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Completed

NCT Number: NCT01370005

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

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

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Key information

Conditions

Diabetes Mellitus, Type 2 Cardiovascular Diseases Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Hypertension Metabolic Diseases Nutritional and Metabolic Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

1245.48.20002 Boehringer Ingelheim Investigational Site, Winnipeg, Manitoba, Canada

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients >=18 years with type 2 diabetes
  • HbA1c of >= 7.0% (53 mmol/mol) and =< 10% (86 mmol/mol)
  • Mean seated systolic blood pressure 130-159 mmHg and diastolic blood pressure 80-99 mmHg

Exclusion criteria

  • Uncontrolled hyperglycaemia with a glucose level >240 mg/dl (>13.3 mmol/L) after an overnight fast before randomization
  • Known or suspected secondary hypertension
  • Acute coronary syndrome (non-STEMI, STEMI and unstable angina pectoris), stroke or transient ischemic attack within 3 months prior to informed consent

Treatment and study plan

Placebo

Drug

Placebo matching BI 10773 low dose

BI 10773

Drug

BI 10773 high dose once daily

Primary outcomes

  1. HbA1c Change From Baseline

    Time frame: Baseline and 12 weeks

    Change from baseline in HbA1c after 12 weeks of treatment.

  2. 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

  1. Mean 24-hour Diastolic Blood Pressure Change From Baseline

    Time frame: Baseline and 12 weeks

    Change from baseline in mean 24-hour diastolic blood pressure (DBP) after 12 weeks.

  2. Proportion of Patients With HbA1c <7%

    Time frame: Baseline and 12 weeks

    Proportion of patients with HbA1c <7% after 12 weeks.

  3. Fasting Plasma Glucose (FPG) Change From Baseline

    Time frame: Baseline and 12 weeks

    Change from baseline in FPG after 12 weeks of treatment.

  4. Body Weight Change From Baseline

    Time frame: Baseline and 12 weeks

    Change from baseline in body weight after 12 weeks of treatment.

  5. Daytime Mean Systolic Blood Pressure (SBP) Change From Baseline

    Time frame: Baseline and 12 weeks

    Change from baseline in daytime mean SBP after 12 weeks of treatment.

  6. Daytime Mean Diastolic Blood Pressure (DBP) Change From Baseline

    Time frame: Baseline and 12 weeks

    Change from baseline in daytime mean DBP after 12 weeks of treatment.

  7. Nighttime Mean Systolic Blood Pressure (SBP) Change From Baseline

    Time frame: Baseline and 12 weeks

    Change from baseline in nighttime mean SBP after 12 weeks of treatment.

  8. Nighttime Mean Diastolic Blood Pressure (DBP) Change From Baseline

    Time frame: Baseline and 12 weeks

    Change from baseline in nighttime mean DBP after 12 weeks of treatment.

  9. Trough Mean Seated Systolic Blood Pressure (SBP) Change From Baseline

    Time frame: Baseline and 12 weeks

    Change from baseline in Trough Mean Seated SBP after 12 weeks of treatment.

  10. Trough Mean Seated Diastolic Blood Pressure (DBP) Change From Baseline

    Time frame: Baseline and 12 weeks

    Change from baseline in trough mean seated DBP after 12 weeks of treatment.

  11. Proportion of Patients Reaching Blood Pressure <130/80 mmHg

    Time frame: Baseline and 12 weeks

    Proportion of patients reaching blood pressure <130/80 mmHg after 12 weeks of treatment

  12. Composite Endpoint of Change From Baseline of HbA1c, Systolic Blood Pressure and Body Weight

    Time frame: 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%

  13. Orthostatic Blood Pressure

    Time frame: Baseline and 12 weeks

    Orthostatic blood pressure (BP) at baseline and after 12 weeks of treatment.

Other outcomes

  1. Confirmed Hypoglycaemic Adverse Events

    Time frame: From drug administration until last drug administration plus seven days, up to 171 days

    Number of participants with confirmed hypoglycaemic adverse events

Sponsors and collaborators

Lead sponsor

Boehringer Ingelheim

Industry

Collaborators

  • Eli Lilly and Company

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Jun 9, 2011
Registry last updated
Feb 22, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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