Empagliflozin (BI 10773) Comprehensive add-on Study in Japanese Subjects With Type 2 Diabetes Mellitus
This study has been completed.
Sponsor:
Boehringer Ingelheim
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
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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
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01368081
Show 87 Study Locations
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 Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases |
ClinicalTrials.gov processed this record on March 03, 2015