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Empagliflozin (BI 10773) Comprehensive add-on Study in Japanese Subjects With Type 2 Diabetes Mellitus

This study has been completed.
Sponsor:
Collaborator:
Eli Lilly and Company
Information provided by (Responsible Party):
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT01368081
First received: May 19, 2011
Last updated: May 16, 2014
Last verified: May 2014
History of Changes
May 19, 2011
May 16, 2014
May 2011
April 2013   (Final data collection date for primary outcome measure)
Number of Patients With Drug Related Adverse Events [ Time Frame: After the first drug intake until 7 days after the last treatment administration, up to 383 days ]
Number of Patients With Drug Related Adverse Events after the first drug intake until 7 days after the last treatment administration, up to 383 days
  • Frequency of number of adverse events [ Time Frame: 52 weeks ]
  • Frequency of hypoglycaemic events [ Time Frame: 52 weeks ]
  • Frequency of protocol specified significant adverse events (decreased renal function and hepatic injury) [ Time Frame: 52 weeks ]
  • Frequency of cardiovascular events (defined based on adjudication results of clinical event committee) [ Time Frame: 52 weeks ]
  • Change from baseline in vital signs (blood pressure and pulse rate) [ Time Frame: Baseline and 52 weeks at the maximum ]
  • Change from baseline in laboratory values [ Time Frame: Baseline and 52 weeks at the maximum ]
Complete list of historical versions of study NCT01368081 on ClinicalTrials.gov Archive Site
Change From Baseline in HbA1c [ Time Frame: Baseline and 52 weeks ]
Change from baseline in HbA1c after 52 weeks of treatment
Change from baseline in HbA1c after 52 weeks of treatment [ Time Frame: Baseline and 52 weeks ]
Confirmed Hypoglycaemic Adverse Events [ Time Frame: After the first drug intake until 7 days after the last treatment administration, up to 383 days ]
Number of patients with confirmed hypoglycaemic adverse events
Not Provided
 
Empagliflozin (BI 10773) Comprehensive add-on Study in Japanese Subjects With Type 2 Diabetes Mellitus
A 52-week, Randomised, Multi-centre, Parallel Group Study to Investigate the Safety and Efficacy of BI 10773 (10 mg or 25 mg Administered Orally Once Daily) as add-on Therapy to an Oral Antidiabetic Drug (Sulfonylurea, Biguanide, Thiazolidinedione, Alpha Glucosidase Inhibitor, DPP-IV Inhibitor, or Glinide) in Patients With Type 2 Diabetes Mellitus With Insufficient Glycaemic Control
The objective of the study is to investigate the long-term safety and efficacy of BI 10773 given for 52 weeks as add-on therapy to one oral antidiabetic drug in patients with type 2 diabetes mellitus with insufficient glycaemic control.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Diabetes Mellitus, Type 2
  • Drug: Metformin
    Metformin tablets 500-2250 mg a day (twice or three times per day)
  • Drug: BI 10773
    BI 10773 low dose tablet once daily
  • Drug: Placebo (low dose)
    Placebo tablets once daily
  • Drug: BI 10773
    BI 10773 high dose tablet once daily
  • Drug: Placebo (high dose)
    Placebo tablets once daily
  • Experimental: BI 10773 low dose
    BI 10773 low dose tablet once daily
    Interventions:
    • Drug: BI 10773
    • Drug: Placebo (high dose)
  • Experimental: BI 10773 high dose
    BI 10773 high dose tablet once daily
    Interventions:
    • Drug: Placebo (low dose)
    • Drug: BI 10773
  • Active Comparator: Metformin
    Metformin tablets 500-2250 mg a day (twice or three times per day)
    Intervention: Drug: Metformin
Araki E, Tanizawa Y, Tanaka Y, Taniguchi A, Koiwai K, Kim G, Salsali A, Woerle HJ, Broedl UC. Long-term treatment with empagliflozin as add-on to oral antidiabetes therapy in Japanese patients with type 2 diabetes mellitus. Diabetes Obes Metab. 2015 Jul;17(7):665-74. doi: 10.1111/dom.12464. Epub 2015 Apr 15.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
1162
April 2013
April 2013   (Final data collection date for primary outcome measure)

Inclusion criteria:

  • .Diagnosis of type 2 diabetes mellitus prior to informed consent
  • Male and female patients, on diet and exercise regimen, who are pre-treated with one of the following oral antidiabetic drugs: sulfonylurea, glinide, biguanide, Alpha-glucosidase inhibitor (a-GI), dipeptidyl peptidase-IV (DPP-IV) inhibitor or thiazolidinedione
  • glycosylated haemoglobin (HbA1c) at Visit 1: >=7.0 to =<10.0% (national glycohemoglobin standardization program)

Exclusion criteria:

  • Uncontrolled hyperglycaemia with a glucose level >240 mg/dL (>13.3 mmol/L)
  • Acute coronary syndrome, stroke or transient ischemic attack (TIA) within 12 weeks prior to informed consent
  • Indication of liver disease, defined by serum levels of either alanine transaminase (ALT), aspartate transaminase (AST), or alkaline phosphatase (ALP) above 3 x upper limit of normal (ULN)
Sexes Eligible for Study: All
20 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Japan
 
 
NCT01368081
1245.52
Not Provided
Not Provided
Not Provided
Not Provided
Boehringer Ingelheim
Boehringer Ingelheim
Eli Lilly and Company
Study Chair: Boehringer Ingelheim Boehringer Ingelheim
Boehringer Ingelheim
May 2014

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