Back to resultsEffects 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
Primary Purpose
Type 2 Diabetes, Hyperlipidemia
Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Colesevelam HCl
rosiglitazone maleate
sitagliptin phosphate
Sponsored by
About this trial
This is an interventional treatment trial for Type 2 Diabetes focused on measuring Colesevelam HCl,, rosiglitazone, sitagliptin, Type 2 diabetes, metformin
Eligibility Criteria
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- HbA1C 7.0 % to 10.0% on metformin monotherapy; may be withdrawn from other (non-metformin) drugs if HbA1C is 6.5% to 9.5 % at screening.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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Active Comparator
Active Comparator
Arm Label
colesevelam
rosiglitazone
sitagliptin
Arm Description
colesevelam tablets 625 mg
rosiglitazone maleate 4mg
sitagliptin phosphate tablets
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Mean Percentage of Change in Glycosylated Hemoglobin (HbA1c) From Week 0(Baseline) to Week 16 Endpoint Least Squares Mean
Change in HbA1c from Week 0(baseline)to Week 16 endpoint least squares mean with 95% confidence intervals, change = week 16 - week 0.
Mean Percentage of Change in HbA1c From Week 0(Baseline) to Week 8
change in HbA1c from Week 0(baseline) to week 8 mean and standard deviation change = week 8 - week 0.
Change in Fasting Plasma Glucose (FPG) From Week 0(Baseline) to Week 8 Least Squares Mean
change in FPG from Week 0(baseline) to week 8 least squares mean and 95% confidence interval change = week 8 - week 0.
Change in FPG From Week 0(Baseline) to Week 16 Least Squares Mean
change in FPG from Week 0(baseline) to week 16 least squares mean and 95% confidence interval change = week 16 - week 0.
Mean Change in FPG From Week 0(Baseline) to Week 8
mean change in FPG from Week 0(baseline) to Week 8 with standard deviation change = week 8 - week 0.
Mean Change in FPG From Week 0(Baseline) to Week 16
change in FPG from Week 0(baseline) to week 16 mean and standard deviation change = week 16 - week 0.
Change in Fasting Insulin From Week 0(Baseline) to Week 8 Least Squares Mean
change in fasting insulin from Week 0(baseline) to week 8 least squares mean and 95% confidence interval change = week 8 - week 0.
Change in Fasting Insulin From Week 0(Baseline) to Week 16 Least Squares Mean
change in fasting insulin from Week 0(baseline) to week 16 least squares mean and 95% confidence interval change = week 16 - week 0.
Mean Change in Fasting Insulin From Week 0(Baseline) to Week 8
mean change in fasting insulin from Week 0(baseline) to week 8 with standard deviation change = week 8 - week 0.
Mean Change in Fasting Insulin From Week 0(Baseline) to Week 16
mean change in fasting insulin from Week 0(baseline) to week 16 with standard deviation change = week 16 - week 0.
Change in Post-prandial Glucose From Week 0(Baseline) to Week 16 Least Squares Mean
change in post-prandial glucose from Week 0(baseline) to week 16 least squares mean with 95% confidence intervals change = week 16 - week 0.
Mean Change in Post-prandial Glucose From Week 0(Baseline) to Week 16
mean change in post-prandial glucose from Week 0(baseline) to week 16 with standard deviation change = week 16 - week 0.
Mean Change in Post-prandial Insulin From Week 0(Baseline) to Week 16
mean change in post-prandial insulin from Week 0(baseline) to week 16 with standard deviation change = week 16 - week 0.
Change in Low-Density Lipoprotein-C(LDL-C) From Week 0(Baseline) to Week 16 Least Squares Mean
change in LDL-C from Week 0(baseline) to week 16 least squares mean with 95% confidence intervals change = week 16 - week 0.
Mean Change in LDL-C From Week 0(Baseline) to Week 16
mean change in LDL-C from Week 0(baseline) to week 16 with standard deviation change = week 16 - week 0.
