A Phase III Randomised, Double-blind, Placebo-controlled, Parallel Group, Efficacy and Safety Study of BI 10773 (10 mg, 25 mg) Administered Orally, Once Daily Over 12 Weeks in Hypertensive Patients With Type 2 Diabetes Mellitus
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Boehringer Ingelheim
- Enrollment
- 825
- Locations
- 120
- Primary Endpoint
- HbA1c Change From Baseline
Study Overview
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
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
BI 10773 high dose
BI 10773 high dose once daily
Intervention: Placebo (Drug)
Placebo
Placebo tablets matching BI 10773
Intervention: Placebo (Drug)
BI 10773 low dose
BI 10773 low dose once daily
Intervention: BI 10773 (Drug)
BI 10773 high dose
BI 10773 high dose once daily
Intervention: BI 10773 (Drug)
BI 10773 low dose
BI 10773 low dose once daily
Intervention: Placebo (Drug)
Outcomes
Primary Outcomes
HbA1c Change From Baseline
Time Frame: Baseline and 12 weeks
Change from baseline in HbA1c after 12 weeks of treatment.
Mean 24-hour Systolic Blood Pressure Change From Baseline
Time Frame: Baseline and 12 weeks
Change from baseline of mean 24-hour systolic blood pressure (SBP).
Secondary Outcomes
- Mean 24-hour Diastolic Blood Pressure Change From Baseline(Baseline and 12 weeks)
- Proportion of Patients With HbA1c <7%(Baseline and 12 weeks)
- Fasting Plasma Glucose (FPG) Change From Baseline(Baseline and 12 weeks)
- Body Weight Change From Baseline(Baseline and 12 weeks)
- Daytime Mean Systolic Blood Pressure (SBP) Change From Baseline(Baseline and 12 weeks)
- Daytime Mean Diastolic Blood Pressure (DBP) Change From Baseline(Baseline and 12 weeks)
- Nighttime Mean Systolic Blood Pressure (SBP) Change From Baseline(Baseline and 12 weeks)
- Nighttime Mean Diastolic Blood Pressure (DBP) Change From Baseline(Baseline and 12 weeks)
- Trough Mean Seated Systolic Blood Pressure (SBP) Change From Baseline(Baseline and 12 weeks)
- Trough Mean Seated Diastolic Blood Pressure (DBP) Change From Baseline(Baseline and 12 weeks)
- Proportion of Patients Reaching Blood Pressure <130/80 mmHg(Baseline and 12 weeks)
- Composite Endpoint of Change From Baseline of HbA1c, Systolic Blood Pressure and Body Weight(Baseline and 12 weeks)
- Orthostatic Blood Pressure(Baseline and 12 weeks)