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BI 10773 (Empagliflozin) Cardiovascular Outcome Event Trial in Type 2 Diabetes Mellitus Patients (EMPA-REG OUTCOME).

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Eli Lilly and Company
Information provided by (Responsible Party):
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT01131676
First received: May 26, 2010
Last updated: November 5, 2014
Last verified: November 2014

May 26, 2010
November 5, 2014
July 2010
April 2015   (final data collection date for primary outcome measure)
The primary endpoint is time to the first occurrence of any of the following adjudicated components of the primary composite endpoint: cardiovascular death (including fatal stroke and fatal myocardial infarction(MI)), non-fatal MI and non-fatal stroke. [ Time Frame: up to 5 years ] [ Designated as safety issue: No ]
The primary endpoint is time to the first occurrence of any of the following adjudicated components of the primary composite endpoint: cardiovascular death (including fatal stroke and fatal myocardial infarction(MI)), non-fatal MI and non-fatal stroke. [ Time Frame: 4 years ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT01131676 on ClinicalTrials.gov Archive Site
  • The composite of all events adjudicated: cardiovascular death (including fatal stroke and fatal myocardial infarction), non-fatal myocardial infarction, non-fatal stroke and hospitalization for unstable angina pectoris. [ Time Frame: up to 5 years ] [ Designated as safety issue: No ]
  • To determine the incidence of new onset albuminuria [ Time Frame: up to 5 years ] [ Designated as safety issue: No ]
  • To determine the incidence of silent MI [ Time Frame: up to 5 years ] [ Designated as safety issue: No ]
  • To determine the incidence of heart failure requiring hospitalization [ Time Frame: up to 5 years ] [ Designated as safety issue: No ]
  • To determine the incidence of new onset macroalbuminuria [ Time Frame: up to 5 years ] [ Designated as safety issue: No ]
  • Composite microvascular outcome [ Time Frame: up to 5 years ] [ Designated as safety issue: No ]
  • The composite of all events adjudicated: cardiovascular death (including fatal stroke and fatal myocardial infarction), non-fatalmyocardial infarctionI, non-fatal stroke and hospitalization for unstable angina pectoris. [ Time Frame: 4 years ] [ Designated as safety issue: Yes ]
  • To determine the incidence of microalbuminuria and the progression of microalbuminuria to macroalbuminuria from baseline to end of trial. [ Time Frame: 4 years ] [ Designated as safety issue: Yes ]
  • To determine the incidence of silent MI [ Time Frame: 4 years ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
 
BI 10773 (Empagliflozin) Cardiovascular Outcome Event Trial in Type 2 Diabetes Mellitus Patients (EMPA-REG OUTCOME).
A Phase III, Multicentre, International, Randomised, Parallel Group, Double Blind Cardiovascular Safety Study of BI 10773 (10 mg and 25 mg Administered Orally Once Daily) Compared to Usual Care in Type 2 Diabetes Mellitus Patients With Increased Cardiovascular Risk

The aim of the present study is to investigate the safety of BI 10773 treatment in patients with Type 2 Diabetes Mellitus and high cardiovascular risk.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Diabetes Mellitus, Type 2
  • Drug: BI 10773 low dose
    BI 10773 tablets once daily
  • Drug: Placebo BI 10773 high dose
    Placebo tablets identical to BI 10773
  • Drug: BI 10773 high dose
    BI 10773 tablets once daily
  • Drug: Placebo BI 10773 low dose
    Placebo tablets identical to BI 10773
  • Experimental: BI 10773 low dose
    BI 10773 tablets once daily
    Interventions:
    • Drug: BI 10773 low dose
    • Drug: Placebo BI 10773 high dose
  • Experimental: BI 10773 high dose
    BI 10773 tablets once daily
    Interventions:
    • Drug: BI 10773 high dose
    • Drug: Placebo BI 10773 low dose
  • Placebo Comparator: Placebo
    Placebo tablets matching BI 10773
    Interventions:
    • Drug: Placebo BI 10773 high dose
    • Drug: Placebo BI 10773 low dose
Zinman B, Inzucchi SE, Lachin JM, Wanner C, Ferrari R, Fitchett D, Bluhmki E, Hantel S, Kempthorne-Rawson J, Newman J, Johansen OE, Woerle HJ, Broedl UC. Rationale, design, and baseline characteristics of a randomized, placebo-controlled cardiovascular outcome trial of empagliflozin (EMPA-REG OUTCOME™). Cardiovasc Diabetol. 2014 Jun 19;13:102. doi: 10.1186/1475-2840-13-102.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
7000
April 2015
April 2015   (final data collection date for primary outcome measure)

