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

This study has been terminated.
(Release of Post Marketing Requirement for this study. Terminated November 2013.)
Sponsor:
ClinicalTrials.gov Identifier:
NCT01525225
First Posted: February 2, 2012
Last Update Posted: June 22, 2015
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
January 31, 2012
February 2, 2012
August 11, 2014
August 26, 2014
June 22, 2015
September 2012
June 2013   (Final data collection date for primary outcome measure)
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.
  • 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 ]
Complete list of historical versions of study NCT01525225 on ClinicalTrials.gov Archive Site
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.
  • 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
Not Provided
Not Provided
 
Study of Saxagliptin, 5-Hydroxy Saxagliptin, and Metformin Concentrations/Levels in Pediatric Subjects With T2DM
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
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
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
Interventional
Phase 1
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Type 2 Diabetes Mellitus
  • 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
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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
4
June 2013
June 2013   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
10 Years to 17 Years   (Child)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01525225
CV181-153
No
Not Provided
Not Provided
AstraZeneca
AstraZeneca
Not Provided
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
AstraZeneca
May 2015

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