Expired Study
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Tucson, Arizona 85723


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.


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.


Study is Available At:


Original ID:

WEL-305


NCT ID:

NCT00789737


Secondary ID:


Study Acronym:


Brief Title:

Welchol as Monotherapy for Type 2 Diabetes Mellitus


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


Overall Status:

Completed


Study Phase:

Phase 3


Genders:

Both


Minimum Age:

18 Years


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Daiichi Sankyo Inc.


Oversight Authority:

United States: Food and Drug Administration


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Allocation: Randomized, Endpoint Classification:


Number of Arms:

2


Number of Groups:

0


Total Enrollment:

357


Enrollment Type:

Actual


Study Dates

Start Date:January 2009
Completion Date:December 2011
Completion Type:Actual
Primary Completion Date:December 2011
Primary Completion Type:Actual
Verification Date:December 2012
Last Changed Date:December 3, 2012
First Received Date:November 10, 2008

Study Outcomes

Outcome Type:Primary Outcome
Measure:Glycemic control, HbA1c
Time Frame:24 week
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Glycemic control - Fasting Plasma Glucose
Time Frame:24 weeks
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Responder rates - HbA1c % Subjects with a decrease in HbA1c of >= 0.7 percentage units
Time Frame:24 weeks
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Responder rates - HbA1c % Subjects achieving an HbA1C goal of <7.0%
Time Frame:24 weeks
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Responder rates - FPG % Subjects with a decrease in FPG >=30 mg/dL
Time Frame:24 weeks
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:To assess the effects of Welchol on changes in plasma lipids, specifically total cholesterol [TC]
Time Frame:24 weeks
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:To assess the effects of Welchol on changes in plasma lipids, specifically low density lipoprotein cholesterol [LDL-C]
Time Frame:24 weeks
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:To assess the effects of Welchol on changes in plasma lipids, specifically high density lipoprotein cholesterol [HDL-C]
Time Frame:24 weeks
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:To assess the effects of Welchol on changes in plasma lipids, specifically non-HDL-C
Time Frame:24 weeks
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:To assess the effects of Welchol on changes in plasma lipids, specifically triglycerides [TG]
Time Frame:24 weeks
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:To assess the effects of Welchol on changes in plasma lipids, specifically apolipoprotein A-I (apoA-I)
Time Frame:24 weeks
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:To assess the effects of Welchol on changes in plasma lipids, specifically apolipoprotein B (apoB)
Time Frame:24 weeks
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:To assess the effects of Welchol on postprandial plasma glucose, before and 2 hours after a meal tolerance test
Time Frame:24 weeks
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:To assess the effects of Welchol on insulin before and 2 hours after a meal tolerance test
Time Frame:24 weeks
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:To assess the effects of Welchol on C-peptide before and 2 hours after a meal tolerance test
Time Frame:24 weeks
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:To assess the effects of Welchol vs. placebo on insulin level
Time Frame:24 weeks
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:To assess the effects of Welchol vs. placebo HOMA indices
Time Frame:24 weeks
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:To assess the effects of Welchol vs. placebo on high sensitivity C- reactive protein [hs-CRP] levels
Time Frame:24 weeks
Safety Issues:False

Study Interventions

Intervention Type:Drug
Name:Welchol
Description:Welchol 625mg tablets
Arm Name:Welchol
Intervention Type:Drug
Name:Placebo
Description:placebo
Arm Name:placebo

Study Arms

Study Arm Type:Experimental
Arm Name:Welchol
Description:Welchol 625mg tablets
Study Arm Type:Placebo Comparator
Arm Name:placebo
Description:placebo

Study Agencies

Agency Class:Industry
Agency Type:Lead Sponsor
Agency Name:Daiichi Sankyo Inc.

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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