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Study of Saxagliptin, 5-Hydroxy Saxagliptin, and Metformin Concentrations/Levels in Pediatric Subjects With T2DM

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ClinicalTrials.gov Identifier: NCT01525225
Recruitment Status : Terminated (Release of Post Marketing Requirement for this study. Terminated November 2013.)
First Posted : February 2, 2012
Results First Posted : August 26, 2014
Last Update Posted : June 22, 2015
Sponsor:
Information provided by (Responsible Party):
AstraZeneca

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label)
Condition Type 2 Diabetes Mellitus
Interventions Drug: Metformin immediate release (IR)
Drug: Saxagliptin
Drug: Metformin IR
Drug: Saxagliptin/Metformin XR FDC
Drug: Metformin XR
Enrollment 4
Recruitment Details Upon approval of Kombiglyze™ XR, the Food and Drug Administration (FDA) required the conduct of this clinical pharmacology study in pediatric patients as a post-marketing requirement (PMR). Study was initiated February 2013. On 14-Nov-13, the FDA issued a letter stating release from this PMR, thus the study was terminated prior to completion.
Pre-assignment Details A total of 4 participants were enrolled. Two participants were treated and completed the study prior to the termination of the study.
Arm/Group Title Metformin + Saxagliptin + Saxagliptin/Metformin XR FDC
Hide Arm/Group Description Each participant received one dose of a 5 mg saxagliptin tablet once a day (QD) and a 1000 mg Glucophage® immediate release (IR) tablet twice a day (BID) on Day 1. On Days 2 through 6, participants received a 1000 mg tablet of Glucophage® IR BID, and on Day 7, participants received one dose of two 2.5 mg saxagliptin/1000 mg metformin extended release (XR) fixed dose combination (FDC) tablets. Finally, on Day 8 participants received four 500 mg Glucophage® IR tablets QD. All study drugs were administered with food.
Period Title: Enrollment
Started 4
Completed 2
Not Completed 2
Reason Not Completed
No longer met study criteria             1
Not Specified             1
Period Title: Treated
Started 2
Completed 2
Not Completed 0
Arm/Group Title Metformin + Saxagliptin + Saxagliptin/Metformin XR FDC
Hide Arm/Group Description Each participant received one dose of a 5 mg saxagliptin tablet once a day (QD) and a 1000 mg Glucophage® IR tablet twice a day (BID) on Day 1. On Days 2 through 6, participants received a 1000 mg tablet of Glucophage® IR BID, and on Day 7, participants received one dose of two 2.5 mg saxagliptin/1000 mg metformin XR FDC tablets. Finally, on Day 8 participants received four 500 mg Glucophage® IR tablets QD. All study drugs were administered with food.
Overall Number of Baseline Participants 2
Hide Baseline Analysis Population Description
All participants who received at least one dose of study drug.
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 2 participants
13.0
(10.0 to 16.0)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 2 participants
Female
2
 100.0%
Male
0
   0.0%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 2 participants
Black/African American 1
White 1
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 2 participants
2
1.Primary Outcome
Title Number of Participants With Adverse Events (AEs) , Serious Adverse Events (SAEs), AEs Leading to Discontinuation, Death
Hide Description AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Treatment-related=having certain, probable, possible, or missing relationship to study drug.
Time Frame Day 1 up to Day 8, plus 30 days
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received at least one dose of study drug.
Arm/Group Title Metformin + Saxagliptin + Saxagliptin/Metformin XR FDC
Hide Arm/Group Description:
Each participant received one dose of a 5 mg saxagliptin tablet once a day (QD) and a 1000 mg Glucophage® IR tablet twice a day (BID) on Day 1. On Days 2 through 6, participants received a 1000 mg tablet of Glucophage® IR BID, and on Day 7, participants received one dose of two 2.5 mg saxagliptin/1000 mg metformin XR FDC tablets. Finally, on Day 8 participants received four 500 mg Glucophage® IR tablets QD. All study drugs were administered with food.
Overall Number of Participants Analyzed 2
Measure Type: Number
Unit of Measure: participants
AE 2
Treatment-Related AE 1
AE Leading to Discontinuation 0
SAE 0
Death 0
2.Secondary Outcome
Title Number of Participants With Marked Chemistry or Hematology Laboratory Abnormalities
Hide Description Lower limit of normal (LLN); upper limit of normal (ULN); treatment (RX); pre-treatment (Pre-Rx); units per liter (U/L); millimoles per liter (mmol/L). Alkaline phosphatase U/L:>1.25*Pre-RX if Pre-RX >ULN or >1.25*ULN if Pre-RX <=ULN; aspartate aminotransferase U/L: >1.25*Pre-RX if Pre-RX>ULN or 1.25*ULN if Pre-RX<=ULN;alanine aminotransferase U/L: >1.25*Pre-RX if Pre-RX>ULN or 1.25*ULN if Pre-RX<=ULN;blood urea nitrogen mmol/L: >1.1*ULN if Pre-RX <=ULN or >1.2*Pre-RX if Pre-RX >ULN; total bilirubin µmol/L: >1.1*ULN if Pre-RX <=ULN or >1.25*Pre-RX if Pre-RX >ULN; creatine phosphokinase U/L: >1.5*Pre-RX if Pre-RX>ULN or >1.5*ULN if Pre-RX <= ULN. Grams per liter (g/L); cells per liter (c/L). Hemoglobin (g/L): <0.85* pre-RX; hematocrit (%): <0.85*pre-RX;erythrocytes (*10^12 c/L): <0.85*pre-RX; platelet count (*10^9 c/L): <0.85*LLN if pre-RX>=LLN, or if Pre-Tx <LLN; leukocytes (*10^9 c/L): <0.85*LLN if pre-RX <LLN,or <0.9*LLN if LLN<=Pre-RX<=ULN.
Time Frame Day 1 to Day 8
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who received at least one dose of study drug.
Arm/Group Title Metformin + Saxagliptin + Saxagliptin/Metformin XR FDC
Hide Arm/Group Description:
Each participant received one dose of a 5 mg saxagliptin tablet once a day (QD) and a 1000 mg Glucophage® IR tablet twice a day (BID) on Day 1. On Days 2 through 6, participants received a 1000 mg tablet of Glucophage® IR BID, and on Day 7, participants received one dose of two 2.5 mg saxagliptin/1000 mg metformin XR FDC tablets. Finally, on Day 8 participants received four 500 mg Glucophage® IR tablets QD. All study drugs were administered with food.
Overall Number of Participants Analyzed 2
Measure Type: Number
Unit of Measure: participants
0
Time Frame Day 1 up to Day 8, plus 30 days.
Adverse Event Reporting Description Study initiated February 2013 and was terminated November 2013. Last patient, last visit was June 2013.
 
