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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 Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01368081
First received: May 19, 2011
Last updated: May 15, 2013
Last verified: May 2013
History of Changes
  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:

U.S. FDA Resources

Further study details as provided by Boehringer Ingelheim Pharmaceuticals:

Primary Outcome Measures:
  • Frequency of number of adverse events [ Time Frame: 52 weeks ] [ Designated as safety issue: Yes ]
  • Frequency of hypoglycaemic events [ Time Frame: 52 weeks ] [ Designated as safety issue: Yes ]
  • Frequency of protocol specified significant adverse events (decreased renal function and hepatic injury) [ Time Frame: 52 weeks ] [ Designated as safety issue: Yes ]
  • Frequency of cardiovascular events (defined based on adjudication results of clinical event committee) [ Time Frame: 52 weeks ] [ Designated as safety issue: Yes ]
  • Change from baseline in vital signs (blood pressure and pulse rate) [ Time Frame: Baseline and 52 weeks at the maximum ] [ Designated as safety issue: Yes ]
  • Change from baseline in laboratory values [ Time Frame: Baseline and 52 weeks at the maximum ] [ Designated as safety issue: Yes ]

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

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

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

No publications provided

Responsible Party: Boehringer Ingelheim Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01368081     History of Changes
Other Study ID Numbers: 1245.52
Study First Received: May 19, 2011
Last Updated: May 15, 2013
Health Authority: Japan: Ministry of Health, Labor and Welfare

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

ClinicalTrials.gov processed this record on May 23, 2013