Effects of Colesevelam HCl, Rosiglitazone, Sitagliptin on Control of Blood Glucose and Lipids in Type 2 Diabetes Patients Whose Blood Glucose Isn't Completely Controlled With Metformin

This study has been completed.

Sponsor:

Information provided by:

Daiichi Sankyo Inc.

ClinicalTrials.gov Identifier:

NCT00484419

First received: June 7, 2007

Last updated: June 17, 2009

Last verified: June 2009

History of Changes

Results First Received: April 29, 2009

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Efficacy Study; Intervention Model: Parallel Assignment; Masking: Open Label; Primary Purpose: Treatment
Conditions:	Type 2 Diabetes Hyperlipidemia
Interventions:	Drug: Colesevelam HCl Drug: rosiglitazone maleate Drug: sitagliptin phosphate

Participant Flow

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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 18 May 2007 to 14 December 2007 at 6 sites in Colombia, 7 sites in Mexico, and 20 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 on metformin-combination therapy entered a 4-week washout period from non-metformin antidiabetic drug. Population is type 2 diabetes mellitus subjects on stable metformin regimen, who discontinued other antidiabetic drugs, glycemia not controlled, and low-density lipoprotein-C (LDL-C) >=60 mg/dL and triglycerides <500 mg/dL

Reporting Groups

	Description
Colesevelam	colesevelam tablets 625 mg
Rosiglitazone	rosiglitazone maleate 4mg
Sitagliptin	sitagliptin phosphate tablets 100mg

Participant Flow: Overall Study

	Colesevelam	Rosiglitazone	Sitagliptin
STARTED	57	56	56
COMPLETED	45	51	45
NOT COMPLETED	12	5	11
Adverse Event	3	0	0
Lost to Follow-up	1	0	2
Withdrawal by Subject	3	1	1
subject met discontinuation criteria	2	2	4
required restricted medication	1	0	1
Physician Decision	1	1	1
subject unable to receive medication	1	0	0
subject relocated	0	1	0
sponsor decision, randomized in error	0	0	2

Baseline Characteristics

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Reporting Groups

	Description
Colesevelam	colesevelam tablets 625 mg
Rosiglitazone	rosiglitazone maleate 4mg
Sitagliptin	sitagliptin phosphate tablets 100mg
Total	Total of all reporting groups

Baseline Measures

	Colesevelam	Rosiglitazone	Sitagliptin	Total
Number of Participants [units: participants]	57	56	56	169
Age [units: participants]
<=18 years	0	0	0	0
Between 18 and 65 years	45	44	46	135
>=65 years	12	12	10	34
Age [units: years] Mean ± Standard Deviation	56.6 ± 9.19	54.7 ± 10.92	54.8 ± 9.76	55.4 ± 9.96
Gender [units: participants]
Female	29	33	36	98
Male	28	23	20	71
Region of Enrollment [units: participants]
Colombia	21	12	19	52
Mexico	12	19	12	43
United States	24	25	25	74
Fasting Insulin ^[1] [units: uIU/mL] Mean ( Full Range )	9.406 ( 1.63 to 47.77 )	9.945 ( 1.22 to 42.37 )	8.886 ( 1.32 to 24.02 )	9.396 ( 1.22 to 47.77 )
Fasting Plasma Glucose ^[2] [units: mg/dL] Mean ( Full Range )	174.5 ( 109 to 270 )	177.7 ( 101 to 469 )	180.6 ( 85 to 456 )	177.6 ( 85 to 469 )
HbA1c ^[3] [units: percent] Mean ( Full Range )	8.10 ( 6.8 to 9.7 )	8.06 ( 6.7 to 9.7 )	8.17 ( 6.5 to 9.9 )	8.11 ( 6.5 to 9.9 )

[1]	baseline fasting insulin
[2]	baseline Fasting Plasma Glucose (FPG)
[3]	baseline glycosylated hemoglobin

Outcome Measures

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1. Primary:

