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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

Tracking Information
First Submitted Date  ICMJE January 31, 2012
First Posted Date  ICMJE February 2, 2012
Results First Submitted Date  ICMJE August 11, 2014
Results First Posted Date  ICMJE August 26, 2014
Last Update Posted Date June 22, 2015
Study Start Date  ICMJE September 2012
Actual Primary Completion Date June 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 11, 2014)
Number of Participants With Adverse Events (AEs) , Serious Adverse Events (SAEs), AEs Leading to Discontinuation, Death [ Time Frame: Day 1 up to Day 8, plus 30 days ]
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.
Original Primary Outcome Measures  ICMJE
 (submitted: January 31, 2012)
  • Maximum observed plasma concentration (Cmax) of Saxagliptin [ Time Frame: Day 1 ]
  • Maximum observed plasma concentration (Cmax) of Saxagliptin [ Time Frame: Day 2 ]
  • Maximum observed plasma concentration (Cmax) of Saxagliptin [ Time Frame: Day 7 ]
  • Maximum observed plasma concentration (Cmax) of Saxagliptin [ Time Frame: Day 8 ]
  • Area under the plasma concentration-time curve from time zero to 24 hours [AUC(0-24)] of Saxagliptin [ Time Frame: Day 1 ]
  • Area under the plasma concentration-time curve from time zero to 24 hours [AUC(0-24)] of Saxagliptin [ Time Frame: Day 2 ]
  • Area under the plasma concentration-time curve from time zero to 24 hours [AUC(0-24)] of Saxagliptin [ Time Frame: Day 7 ]
  • Area under the plasma concentration-time curve from time zero to 24 hours [AUC(0-24)] of Saxagliptin [ Time Frame: Day 8 ]
  • Area under the plasma concentration-time curve from time zero extrapolated to infinite time [AUC(INF)] of Saxagliptin [ Time Frame: Day 1 ]
  • Area under the plasma concentration-time curve from time zero extrapolated to infinite time [AUC(INF)] of Saxagliptin [ Time Frame: Day 2 ]
  • Area under the plasma concentration-time curve from time zero extrapolated to infinite time [AUC(INF)] of Saxagliptin [ Time Frame: Day 7 ]
  • Area under the plasma concentration-time curve from time zero extrapolated to infinite time [AUC(INF)] of Saxagliptin [ Time Frame: Day 8 ]
  • Maximum observed plasma concentration (Cmax) of 5-hydroxy Saxagliptin [ Time Frame: Day 1 ]
  • Maximum observed plasma concentration (Cmax) of 5-hydroxy Saxagliptin [ Time Frame: Day 2 ]
  • Maximum observed plasma concentration (Cmax) of 5-hydroxy Saxagliptin [ Time Frame: Day 7 ]
  • Maximum observed plasma concentration (Cmax) of 5-hydroxy Saxagliptin [ Time Frame: Day 8 ]
  • Area under the plasma concentration-time curve from time zero to 24 hours [AUC(0-24)] of 5-hydroxy Saxagliptin [ Time Frame: Day 1 ]
  • Area under the plasma concentration-time curve from time zero to 24 hours [AUC(0-24)] of 5-hydroxy Saxagliptin [ Time Frame: Day 2 ]
  • Area under the plasma concentration-time curve from time zero to 24 hours [AUC(0-24)] of 5-hydroxy Saxagliptin [ Time Frame: Day 7 ]
  • Area under the plasma concentration-time curve from time zero to 24 hours [AUC(0-24)] of 5-hydroxy Saxagliptin [ Time Frame: Day 8 ]
  • Area under the plasma concentration-time curve from time zero extrapolated to infinite time [AUC(INF)] of 5-hydroxy Saxagliptin [ Time Frame: Day 1 ]
  • Area under the plasma concentration-time curve from time zero extrapolated to infinite time [AUC(INF)] of 5-hydroxy Saxagliptin [ Time Frame: Day 2 ]
  • Area under the plasma concentration-time curve from time zero extrapolated to infinite time [AUC(INF)] of 5-hydroxy Saxagliptin [ Time Frame: Day 7 ]
  • Area under the plasma concentration-time curve from time zero extrapolated to infinite time [AUC(INF)] of 5-hydroxy Saxagliptin [ Time Frame: Day 8 ]
  • Maximum observed plasma concentration (Cmax) of Metformin [ Time Frame: Day 1 ]
  • Maximum observed plasma concentration (Cmax) of Metformin [ Time Frame: Day 2 ]
  • Maximum observed plasma concentration (Cmax) of Metformin [ Time Frame: Day 7 ]
  • Maximum observed plasma concentration (Cmax) of Metformin [ Time Frame: Day 8 ]
  • Area under the plasma concentration-time curve from time zero to 24 hours [AUC(0-24)] of Metformin [ Time Frame: Day 1 ]
  • Area under the plasma concentration-time curve from time zero to 24 hours [AUC(0-24)] of Metformin [ Time Frame: Day 2 ]
  • Area under the plasma concentration-time curve from time zero to 24 hours [AUC(0-24)] of Metformin [ Time Frame: Day 7 ]
  • Area under the plasma concentration-time curve from time zero to 24 hours [AUC(0-24)] of Metformin [ Time Frame: Day 8 ]
  • Area under the plasma concentration-time curve from time zero to 12 hours [AUC(0-12)] of Metformin [ Time Frame: Day 1 ]
