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

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ClinicalTrials.gov Identifier: NCT01204775
Recruitment Status : Completed
First Posted : September 17, 2010
Results First Posted : April 18, 2017
Last Update Posted : April 18, 2017
Sponsor:
Information provided by (Responsible Party):
AstraZeneca

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)
Enrollment 26
Recruitment Details  
Pre-assignment Details Of 26 subjects enrolled, 12 subjects entered the lead in period. Of these 12 subjects, 8 subjects were randomized
Arm/Group Title Saxagliptin Placebo
Hide Arm/Group Description Saxagliptin 2.5 mg or 5 mg depending on body weight Placebo matching saxagliptin
Period Title: Overall Study
Started 4 4
Double-blind Treatment Period 4 4
Completed 3 3
Not Completed 1 1
Reason Not Completed
Poor/non-compliance             0             1
Withdrawal by Subject             1             0
Arm/Group Title Saxagliptin Placebo Total
Hide Arm/Group Description Saxagliptin 2.5 mg or 5 mg depending on body weight Placebo matching saxagliptin Total of all reporting groups
Overall Number of Baseline Participants 4 4 8
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 4 participants 4 participants 8 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  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 4 participants 4 participants 8 participants
Female
1
  25.0%
3
  75.0%
4
  50.0%
Male
3
  75.0%
1
  25.0%
4
  50.0%
1.Primary Outcome
Title Mean Change in HbA1c From Baseline to Week 16
Hide Description [Not Specified]
Time Frame 16 week short term treatment period
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Saxagliptin Placebo
Hide Arm/Group Description:
Saxagliptin 2.5 mg or 5 mg depending on body weight
Placebo matching saxagliptin
Overall Number of Participants Analyzed 4 4
Mean (Standard Deviation)
Unit of Measure: percentage
-0.7  (0.83) 0.6  (1.53)
Time Frame 52 week
Adverse Event Reporting Description 16 week double-blind treatment period and 36 week long-term extension period
 
Arm/Group Title Placebo Saxagliptin
Hide Arm/Group Description Placebo matching saxagliptin Saxagliptin 2.5 mg or 5 mg depending on body weight
All-Cause Mortality
Placebo Saxagliptin
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Hide Serious Adverse Events
Placebo Saxagliptin
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/4 (25.00%)      0/4 (0.00%)    
Infections and infestations     
Pneumonia *  1/4 (25.00%)  1 0/4 (0.00%)  0
*
Indicates events were collected by non-systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Placebo Saxagliptin
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   3/4 (75.00%)      3/4 (75.00%)    
Blood and lymphatic system disorders     
LYMPHADENOPATHY *  1/4 (25.00%)  0/4 (0.00%) 
Eye disorders     
VISION BLURRED *  1/4 (25.00%)  0/4 (0.00%) 
Gastrointestinal disorders     
DIARRHOEA *  0/4 (0.00%)  1/4 (25.00%) 
VOMITING *  0/4 (0.00%)  1/4 (25.00%) 
ABDOMINAL PAIN *  1/4 (25.00%)  0/4 (0.00%) 
GASTROOESOPHAGEAL REFLUX DISEASE *  1/4 (25.00%)  0/4 (0.00%) 
General disorders     
PERIPHERAL SWELLING *  1/4 (25.00%)  0/4 (0.00%) 
Infections and infestations     
VIRAL UPPER RESPIRATORY TRACT INFECTION *  0/4 (0.00%)  1/4 (25.00%) 
UPPER RESPIRATORY TRACT INFECTION *  1/4 (25.00%)  1/4 (25.00%) 
INFLUENZA *  1/4 (25.00%)  0/4 (0.00%) 
Injury, poisoning and procedural complications     
FALL *  0/4 (0.00%)  1/4 (25.00%) 
THERMAL BURN *  1/4 (25.00%)  0/4 (0.00%) 
LACERATION *  1/4 (25.00%)  0/4 (0.00%) 
Metabolism and nutrition disorders     
HYPERNATRAEMIA *  0/4 (0.00%)  1/4 (25.00%) 
Musculoskeletal and connective tissue disorders     
JOINT SWELLING *  1/4 (25.00%)  0/4 (0.00%) 
Nervous system disorders     
Headache   1/4 (25.00%)  1/4 (25.00%) 
Renal and urinary disorders     
POLLAKIURIA *  1/4 (25.00%)  0/4 (0.00%) 
Respiratory, thoracic and mediastinal disorders     
OROPHARYNGEAL PAIN   1/4 (25.00%)  2/4 (50.00%) 
COUGH   1/4 (25.00%)  1/4 (25.00%) 
EPISTAXIS *  1/4 (25.00%)  0/4 (0.00%) 
NASAL CONGESTION *  1/4 (25.00%)  0/4 (0.00%) 
WHEEZING *  1/4 (25.00%)  0/4 (0.00%) 
Skin and subcutaneous tissue disorders     
ACNE   0/4 (0.00%)  1/4 (25.00%) 
ONYCHOLYSIS *  0/4 (0.00%)  1/4 (25.00%) 
HYPERHIDROSIS *  1/4 (25.00%)  0/4 (0.00%) 
ERYTHEMA *  1/4 (25.00%)  0/4 (0.00%) 
Indicates events were collected by systematic assessment
*
Indicates events were collected by non-systematic assessment
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
Layout table for Results Point of Contact information
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
EMail: Eva.Johnsson@astrazeneca.com
Layout table for additonal information
Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT01204775    
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