Safety and Efficacy of BI 1356 as Monotherapy or in Combination in Type 2 DM - NCT00736099-Tainan - 00195 (Clinical Trial 236927)
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Tainan |
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Country:
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Taiwan |
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| Conditions: |
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Diabetes Mellitus, Type 2 |
| Purpose: |
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The objective of the current study is to investigate the safety and tolerability of BI 1356
(5 mg / once daily) given for 78 weeks in different modalities of treatment. The treatment
modalities are determined by the treatment in the blinded trial in which every patient was
included previously as BI 1356 in monotherapy (patients in 1218.16 trial), BI 1356 in
combination with pioglitazone (patients in 1218.15 trial), BI 1356 added to metformin
background (patients in 1218.17 trial) or BI 1356 added to a background therapy of metformin
in combination with a sulphonylurea (patients in 1218.18 study)
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| Study summary: |
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| Criteria: |
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Inclusion Criteria:
1. Signed and dated written informed consent in accordance with the GCP and local
legislation.
2. Patients completing the entire treatment period as a double blind trial whether or
not they have been treated with rescue medication.
Exclusion Criteria:
1. Patients who meet one or more of the withdrawal criteria of the treatment period of
the previous trial.
2. Pre-menopausal women (last menstruation =< 1 year prior to signing informed consent)
who:
- are nursing or pregnant,
- or are of child-bearing potential and are not practicing an acceptable method of
birth control, or do not plan to continue using this method throughout the study
and do not agree to submit to periodic pregnancy testing during participation in
the trial. Acceptable methods of birth control include transdermal patch, intra
uterine devices/systems (IUDs/IUSs), oral, implantable or injectable
contraceptives, true sexual abstinence (when this is in line with the preferred
and usual lifestyle of the patient; periodic abstinence [e.g.
calendar, ovulation, symptothermal, post-ovulation methods] and withdrawal are not
acceptable methods of birth control) and vasectomised partners. No exception will be
made.
3. Alcohol abuse within the 3 months prior to informed consent that would interfere with
trial participation.
4. Drug abuse which, in the opinion of the investigator, would interfere with trial
participation.
5. Any other clinical condition which, in the opinion of the investigator, would not
allow safe completion of the protocol and safe administration of the trial
medication. |
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If you are interested in this clinical trial please use the contact information above. If you would like to get additional information about this clinical trial please visit ClinicalTrials.gov.
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| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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September 24, 2009 |
Modifications to
this listing: |
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Only selected fields are shown, please use the link
above to view all information about this clinical trial. |
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Clinical trials are medical research studies designed to test the safety and/or
effectiveness of new drugs, devices, or treatments in humans. These studies are
conducted worldwide for a range of conditions and illnesses. Learn more about
clinical research and participating in a study at
About Clinical Trials.
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