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Roflumilast Plus Alogliptin Proof-of-Mechanism Study in Type2 Diabetes

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Takeda
ClinicalTrials.gov Identifier:
NCT01664624
First received: August 10, 2012
Last updated: January 22, 2014
Last verified: January 2014
Results First Received: November 25, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Type 2 Diabetes
Interventions: Drug: Roflumilast
Drug: Alogliptin
Drug: Exenatide
Drug: Placebo to roflumilast
Drug: Placebo to alogliptin

  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 2 investigative sites in the United States from 10 July 2012 to 29 November 2012.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Participants with a diagnosis of type 2 diabetes mellitus and inadequate glycemic control were enrolled equally in 1 of 4 treatment groups, roflumilast + alogliptin, alogliptin alone, roflumilast alone, or exenatide.

Reporting Groups
  Description
Roflumilast + Alogliptin Roflumilast 500 μg, tablets, orally and alogliptin 25 mg, tablets, orally, once a day for 11 days.
Alogliptin Alone Placebo to roflumilast, tablets, orally and alogliptin, 25 mg, tablets, orally, once a day for 11 days.
Roflumilast Alone Roflumilast 500 μg, tablets, orally and placebo to alogliptin, tablets, orally, once a day, for 11 days.
Exenatide Exenatide 5 μg subcutaneous injection twice a day for 11 days.

Participant Flow:   Overall Study
    Roflumilast + Alogliptin     Alogliptin Alone     Roflumilast Alone     Exenatide  
STARTED     10     11     10     9  
COMPLETED     10     10     10     9  
NOT COMPLETED     0     1     0     0  
Adverse Event                 0                 1                 0                 0  



  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
Roflumilast + Alogliptin Roflumilast 500 μg, tablets, orally and alogliptin 25 mg, tablets, orally, once a day for 11 days.
Alogliptin Alone Placebo to roflumilast, tablets, orally and alogliptin, 25 mg, tablets, orally, once a day for 11 days.
Roflumilast Alone Roflumilast 500 μg, tablets, orally and placebo to alogliptin, tablets, orally, once a day, for 11 days.
Exenatide Exenatide 5 μg subcutaneous injection twice a day for 11 days.
Total Total of all reporting groups

Baseline Measures
    Roflumilast + Alogliptin     Alogliptin Alone     Roflumilast Alone     Exenatide     Total  
Number of Participants  
[units: participants]
  10     11     10     9     40  
Age  
[units: years]
Mean ± Standard Deviation
  50.7  ± 10.15     52.9  ± 7.52     60.7  ± 4.24     54.6  ± 6.88     54.7  ± 8.15  
Age, Customized  
[units: participants]
         
< 65 years     10     11     9     9     39  
≥ 65 years     0     0     1     0     1  
Gender  
[units: participants]
         
Female     4     3     4     4     15  
Male     6     8     6     5     25  
Race/Ethnicity, Customized  
[units: participants]
         
Hispanic or Latino     7     6     7     6     26  
Non-Hispanic or Latino     3     5     3     3     14  
Race/Ethnicity, Customized  
[units: participants]
         
Black or African American     3     3     2     0     8  
White     7     8     8     9     32  
Region of Enrollment  
[units: participants]
         
United States     10     11     10     9     40  
Height  
[units: cm]
Mean ± Standard Deviation
  171.1  ± 8.91     171.2  ± 6.03     166.6  ± 10.44     166.4  ± 5.90     169.0  ± 8.09  
Weight  
[units: kg]
Mean ± Standard Deviation
  103.12  ± 21.688     93.24  ± 11.670     89.33  ± 17.961     86.98  ± 14.713     93.32  ± 17.329  
Body Mass Index (BMI)  
[units: kg/m^2]
Mean ± Standard Deviation
  34.93  ± 4.708     31.75  ± 3.184     32.03  ± 5.311     31.37  ± 4.653     32.53  ± 4.548  
Smoking Classification  
[units: participants]
         
Never smoked     6     6     10     7     29  
Current smoker     1     0     0     0     1  
Ex-smoker     3     5     0     2     10  
Duration of Diabetes  
[units: years]
Mean ± Standard Deviation
  6.9  ± 4.63     8.5  ± 6.39     7.0  ± 3.86     8.2  ± 6.63     7.7  ± 5.33  
Metformin Dose  
[units: mg]
Mean ± Standard Deviation
  875.0  ± 151.38     745.0  ± 225.40     805.0  ± 220.42     855.6  ± 211.31     819.2  ± 202.49  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Change From Baseline in Postprandial Area Under the Curve From Time 0 to 8 Hours (AUC[0-8]) for Active Glucagon-like Peptide-1   [ Time Frame: Baseline and Day 11; samples were taken at -15 min and -5 min (pre-meal), and 15 min, 30 min, and 1, 2, 3, 4, 6, and 8 hours (post-meal). ]

2.  Secondary:   Change From Baseline in AUC(0-8) of Postprandial Plasma Glucose   [ Time Frame: Baseline and Day 11 at -15 min and -5 min (pre-meal), and 15 min, 30 min, and 1, 2, 3, 4, 6, and 8 hours (post-meal). ]

3.  Secondary:   Change From Baseline in Postprandial AUC(0-8) of C-peptide   [ Time Frame: Baseline and Day 11; samples were taken at -15 min and -5 min (pre-meal), and 15 min, 30 min, and 1, 2, 3, 4, 6, and 8 hours (post-meal). ]

4.  Secondary:   Change From Baseline in Postprandial AUC(0-8) of Insulin   [ Time Frame: Baseline and Day 11; samples were taken at -15 min and -5 min (pre-meal), and 15 min, 30 min, and 1, 2, 3, 4, 6, and 8 hours (post-meal). ]

5.  Secondary:   Change From Baseline to Day 11 in AUC(0-8) of Appetite Sensation   [ Time Frame: At Baseline and Day 11, every 30 minutes, starting 1 hour before eating until 8 hour after the meal. ]

6.  Secondary:   Change From Baseline to Day 11 in 24-hour Average Plasma Glucose   [ Time Frame: Baseline (Day -1) and Day 11, from 12 AM through 24 hours. ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats


  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: NCT01664624     History of Changes
Other Study ID Numbers: ROF-T2D_107, U1111-1128-6945
Study First Received: August 10, 2012
Results First Received: November 25, 2013
Last Updated: January 22, 2014
Health Authority: United States: Food and Drug Administration