Clinical trial NCT00484419: 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
Overall status: COMPLETED
Phase: PHASE3
Conditions: Type 2 Diabetes
Hyperlipidemia
Keywords: Colesevelam HCl,
rosiglitazone
sitagliptin
Type 2 diabetes
metformin
Lead sponsor: Daiichi Sankyo
Sponsor class: INDUSTRY
First posted: 2007-06-08
Enrollment: 169
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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* HbA1C 7.0 % to 10.0% on metformin monotherapy; may be withdrawn from other (non-metformin) drugs if HbA1C is 6.5% to 9.5 % at screening.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

Primary outcomes:
measure: Mean Percentage of Change in HbA1c From Week 0(Baseline) to Week 16 Endpoint
timeFrame: 16 weeks change = week 16 - week 0.
Secondary outcomes:
measure: Mean Percentage of Change in Glycosylated Hemoglobin (HbA1c) From Week 0(Baseline) to Week 16 Endpoint Least Squares Mean
timeFrame: 16 weeks change = week 16 - week 0.
measure: Mean Percentage of Change in HbA1c From Week 0(Baseline) to Week 8
timeFrame: 8 weeks change = week 8- week 0.
measure: Change in Fasting Plasma Glucose (FPG) From Week 0(Baseline) to Week 8 Least Squares Mean
timeFrame: 8 weeks change = week 8- week 0.
measure: Change in FPG From Week 0(Baseline) to Week 16 Least Squares Mean
timeFrame: 16 weeks change = week 16 - week 0.
measure: Mean Change in FPG From Week 0(Baseline) to Week 8
timeFrame: 8 weeks change = week 8- week 0.
measure: Mean Change in FPG From Week 0(Baseline) to Week 16
timeFrame: 16 weeks change = week 16 - week 0.
measure: Change in Fasting Insulin From Week 0(Baseline) to Week 8 Least Squares Mean
timeFrame: 8 weeks change = week 8- week 0.
measure: Change in Fasting Insulin From Week 0(Baseline) to Week 16 Least Squares Mean
timeFrame: 16 weeks change = week 16 - week 0.
measure: Mean Change in Fasting Insulin From Week 0(Baseline) to Week 8
timeFrame: 8 weeks change = week 8- week 0.
measure: Mean Change in Fasting Insulin From Week 0(Baseline) to Week 16
timeFrame: 16 weeks change = week 16 - week 0.
measure: Change in Post-prandial Glucose From Week 0(Baseline) to Week 16 Least Squares Mean
timeFrame: 16 weeks change = week 16 - week 0.
measure: Mean Change in Post-prandial Glucose From Week 0(Baseline) to Week 16
timeFrame: 16 weeks change = week 16 - week 0.
measure: Mean Change in Post-prandial Insulin From Week 0(Baseline) to Week 16
timeFrame: 16 weeks change = week 16 - week 0.
measure: Change in Low-Density Lipoprotein-C(LDL-C) From Week 0(Baseline) to Week 16 Least Squares Mean
timeFrame: 16 weeks change = week 16 - week 0.
measure: Mean Change in LDL-C From Week 0(Baseline) to Week 16
timeFrame: 16 weeks change = week 16 - week 0.
measure: Mean Percentage of Change in LDL-C Levels From Week 0(Baseline) to Week 16
timeFrame: 16 weeks change = week 16 - week 0.
measure: Mean Percentage of Change in LDL-C Levels From Week 0(Baseline) to Week 16 (Least Squares Mean)
timeFrame: 16 weeks change = week 16 - week 0.
Other outcomes:
Locations:
city: La Mesa
country: United States
state: California
city: Los Angeles
country: United States
state: California
city: Los Gatos
country: United States
state: California
city: San Antonio
country: United States
state: California
city: Chiefland
country: United States
state: Florida
city: Gary
country: United States
state: Indiana
city: Baltimore
country: United States
state: Maryland
city: Dearborn
country: United States
state: Michigan
city: W. Bloomfield
country: United States
state: Michigan
city: Las Vegas
country: United States
state: Nevada
city: Yonkers
country: United States
state: New York
city: Lexington
country: United States
state: North Carolina
city: Winston-Salem
country: United States
state: North Carolina
city: Munroe Falls
country: United States
state: Ohio
city: Zaneville
country: United States
state: Ohio
city: Portland
country: United States
state: Oregon
city: Jersey Shore
country: United States
state: Pennsylvania
city: Clemson
country: United States
state: South Carolina
city: Harriman
country: United States
state: Tennessee
city: Dallas
country: United States
state: Texas
Study officials:
References: