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 Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00484419
• Other study ID #: Wel-409
• Status: Completed
• Phase: Phase 3
• First received: June 7, 2007
• Last updated: June 17, 2009
• Start date: May 2007
• Est. completion date: April 2008

Study information

• Verified date: June 2009
• Source: Daiichi Sankyo Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 169
• Est. completion date: April 2008
• Est. primary completion date: April 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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• HbA1C 7.0 % to 10.0% on metformin monotherapy; may be withdrawn from other (non-metformin) drugs if HbA1C is 6.5% to 9.5 % at screening.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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Hyperlipidemia
• Hyperlipidemias
• Type 2 Diabetes

Intervention

Drug:
• Colesevelam HCl
coleveselam tablets 625 mg; 6 tablets/day
• rosiglitazone maleate
rosiglitazone tablets 4mg
• sitagliptin phosphate
sitagliptin phosphate tablets 100mg/day

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Daiichi Sankyo Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean Percentage of Change in HbA1c From Week 0(Baseline) to Week 16 Endpoint		16 weeks change = week 16 - week 0.	No
Secondary	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.	No
Secondary	Mean Percentage of Change in HbA1c From Week 0(Baseline) to Week 8		8 weeks change = week 8- week 0.	No
Secondary	Change in Fasting Plasma Glucose (FPG) From Week 0(Baseline) to Week 8 Least Squares Mean		8 weeks change = week 8- week 0.	No
Secondary	Change in FPG From Week 0(Baseline) to Week 16 Least Squares Mean		16 weeks change = week 16 - week 0.	No
Secondary	Mean Change in FPG From Week 0(Baseline) to Week 8		8 weeks change = week 8- week 0.	No
Secondary	Mean Change in FPG From Week 0(Baseline) to Week 16		16 weeks change = week 16 - week 0.	No
Secondary	Change in Fasting Insulin From Week 0(Baseline) to Week 8 Least Squares Mean		8 weeks change = week 8- week 0.	No
Secondary	Change in Fasting Insulin From Week 0(Baseline) to Week 16 Least Squares Mean		16 weeks change = week 16 - week 0.	No
Secondary	Mean Change in Fasting Insulin From Week 0(Baseline) to Week 8		8 weeks change = week 8- week 0.	No
Secondary	Mean Change in Fasting Insulin From Week 0(Baseline) to Week 16		16 weeks change = week 16 - week 0.	No
Secondary	Change in Post-Prandial Glucose From Week 0(Baseline) to Week 16 Least Squares Mean		16 weeks change = week 16 - week 0.	No
Secondary	Mean Change in Post-Prandial Glucose From Week 0(Baseline) to Week 16		16 weeks change = week 16 - week 0.	No
Secondary	Mean Change in Post-Prandial Insulin From Week 0(Baseline) to Week 16		16 weeks change = week 16 - week 0.	No
Secondary	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.	No
Secondary	Mean Change in LDL-C From Week 0(Baseline) to Week 16		16 weeks change = week 16 - week 0.	No
Secondary	Mean Percentage of Change in LDL-C Levels From Week 0(Baseline) to Week 16		16 weeks change = week 16 - week 0.	No
Secondary	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.	No