Long-term Study of Alogliptin as an Add-on to Rapid-Acting Insulin Secretagogues in Type 2 Diabetes

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Takeda
ClinicalTrials.gov Identifier:
NCT01456130
First received: October 13, 2011
Last updated: March 17, 2014
Last verified: March 2014
Results First Received: March 17, 2014  
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label
Condition: Diabetes Mellitus
Interventions: Drug: Alogliptin
Drug: Rapid-acting insulin secretagogue

  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 took part in the study at 14 investigative sites in Japan from 10 November 2011 to 16 March 2013.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Patients with type 2 diabetes with inadequate blood glucose control despite treatment with a rapid-acting insulin secretagogue as well as diet and exercise therapies were enrolled in a single treatment group.

Reporting Groups
  Description
Alogliptin Alogliptin 25 mg (or 12.5 mg for participants with moderate renal dysfunction) tablets, orally once daily and a rapid-acting insulin secretagogue as prescribed by the Investigator for up to 52 weeks.

Participant Flow:   Overall Study
    Alogliptin  
STARTED     67  
COMPLETED     57  
NOT COMPLETED     10  
Adverse Event                 4  
Voluntary Withdrawal                 1  
Lack of Efficacy                 4  
Other                 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
Alogliptin Alogliptin 25 mg (or 12.5 mg for participants with moderate renal dysfunction) tablets, orally once daily and a rapid-acting insulin secretagogue as prescribed by the Investigator for up to 52 weeks.

Baseline Measures
    Alogliptin  
Number of Participants  
[units: participants]
  67  
Age  
[units: years]
Mean ± Standard Deviation
  61.6  ± 10.52  
Age, Customized  
[units: participants]
 
< 65 years     37  
≥ 65 years     30  
Gender  
[units: participants]
 
Female     26  
Male     41  
Weight  
[units: kg]
Mean ± Standard Deviation
  66.64  ± 14.409  
Height  
[units: cm]
Mean ± Standard Deviation
  161.7  ± 10.22  
Body Mass Index (BMI)  
[units: kg/m^2]
Mean ± Standard Deviation
  25.38  ± 4.347  
Duration of Diabetes  
[units: years]
Mean ± Standard Deviation
  7.44  ± 5.872  
Glycosylated Hemoglobin (HbA1c)  
[units: percent glycosylated hemoglobin]
Mean ± Standard Deviation
  7.63  ± 0.957  
Baseline hemoglobin A1c (HbA1c) categories  
[units: participants]
 
< 6.5 %     3  
≥ 6.5 and < 7.0%     17  
≥ 7.0 and < 8.0%     25  
≥ 8.0%     22  
Fasting blood glucose  
[units: mg/dL]
Mean ± Standard Deviation
  182.1  ± 45.07  
Fasting blood glucose categories  
[units: participants]
 
< 130 mg/dL     6  
≥ 130 to < 160 mg/dL     17  
≥ 160 mg/dL     44  



  Outcome Measures
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1.  Primary:   Number of Participants With Treatment Emergent Adverse Events (TEAEs)   [ Time Frame: 52 Weeks ]

2.  Secondary:   Change From Baseline in Glycosylated Hemoglobin (HbA1c)   [ Time Frame: Baseline and Week 52 ]
  Hide Outcome Measure 2

Measure Type Secondary
Measure Title Change From Baseline in Glycosylated Hemoglobin (HbA1c)
Measure Description The change in the value of glycosylated hemoglobin collected at Week 52 or at the final visit relative to Baseline.
Time Frame Baseline and Week 52  
Safety Issue No  

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.
Full analysis set: All randomized participants who received at least one dose of double-blind study medication.

Reporting Groups
  Description
Alogliptin Alogliptin 25 mg (or 12.5 mg for participants with moderate renal dysfunction) tablets, orally once daily and a rapid-acting insulin secretagogue as prescribed by the Investigator for up to 52 weeks.

Measured Values
    Alogliptin  
Number of Participants Analyzed  
[units: participants]
  67  
Change From Baseline in Glycosylated Hemoglobin (HbA1c)  
[units: percentage of glycosylated hemoglobin]
Mean ( 95% Confidence Interval )
  -0.46  
  ( -0.690 to 0.221 )  

No statistical analysis provided for Change From Baseline in Glycosylated Hemoglobin (HbA1c)



3.  Secondary:   Percentage of Participants With a Clinical Response   [ Time Frame: Week 52 ]

4.  Secondary:   Change From Baseline in Fasting Glucose   [ Time Frame: Baseline and Week 52 ]


  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: Medical Director, Clinical Science
Organization: Takeda
phone: 800-778-2860
e-mail: clinicaltrialregistry@tpna.com


No publications provided


Responsible Party: Takeda
ClinicalTrials.gov Identifier: NCT01456130     History of Changes
Other Study ID Numbers: SYR-322/OCT-901, U1111-1124-8848, JapicCTI-111643
Study First Received: October 13, 2011
Results First Received: March 17, 2014
Last Updated: March 17, 2014
Health Authority: Japan: Ministry of Health, Labor and Welfare