Dipeptidyl Peptidase-4 Inhibitors and Alpha-cell Recovery (DARE)

This study has been completed.
Sponsor:
Collaborator:
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
F Holleman, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
ClinicalTrials.gov Identifier:
NCT01272583
First received: January 5, 2011
Last updated: February 14, 2014
Last verified: February 2014
Results First Received: October 15, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator)
Conditions: Type 1 Diabetes
Hypoglycemia
Interventions: Drug: Sitagliptin
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 came to the Academic Medical Center in Amsterdam for a screening visit to determine eligibility for the study.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Patients were excluded if they were found to have impaired awareness of hypoglycaemia, had a history of seizures, cardiac arrhythmia (or used beta-adrenoreceptor blockers) and/or acute infection in the 12 weeks before the study, or evidence of severe diabetes complications (autonomic neuropathy, nephropathy or proliferative retinopathy).

Reporting Groups
  Description
Sequence A (Sitagliptin→Placebo)

Cross-over, both arms reveived the same intervention in different order.

Sitagliptin : 100 mg once daily for six weeks

Placebo : placebo, once daily for six weeks

Sequence B (Placebo→Sitagliptin)

Cross-over, both arms reveived the same intervention in different order.

Sitagliptin : 100 mg once daily for six weeks

Placebo : placebo, once daily for six weeks


Participant Flow:   Overall Study
    Sequence A (Sitagliptin→Placebo)     Sequence B (Placebo→Sitagliptin)  
STARTED     8     8  
COMPLETED     8     8  
NOT COMPLETED     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
Sequence A (Sitagliptin→Placebo)

Cross-over, both arms reveived the same intervention in different order.

Sitagliptin : 100 mg once daily for six weeks

Placebo : placebo, once daily for six weeks

Sequence B (Placebo→Sitagliptin)

Cross-over, both arms reveived the same intervention in different order.

Sitagliptin : 100 mg once daily for six weeks

Placebo : placebo, once daily for six weeks

Total Total of all reporting groups

Baseline Measures
    Sequence A (Sitagliptin→Placebo)     Sequence B (Placebo→Sitagliptin)     Total  
Number of Participants  
[units: participants]
  8     8     16  
Age  
[units: years]
Median ( Inter-Quartile Range )
  30.5  
  ( 26.3 to 39 )  
  33.5  
  ( 27.8 to 40.8 )  
  31.5  
  ( 27.0 to 40.0 )  
Gender  
[units: participants]
     
Female     0     0     0  
Male     8     8     16  
Region of Enrollment  
[units: participants]
     
Netherlands     8     8     16  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Glucagon Response to Acute Hypoglycaemia   [ Time Frame: Change from initialisation phase to 40 minutes after onset of hypoglycaemia ]

2.  Primary:   Glucagon Response to Acute Hypoglycaemia   [ Time Frame: 0, 10, 20 and 40 minutes ]

3.  Secondary:   Intact and Total Glucagon Like Peptide-1 (GLP-1), Intact and Total Gastric Inhibitory Peptide (GIP) Response to Acute Hypoglycaemia   [ Time Frame: 0, 10, 20, 40 minutes ]

4.  Secondary:   Epinephrine Response to Acute Hypoglycaemia   [ Time Frame: 0, 10, 20, 40 minutes ]

5.  Secondary:   Norepinephrine Response to Acute Hypoglycaemia   [ Time Frame: 0, 10, 20, 40 minutes ]

6.  Secondary:   Growth Hormone Response to Acute Hypoglycaemia   [ Time Frame: 0, 10, 20, 40 minutes ]

7.  Secondary:   Cortisol Response to Acute Hypoglycaemia   [ Time Frame: 0, 10, 20, 40 minutes ]

8.  Secondary:   Symptomatic Hormone Responses to Acute Hypoglycaemia.   [ Time Frame: Change from baseline symptomatic response at hypoglycaemia and 30 minutes after hypoglycaemia ]


  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
No text entered.


  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 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.
unchecked Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Dr. Josefine E. Schopman
Organization: Academic Medical Center
phone: +31 20 5669111
e-mail: j.e.schopman@amc.uva.nl


No publications provided


Responsible Party: F Holleman, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
ClinicalTrials.gov Identifier: NCT01272583     History of Changes
Other Study ID Numbers: DARE_2010
Study First Received: January 5, 2011
Results First Received: October 15, 2013
Last Updated: February 14, 2014
Health Authority: Netherlands: Medical Ethics Review Committee (METC)
Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)