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

Phase 1TerminatedNCT01525225

AstraZeneca4 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

Masking

NONE

Enrollment

Conditions

Type 2 Diabetes Mellitus

Interventions

Metformin immediate release (IR)DRUG

Tablet, Oral, 1000 mg, twice daily, 1 day

SaxagliptinDRUG

Tablet, Oral, 5 mg, single-dose, 1 day

Metformin IRDRUG

Tablet, Oral, 1000 mg, twice daily, 5 days

Eligibility

Sex: ALLMin age: 10 YearsMax age: 17 Years

Medical Language ↔ Plain English

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

Locations (7)

Osborne Research Center

Little Rock, Arkansas, United States

Axis Clinical Trials

Los Angeles, California, United States

Kosair Charities Pediatric Clinical Research Unit

Louisville, Kentucky, United States

The Children'S Mercy Hospital And Clinics

Kansas City, Missouri, United States

Outcomes

Primary Outcomes

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

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

Secondary Outcomes

Number of Participants With Marked Chemistry or Hematology Laboratory Abnormalities

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

Data from ClinicalTrials.gov

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