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 - Full Text View

Sponsor:	Daiichi Sankyo Inc.
Information provided by:	Daiichi Sankyo Inc.
ClinicalTrials.gov Identifier:	NCT00484419

Purpose

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.

Condition	Intervention	Phase
Type 2 Diabetes Hyperlipidemia	Drug: Colesevelam HCl Drug: rosiglitazone maleate Drug: sitagliptin phosphate	Phase III

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

Resource links provided by NLM:

Genetics Home Reference related topics: 6q24-related transient neonatal diabetes mellitus

MedlinePlus related topics: Diabetes Diabetes Medicines Diabetes Type 2

Drug Information available for: Lipids Rosiglitazone Rosiglitazone Maleate Colesevelam GT31-104 Sitagliptin Sitagliptin phosphate Metformin Metformin hydrochloride

U.S. FDA Resources

Further study details as provided by Daiichi Sankyo Inc.:

Primary Outcome Measures:

Mean Percentage of Change in HbA1c From Week 0(Baseline) to Week 16 Endpoint [ Time Frame: 16 weeks change = week 16 - week 0. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Mean Percentage of Change in Glycosylated Hemoglobin (HbA1c) From Week 0(Baseline) to Week 16 Endpoint Least Squares Mean [ Time Frame: 16 weeks change = week 16 - week 0. ] [ Designated as safety issue: No ]
Mean Percentage of Change in HbA1c From Week 0(Baseline) to Week 8 [ Time Frame: 8 weeks change = week 8- week 0. ] [ Designated as safety issue: No ]
Change in Fasting Plasma Glucose (FPG) From Week 0(Baseline) to Week 8 Least Squares Mean [ Time Frame: 8 weeks change = week 8- week 0. ] [ Designated as safety issue: No ]
Change in FPG From Week 0(Baseline) to Week 16 Least Squares Mean [ Time Frame: 16 weeks change = week 16 - week 0. ] [ Designated as safety issue: No ]
Mean Change in FPG From Week 0(Baseline) to Week 8 [ Time Frame: 8 weeks change = week 8- week 0. ] [ Designated as safety issue: No ]
Mean Change in FPG From Week 0(Baseline) to Week 16 [ Time Frame: 16 weeks change = week 16 - week 0. ] [ Designated as safety issue: No ]
Change in Fasting Insulin From Week 0(Baseline) to Week 8 Least Squares Mean [ Time Frame: 8 weeks change = week 8- week 0. ] [ Designated as safety issue: No ]
Change in Fasting Insulin From Week 0(Baseline) to Week 16 Least Squares Mean [ Time Frame: 16 weeks change = week 16 - week 0. ] [ Designated as safety issue: No ]
Mean Change in Fasting Insulin From Week 0(Baseline) to Week 8 [ Time Frame: 8 weeks change = week 8- week 0. ] [ Designated as safety issue: No ]
Mean Change in Fasting Insulin From Week 0(Baseline) to Week 16 [ Time Frame: 16 weeks change = week 16 - week 0. ] [ Designated as safety issue: No ]
Change in Post-Prandial Glucose From Week 0(Baseline) to Week 16 Least Squares Mean [ Time Frame: 16 weeks change = week 16 - week 0. ] [ Designated as safety issue: No ]
Mean Change in Post-Prandial Glucose From Week 0(Baseline) to Week 16 [ Time Frame: 16 weeks change = week 16 - week 0. ] [ Designated as safety issue: No ]
Mean Change in Post-Prandial Insulin From Week 0(Baseline) to Week 16 [ Time Frame: 16 weeks change = week 16 - week 0. ] [ Designated as safety issue: No ]
Change in Low-Density Lipoprotein-C(LDL-C) From Week 0(Baseline) to Week 16 Least Squares Mean [ Time Frame: 16 weeks change = week 16 - week 0. ] [ Designated as safety issue: No ]
Mean Change in LDL-C From Week 0(Baseline) to Week 16 [ Time Frame: 16 weeks change = week 16 - week 0. ] [ Designated as safety issue: No ]
Mean Percentage of Change in LDL-C Levels From Week 0(Baseline) to Week 16 [ Time Frame: 16 weeks change = week 16 - week 0. ] [ Designated as safety issue: No ]
Mean Percentage of Change in LDL-C Levels From Week 0(Baseline) to Week 16 (Least Squares Mean) [ Time Frame: 16 weeks change = week 16 - week 0. ] [ Designated as safety issue: No ]

Enrollment:	169
Study Start Date:	May 2007
Study Completion Date:	April 2008
Primary Completion Date:	April 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: colesevelam colesevelam tablets 625 mg	Drug: Colesevelam HCl coleveselam tablets 625 mg; 6 tablets/day
Active Comparator: rosiglitazone rosiglitazone maleate 4mg	Drug: rosiglitazone maleate rosiglitazone tablets 4mg
Active Comparator: sitagliptin sitagliptin phosphate tablets	Drug: sitagliptin phosphate sitagliptin phosphate tablets 100mg/day

Eligibility

Ages Eligible for Study:	18 Years to 80 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00484419

Locations

United States, California

La Mesa, California, United States

Los Angeles, California, United States

Los Gatos, California, United States

San Antonio, California, United States
United States, Florida

Chiefland, Florida, United States
United States, Indiana

Gary, Indiana, United States
United States, Maryland

Baltimore, Maryland, United States
United States, Michigan

Dearborn, Michigan, United States

W. Bloomfield, Michigan, United States
United States, Nevada

Las Vegas, Nevada, United States
United States, New York

Yonkers, New York, United States
United States, North Carolina

Lexington, North Carolina, United States

Winston-Salem, North Carolina, United States
United States, Ohio

Munroe Falls, Ohio, United States

Zaneville, Ohio, United States
United States, Oregon

Portland, Oregon, United States
United States, Pennsylvania

Jersey Shore, Pennsylvania, United States
United States, South Carolina

Clemson, South Carolina, United States
United States, Tennessee

Harriman, Tennessee, United States
United States, Texas

Dallas, Texas, United States

Sponsors and Collaborators

Daiichi Sankyo Inc.

More Information

No publications provided

Responsible Party:	Yu-Ling Lai, Daiichi Sankyo
ClinicalTrials.gov Identifier:	NCT00484419 History of Changes
Other Study ID Numbers:	Wel-409
Study First Received:	June 7, 2007
Results First Received:	April 29, 2009
Last Updated:	June 17, 2009
Health Authority:	United States: Food and Drug Administration

Keywords provided by Daiichi Sankyo Inc.:

Colesevelam HCl,
rosiglitazone
sitagliptin
Type 2 diabetes
metformin

Additional relevant MeSH terms:

Diabetes Mellitus
Diabetes Mellitus, Type 2
Hyperlipidemias
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Dyslipidemias
Lipid Metabolism Disorders
Maleic acid
Sitagliptin
Rosiglitazone
Metformin
Colesevelam

Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Hypoglycemic Agents
Physiological Effects of Drugs
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Lipid Regulating Agents
Therapeutic Uses
Dipeptidyl-Peptidase IV Inhibitors
Protease Inhibitors

ClinicalTrials.gov processed this record on February 09, 2012