Mean Percentage of Change in HbA1c From Week 0(Baseline) to Week 16 Endpoint [ Time Frame: 16 weeks change = week 16 - week 0. ]

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2. Secondary:

Mean Percentage of Change in Glycosylated Hemoglobin (HbA1c) From Week 0(Baseline) to Week 16 Endpoint Least Squares Mean [ Time Frame: 16 weeks change = week 16 - week 0. ]

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3. Secondary:

Mean Percentage of Change in HbA1c From Week 0(Baseline) to Week 8 [ Time Frame: 8 weeks change = week 8- week 0. ]

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4. Secondary:

Change in Fasting Plasma Glucose (FPG) From Week 0(Baseline) to Week 8 Least Squares Mean [ Time Frame: 8 weeks change = week 8- week 0. ]

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5. Secondary:

Change in FPG From Week 0(Baseline) to Week 16 Least Squares Mean [ Time Frame: 16 weeks change = week 16 - week 0. ]

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6. Secondary:

Mean Change in FPG From Week 0(Baseline) to Week 8 [ Time Frame: 8 weeks change = week 8- week 0. ]

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7. Secondary:

Mean Change in FPG From Week 0(Baseline) to Week 16 [ Time Frame: 16 weeks change = week 16 - week 0. ]

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8. Secondary:

Change in Fasting Insulin From Week 0(Baseline) to Week 8 Least Squares Mean [ Time Frame: 8 weeks change = week 8- week 0. ]

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9. Secondary:

Change in Fasting Insulin From Week 0(Baseline) to Week 16 Least Squares Mean [ Time Frame: 16 weeks change = week 16 - week 0. ]

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10. Secondary:

Mean Change in Fasting Insulin From Week 0(Baseline) to Week 8 [ Time Frame: 8 weeks change = week 8- week 0. ]

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11. Secondary:

Mean Change in Fasting Insulin From Week 0(Baseline) to Week 16 [ Time Frame: 16 weeks change = week 16 - week 0. ]

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12. Secondary:

Change in Post-prandial Glucose From Week 0(Baseline) to Week 16 Least Squares Mean [ Time Frame: 16 weeks change = week 16 - week 0. ]

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13. Secondary:

Mean Change in Post-prandial Glucose From Week 0(Baseline) to Week 16 [ Time Frame: 16 weeks change = week 16 - week 0. ]

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14. Secondary:

Mean Change in Post-prandial Insulin From Week 0(Baseline) to Week 16 [ Time Frame: 16 weeks change = week 16 - week 0. ]

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15. Secondary:

Change in Low-Density Lipoprotein-C(LDL-C) From Week 0(Baseline) to Week 16 Least Squares Mean [ Time Frame: 16 weeks change = week 16 - week 0. ]

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16. Secondary:

Mean Change in LDL-C From Week 0(Baseline) to Week 16 [ Time Frame: 16 weeks change = week 16 - week 0. ]

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17. Secondary:

Mean Percentage of Change in LDL-C Levels From Week 0(Baseline) to Week 16 [ Time Frame: 16 weeks change = week 16 - week 0. ]

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18. Secondary:

Mean Percentage of Change in LDL-C Levels From Week 0(Baseline) to Week 16 (Least Squares Mean) [ Time Frame: 16 weeks change = week 16 - week 0. ]

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Serious Adverse Events

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Other Adverse Events

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More Information

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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: Sponsor reflects the following restrictive language in the Clinical Study Agreements: "If identified by 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 the 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, Director, Professional Affairs
Organization: Daiichi Sankyo Inc.
phone: 973-630-2683
e-mail: jraia@dsus.com

No publications provided

Responsible Party:	Yu-Ling Lai, Daiichi Sankyo
ClinicalTrials.gov Identifier:	NCT00484419 History of Changes
Other Study ID Numbers:	Wel-409
Study First Received:	June 7, 2007
Results First Received:	April 29, 2009
Last Updated:	June 17, 2009
Health Authority:	United States: Food and Drug Administration

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