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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Type 2 Diabetes, Hyperlipidemia

Intervention / Treatment
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* Drug: Colesevelam HCl
* Drug: rosiglitazone maleate
* Drug: sitagliptin phosphate


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: HbA1C 7.0 % to 10.0% on metformin monotherapy; may be withdrawn from other (non-metformin) drugs if HbA1C is 6.5% to 9.5 % at screening.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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: colesevelam<br>colesevelam tablets 625 mg | Drug: Colesevelam HCl<br>* coleveselam tablets 625 mg; 6 tablets/day<br>|
| Active Comparator: rosiglitazone<br>rosiglitazone maleate 4mg | Drug: rosiglitazone maleate<br>* rosiglitazone tablets 4mg<br>|
| Active Comparator: sitagliptin<br>sitagliptin phosphate tablets | Drug: sitagliptin phosphate<br>* sitagliptin phosphate tablets 100mg/day<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 16 weeks 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. | 8 weeks 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. | 8 weeks 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. | 16 weeks 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. | 8 weeks 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. | 16 weeks 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. | 8 weeks 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. | 16 weeks 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. | 8 weeks 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. | 16 weeks 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. | 16 weeks 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. | 16 weeks 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. | 16 weeks 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. | 16 weeks 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. | 16 weeks 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. | 16 weeks 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) | 16 weeks change = week 16 - week 0. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Colesevelam HCl,, rosiglitazone, sitagliptin, Type 2 diabetes, metformin