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

Phase 1

Terminated

Interventions: Drug: Metformin immediate release (IR)
Drug: Saxagliptin
Drug: Metformin IR
Drug: Saxagliptin/Metformin XR FDC
Drug: Metformin XR

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

Recruitment & Eligibility

Inclusion Criteria

Exclusion Criteria

Arm && Interventions

Group	Intervention	Description
Metformin + Saxagliptin + Saxagliptin/Metformin XR FDC	Metformin IR	-
Metformin + Saxagliptin + Saxagliptin/Metformin XR FDC	Saxagliptin/Metformin XR FDC	-
Metformin + Saxagliptin + Saxagliptin/Metformin XR FDC	Metformin XR	-
Metformin + Saxagliptin + Saxagliptin/Metformin XR FDC	Metformin immediate release (IR)	-
Metformin + Saxagliptin + Saxagliptin/Metformin XR FDC	Saxagliptin	-

Primary Outcome Measures

Name	Time	Method
Number of Participants With Adverse Events (AEs) , Serious Adverse Events (SAEs), AEs Leading to Discontinuation, Death	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.

Secondary Outcome Measures

Name	Time	Method
Number of Participants With Marked Chemistry or Hematology Laboratory Abnormalities	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.

Locations (7): Childrens Hospital Of Pittsburgh Of Upmc
🇺🇸
Pittsburgh, Pennsylvania, United States
Promedica Toledo Children'S Hospital
🇺🇸
Toledo, Ohio, United States
Axis Clinical Trials
🇺🇸
Los Angeles, California, United States
Osborne Research Center
🇺🇸
Little Rock, Arkansas, United States
Promedica Toledo Childrens Hospital
🇺🇸
Toledo, Ohio, United States
The Children'S Mercy Hospital And Clinics
🇺🇸
Kansas City, Missouri, United States
Kosair Charities Pediatric Clinical Research Unit
🇺🇸
Louisville, Kentucky, United States