Welchol as Monotherapy for Type 2 Diabetes Mellitus

Study Overview
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Brief Summary
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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.

Official Title
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A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study of the Efficacy and Safety of Welchol as Monotherapy for Type 2 Diabetes Mellitus

Conditions
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Type 2 Diabetes Mellitus

Intervention / Treatment
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* Drug: Welchol
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Welchol<br>Welchol 625mg tablets | Drug: Welchol<br>* Welchol 625mg tablets<br>|
| Placebo Comparator: placebo<br>placebo | Drug: Placebo<br>* placebo<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent Change in Hemoglobin A1c | change in HbA1c from baseline to Week 24 | 24 week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Fasting Plasma Glucose | to determine changes in Glycemic control after 24 weeks on therapy | from baseline to 24 weeks | 
| % Subjects With a Decrease in HbA1c of >= 0.7 Percentage Units | to determine the percentage of participants who experience a reduction in HbA1c of at least 0.7 percentage units at 24 weeks from baseline. | 24 weeks | 
| % Subjects Achieving an HbA1C Goal of <7.0 | % Subjects achieving an HbA1C goal of <7.0 at 24 weeks | 24 weeks | 
| % Subjects With a Decrease in FPG >=30 mg/dL | % Subjects with a decrease in Fasting Plasma Glucose >=30 mg/dL from baseline to 24 weeks | from baseline to 24 weeks | 
| Changes in Total Cholesterol [TC] | To assess the effects of Welchol on changes in total cholesterol [TC] | from baseline to 24 weeks | 
| Changes in Low Density Lipoprotein Cholesterol [LDL-C] | To assess the effects of Welchol on changes in low density lipoprotein cholesterol [LDL-C] | from baseline to 24 weeks | 
| Changes in High Density Lipoprotein Cholesterol [HDL-C] | To assess the effects of Welchol on changes in high density lipoprotein cholesterol [HDL-C] | from baseline to 24 weeks | 
| Changes in Non-HDL-C | To assess the effects of Welchol on changes in non-HDL-C | from baseline to 24 weeks | 
| Changes in Triglycerides [TG] | To assess the effects of Welchol on changes in triglycerides [TG] | from baseline to 24 weeks | 
| Changes in Apolipoprotein A-I (apoA-I) | To assess the effects of Welchol on changes in apolipoprotein A-I (apoA-I) | from baseline to 24 weeks | 
| Changes in Apolipoprotein B (apoB) | To assess the effects of Welchol on changes in apolipoprotein B (apoB) | from baseline to 24 weeks | 
| Change in Postprandial Plasma Glucose, 2 Hours After a Meal Tolerance Test | To assess the change from baseline on postprandial plasma glucose, 2 hours after a meal tolerance test | from baseline to 24 weeks |