Mean Percentage of Change in LDL-C Levels From Week 0(Baseline) to Week 16
mean percent change in LDL-C levels from Week 0(baseline) to Week 16 mean with standard deviation change = week 16 - week 0.
Mean Percentage of Change in LDL-C Levels From Week 0(Baseline) to Week 16 (Least Squares Mean)
percent change in LDL-C levels from Week 0(baseline) to Week 16 (least squares mean with 95% confidence interval)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00484419
Brief Title
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
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
Study Type
Interventional
2. Study Status
Record Verification Date
August 2016
Overall Recruitment Status
Completed
Study Start Date
May 2007 (undefined)
Primary Completion Date
April 2008 (Actual)
Study Completion Date
April 2008 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Daiichi Sankyo, Inc.
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes, Hyperlipidemia
Keywords
Colesevelam HCl,, rosiglitazone, sitagliptin, Type 2 diabetes, metformin
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
169 (Actual)
8. Arms, Groups, and Interventions
Arm Title
colesevelam
Arm Type
Experimental
Arm Description
colesevelam tablets 625 mg
Arm Title
rosiglitazone
Arm Type
Active Comparator
Arm Description
rosiglitazone maleate 4mg
Arm Title
sitagliptin
Arm Type
Active Comparator
Arm Description
sitagliptin phosphate tablets
Intervention Type
Drug
Intervention Name(s)
Colesevelam HCl
Intervention Description
coleveselam tablets 625 mg; 6 tablets/day
Intervention Type
Drug
Intervention Name(s)
rosiglitazone maleate
Intervention Description
rosiglitazone tablets 4mg
Intervention Type
Drug
Intervention Name(s)
sitagliptin phosphate
Intervention Description
sitagliptin phosphate tablets 100mg/day
Primary Outcome Measure Information:
Title
Mean Percentage of Change in HbA1c From Week 0(Baseline) to Week 16 Endpoint
Description
Change in HbA1c from Week 0(baseline) to Week 16 endpoint mean with standard deviation change = week 16 - week 0.
Time Frame
16 weeks change = week 16 - week 0.
Secondary Outcome Measure Information:
Title
Mean Percentage of Change in Glycosylated Hemoglobin (HbA1c) From Week 0(Baseline) to Week 16 Endpoint Least Squares Mean
Description
Change in HbA1c from Week 0(baseline)to Week 16 endpoint least squares mean with 95% confidence intervals, change = week 16 - week 0.
Time Frame
16 weeks change = week 16 - week 0.
Title
Mean Percentage of Change in HbA1c From Week 0(Baseline) to Week 8
Description
change in HbA1c from Week 0(baseline) to week 8 mean and standard deviation change = week 8 - week 0.
Time Frame
8 weeks change = week 8- week 0.
Title
Change in Fasting Plasma Glucose (FPG) From Week 0(Baseline) to Week 8 Least Squares Mean
Description
change in FPG from Week 0(baseline) to week 8 least squares mean and 95% confidence interval change = week 8 - week 0.
Time Frame
8 weeks change = week 8- week 0.
Title
Change in FPG From Week 0(Baseline) to Week 16 Least Squares Mean
Description
change in FPG from Week 0(baseline) to week 16 least squares mean and 95% confidence interval change = week 16 - week 0.
Time Frame
16 weeks change = week 16 - week 0.
Title
Mean Change in FPG From Week 0(Baseline) to Week 8
Description
mean change in FPG from Week 0(baseline) to Week 8 with standard deviation change = week 8 - week 0.
Time Frame
8 weeks change = week 8- week 0.
Title
Mean Change in FPG From Week 0(Baseline) to Week 16
Description
change in FPG from Week 0(baseline) to week 16 mean and standard deviation change = week 16 - week 0.
Time Frame
16 weeks change = week 16 - week 0.
Title
Change in Fasting Insulin From Week 0(Baseline) to Week 8 Least Squares Mean
Description
change in fasting insulin from Week 0(baseline) to week 8 least squares mean and 95% confidence interval change = week 8 - week 0.
Time Frame
8 weeks change = week 8- week 0.
