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
  Purpose

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.


Condition Intervention Phase
Diabetes Mellitus, Type 2
Drug: Metformin
Drug: BI 10773
Drug: Placebo (low dose)
Drug: Placebo (high dose)
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Boehringer Ingelheim:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    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


Secondary Outcome Measures:
  • Change From Baseline in HbA1c [ Time Frame: Baseline and 52 weeks ] [ Designated as safety issue: No ]
    Change from baseline in HbA1c after 52 weeks of treatment


Other Outcome Measures:
  • Confirmed Hypoglycaemic Adverse Events [ Time Frame: After the first drug intake until 7 days after the last treatment administration, up to 383 days ] [ Designated as safety issue: No ]
    Number of patients with confirmed hypoglycaemic adverse events


Enrollment: 1162
Study Start Date: May 2011
Study Completion Date: April 2013
Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: BI 10773 low dose
BI 10773 low dose tablet once daily
Drug: BI 10773
BI 10773 low dose tablet once daily
Drug: Placebo (high dose)
Placebo tablets once daily
Experimental: BI 10773 high dose
BI 10773 high dose tablet once daily
Drug: Placebo (low dose)
Placebo tablets once daily
Drug: BI 10773
BI 10773 high dose tablet once daily
Active Comparator: Metformin
Metformin tablets 500-2250 mg a day (twice or three times per day)
Drug: Metformin
Metformin tablets 500-2250 mg a day (twice or three times per day)

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01368081

  Show 87 Study Locations
Sponsors and Collaborators
Boehringer Ingelheim
Eli Lilly and Company
Investigators
Study Chair: Boehringer Ingelheim Boehringer Ingelheim
  More Information

Additional Information:
No publications provided

Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT01368081     History of Changes
Other Study ID Numbers: 1245.52
Study First Received: May 19, 2011
Results First Received: May 16, 2014
Last Updated: May 16, 2014
Health Authority: Japan: Ministry of Health, Labor and Welfare

Additional relevant MeSH terms:
Diabetes Mellitus, Type 2
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Metformin
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 16, 2014