Full Text View
Tabular View
Study Results
Related Studies
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
This study has been completed.
First Received: June 7, 2007   Last Updated: June 17, 2009   History of Changes
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: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
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:

MedlinePlus related topics: Diabetes
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
colesevelam: Experimental
colesevelam tablets 625 mg
Drug: Colesevelam HCl
coleveselam tablets 625 mg; 6 tablets/day
rosiglitazone: Active Comparator
rosiglitazone maleate 4mg
Drug: rosiglitazone maleate
rosiglitazone tablets 4mg
sitagliptin: Active Comparator
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
San Antonio, California, United States
Los Gatos, California, United States
La Mesa, California, United States
Los Angeles, 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
W. Bloomfield, Michigan, United States
Dearborn, 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: Daiichi Sankyo ( Yu-Ling Lai )
Study ID Numbers: Wel-409
Study First Received: June 7, 2007
Results First Received: April 29, 2009
Last Updated: June 17, 2009
ClinicalTrials.gov Identifier: NCT00484419     History of Changes
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:
Antimetabolites
Hyperlipidemias
Metabolic Diseases
Colesevelam
Molecular Mechanisms of Pharmacological Action
Antilipemic Agents
Physiological Effects of Drugs
Metformin
Diabetes Mellitus
Endocrine System Diseases
Enzyme Inhibitors
Anticholesteremic Agents
 Pharmacologic Actions
Protease Inhibitors
Sitagliptin
Dipeptidyl-Peptidase IV Inhibitors
Hypoglycemic Agents
Therapeutic Uses
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Rosiglitazone
Dyslipidemias
Lipid Metabolism Disorders

ClinicalTrials.gov processed this record on February 08, 2010



Contact Help Desk
Lister Hill National Center for Biomedical Communications,  U.S. National Library of Medicine,
U.S. National Institutes of Health,  U.S. Department of Health & Human Services,
USA.gov,  Copyright,  Privacy,  Accessibility,  Freedom of Information Act

U.S. National Institutes of Health U.S. National Library of Medicine U.S. Department of Health & Human Services