Investigational Site; 🇺🇸 Edgewater, Florida, United States

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