Effects of Colesevelam on How the Body Responds to Insulin in Patients With Type 2 Diabetes

This study has been completed.

Study NCT00147745 Information provided by Daiichi Sankyo Inc.

First Received on September 2, 2005. Last Updated on December 15, 2009 History of Changes

Results First Received: July 15, 2009

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Pharmacodynamics Study; Intervention Model: Parallel Assignment; Masking: Double Blind (Subject, Caregiver); Primary Purpose: Treatment
Condition:	Type 2 Diabetes
Interventions:	Drug: Colesevelam Drug: Colesevelam matching placebo Drug: Insulin glargine (Lantus)

Participant Flow

Hide Participant Flow

Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Subjects were recruited from 21 June 2005 to 22 January 2008 at 3 clinical research sites in the United States of America.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Subjects were taken off any non-sulfonylurea oral anti-diabetic agents for a period of time appropriate to the drug. Qualified subjects were randomized to colesevelam hydrochloride, placebo, or open-label insulin glargine for 12 weeks. Difficulties enrolling into the insulin group caused the size of this group to decrease from 15 to 6 subjects.

Reporting Groups

	Description
Colesevelam 3.8g	colesevelam 3.8g administered daily for 12 weeks
Colesevelam Matching Placebo	Colesevelam matching placebo for 12 weeks
Open-label Insulin Glargine	open-label Insulin Glargine for 12 weeks

Participant Flow: Overall Study

	Colesevelam 3.8g	Colesevelam Matching Placebo	Open-label Insulin Glargine
STARTED	16	14	6
COMPLETED	15	14	6
NOT COMPLETED	1	0	0
Withdrawal by Subject	1	0	0

Baseline Characteristics

Hide Baseline Characteristics

Reporting Groups

	Description
Colesevelam 3.8g	colesevelam 3.8g administered daily for 12 weeks
Colesevelam Matching Placebo	Colesevelam matching placebo for 12 weeks
Open-label Insulin Glargine	open-label Insulin Glargine for 12 weeks

Baseline Measures

	Colesevelam 3.8g	Colesevelam Matching Placebo	Open-label Insulin Glargine	Total
Number of Participants [units: participants]	16	14	6	36
Age [units: years] Mean ( Full Range )	55.7 ( 30 to 71 )	54.0 ( 38 to 66 )	52.8 ( 34 to 71 )	54.6 ( 30 to 71 )
Gender [units: participants]
Female	4	6	1	11
Male	12	8	5	25
Race/Ethnicity, Customized [units: Participants]
Hispanic	1	2	2	5
Black or African American	5	3	1	9
White	8	9	3	20
Unknown or Not Reported	2	0	0	2
Region of Enrollment [units: participants]
United States	16	14	6	36
Body Mass [units: kg/m2] Mean ( Full Range )	33.7 ( 24.6 to 46.1 )	33.7 ( 27.7 to 44.8 )	35.2 ( 29.9 to 46.7 )	34.0 ( 24.6 to 46.7 )
Fasting Plasma Glucose [units: mg/dL] Mean ( Full Range )	162.6 ( 81 to 208 )	207.9 ( 135 to 418 )	199.0 ( 129 to 314 )	186.3 ( 81 to 418 )
HbA1c [units: percent] Mean ( Full Range )	8.2 ( 7.1 to 9.8 )	8.5 ( 7.3 to 10.0 )	9.3 ( 8.2 to 10.9 )	8.5 ( 7.1 to 10.9 )
Height [units: cm] Mean ( Full Range )	171.7 ( 159 to 190 )	168.6 ( 162 to 187 )	170.8 ( 157 to 179 )	170.4 ( 157 to 190 )
Weight [units: kg] Mean ( Full Range )	98.6 ( 73.2 to 128.5 )	95.8 ( 72.8 to 130.5 )	103.4 ( 75.8 to 144.8 )	98.3 ( 72.8 to 144.8 )

Outcome Measures

Show All Outcome Measures

1. Primary:

Difference in Endogenous (Hepatic) Glucose Output During a High-dose Insulin Infusion From Baseline to After 12 Weeks of Treatment. [ Time Frame: Baseline to 12 weeks ]

Show Outcome Measure 1

2. Primary:

Difference in Endogenous (Hepatic) Glucose Output During a Low-dose Insulin Infusion From Baseline to Week 12. [ Time Frame: Baseline to 12 weeks ]

Show Outcome Measure 2

3. Primary:

Acute Effect of a Single Dose of Colesevelam on Oral Glucose Absorption From Baseline to First Dose [ Time Frame: Baseline (Day -4) to first dose (Day 1) ]

Show Outcome Measure 3

4. Secondary:

The Acute Effect of Colesevelam (Multiple Doses) on Oral Glucose Absorption From Baseline to 12 Weeks [ Time Frame: Baseline to 12 weeks ]

Show Outcome Measure 4

5. Secondary:

Change in Hemoglobin A1C Due to Effect of Colesevelam From Baseline to 12 Weeks [ Time Frame: Baseline to 12 weeks ]

Show Outcome Measure 5

Serious Adverse Events

Show Serious Adverse Events

Other Adverse Events

Show Other Adverse Events

More Information

Hide More Information

Certain Agreements:

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

The agreement is:

	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed. Restriction Description: If identified by Daiichi Sankyo, Inc. (DSI), any of DSI's confidential information as defined herein shall be deleted…Nothing in this publication section shall be taken as giving DSI any right of editorial control over any publication prepared by Study Site.

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.

Results Point of Contact:

Name/Title: John Raia, Senior Director, Professional Affairs
Organization: Daiichi Sankyo, Inc
phone: (973) 944-2683
e-mail: jraia@dsi.com

No publications provided

Responsible Party:	Michael Jones, Ph.D. Senior Director, Daiichi Sankyo Inc
ClinicalTrials.gov Identifier:	NCT00147745 History of Changes
Other Study ID Numbers:	WEL-201
Study First Received:	September 2, 2005
Results First Received:	July 15, 2009
Last Updated:	December 15, 2009
Health Authority:	United States: Food and Drug Administration