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

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:

MedlinePlus related topics: Diabetes Type 2

Drug Information available for: Metformin Metformin hydrochloride Empagliflozin

U.S. FDA Resources

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 (Adult, Senior)
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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.


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 Diabetes Mellitus, Type 2 Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases Empagliflozin	Metformin Glycoside Hydrolase Inhibitors Hypoglycemic Agents Physiological Effects of Drugs Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on September 26, 2016