Title
Change in Fasting Insulin From Week 0(Baseline) to Week 16 Least Squares Mean
Description
change in fasting insulin from Week 0(baseline) to week 16 least squares mean and 95% confidence interval change = week 16 - week 0.
Time Frame
16 weeks change = week 16 - week 0.
Title
Mean Change in Fasting Insulin From Week 0(Baseline) to Week 8
Description
mean change in fasting insulin from Week 0(baseline) to week 8 with standard deviation change = week 8 - week 0.
Time Frame
8 weeks change = week 8- week 0.
Title
Mean Change in Fasting Insulin From Week 0(Baseline) to Week 16
Description
mean change in fasting insulin from Week 0(baseline) to week 16 with standard deviation change = week 16 - week 0.
Time Frame
16 weeks change = week 16 - week 0.
Title
Change in Post-prandial Glucose From Week 0(Baseline) to Week 16 Least Squares Mean
Description
change in post-prandial glucose from Week 0(baseline) to week 16 least squares mean with 95% confidence intervals change = week 16 - week 0.
Time Frame
16 weeks change = week 16 - week 0.
Title
Mean Change in Post-prandial Glucose From Week 0(Baseline) to Week 16
Description
mean change in post-prandial glucose from Week 0(baseline) to week 16 with standard deviation change = week 16 - week 0.
Time Frame
16 weeks change = week 16 - week 0.
Title
Mean Change in Post-prandial Insulin From Week 0(Baseline) to Week 16
Description
mean change in post-prandial insulin from Week 0(baseline) to week 16 with standard deviation change = week 16 - week 0.
Time Frame
16 weeks change = week 16 - week 0.
Title
Change in Low-Density Lipoprotein-C(LDL-C) From Week 0(Baseline) to Week 16 Least Squares Mean
Description
change in LDL-C from Week 0(baseline) to week 16 least squares mean with 95% confidence intervals change = week 16 - week 0.
Time Frame
16 weeks change = week 16 - week 0.
Title
Mean Change in LDL-C From Week 0(Baseline) to Week 16
Description
mean change in LDL-C from Week 0(baseline) to week 16 with standard deviation change = week 16 - week 0.
Time Frame
16 weeks change = week 16 - week 0.
Title
Mean Percentage of Change in LDL-C Levels From Week 0(Baseline) to Week 16
Description
mean percent change in LDL-C levels from Week 0(baseline) to Week 16 mean with standard deviation change = week 16 - week 0.
Time Frame
16 weeks change = week 16 - week 0.
Title
Mean Percentage of Change in LDL-C Levels From Week 0(Baseline) to Week 16 (Least Squares Mean)
Description
percent change in LDL-C levels from Week 0(baseline) to Week 16 (least squares mean with 95% confidence interval)
Time Frame
16 weeks change = week 16 - week 0.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
City
La Mesa
State/Province
California
Country
United States
City
Los Angeles
State/Province
California
Country
United States
City
Los Gatos
State/Province
California
Country
United States
City
San Antonio
State/Province
California
Country
United States
City
Chiefland
State/Province
Florida
Country
United States
City
Gary
State/Province
Indiana
Country
United States
City
Baltimore
State/Province
Maryland
Country
United States
City
Dearborn
State/Province
Michigan
Country
United States
City
W. Bloomfield
State/Province
Michigan
Country
United States
City
Las Vegas
State/Province
Nevada
Country
United States
City
Yonkers
State/Province
New York
Country
United States
City
Lexington
State/Province
North Carolina
Country
United States
City
Winston-Salem
State/Province
North Carolina
Country
United States
City
Munroe Falls
State/Province
Ohio
Country
United States
City
Zaneville
State/Province
Ohio
Country
United States
City
Portland
State/Province
Oregon
Country
United States
City
Jersey Shore
State/Province
Pennsylvania
Country
United States
City
Clemson
State/Province
South Carolina
Country
United States
City
Harriman
State/Province
Tennessee
Country
United States
City
Dallas
State/Province
Texas
Country
United States
12. IPD Sharing Statement
Learn more about this trial
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
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