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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Daiichi Sankyo Inc.
ClinicalTrials.gov Identifier:
NCT00789750
First received: November 10, 2008
Last updated: August 27, 2013
Last verified: August 2013
  Purpose

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.


Condition Intervention Phase
Type 2 Diabetes Mellitus
Drug: Welchol
Drug: placebo
Drug: Pioglitazone
Phase 3

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

Resource links provided by NLM:


Further study details as provided by Daiichi Sankyo Inc.:

Primary Outcome Measures:
  • mean change from baseline in HbA1C [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 562
Study Start Date: April 2009
Study Completion Date: July 2012
Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Welchol
Welchol 625 mg Tablets patients will be on stable pioglitazone 30mg or 45 mg
Drug: Welchol
Welchol 625 mg Tablets
Drug: Pioglitazone
patients will be on stable pioglitazone 30mg or 45 mg
Other Name: Actos
Placebo Comparator: placebo
placebo patients will be on stable pioglitazone 30mg or 45 mg
Drug: placebo
placebo tablets
Drug: Pioglitazone
patients will be on stable pioglitazone 30mg or 45 mg
Other Name: Actos

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00789750

  Show 141 Study Locations
Sponsors and Collaborators
Daiichi Sankyo Inc.
  More Information

No publications provided

Responsible Party: Daiichi Sankyo Inc.
ClinicalTrials.gov Identifier: NCT00789750     History of Changes
Other Study ID Numbers: WEL-306
Study First Received: November 10, 2008
Last Updated: August 27, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Pioglitazone
Colesevelam
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on August 26, 2014