Empagliflozin (BI 10773) Comprehensive add-on Study in Japanese Subjects With Type 2 Diabetes Mellitus
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| ClinicalTrials.gov Identifier: NCT01368081 |
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Recruitment Status :
Completed
First Posted : June 7, 2011
Results First Posted : June 17, 2014
Last Update Posted : June 17, 2014
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Sponsor:
Boehringer Ingelheim
Collaborator:
Eli Lilly and Company
Information provided by (Responsible Party):
Boehringer Ingelheim
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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 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 |
Resource links provided by the National Library of Medicine
Genetics Home Reference related topics:
Type 2 diabetes
Drug Information available for:
Empagliflozin
| Arm | Intervention/treatment |
|---|---|
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Experimental: BI 10773 low dose
BI 10773 low dose tablet once daily
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Drug: BI 10773
BI 10773 low dose tablet once daily Drug: Placebo (high dose) Placebo tablets once daily |
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Experimental: BI 10773 high dose
BI 10773 high dose tablet once daily
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Drug: Placebo (low dose)
Placebo tablets once daily Drug: BI 10773 BI 10773 high dose tablet once daily |
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Active Comparator: Metformin
Metformin tablets 500-2250 mg a day (twice or three times per day)
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Drug: Metformin
Metformin tablets 500-2250 mg a day (twice or three times per day) |
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 ]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 ]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 ]Number of patients with confirmed hypoglycaemic adverse events
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| Ages Eligible for Study: | 20 Years and older (Adult, Older Adult) |
| 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)
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01368081
Show 87 Study Locations
Sponsors and Collaborators
Boehringer Ingelheim
Eli Lilly and Company
Investigators
| Study Chair: | Boehringer Ingelheim | Boehringer Ingelheim |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Boehringer Ingelheim |
| ClinicalTrials.gov Identifier: | NCT01368081 History of Changes |
| Other Study ID Numbers: |
1245.52 |
| First Posted: | June 7, 2011 Key Record Dates |
| Results First Posted: | June 17, 2014 |
| Last Update Posted: | June 17, 2014 |
| Last Verified: | May 2014 |
Additional relevant MeSH terms:
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Diabetes Mellitus Diabetes Mellitus, Type 2 Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases |
Empagliflozin Metformin Hypoglycemic Agents Physiological Effects of Drugs |