Official Title: “A Single-Center, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study Comparing SYR-322 Alone and Combination SYR-322 With Pioglitazone Versus Placebo on Postprandial Lipids in Subjects With Type 2 Diabetes”

The purpose of the study is to determine the effects of lipid and lipoprotein parameters in the blood following a balanced meal after treatment with SYR-322 alone or in combination with pioglitazone HCl.

Study Type: Interventional

Study Design: Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Efficacy Study

Study Primary Completion Date: April 2009

Eligible subjects will receive SYR-322 alone or SYR-322 together with pioglitazone HCl once daily for 16 weeks. Additional screening and follow up periods allow for an approximate 20 week evaluation period. During the time of treatment (at weeks 0, 4, and 16) each subject will a standardized meal. Before and during these meals several timed blood samples will be taken and analyzed to evaluate the levels of triglycerides and other lipids and lipoproteins.

This study is also being conducted to further evaluate the safety and tolerability of the study drug.

Intervention(s) in this Clinical Trial

• Drug: SYR-322, pioglitazone HCl
  • SYR-322 25 mg once daily oral, with or without pioglitazone HCl 30 mg once daily oral
• Drug: Placebo
  • placebo once daily oral

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: 1
  • SYR-322 25 mg once daily oral
• Placebo Comparator: 2
  • oral placebo once daily
• Experimental: 3
  • SYR-322 25 mg once daily oral plus pioglitazone HCl 30 mg once daily oral

Primary Measures

• To evaluate the change from Baseline in postprandial incremental area under the curve for triglycerides at Week 16.
  • Time Frame: 16 weeks
    Safety Issue?: No

Secondary Measures

• Efficacy: Postprandial incremental AUC changes for triglycerides at Week 4.
  • Time Frame: 16 weeks
    Safety Issue?: Yes
• Postprandial incremental AUC changes for lipid parameters.
  • Time Frame: 16 weeks
    Safety Issue?: Yes
• Postprandial incremental AUC changes for lipoprotein parameters.
  • Time Frame: 16 weeks
    Safety Issue?: Yes
• Postprandial changes over time
  • Time Frame: 16 weeks
    Safety Issue?: Yes

Inclusion Criteria:

• The subject is male or female, with a historical diagnosis of type 2 diabetes, and must be aged 18 to 70 years, inclusive.
• The subject has either failed treatment with diet and exercise for 3 months prior to Screening or has been receiving a stable dose of metformin, sulfonylurea, nataglinide, or repaglinide for more than 3 months prior to Screening.
• The subject has inadequate glycemic control as defined by HbA1C concentration between 6.5 and 9.0%, inclusive.

Exclusion Criteria:

• The subject has a history of type 1 diabetes.
• The subject has New York Heart Association heart failure of any Class (I-IV) regardless of therapy.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 70 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Takeda Global Research & Development Center, Inc.

Overall Clinical Trial Officials and Contacts

Qais Mekki, MD, PhD Study Director Takeda Global Research & Development Center, Inc.  

Overall Contact: Mags McDonagh, PhD 0044 (0)20 775 95000 m.mcdonagh@tgrd.com

Information obtained from ClinicalTrials.gov on November 20, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00655863

Study ID Number: SYR-322_301

ClinicalTrials.gov Identifier: NCT00655863

Health Authority: United States: Food and Drug Administration