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A Study of LY2189265 Compared to Sitagliptin in Patients With Type 2 Diabetes Mellitus on Metformin - NCT00734474-04005(Clinical Trial 236068)



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City:  Biddeford
State:  
ME
Zip Code: 04005
Conditions: Diabetes Mellitus, Type 2
Purpose: 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.
Study summary:
Criteria: 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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Data Source: ClinicalTrials.gov
Date Processed: August 16, 2010
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