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.
Sponsor:
Information provided by:
Daiichi Sankyo Inc.
ClinicalTrials.gov Identifier:
NCT00484419
First received: June 7, 2007
Last updated: June 17, 2009
Last verified: June 2009
  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 3

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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 July 24, 2014