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Study to Evaluate the Efficacy, Safety, Tolerability, and Pharmacokinetics of Saxagliptin as Monotherapy in Pediatric Patients With Type 2 Diabetes

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01204775
First Posted: September 17, 2010
Last Update Posted: April 18, 2017
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):
AstraZeneca
Results First Submitted: March 7, 2017  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Type 2 Diabetes
Interventions: Drug: Saxagliptin
Drug: Placebo (Saxagliptin)
Drug: Metformin IR
Drug: Placebo (Metformin)
Drug: Metformin (Active Rescue)

  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
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Of 26 subjects enrolled, 12 subjects entered the lead in period. Of these 12 subjects, 8 subjects were randomized

Reporting Groups
  Description
Saxagliptin Saxagliptin 2.5 mg or 5 mg depending on body weight
Placebo Placebo matching saxagliptin

Participant Flow:   Overall Study
    Saxagliptin   Placebo
STARTED   4   4 
Double-blind Treatment Period   4   4 
COMPLETED   3   3 
NOT COMPLETED   1   1 
Poor/non-compliance                0                1 
Withdrawal by Subject                1                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
Saxagliptin Saxagliptin 2.5 mg or 5 mg depending on body weight
Placebo Placebo matching saxagliptin
Total Total of all reporting groups

Baseline Measures
   Saxagliptin   Placebo   Total 
Overall Participants Analyzed 
[Units: Participants]
 4   4   8 
Age 
[Units: Participants]
Count of Participants
     
<=18 years      4 100.0%      4 100.0%      8 100.0% 
Between 18 and 65 years      0   0.0%      0   0.0%      0   0.0% 
>=65 years      0   0.0%      0   0.0%      0   0.0% 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      1  25.0%      3  75.0%      4  50.0% 
Male      3  75.0%      1  25.0%      4  50.0% 


  Outcome Measures

1.  Primary:   Mean Change in HbA1c From Baseline to Week 16   [ Time Frame: 16 week short term treatment period ]


  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 NOT 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.


Results Point of Contact:  
Name/Title: Eva Johnsson, Clinical Science Lead, GLOBAL_MEDICINES_DEV
Organization: AstraZeneca AB, S-151 85 Södertälje, Sweden
phone: +46 31 7762484 ext 762 484
e-mail: Eva.Johnsson@astrazeneca.com



Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT01204775     History of Changes
Other Study ID Numbers: CV181-058
2010-020360-38 ( EudraCT Number )
First Submitted: September 16, 2010
First Posted: September 17, 2010
Results First Submitted: March 7, 2017
Results First Posted: April 18, 2017
Last Update Posted: April 18, 2017