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

Daiichi Sankyo169 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

169

Conditions

Type 2 Diabetes Hyperlipidemia

Interventions

Colesevelam HClDRUG

coleveselam tablets 625 mg; 6 tablets/day

rosiglitazone maleateDRUG

rosiglitazone tablets 4mg

sitagliptin phosphateDRUG

sitagliptin phosphate tablets 100mg/day

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

Inclusion Criteria: * HbA1C 7.0 % to 10.0% on metformin monotherapy; may be withdrawn from other (non-metformin) drugs if HbA1C is 6.5% to 9.5 % at screening.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

Locations (20)

Unnamed facility

La Mesa, California, United States

Unnamed facility

Los Angeles, California, United States

Unnamed facility

Los Gatos, California, United States

Outcomes

Primary Outcomes

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.

Time frame: 16 weeks change = week 16 - week 0.

Secondary Outcomes

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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 8 weeks change = week 8- week 0.

Data from ClinicalTrials.gov

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Unnamed facility

San Antonio, California, United States

Unnamed facility

Chiefland, Florida, United States

Unnamed facility

Gary, Indiana, United States

Unnamed facility

Baltimore, Maryland, United States

Unnamed facility

Dearborn, Michigan, United States

Unnamed facility

West Bloomfield, Michigan, United States

Unnamed facility

Las Vegas, Nevada, United States

...and 10 more locations

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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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)

Time frame: 16 weeks change = week 16 - week 0.