Welchol as Add-on to Pioglitazone Therapy for Type 2 Diabetes Mellitus

This study is ongoing, but not recruiting participants.

Sponsor:

Information provided by (Responsible Party):

Daiichi Sankyo Inc.

ClinicalTrials.gov Identifier:

NCT00789750

First received: November 10, 2008

Last updated: July 24, 2012

Last verified: July 2012

History of Changes

Tracking Information
First Received Date ^ICMJE	November 10, 2008
Last Updated Date	July 24, 2012
Start Date ^ICMJE	April 2009
Estimated Primary Completion Date	July 2012 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: November 10, 2008)	mean change from baseline in HbA1C [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT00789750 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: November 10, 2008)	mean change from baseline in fasting plasma glucose [ Time Frame: 24 weeks ] [ Designated as safety issue: No ] Subjects with a decrease of >= 0.7 percentage units in HbA1C [ Time Frame: 24 weeks ] [ Designated as safety issue: No ] Subjects achieving an HbA1C goal of <7.0% [ Time Frame: 24 weeks ] [ Designated as safety issue: No ] Subjects with a reduction of FPG of >= 30 mg/dL [ Time Frame: 24 weeks ] [ Designated as safety issue: No ] change from baseline and percent change from baseline in TC [ Time Frame: 24 weeks ] [ Designated as safety issue: No ] change from baseline and percent change from baseline in LDL-C [ Time Frame: 24 weeks ] [ Designated as safety issue: No ] change from baseline and percent change from baseline in HDL-C [ Time Frame: 24 weeks ] [ Designated as safety issue: No ] change from baseline and percent change from baseline in non-HDL-C [ Time Frame: 24 weeks ] [ Designated as safety issue: No ] change from baseline and percent change from baseline in TG [ Time Frame: 24 weeks ] [ Designated as safety issue: No ] change from baseline and percent change from baseline in apoA-I [ Time Frame: 24 weeks ] [ Designated as safety issue: No ] change from baseline and percent change from baseline in apoB [ Time Frame: 24 weeks ] [ Designated as safety issue: No ] effects on insulin levels [ Time Frame: 24 weeks ] [ Designated as safety issue: No ] effects on HOMA indices [ Time Frame: 24 weeks ] [ Designated as safety issue: No ] effects on hs-CRP. [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
Original Secondary Outcome Measures ^ICMJE	Same as current
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Welchol as Add-on to Pioglitazone Therapy for Type 2 Diabetes Mellitus
Official Title ^ICMJE	A Randomized, Double-Blind, Placebo Controlled, Parallel Group Study of the Efficacy and Safety of WELCHOL as Add-on to Pioglitazone Therapy for Type 2 Diabetes Mellitus (T2DM)
Brief Summary	The current study investigates Welchol as add-on therapy to pioglitazone to improve glycemic control in subjects with Type 2 Diabetes Mellitus not adequately controlled with pioglitazone monotherapy or pioglitazone in combination with either metformin or a sulfonylurea. The study will evaluate if Welchol add-on to pioglitazone therapy for Type 2 Diabetes Mellitus will be safe, well tolerated, and efficacious.
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Phase 3
Study Design ^ICMJE	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment
Condition ^ICMJE	Type 2 Diabetes Mellitus
Intervention ^ICMJE	Drug: Welchol Welchol 625 mg Tablets Drug: placebo tablets placebo
Study Arm (s)	Experimental: Welchol Welchol 625 mg Tablets Intervention: Drug: Welchol Placebo Comparator: placebo placebo Intervention: Drug: placebo tablets
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Active, not recruiting
Estimated Enrollment ^ICMJE	540
Estimated Completion Date	August 2012
Estimated Primary Completion Date	July 2012 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	Inclusion Criteria: Diagnosis of Type 2 Diabetes Mellitus. Inadequate glycemic control on a stable dose (at least 2 months prior to screening) of pioglitazone at 30 or 45 mg/day, with or without one or two other oral antidiabetic medications (metformin or a sulfonylurea. or DPP-IV inhibitor) A1C >= 7.5% and =< 9.5% at screening. Fasting plasma glucose =<240 mg/dL at randomization (Week0/Day 1). Male or female >= 18 years of age. Women of childbearing potential (WOCBP) must be using an adequate method of contraception as detailed per-protocol. Fasting C-peptide level >0.5 ng/mL at screening. Clinically stable in regards to medical conditions other than type 2 diabetes. Concomitant medications are at stable doses for at least 30 days prior to enrollment, and are not anticipated to need adjustment during the study period. Exclusion Criteria: History of Type 1 diabetes and/or history of ketoacidosis. History of bowel obstruction History of hypertriglyceridemia-induced pancreatitis Fasting serum triglyceride concentration >500 mg/dL History of dysphagia, swallowing disorders, gastroparesis, other gastrointestinal motility disorders, major gastrointestinal surgery History of insulin use >= 2 weeks duration during the previous 3 months or a total of >2 months 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 Body mass index >40 kg/m2 at screening Weight loss >3% in the 3 months prior to screening Treatment with bile acid sequestrants, including Welchol within 3 months prior to screening LDL level <60 mg/dL Female subject who is pregnant or breastfeeding SBP >= 180 mmHg and/or DBP >= 110 mmHg History of unstable angina, myocardial infarction, cerebrovascular accident, transient ischemic attack, or any revascularization within 6 months prior to screening History of malignancy, except subjects who have been disease-free for >10 years or whose malignancy was a basal or squamous cell skin carcinoma. Women with a history of cervical dysplasia (CIN2 or higher) should be excluded unless 2 consecutive normal cervical smears have subsequently been recorded prior to enrollment Known (or evidence of) infection with human immunodeficiency virus (HIV) History of alcohol or drug abuse within 1 year prior to screening History of untreated major psychiatric disorders that could inhibit abilities to comply with the protocol Any condition, lab abnormality or concomitant therapy which, in the opinion of the investigator, might pose a risk to the subject or make participation not in the subject's best interest Known or suspected allergy, hypersensitivity or intolerance to the excipients of the investigational study medication Participation in an interventional medical, surgical, or pharmaceutical study within 30 days prior to the screening visit A direct or familial relationship with the sponsor, investigator, or site personnel affiliated with the study.
Gender	Both
Ages	18 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT Number ^ICMJE	NCT00789750
Other Study ID Numbers ^ICMJE	WEL-306
Has Data Monitoring Committee	No
Responsible Party	Daiichi Sankyo Inc.
Study Sponsor ^ICMJE	Daiichi Sankyo Inc.
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Daiichi Sankyo Inc.
Verification Date	July 2012
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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