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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

November 10, 2008
January 24, 2014
January 2009
December 2011   (final data collection date for primary outcome measure)
Percent Change in Hemoglobin A1c [ Time Frame: 24 week ] [ Designated as safety issue: No ]
change in HbA1c from baseline to Week 24
Glycemic control, HbA1c [ Time Frame: 24 week ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00789737 on ClinicalTrials.gov Archive Site
  • 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
  • Glycemic control - Fasting Plasma Glucose [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • Responder rates - HbA1c % Subjects with a decrease in HbA1c of >= 0.7 percentage units [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • Responder rates - HbA1c % Subjects achieving an HbA1C goal of <7.0% [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • Responder rates - FPG % Subjects with a decrease in FPG >=30 mg/dL [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • To assess the effects of Welchol on changes in plasma lipids, specifically total cholesterol [TC] [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • To assess the effects of Welchol on changes in plasma lipids, specifically low density lipoprotein cholesterol [LDL-C] [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • To assess the effects of Welchol on changes in plasma lipids, specifically high density lipoprotein cholesterol [HDL-C] [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • To assess the effects of Welchol on changes in plasma lipids, specifically non-HDL-C [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • To assess the effects of Welchol on changes in plasma lipids, specifically triglycerides [TG] [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • To assess the effects of Welchol on changes in plasma lipids, specifically apolipoprotein A-I (apoA-I) [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • To assess the effects of Welchol on changes in plasma lipids, specifically apolipoprotein B (apoB) [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • To assess the effects of Welchol on changes in plasma lipids, specifically lipid particle profile, including very low-density lipoprotein (VLDL) [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • To assess the effects of Welchol on postprandial plasma glucose, before and 2 hours after a meal tolerance test [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • To assess the effects of Welchol on insulin before and 2 hours after a meal tolerance test [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • To assess the effects of Welchol on C-peptide before and 2 hours after a meal tolerance test [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • To assess the effects of Welchol vs. placebo on insulin level [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • To assess the effects of Welchol vs. placebo HOMA indices [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • To assess the effects of Welchol vs. placebo on high sensitivity C- reactive protein [hs-CRP] levels [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Welchol as Monotherapy for Type 2 Diabetes Mellitus
A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study of the Efficacy and Safety of Welchol as Monotherapy for Type 2 Diabetes Mellitus

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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Type 2 Diabetes Mellitus
  • Drug: Welchol
    Welchol 625mg tablets
  • Drug: Placebo
    placebo
  • Experimental: Welchol
    Welchol 625mg tablets
    Intervention: Drug: Welchol
  • Placebo Comparator: placebo
    placebo
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
357
December 2011
December 2011   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00789737
WEL-305
No
Daiichi Sankyo Inc.
Daiichi Sankyo Inc.
Not Provided
Not Provided
Daiichi Sankyo Inc.
January 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP