Colesevelam as Add-on to Pioglitazone Therapy 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 Add-on to Pioglitazone Therapy for Type 2 Diabetes Mellitus (T2DM)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00789750
• Other study ID #: WEL-A-U306
• Status: Completed
• Phase: Phase 3
• First received: November 10, 2008
• Last updated: June 23, 2017
• Start date: April 2009
• Est. completion date: July 2012

Study information

• Verified date: June 2017
• Source: Daiichi Sankyo Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The current study investigates colesevelam 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 colesevelam add-on to pioglitazone therapy for type 2 diabetes mellitus will be safe, well tolerated, and efficacious.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 562
• Est. completion date: July 2012
• Est. primary completion date: July 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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 dipeptidyl peptidase (DPP-IV) inhibitor]

• Hemoglobin A1c (HbA1c) >= 7.5% and =< 9.5% at screening

• Fasting plasma glucose =<240 mg/dL at randomization (Week 0/Day 1).

• Male or female >= 18 years of age.

• Women of childbearing potential 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

• Treatment with bile acid sequestrants, including colesevelam within 3 months prior to screening

• Female subject who is pregnant or breastfeeding

• History of unstable angina, myocardial infarction, cerebrovascular accident, transient ischemic attack, or any revascularization within 6 months prior to screening

Related Conditions & MeSH terms

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

Intervention

Drug:
• Colesevelam
Colesevelam 625 mg tablets
• Placebo
Placebo tablets appearing to be colesevelam
• Pioglitazone
30 mg or 45 mg pioglitazone therapy

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	Change From Baseline in Hemoglobin A1c (HbA1c) at Week 24		Baseline, Week 24
Secondary	Change From Baseline in HbA1c at Week 4		Baseline, Week 4
Secondary	Change From Baseline in HbA1c at Week 8		Baseline, Week 8
Secondary	Change From Baseline in HbA1c at Week 16		Baseline, Week 16
Secondary	Number of Participants Achieving an HbA1c Goal of <7.0%		Week 24
Secondary	Change From Baseline in Fasting Plasma Glucose (FPG)	In this study a reduction in FPG of at least 30 mg/dL is considered glycemic response.	Baseline, Week 24
Secondary	Number of Participants With a Decrease of >= 0.7 Percent in HbA1c		Week 24
Secondary	Number of Participants With a Decrease of >= 0.5 Percent in HbA1c		Week 24
Secondary	Number of Participants With a Reduction in FPG of >= 30 mg/dL		Week 24
Secondary	Percent Change From Baseline in Total Cholesterol (TC)	TC is measured in milligrams per deciliter (mg/dL)	Baseline, Week 24
Secondary	Percent Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C)	LDL-C is measured in mg/dL	Baseline, Week 24
Secondary	Percent Change From Baseline in High-density Lipoprotein Cholesterol (HDL-C)	HDL-C is measured in mg/dL	Baseline, Week 24
Secondary	Percent Change From Baseline in Non-HDL-C	Non-HDL-C is measured in mg/dL	Baseline, Week 24
Secondary	Percent Change From Baseline in Triglycerides (TG)	TG are measured in mg/dL	Baseline, Week 24
Secondary	Percent Change From Baseline in Apolipoprotein A-1 (Apo A-I)	Apo A-1 is measured in mg/dL	Baseline, Week 24
Secondary	Percent Change From Baseline in Apolipoprotein B (Apo B)	Apo B is measured in mg/dL	Baseline, Week 24
Secondary	Change From Baseline in Fasting Insulin Levels		Baseline, Week 24
Secondary	Change From Baseline in Fasting C-peptide		Baseline, Week 24
Secondary	Change From Baseline in Homeostatic Model Assessment of Insulin Resistance (HOMA-IR)	HOMA-IR is a calculation of fasting insulin and fasting glucose that shows the level of insulin resistance. Lower numbers are better.	Baseline, Week 24