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
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
1 other identifier
interventional
169
1 country
20
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3 type-2-diabetes
Started May 2007
Shorter than P25 for phase_3 type-2-diabetes
20 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2007
CompletedFirst Submitted
Initial submission to the registry
June 7, 2007
CompletedFirst Posted
Study publicly available on registry
June 8, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2008
CompletedResults Posted
Study results publicly available
June 17, 2009
CompletedOctober 4, 2016
August 1, 2016
11 months
June 7, 2007
April 29, 2009
August 23, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Mean Percentage of Change in HbA1c From Week 0(Baseline) to Week 16 Endpoint
Change in HbA1c from Week 0(baseline) to Week 16 endpoint mean with standard deviation change = week 16 - week 0.
16 weeks change = week 16 - week 0.
Secondary Outcomes (17)
Mean Percentage of Change in Glycosylated Hemoglobin (HbA1c) From Week 0(Baseline) to Week 16 Endpoint Least Squares Mean
16 weeks change = week 16 - week 0.
Mean Percentage of Change in HbA1c From Week 0(Baseline) to Week 8
8 weeks change = week 8- week 0.
Change in Fasting Plasma Glucose (FPG) From Week 0(Baseline) to Week 8 Least Squares Mean
8 weeks change = week 8- week 0.
Change in FPG From Week 0(Baseline) to Week 16 Least Squares Mean
16 weeks change = week 16 - week 0.
Mean Change in FPG From Week 0(Baseline) to Week 8
8 weeks change = week 8- week 0.
- +12 more secondary outcomes
Study Arms (3)
colesevelam
EXPERIMENTALcolesevelam tablets 625 mg
rosiglitazone
ACTIVE COMPARATORrosiglitazone maleate 4mg
sitagliptin
ACTIVE COMPARATORsitagliptin phosphate tablets
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- Subjects currently treated with a thiazolidinedione are excluded.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Daiichi Sankyolead
Study Sites (20)
Unknown Facility
La Mesa, California, United States
Unknown Facility
Los Angeles, California, United States
Unknown Facility
Los Gatos, California, United States
Unknown Facility
San Antonio, California, United States
Unknown Facility
Chiefland, Florida, United States
Unknown Facility
Gary, Indiana, United States
Unknown Facility
Baltimore, Maryland, United States
Unknown Facility
Dearborn, Michigan, United States
Unknown Facility
West Bloomfield, Michigan, United States
Unknown Facility
Las Vegas, Nevada, United States
Unknown Facility
Yonkers, New York, United States
Unknown Facility
Lexington, North Carolina, United States
Unknown Facility
Winston-Salem, North Carolina, United States
Unknown Facility
Munroe Falls, Ohio, United States
Unknown Facility
Zaneville, Ohio, United States
Unknown Facility
Portland, Oregon, United States
Unknown Facility
Jersey Shore, Pennsylvania, United States
Unknown Facility
Clemson, South Carolina, United States
Unknown Facility
Harriman, Tennessee, United States
Unknown Facility
Dallas, Texas, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- John Raia, Director, Professional Affairs
- Organization
- Daiichi Sankyo Inc.
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 7, 2007
First Posted
June 8, 2007
Study Start
May 1, 2007
Primary Completion
April 1, 2008
Study Completion
April 1, 2008
Last Updated
October 4, 2016
Results First Posted
June 17, 2009
Record last verified: 2016-08