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

Study Description

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Brief Summary:

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 or disease	Intervention/treatment	Phase
Diabetes Mellitus, Type 2	Drug: Metformin; Drug: BI 10773; Drug: Placebo (low dose); Drug: Placebo (high dose)	Phase 3

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	1162 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Double
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
Study Start Date :	May 2011
Actual Primary Completion Date :	April 2013
Actual Study Completion Date :	April 2013

Arms and Interventions

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Arm	Intervention/treatment
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)

Outcome Measures

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Primary Outcome Measures :

1. 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

Secondary Outcome Measures :

1. Change From Baseline in HbA1c [ Time Frame: Baseline and 52 weeks ]
   Change from baseline in HbA1c after 52 weeks of treatment

Other Outcome Measures:

1. 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

Eligibility Criteria

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Ages Eligible for Study:	20 Years and older (Adult, Senior)
Sexes Eligible for Study:	All
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

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  Show 87 Study Locations

Sponsors and Collaborators

Boehringer Ingelheim

Eli Lilly and Company

Investigators

Study Chair:	Boehringer Ingelheim	Boehringer Ingelheim

More Information

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

Shiba T, Ishii S, Okamura T, Mitsuyoshi R, Pfarr E, Koiwai K. Efficacy and safety of empagliflozin in Japanese patients with type 2 diabetes mellitus: A sub-analysis by body mass index and age of pooled data from three clinical trials. Diabetes Res Clin Pract. 2017 Sep;131:169-178. doi: 10.1016/j.diabres.2017.07.004. Epub 2017 Jul 8.

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
First Posted:	June 7, 2011
Results First Posted:	June 17, 2014
Last Update Posted:	June 17, 2014
Last Verified:	May 2014

Additional relevant MeSH terms:

Diabetes Mellitus; Diabetes Mellitus, Type 2; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases	Empagliflozin; Metformin; Hypoglycemic Agents; Physiological Effects of Drugs