  • Area under the plasma concentration-time curve from time zero to 12 hours [AUC(0-12)] of Metformin [ Time Frame: Day 2 ]
  • Area under the plasma concentration-time curve from time zero to 12 hours [AUC(0-12)] of Metformin [ Time Frame: Day 7 ]
  • Area under the plasma concentration-time curve from time zero to 12 hours [AUC(0-12)] of Metformin [ Time Frame: Day 8 ]
Change History Complete list of historical versions of study NCT01525225 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: August 11, 2014)
Number of Participants With Marked Chemistry or Hematology Laboratory Abnormalities [ Time Frame: Day 1 to Day 8 ]
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.
Original Secondary Outcome Measures  ICMJE
 (submitted: January 31, 2012)
  • Safety: based on medical review of adverse event reports and the results of vital sign measurements, ECGs, physical examinations, and clinical laboratory tests [ Time Frame: Up to 8 days ]
  • Formulation swallowability of Saxagliptin-Metformin FDC tablet, Glucophage® IR tablet and Glucophage® XR tablet [ Time Frame: Days 1, Days 7, and Days 8 ]
    Formulation Swallowability: Subjects will respond to a questionnaire regarding their experience swallowing Saxagliptin-Metformin fixed dose combination (FDC) tablet, Glucophage® immediate release (IR) tablet and Glucophage® extended release (XR) tablet. The question regarding ease of swallowability will consist of the following categories for a response: easy, acceptable, difficult, and unable to swallow
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study of Saxagliptin, 5-Hydroxy Saxagliptin, and Metformin Concentrations/Levels in Pediatric Subjects With T2DM
Official Title  ICMJE Evaluation of the Pharmacokinetics of Saxagliptin, 5-Hydroxy Saxagliptin, and Metformin in Children and Adolescents Aged 10 to 17 Years With Type 2 Diabetes Mellitus Following Oral Administration of Saxagliptin and Metformin XR Fixed Dose Combination Tablet and Co-Administration of Saxagliptin and Glucophage® (Metformin) IR Tablets
Brief Summary The purpose of this study is to evaluate the pharmacokinetics of Saxagliptin, 5-hydroxy Saxagliptin, and Metformin in pediatric subjects with Type 2 diabetes mellitus (T2DM) following oral administration of Saxagliptin and Metformin XR fixed dose combination tablet and co-administration of Saxagliptin and Glucophage® (Metformin) IR tablets
Detailed Description The primary purpose is to assess the pharmacokinetics of Saxagliptin, 5-hydroxy Saxagliptin, and Metformin in pediatric subjects aged 10 to 17 years with T2DM following oral administration of Saxagliptin and Metformin XR fixed dose combination tablet and co-administration of Saxagliptin and Glucophage® (Metformin) IR tablets
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Condition  ICMJE Type 2 Diabetes Mellitus
Intervention  ICMJE
  • Drug: Metformin immediate release (IR)
    Tablet, Oral, 1000 mg, twice daily, 1 day
    Other Name: Glucophage® IR
  • Drug: Saxagliptin
    Tablet, Oral, 5 mg, single-dose, 1 day
  • Drug: Metformin IR
    Tablet, Oral, 1000 mg, twice daily, 5 days
    Other Name: Glucophage® IR
  • Drug: Saxagliptin/Metformin XR FDC
    Tablet, Oral, 2.5 mg Saxagliptin/1000 mg Metformin extended release (XR), Single-dose of 2 tablets. Fixed dose combination (FDC).
  • Drug: Metformin XR
    Tablet, Oral, 500 mg, Single-dose of 4 tablets
    Other Name: Glucophage® XR
Study Arms  ICMJE Experimental: Metformin + Saxagliptin + Saxagliptin/Metformin XR FDC
Interventions:
  • Drug: Metformin immediate release (IR)
  • Drug: Saxagliptin
  • Drug: Metformin IR
  • Drug: Saxagliptin/Metformin XR FDC
  • Drug: Metformin XR
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: August 11, 2014)
4
Original Estimated Enrollment  ICMJE
 (submitted: January 31, 2012)
12
Actual Study Completion Date  ICMJE June 2013
Actual Primary Completion Date June 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Clinical diagnosis of T2DM
  • Male and female subjects ages 10-17
  • Body weight ≥50 kg
  • Glycosylated hemoglobin (HbA1c) 6.5 to 10%

Exclusion Criteria:

  • Fasting plasma glucose (FPG) > 240 mg/dL at screening
  • Abnormal renal function
  • Active liver disease and/or significant abnormal liver function
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 10 Years to 17 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01525225
Other Study ID Numbers  ICMJE CV181-153
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party AstraZeneca
Study Sponsor  ICMJE AstraZeneca
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
PRS Account AstraZeneca
Verification Date May 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP