Welchol as Monotherapy for Type 2 Diabetes Mellitus

Type 2 Diabetes Mellitus Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00789737
• Other study ID #: WEL-305
• Status: Completed
• Phase: Phase 3
• First received: November 10, 2008
• Last updated: January 24, 2014
• Start date: January 2009
• Est. completion date: December 2011

Study information

• Verified date: January 2014
• Source: Daiichi Sankyo Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 357
• Est. completion date: December 2011
• Est. primary completion date: December 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type 2 Diabetes Mellitus

Intervention

Drug:
• Welchol
Welchol 625mg tablets
• Placebo
placebo

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Daiichi Sankyo Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percent Change in Hemoglobin A1c	change in HbA1c from baseline to Week 24	24 week	No
Secondary	Change in Fasting Plasma Glucose	to determine changes in Glycemic control after 24 weeks on therapy	from baseline to 24 weeks	No
Secondary	% Subjects With a Decrease in HbA1c of >= 0.7 Percentage Units	to determine the percentage of participants who experience a reduction in HbA1c of at least 0.7 percentage units at 24 weeks from baseline.	24 weeks	No
Secondary	% Subjects Achieving an HbA1C Goal of <7.0	% Subjects achieving an HbA1C goal of <7.0 at 24 weeks	24 weeks	No
Secondary	% Subjects With a Decrease in FPG >=30 mg/dL	% Subjects with a decrease in Fasting Plasma Glucose >=30 mg/dL from baseline to 24 weeks	from baseline to 24 weeks	No
Secondary	Changes in Total Cholesterol [TC]	To assess the effects of Welchol on changes in total cholesterol [TC]	from baseline to 24 weeks	No
Secondary	Changes in Low Density Lipoprotein Cholesterol [LDL-C]	To assess the effects of Welchol on changes in low density lipoprotein cholesterol [LDL-C]	from baseline to 24 weeks	No
Secondary	Changes in High Density Lipoprotein Cholesterol [HDL-C]	To assess the effects of Welchol on changes in high density lipoprotein cholesterol [HDL-C]	from baseline to 24 weeks	No
Secondary	Changes in Non-HDL-C	To assess the effects of Welchol on changes in non-HDL-C	from baseline to 24 weeks	No
Secondary	Changes in Triglycerides [TG]	To assess the effects of Welchol on changes in triglycerides [TG]	from baseline to 24 weeks	No
Secondary	Changes in Apolipoprotein A-I (apoA-I)	To assess the effects of Welchol on changes in apolipoprotein A-I (apoA-I)	from baseline to 24 weeks	No
Secondary	Changes in Apolipoprotein B (apoB)	To assess the effects of Welchol on changes in apolipoprotein B (apoB)	from baseline to 24 weeks	No
Secondary	Change in Postprandial Plasma Glucose, 2 Hours After a Meal Tolerance Test	To assess the change from baseline on postprandial plasma glucose, 2 hours after a meal tolerance test	from baseline to 24 weeks	No