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Trial record 1 of 1 for:    SYR-322_301
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Efficacy of Alogliptin and With Pioglitazone in Patients With Type 2 Diabetes.

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00655863
First Posted: April 10, 2008
Last Update Posted: May 27, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Takeda
Results First Submitted: February 17, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Diabetes Mellitus
Interventions: Drug: Alogliptin and Pioglitazone
Drug: Alogliptin
Drug: Placebo

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Participants enrolled at 2 investigative sites in The Netherlands and Sweden from 16 July 2007 to 17 December 2009.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Participants with a historical diagnosis of type 2 diabetes mellitus were enrolled in one of three, once-daily (QD) treatment groups.

Reporting Groups
  Description
Placebo QD Alogliptin placebo-matching tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 16 weeks.
Alogliptin 25 mg QD Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 16 weeks.
Alogliptin 25 mg QD + Pioglitazone 30 mg QD Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 16 weeks.

Participant Flow:   Overall Study
    Placebo QD   Alogliptin 25 mg QD   Alogliptin 25 mg QD + Pioglitazone 30 mg QD
STARTED   24   25   22 
COMPLETED   24   25   21 
NOT COMPLETED   0   0   1 
Lost to Follow-up                0                0                1 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Placebo QD Alogliptin placebo-matching tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 16 weeks.
Alogliptin 25 mg QD Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 16 weeks.
Alogliptin 25 mg QD + Pioglitazone 30 mg QD Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 16 weeks.
Total Total of all reporting groups

Baseline Measures
   Placebo QD   Alogliptin 25 mg QD   Alogliptin 25 mg QD + Pioglitazone 30 mg QD   Total 
Overall Participants Analyzed 
[Units: Participants]
 24   25   22   71 
Age 
[Units: Years]
Mean (Standard Deviation)
 59.1  (6.23)   58.7  (6.47)   59.1  (6.94)   59.0  (6.45) 
Gender 
[Units: Participants]
       
Female   4   10   7   21 
Male   20   15   15   50 
Region of Enrollment 
[Units: Participants]
       
Netherlands   9   10   9   28 
Sweden   15   15   13   43 
Race (NIH/OMB) [1] 
[Units: Participants]
 24   25   22   71 
[1] White
Weight 
[Units: Kg]
Mean (Standard Deviation)
 101.83  (11.989)   93.68  (10.816)   93.05  (13.160)   96.24  (12.471) 
Height 
[Units: Cm]
Mean (Standard Deviation)
 178.3  (6.74)   173.9  (8.17)   172.8  (10.97)   175.0  (8.91) 
Body Mass Index (BMI) 
[Units: Kg/m2]
Mean (Standard Deviation)
 32.12  (3.997)   31.09  (4.196)   31.15  (3.503)   31.46  (3.898) 
Diabetes duration 
[Units: Years]
Mean (Standard Deviation)
 5.55  (3.243)   6.40  (3.622)   5.03  (3.791)   5.69  (3.548) 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Change From Baseline in Postprandial Incremental Area Under the Curve for Total Triglycerides at Week 16.   [ Time Frame: Baseline and Week 16. ]

2.  Secondary:   Change From Baseline in Postprandial Incremental Area Under the Curve for Total Triglycerides at Week 4.   [ Time Frame: Baseline and Week 4. ]

3.  Secondary:   Change From Baseline in Postprandial Incremental Area Under the Curve Changes for Lipid Parameters.   [ Time Frame: Baseline, Week 4 and Week 16. ]

4.  Secondary:   Change From Baseline in Postprandial Incremental Area Under the Curve for Lipoprotein Parameters.   [ Time Frame: Baseline, Week 4 and Week 16. ]

5.  Secondary:   Postprandial Changes Over Time From Baseline for Glucagon-like Peptide-1 (GLP-1)   [ Time Frame: Baseline, Week 4 and Week 16. ]

6.  Secondary:   Postprandial Changes Over Time From Baseline for Glucose   [ Time Frame: Baseline, Week 4 and Week 16. ]

7.  Secondary:   Postprandial Changes Over Time From Baseline for Insulin   [ Time Frame: Baseline, Week 4 and Week 16. ]

8.  Secondary:   Postprandial Changes Over Time From Baseline for Glucagon   [ Time Frame: Baseline, Week 4 and Week 16. ]

9.  Secondary:   Change From Baseline in Glycosylated Hemoglobin   [ Time Frame: Baseline, Week 8 and Week 16. ]

10.  Secondary:   Change From Baseline in Fasting Plasma Glucose   [ Time Frame: Baseline, Week 4, Week 8 and Week 16. ]

11.  Secondary:   Change From Baseline in Postprandial C-Peptide   [ Time Frame: Baseline, Week 4 and Week 16. ]

12.  Secondary:   Change From Baseline in Postprandial Proinsulin   [ Time Frame: Baseline, Week 4 and Week 16. ]

13.  Secondary:   Change From Baseline in High-sensitive C-reactive Protein (Hs-CRP)   [ Time Frame: Baseline, Week 4 and Week 16. ]

14.  Secondary:   Change From Baseline in Adiponectin   [ Time Frame: Baseline, Week 4 and Week 16. ]

15.  Secondary:   Change From Baseline in Anti-Vascular Cell Adhesion Molecule (VCAM)   [ Time Frame: Baseline, Week 4 and Week 16. ]

16.  Secondary:   Change From Baseline in Anti-Intercellular Adhesion Molecule (ICAM)   [ Time Frame: Baseline, Week 4 and Week 16. ]

17.  Secondary:   Change From Baseline in e-Selectin   [ Time Frame: Baseline, Week 4 and Week 16. ]

18.  Secondary:   Change From Baseline in Endothelial Function Through Pulse Wave Tonometry   [ Time Frame: Baseline and Week 16. ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Sr. VP, Clinical Science
Organization: Takeda Global Research and Development Center, Inc.
phone: 800-778-2860
e-mail: clinicaltrialregistry@tpna.com


Publications of Results:

Responsible Party: Takeda
ClinicalTrials.gov Identifier: NCT00655863     History of Changes
Other Study ID Numbers: SYR-322_301
2007-000486-38 ( EudraCT Number )
U1111-1113-2081 ( Registry Identifier: WHO )
NL22649.029.08 ( Registry Identifier: CCMO )
First Submitted: April 4, 2008
First Posted: April 10, 2008
Results First Submitted: February 17, 2013
Results First Posted: May 27, 2013
Last Update Posted: May 27, 2013



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