Welchol as Monotherapy for Type 2 Diabetes Mellitus

• Status: Completed
• Trial end date: 2011-12-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Daiichi Sankyo Inc.; Daiichi Sankyo, Inc.
• Treatments: Colesevelam Hydrochloride

Criteria

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.