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Birmingham, Alabama 35294


The current study investigates Welchol as monotherapy to improve glycemic control in subjects with Type 2 Diabetes Mellitus not adequately controlled with diet and exercise alone. The study will evaluate if Welchol monotherapy for Type 2 Diabetes Mellitus will be safe, well tolerated and efficacious.


Inclusion Criteria: - Male or female subjects >= 18 years of age; - Women of childbearing potential (WOCBP) must be using an adequate method of contraception as detailed in the protocol. - Diagnosis of Type 2 Diabetes Mellitus; - HbA1C >= 7.5% and =< 9.5 % at screening; - Fasting C-peptide >0.5 ng/mL at screening; - Drug naïve (no prior treatment with OAD) or having received no pharmacologic therapy for diabetes for the 3 month period prior to screening; - Clinically stable in regards to medical conditions other than type 2 diabetes; - Concomitant medications must be at stable doses for at least 30 days prior to enrollment, and are not anticipated to need adjustment during the study period; and - Fasting glucose =< 240 mg/dL at randomization Exclusion Criteria: - A history of type 1 diabetes and/or a history of ketoacidosis; - History of bowel obstruction; - History of hypertriglyceridemia-induced pancreatitis; - Fasting serum triglyceride concentrations >500 mg/dL; - History of dysphagia, swallowing disorders, gastroparesis, other gastrointestinal (GI) motility disorders, or major GI surgery; - History of insulin use of >= 2 weeks duration in the previous 3 months or a total of > 2 months of insulin therapy at any time prior to screening; - Two or more fasting self-monitored blood glucose (SMBG) levels >240 mg/dL during the placebo lead-in period. - Previous treatment with a bile acid sequestrant, including Welchol within the 3 months prior to screening; - Body mass index (BMI) >40 kg/m2; - Weight loss > 3% in prior 3 months; and - LDL <60 mg/dL.



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Birmingham, Alabama 35294
United States

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Site Status: N/A

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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