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A Study to Evaluate SYR-322 Plus Pioglitazone HCl (ACTOS®) for the Treatment of Subjects With Inadequately Controlled Type 2 Diabetes

This study is currently recruiting participants.
Verified by Takeda Global Research & Development Center, Inc., March 2007

Sponsors and Collaborators: Takeda Global Research & Development Center, Inc.
PPD
Information provided by: Takeda Global Research & Development Center, Inc.
ClinicalTrials.gov Identifier: NCT00432276
  Purpose

The purpose of the study is to compare the effect of increasing pioglitazone HCl dose to the effect of adding SYR-322 to the treatment regimen in subjects with inadequate glycemic control while receiving pioglitazone HCl and metformin.


Condition Intervention Phase
Type 2 Diabetes Mellitus
Drug: SYR-322, pioglitazone HCl
Phase III

MedlinePlus related topics:   Diabetes   

Drug Information available for:   Pioglitazone    Pioglitazone hydrochloride    Metformin    Metformin hydrochloride    Alogliptin   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:   A Multicenter, Randomized, Double-Blind Study to Determine the Efficacy and Safety of the Addition of SYR-322 25 mg Versus Dose Titration From 30 mg to 45 mg of Pioglitazone HCl (ACTOS®) in Subjects With Type 2 Diabetes Mellitus Who Have Inadequate Control on a Combination of Metformin and 30 mg of Pioglitazone HCl Therapy

Further study details as provided by Takeda Global Research & Development Center, Inc.:

Primary Outcome Measures:
  • Change in HbA1c at end of study.

Estimated Enrollment:   780
Study Start Date:   December 2006
Estimated Study Completion Date:   June 2009

Detailed Description:

The purpose of the study is to evaluate the efficacy of the addition of SYR-322 versus increasing dose of pioglitazone HCl in subjects with type 2 diabetes mellitus who are inadequately controlled on a combination of metformin and pioglitazone HCl therapy. Subjects will undergo necessary evaluations to determine eligibility for the study during a Screening period, and eligible subjects will participate in a Stabilization period. Randomized subjects will receive treatment with SYR-322 plus pioglitazone HCl placebo or SYR-322 placebo plus pioglitazone HCl (in addition to metformin), followed by a Follow-Up period.

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

Criteria

Inclusion Criteria:

  • The subject is male or female, 18 to 80 years of age, with a historical diagnosis of type 2 diabetes mellitus.
  • The subject’s diabetes is inadequately controlled on a stable dose of metformin plus pioglitazone HCl.
  • Female subjects of childbearing potential (ie, not surgically sterile and/or not postmenopausal) must be practicing adequate contraception.

Exclusion Criteria:

  • The subject has a urine albumin/creatine ratio of greater then 100 µg/mg (113 mg/mmol).
  • The subject has a history of laser treatment for proliferative diabetic retinopathy within the 6 months prior to Screening.
  • The subject has had gastric bypass surgery.
  • The subject has New York Heart Association Class III or IV heart failure regardless of therapy. Currently treated subjects who are stable at class I or II are candidates for the study.
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00432276

Contacts
Contact: Laura Rodriguez     224-554-5970     lrodriguez@tgrd.com    

Show 86 study locations  Show 86 Study Locations

Sponsors and Collaborators
Takeda Global Research & Development Center, Inc.
PPD
  More Information


Study ID Numbers:   01-06-TL-322OPI-004
First Received:   February 5, 2007
Last Updated:   March 22, 2007
ClinicalTrials.gov Identifier:   NCT00432276
Health Authority:   United States: Food and Drug Administration

Keywords provided by Takeda Global Research & Development Center, Inc.:
Hyperglycemia  

Study placed in the following topic categories:
Metabolic Diseases
Hyperglycemia
Pioglitazone
Metformin
Diabetes Mellitus, Type 2
Diabetes Mellitus
Endocrine System Diseases
Endocrinopathy
Metabolic disorder
Glucose Metabolism Disorders

Additional relevant MeSH terms:
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on November 20, 2008




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