Welchol as Monotherapy for Type 2 Diabetes Mellitus

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Daiichi Sankyo Inc.
ClinicalTrials.gov Identifier:
NCT00789737
First received: November 10, 2008
Last updated: January 24, 2014
Last verified: January 2014
  Purpose

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.


Condition Intervention Phase
Type 2 Diabetes Mellitus
Drug: Welchol
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study of the Efficacy and Safety of Welchol as Monotherapy for Type 2 Diabetes Mellitus

Resource links provided by NLM:


Further study details as provided by Daiichi Sankyo Inc.:

Primary Outcome Measures:
  • Percent Change in Hemoglobin A1c [ Time Frame: 24 week ] [ Designated as safety issue: No ]
    change in HbA1c from baseline to Week 24


Secondary Outcome Measures:
  • Change in Fasting Plasma Glucose [ Time Frame: from baseline to 24 weeks ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    % 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 ] [ Designated as safety issue: No ]
    % 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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    To assess the effects of Welchol on changes in non-HDL-C

  • Changes in Triglycerides [TG] [ Time Frame: from baseline to 24 weeks ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    To assess the change from baseline on postprandial plasma glucose, 2 hours after a meal tolerance test


Enrollment: 357
Study Start Date: January 2009
Study Completion Date: December 2011
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Welchol
Welchol 625mg tablets
Drug: Welchol
Welchol 625mg tablets
Placebo Comparator: placebo
placebo
Drug: Placebo
placebo

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00789737

  Show 107 Study Locations
Sponsors and Collaborators
Daiichi Sankyo Inc.
  More Information

No publications provided

Responsible Party: Daiichi Sankyo Inc.
ClinicalTrials.gov Identifier: NCT00789737     History of Changes
Other Study ID Numbers: WEL-305
Study First Received: November 10, 2008
Results First Received: December 4, 2013
Last Updated: January 24, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Endocrine System Diseases
Glucose Metabolism Disorders
Metabolic Diseases
Colesevelam
Anticholesteremic Agents
Antimetabolites
Hypolipidemic Agents
Lipid Regulating Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014