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Completed

NCT Number: NCT01167881

Efficacy and Safety of Empagliflozin (BI 10773) With Metformin in Patients With Type 2 Diabetes

This is a pivotal phase III study, mandatory to seek approval by regulatory authorities for BI 10773 as an anti-diabetic agent compared to an active comparator in patients with type 2 diabetes mellitus and insufficient glycaemic control.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

1245.28.54010 Boehringer Ingelheim Investigational Site, Buenos Aires, Argentina

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Diagnosis typ 2 diabetes mellitus
  • Male and female on diet and exercise regimen, pre-treated with metformin 12 weeks prior to randomisation
  • HbA1c equal or greater than 7.0% and less than or equal to 10% at visit 1
  • 18 years or more
  • BMI equal or less than 45Kg/m2

Exclusion criteria

  • Uncontrolled hyperglycemia defined as glucose more that 13.3 mmol/L after overnight fast during placebo run-in
  • Any other antidiabetic drug within 12 weeks prior to randomisation except metformin
  • Acute coronary syndrome (non-STEMI, STEMI unstable angina pectoris), stroke or transient ischemic attack within 12 weeks of informed consent
  • Indication of liver disease
  • Moderate to severe renal impairment
  • Bariatric surgery within past 2 years
  • Medical history of cancer or treatment for cancer within last 5 years
  • Blood dyscrasias or any disorders causing haemolysis or unstable red blood cell
  • Contraindications hypersensitivity to concomitant drugs
  • Treatment with anti-obesity drugs

Treatment and study plan

BI 10773

Drug

Medium dose once daily

Glimepiride

Drug

1-4 mg once daily

Placebo

Drug

Placebo matching BI 10773

Primary outcomes

  1. The Change From Baseline in Glycosylated Haemoglobin (HbA1c) After 104 Weeks of Treatment.

    Time frame: Baseline and 104 weeks

Secondary outcomes

  1. The Change in Body Weight From Baseline After 104 Weeks of Treatment.

    Time frame: baseline and 104 weeks

  2. The Occurrence of Confirmed Hypoglycaemic Events During 104 Weeks of Treatment.

    Time frame: baseline and 104 weeks

  3. The Change in Systolic Blood Pressure (SBP) From Baseline After 104 Weeks of Treatment.

    Time frame: baseline and 104 weeks

  4. The Change in Diastolic Blood Pressure (DBP) From Baseline After 104 Weeks of Treatment.

    Time frame: baseline and 104 weeks

  5. The Change From Baseline in HbA1c After 52 Weeks of Treatment.

    Time frame: baseline and 52 weeks

  6. The Change in Body Weight From Baseline After 52 Weeks of Treatment.

    Time frame: baseline and 52 weeks

  7. The Occurrence of Confirmed Hypoglycaemic Events During 52 Weeks of Treatment.

    Time frame: baseline and 52 weeks

  8. The Change in Systolic Blood Pressure (SBP) From Baseline After 52 Weeks of Treatment.

    Time frame: baseline and 52 weeks

  9. The Change in Diastolic Blood Pressure (DBP) From Baseline After 52 Weeks of Treatment.

    Time frame: baseline and 52 weeks

Sponsors and collaborators

Lead sponsor

Boehringer Ingelheim

Industry

Collaborators

  • Eli Lilly and Company

Registry information

Official study title

A Phase III Randomised, Double-blind, Active-controlled Parallel Group Efficacy and Safety Study of BI 10773 Compared to Glimepiride Administered Orally During 104 Weeks With a 104 Week Extension Period in Patients With Type 2 Diabetes Mellitus and Insufficient Glycaemic Control Despite Metformin Treatment

Important dates

Study start
2010
Primary completion
2013
Study completion
2015
First posted
Jul 22, 2010
Registry last updated
Sep 2, 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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