Welchol as Monotherapy for Type 2 Diabetes Mellitus

Phase 3

Completed

• Conditions: Type 2 Diabetes Mellitus
• Interventions: Drug: Placebo; Drug: Welchol

• Registration Number: NCT00789737
• Lead Sponsor: Daiichi Sankyo

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2008-11-10
• Study First Submitted QC: 2008-11-10
• Study First Posted: 2008-11-13
• Study Start: 2009-01
• Primary Completion: 2011-12
• Study Completion: 2011-12
• Disposition First Submitted: 2012-12-03
• Disposition First Submitted QC: 2012-12-03
• Disposition First Posted: 2012-12-05
• Results First Submitted: 2013-12-04
• Results First Submitted QC: 2013-12-04
• Status Verified: 2014-01
• Results First Posted: 2014-01-22
• Last Update Submitted: 2014-01-24
• Last Update Posted: 2014-02-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 357

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

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
placebo	Placebo	placebo
Welchol	Welchol	Welchol 625mg tablets

Primary Outcome Measures

Name	Time	Method
Percent Change in Hemoglobin A1c	24 week	change in HbA1c from baseline to Week 24

Secondary Outcome Measures

Name	Time	Method
Change in Fasting Plasma Glucose	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	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	24 weeks	% Subjects achieving an HbA1C goal of \<7.0 at 24 weeks
% Subjects With a Decrease in FPG >=30 mg/dL	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]	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]	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]	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	from baseline to 24 weeks	To assess the effects of Welchol on changes in non-HDL-C
Changes in Triglycerides [TG]	from baseline to 24 weeks	To assess the effects of Welchol on changes in triglycerides \[TG\]
Changes in Apolipoprotein A-I (apoA-I)	from baseline to 24 weeks	To assess the effects of Welchol on changes in apolipoprotein A-I (apoA-I)
Changes in Apolipoprotein B (apoB)	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	from baseline to 24 weeks	To assess the change from baseline on postprandial plasma glucose, 2 hours after a meal tolerance test