A Study of LY2189265 Compared to Sitagliptin in Patients With Type 2 Diabetes Mellitus on Metformin - NCT00734474-04005 (Clinical Trial 236068)
Permalink: http://www.ClinicalConnection.com/exp/ExpandedPatientViewStudy236068.aspx
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| City: |
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Biddeford |
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State:
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ME |
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04005 |
| Conditions: |
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Diabetes Mellitus, Type 2 |
| Purpose: |
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This is an adaptive dose finding study and a phase 3 efficacy study to evaluate the effects
of once weekly injection of LY2189265 compared to sitagliptin on glucose by measuring HbA1c
change from baseline after twelve months in patients with type 2 diabetes mellitus on
metformin.
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| Study summary: |
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| Criteria: |
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Inclusion Criteria:
- Diabetes mellitus, type 2 for at least 6 months
- Treatment regimens: diet and exercise, metformin as monotherapy or in combination
with another oral antihyperglycemic medication (OAM), or another OAM as monotherapy.
Must be able to tolerate metformin at a dose of at least 1500 mg daily for 6 weeks
prior to randomization.
- HbA1c value of ≥7.0% to ≤9.5%
- Body mass index (BMI) between 25 and 40 kg/m2, inclusive
- Stable weight for 3 months prior to screening
- Females of childbearing potential must test negative for pregnancy and agree to use a
reliable birth control method
Exclusion Criteria:
- Diabetes mellitus, type 1
- Use of a GLP-1 analog (for example, exenatide) within 6 months prior to screening or
are being treated with insulin
- Gastric emptying abnormality, history of bariatric surgery or chronic use of drugs
that affect gastrointestinal motility
- Use of medications to promote weight loss
- Cardiovascular event within 6 months prior to screening
- Poorly controlled hypertension
- ECG reading considered outside the normal limits or indicating cardiac disease
- Liver disease, hepatitis, chronic pancreatitis, idiopathic acute pancreatitis, or
alanine transaminase (ALT) levels >3.0 times the upper limit of normal
- Serum creatinine ≥1.5 mg/dL or a creatinine clearance < 60 ml/minute
- Uncontrolled diabetes
- Uncontrolled endocrine or autoimmune abnormality
- History of a transplanted organ
- Chronic use of systemic glucocorticoid therapy
- Active or untreated malignancy
- Use of CNS stimulants |
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| Study is available at: |
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For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Biddeford, ME 04005
United States
Primary Contact:
There may be multiple sites in this clinical trial. 1-877-CTLILLY(1-877-285-4559) or
Phone: 1-317-615-4559 |
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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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March 16, 2010 |
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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