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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 October 2017 |
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Main ID: |
NCT00881530 |
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Date of registration:
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14/04/2009 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Empagliflozin (BI 10773) in Type Two Diabetes (T2D) Patients, Open Label Extension
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Scientific title:
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A 78 Week Open Label Extension to Trials Assessing the Safety and Efficacy of BI 10773 as Monotherapy or in Combination With Metformin in Type 2 Diabetic Patients |
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Date of first enrolment:
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March 2009 |
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Target sample size:
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660 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT00881530 |
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Study type:
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Interventional |
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Study design:
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Phase:
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Phase 2
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Countries of recruitment
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Argentina
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Austria
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Croatia
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Czech Republic
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Estonia
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Finland
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France
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Germany
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Hungary
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Italy
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Korea, Republic of
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Latvia
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Lithuania
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Norway
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Romania
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Russian Federation
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Slovakia
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Spain
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Sweden
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Taiwan
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Ukraine
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United States
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Contacts
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Name:
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Boehringer Ingelheim |
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Address:
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Telephone:
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Email:
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Affiliation:
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Boehringer Ingelheim |
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Key inclusion & exclusion criteria
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Inclusion criteria:
- patients completing one of double blind phase II trials 1245.9 or 1245.10
- informed consent
Exclusion criteria:
- patients meeting withdrawal criteria of preceding trial
- significant hepatic impairment
- significant renal impairment with creatinine clearance < 50 ml/min
- contraindication to Metformin for all patients treated with Metformin
- premenopausal women that are nursing or pregnant or not practicing acceptable methods
of birth control
- drug or alcohol abuse
Age minimum:
18 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Diabetes Mellitus, Type 2
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Intervention(s)
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Drug: Sitagliptin
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Drug: BI 10773
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Drug: Metformin
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Primary Outcome(s)
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Clinical Relevant Abnormalities for Physical Examination, Vital Signs, ECG and Laboratory Measurements
[Time Frame: 78 weeks plus 1 week of follow-up]
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Hypoglycaemic Events
[Time Frame: 78 weeks plus 1 week of follow-up]
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Change From Baseline to Week 78 in Lipid Parameters
[Time Frame: Weeks 1 and 78]
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Secondary Outcome(s)
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Change From Baseline in HbA1c Over Time
[Time Frame: Weeks 1, 6, 18, 30, 42, 54, 66 and 78]
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Occurrence of a Relative Efficacy Response
[Time Frame: Weeks 1, 6, 18, 30, 42, 54, 66 and 78]
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Change From Baseline in Fasting Plasma Glucose (FPG) Over Time
[Time Frame: Weeks 1, 6, 18, 30, 42, 54, 66 and 78]
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Occurrence of a Treat-to-target Response (HbA1c < 6.5%)
[Time Frame: Weeks 1, 6, 18, 30, 42, 54, 66 and 78]
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Occurence of a Treat-to-target Response (HbA1c < 7.0%)
[Time Frame: Weeks 1, 6, 18, 30, 42, 54, 66 and 78]
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Secondary ID(s)
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2008-007938-21
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1245.24
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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