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

Tracking Information
First Received Date ^ICMJE	June 7, 2007
Last Updated Date	June 17, 2009
Start Date ^ICMJE	May 2007
Primary Completion Date	April 2008 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: June 17, 2009)	Mean Percentage of Change in HbA1c From Week 0(Baseline) to Week 16 Endpoint [ Time Frame: 16 weeks change = week 16 - week 0. ] [ Designated as safety issue: No ]
Original Primary Outcome Measures ^ICMJE (submitted: June 7, 2007)	Change in HbA1c from baseline to Week 16 endpoint [ Time Frame: 16 weeks ]
Change History	Complete list of historical versions of study NCT00484419 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: June 17, 2009)	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. ] [ Designated as safety issue: No ] Mean Percentage of Change in HbA1c From Week 0(Baseline) to Week 8 [ Time Frame: 8 weeks change = week 8- week 0. ] [ Designated as safety issue: No ] 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. ] [ Designated as safety issue: No ] Change in FPG From Week 0(Baseline) to Week 16 Least Squares Mean [ Time Frame: 16 weeks change = week 16 - week 0. ] [ Designated as safety issue: No ] Mean Change in FPG From Week 0(Baseline) to Week 8 [ Time Frame: 8 weeks change = week 8- week 0. ] [ Designated as safety issue: No ] Mean Change in FPG From Week 0(Baseline) to Week 16 [ Time Frame: 16 weeks change = week 16 - week 0. ] [ Designated as safety issue: No ] Change in Fasting Insulin From Week 0(Baseline) to Week 8 Least Squares Mean [ Time Frame: 8 weeks change = week 8- week 0. ] [ Designated as safety issue: No ] Change in Fasting Insulin From Week 0(Baseline) to Week 16 Least Squares Mean [ Time Frame: 16 weeks change = week 16 - week 0. ] [ Designated as safety issue: No ] Mean Change in Fasting Insulin From Week 0(Baseline) to Week 8 [ Time Frame: 8 weeks change = week 8- week 0. ] [ Designated as safety issue: No ] Mean Change in Fasting Insulin From Week 0(Baseline) to Week 16 [ Time Frame: 16 weeks change = week 16 - week 0. ] [ Designated as safety issue: No ] Change in Post-Prandial Glucose From Week 0(Baseline) to Week 16 Least Squares Mean [ Time Frame: 16 weeks change = week 16 - week 0. ] [ Designated as safety issue: No ] Mean Change in Post-Prandial Glucose From Week 0(Baseline) to Week 16 [ Time Frame: 16 weeks change = week 16 - week 0. ] [ Designated as safety issue: No ] Mean Change in Post-Prandial Insulin From Week 0(Baseline) to Week 16 [ Time Frame: 16 weeks change = week 16 - week 0. ] [ Designated as safety issue: No ] 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. ] [ Designated as safety issue: No ] Mean Change in LDL-C From Week 0(Baseline) to Week 16 [ Time Frame: 16 weeks change = week 16 - week 0. ] [ Designated as safety issue: No ] Mean Percentage of Change in LDL-C Levels From Week 0(Baseline) to Week 16 [ Time Frame: 16 weeks change = week 16 - week 0. ] [ Designated as safety issue: No ] 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. ] [ Designated as safety issue: No ]
Original Secondary Outcome Measures ^ICMJE (submitted: June 7, 2007)	- Change in HbA1c from baseline to week 8 - change in FPG from baseline to weeks 8 and 16 - Change in fasting insulin levels from baseline to weeks 8 and 16
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	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
Official Title ^ICMJE	Effects of Colesevelam HCl, Avandia® (Rosiglitazone Maleate), or JanuviaTM (Sitagliptin) on Glycemic Parameters and Lipid Profiles in Subjects With Type 2 Diabetes Mellitus Inadequately Controlled on Metformin Monotherapy
Brief Summary	A 16 week open-label study with subjects receiving background metformin monotherapy. 150 subjects randomized 1:1:1 to receive 1 of the following: open-label colesevelam HCl, open label rosiglitazone, or open-label sitagliptin.
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Phase 3
Study Design ^ICMJE	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Condition ^ICMJE	Type 2 Diabetes Hyperlipidemia
Intervention ^ICMJE	Drug: Colesevelam HCl coleveselam tablets 625 mg; 6 tablets/day Drug: rosiglitazone maleate rosiglitazone tablets 4mg Drug: sitagliptin phosphate sitagliptin phosphate tablets 100mg/day
Study Arm (s)	Experimental: colesevelam colesevelam tablets 625 mg Intervention: Drug: Colesevelam HCl Active Comparator: rosiglitazone rosiglitazone maleate 4mg Intervention: Drug: rosiglitazone maleate Active Comparator: sitagliptin sitagliptin phosphate tablets Intervention: Drug: sitagliptin phosphate
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	Completed
Enrollment ^ICMJE	169
Completion Date	April 2008
Primary Completion Date	April 2008 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	Inclusion Criteria: HbA1C 7.0 % to 10.0% on metformin monotherapy; may be withdrawn from other (non-metformin) drugs if HbA1C is 6.5% to 9.5 % at screening. Exclusion Criteria: Subjects currently treated with a thiazolidinedione are excluded.
Gender	Both
Ages	18 Years to 80 Years
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	NCT00484419
Other Study ID Numbers ^ICMJE	Wel-409
Has Data Monitoring Committee	Not Provided
Responsible Party	Yu-Ling Lai, Daiichi Sankyo
Study Sponsor ^ICMJE	Daiichi Sankyo Inc.
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Daiichi Sankyo Inc.
Verification Date	June 2009
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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