Welchol as Monotherapy for Type 2 Diabetes Mellitus

Daiichi Sankyo

Status and phase: Completed; Phase 3

Conditions: Type 2 Diabetes Mellitus

Treatments: Drug: Placebo; Drug: Welchol

Study type: Interventional

Funder types: Industry

Identifiers

NCT00789737

WEL-305

Details and patient eligibility

About

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.

Enrollment: 357 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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357 participants in 2 patient groups, including a placebo group

Welchol

Experimental group

Description:

Welchol 625mg tablets

Treatment:

Drug: Welchol

placebo

Placebo Comparator group

Description:

placebo

Treatment:

Drug: Placebo