Welchol as Monotherapy for Type 2 Diabetes Mellitus

Overview

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.

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

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: December 2011

Interventions

  • Drug: Welchol
    • Welchol 625mg tablets
  • Drug: Placebo
    • placebo

Arms, Groups and Cohorts

  • Experimental: Welchol
    • Welchol 625mg tablets
  • Placebo Comparator: placebo
    • placebo

Clinical Trial Outcome Measures

Primary Measures

  • Percent Change in Hemoglobin A1c
    • Time Frame: 24 week
    • change in HbA1c from baseline to Week 24

Secondary Measures

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

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Daiichi Sankyo
  • Provider of Information About this Clinical Study
    • Sponsor

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