Inclusion criteria:

  1. Diagnosis of type 2 diabetes mellitus prior to informed consent
  2. Male or female patients on diet and exercise regimen who are drug naive or pre treated with any background therapy. Antidiabetic therapy has to be unchanged for 12 weeks prior to randomization.
  3. Glycosylated haemoglobin (HbA1c) of >= 7.0% and <=10% for patients on background therapy or HbA1c >= 7.0% and <= 9.0% for drug naive patients
  4. Age >= 18 years
  5. Body Mass index <= 45 at Visit 1
  6. Signed and dated informed consent
  7. High cardiovascular risk

Exclusion criteria:

  1. Uncontrolled hyperglycaemia with a glucose level >240 mg/dl (>13.3 mmol/L) after an overnight fast during placebo run-in and confirmed by a second measurement (not on the same day)
  2. Indication of liver disease, defined by serum levels of either alanine aminotransferase (ALT), aspartate aminotransferase ALT or alkaline phosphatase above 3 x upper limit of normal (ULN) as determined at screening and/or run in.
  3. Planned cardiac surgery or angioplasty within 3 months
  4. Impaired renal function, defined as Glomerular Filtration Rate <30 ml/min (severe renal impairment, Modification of Diet in Renal Disease formula) during screening or run in.
  5. Bariatric surgery within the past two years and other gastrointestinal surgeries that induce chronic malabsorption
  6. Blood dyscrasias or any disorders causing haemolysis or unstable Red Blood Cell (e.g. malaria, babesiosis, haemolytic anemia)
  7. Medical history of cancer (except for basal cell carcinoma) and/or treatment for cancer within the last 5 years
  8. Contraindications to background therapy according to the local label
  9. Treatment with anti-obesity drugs (e.g. sibutramine, orlistat) 3 months prior to informed consent or any other treatment at the time of screening (i.e. surgery, aggressive diet regimen, etc.) leading to unstable body weight
  10. Current treatment with systemic steroids at time of informed consent or change in dosage of thyroid hormones within 6 weeks prior to informed consent or any other uncontrolled endocrine disorder except type 2 diabetes mellitus
  11. Pre-menopausal women (last menstruation <+ 1 year prior to informed consent) who:

    • are nursing or pregnant or
    • are of child-bearing potential and are not practicing an acceptable method of birth control, or do not plan to continue using this method throughout the study and do not agree to submit to periodic pregnancy testing during participation in the trial. Acceptable methods of birth control include tubal ligation, transdermal patch, intra uterine devices/systems, oral, implantable or injectable contraceptives, sexual abstinence, double barrier method and vasectomised partner
  12. Alcohol or drug abuse within the 3 months prior to informed consent that would interfere with trial participation or any ongoing condition leading to a decreased compliance to study procedures or study drug intake
  13. Participation in another trial with an investigational drug within 30 days prior to informed consent
  14. Any other clinical condition that would jeopardize patients safety while participating in this clinical trial
  15. Acute coronary syndrome, stroke or TIA within 2 months prior to informed consent
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Argentina,   Australia,   Austria,   Belgium,   Brazil,   Canada,   Colombia,   Croatia,   Czech Republic,   Denmark,   Estonia,   France,   Georgia,   Greece,   Hong Kong,   Hungary,   India,   Indonesia,   Israel,   Italy,   Japan,   Korea, Republic of,   Malaysia,   Mexico,   Netherlands,   New Zealand,   Norway,   Peru,   Philippines,   Poland,   Portugal,   Romania,   Russian Federation,   Singapore,   South Africa,   Spain,   Sri Lanka,   Taiwan,   Thailand,   Ukraine,   United Kingdom
 
NCT01131676
1245.25, 2009-016178-33
Not Provided
Boehringer Ingelheim
Boehringer Ingelheim
Eli Lilly and Company
Study Chair: Boehringer Ingelheim Boehringer Ingelheim
Boehringer Ingelheim
November 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP