Phase 3 Completed N=169 Randomized Treatment

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

Type 2 Diabetes · Hyperlipidemia

Source: ClinicalTrials.gov NCT00484419 ↗

Enrolled (actual)

169

Serious AEs

—

Results posted

Jun 2009

Primary outcomePrimary: Mean Percentage of Change in HbA1c From Week 0(Baseline) to Week 16 Endpoint — -0.31; -0.65; -0.56 % change HbA1c — p=0.0234

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.

Outcome Measures

Outcome	Result	p-value
PRIMARY Mean Percentage of Change in HbA1c From Week 0(Baseline) to Week 16 Endpoint	-0.31; -0.65; -0.56	0.0234 sig
SECONDARY Mean Percentage of Change in Glycosylated Hemoglobin (HbA1c) From Week 0(Baseline) to Week 16 Endpoint Least Squares Mean	-0.27; -0.58; -0.38	—
SECONDARY Mean Percentage of Change in HbA1c From Week 0(Baseline) to Week 8	-0.31; -0.19; -0.48	0.0061 sig
SECONDARY Change in Fasting Plasma Glucose (FPG) From Week 0(Baseline) to Week 8 Least Squares Mean	-15.6; -28.9; -17.4	—
SECONDARY Change in FPG From Week 0(Baseline) to Week 16 Least Squares Mean	-17.3; -31.4; -24.4	—
SECONDARY Mean Change in FPG From Week 0(Baseline) to Week 8	-12.5; -30.8; -18.6	0.0077 sig
SECONDARY Mean Change in FPG From Week 0(Baseline) to Week 16	-15.8; -34.0; -23.1	0.0133 sig
SECONDARY Change in Fasting Insulin From Week 0(Baseline) to Week 8 Least Squares Mean	0.075; -2.156; 4.002	—
SECONDARY Change in Fasting Insulin From Week 0(Baseline) to Week 16 Least Squares Mean	-0.320; -1.482; 0.092	—
SECONDARY Mean Change in Fasting Insulin From Week 0(Baseline) to Week 8	0.107; -2.213; 4.028	0.8596
SECONDARY Mean Change in Fasting Insulin From Week 0(Baseline) to Week 16	-0.212; -1.910; -0.419	0.7094
SECONDARY Change in Post-prandial Glucose From Week 0(Baseline) to Week 16 Least Squares Mean	-17.7; -53.6; -43.6	—
SECONDARY Mean Change in Post-prandial Glucose From Week 0(Baseline) to Week 16	-20.1; -54.0; -40.9	0.0374 sig
SECONDARY Mean Change in Post-prandial Insulin From Week 0(Baseline) to Week 16	3.898; 1.962; 4.832	0.2701
SECONDARY Change in Low-Density Lipoprotein-C(LDL-C) From Week 0(Baseline) to Week 16 Least Squares Mean	-19.5; 4.9; 6.2	—
SECONDARY Mean Change in LDL-C From Week 0(Baseline) to Week 16	-19.7; 5.5; 5.7	<0.0001 sig
SECONDARY Mean Percentage of Change in LDL-C Levels From Week 0(Baseline) to Week 16	-16.40; 7.41; 7.61	<0.0001 sig
SECONDARY Mean Percentage of Change in LDL-C Levels From Week 0(Baseline) to Week 16 (Least Squares Mean)	-16.24; 6.92; 7.98	—

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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00484419). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.