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

Phase 3

Completed

• Conditions: Type 2 Diabetes; Hyperlipidemia
• Interventions: Drug: Colesevelam HCl; Drug: rosiglitazone maleate; Drug: sitagliptin phosphate

• Registration Number: NCT00484419
• Lead Sponsor: Daiichi Sankyo

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 available

Study Timeline

• Study Start: 2007-05
• Study First Submitted: 2007-06-07
• Study First Submitted QC: 2007-06-07
• Study First Posted: 2007-06-08
• Primary Completion: 2008-04
• Study Completion: 2008-04
• Results First Submitted: 2009-04-29
• Results First Submitted QC: 2009-04-29
• Results First Posted: 2009-06-17
• Status Verified: 2016-08
• Last Update Submitted: 2016-08-23
• Last Update Posted: 2016-10-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 169

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• HbA1C 7.0 % to 10.0% on metformin monotherapy; may be withdrawn from other (non-metformin) drugs if HbA1C is 6.5% to 9.5 % at screening.

Read More

Exclusion Criteria

• Subjects currently treated with a thiazolidinedione are excluded.

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
colesevelam	Colesevelam HCl	colesevelam tablets 625 mg
rosiglitazone	rosiglitazone maleate	rosiglitazone maleate 4mg
sitagliptin	sitagliptin phosphate	sitagliptin phosphate tablets

Primary Outcome Measures

Name	Time	Method
Mean Percentage of Change in HbA1c From Week 0(Baseline) to Week 16 Endpoint	16 weeks change = week 16 - week 0.	Change in HbA1c from Week 0(baseline) to Week 16 endpoint mean with standard deviation change = week 16 - week 0.

Secondary Outcome Measures

Name	Time	Method
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.	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	8 weeks change = week 8- week 0.	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	8 weeks change = week 8- week 0.	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	16 weeks change = week 16 - week 0.	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	8 weeks change = week 8- week 0.	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	16 weeks change = week 16 - week 0.	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	8 weeks change = week 8- week 0.	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	16 weeks change = week 16 - week 0.	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	8 weeks change = week 8- week 0.	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	16 weeks change = week 16 - week 0.	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	16 weeks change = week 16 - week 0.	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	16 weeks change = week 16 - week 0.	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	16 weeks change = week 16 - week 0.	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	16 weeks change = week 16 - week 0.	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	16 weeks change = week 16 - week 0.	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	16 weeks change = week 16 - week 0.	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)	16 weeks change = week 16 - week 0.	percent change in LDL-C levels from Week 0(baseline) to Week 16 (least squares mean with 95% confidence interval)