Arm/Group Title Metformin + Saxagliptin + Saxagliptin/Metformin XR FDC
Hide Arm/Group Description Each participant received one dose of a 5 mg saxagliptin tablet once a day (QD) and a 1000 mg Glucophage® IR tablet twice a day (BID) on Day 1. On Days 2 through 6, participants received a 1000 mg tablet of Glucophage® IR BID, and on Day 7, participants received one dose of two 2.5 mg saxagliptin/1000 mg metformin XR FDC tablets. Finally, on Day 8 participants received four 500 mg Glucophage® IR tablets QD. All study drugs were administered with food.
All-Cause Mortality
Metformin + Saxagliptin + Saxagliptin/Metformin XR FDC
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Metformin + Saxagliptin + Saxagliptin/Metformin XR FDC
Affected / at Risk (%)
Total   0/2 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Metformin + Saxagliptin + Saxagliptin/Metformin XR FDC
Affected / at Risk (%)
Total   2/2 (100.00%) 
Nervous system disorders   
Headache * 1  2/2 (100.00%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 16.1
Due to the small number of participants (2), the primary endpoints, pharmacokinetic parameters, were not calculated.
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.
Bristol-Myers Squibb Co. agreements with investigators vary; constant is our right to embargo communications regarding trial results prior to public release for a period ≤60 days from submittal for review. We will not prohibit investigators from publishing, but will prohibit the disclosure of previously undisclosed confidential information other than study results, and request postponement of single-center publications until after disclosure of the clinical trial's primary publication.
Results Point of Contact
Name/Title: Bristol-Myers Squibb Study Director
Organization: Bristol-Myers Squibb
Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT01525225     History of Changes
Other Study ID Numbers: CV181-153
First Submitted: January 31, 2012
First Posted: February 2, 2012
Results First Submitted: August 11, 2014
Results First Posted: August 26, 2014
Last Update Posted: June 22, 2015