| Trial ID: | L2259 |
| Source ID: | NCT01525225
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| Associated Drug: |
Metformin Immediate Release (Ir)
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| Title: |
Study of Saxagliptin, 5-Hydroxy Saxagliptin, and Metformin Concentrations/Levels in Pediatric Subjects With T2DM
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| Acronym: |
|
| Status: |
TERMINATED
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| Study Results: |
YES
|
| Results: |
https://ClinicalTrials.gov/show/NCT01525225/results
|
| Conditions: |
Type 2 Diabetes Mellitus
|
| Interventions: |
DRUG: Metformin immediate release (IR)|DRUG: Saxagliptin|DRUG: Metformin IR|DRUG: Saxagliptin/Metformin XR FDC|DRUG: Metformin XR
|
| Outcome Measures: |
Primary: 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., Day 1 up to Day 8, plus 30 days | Secondary: 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., Day 1 to Day 8
|
| Sponsor/Collaborators: |
Sponsor: AstraZeneca
|
| Gender: |
ALL
|
| Age: |
CHILD
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| Phases: |
PHASE1
|
| Enrollment: |
4
|
| Study Type: |
INTERVENTIONAL
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| Study Designs: |
Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose:
|
| Start Date: |
2012-09
|
| Completion Date: |
2013-06
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| Results First Posted: |
2014-08-26
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| Last Update Posted: |
2015-06-22
|
| Locations: |
Osborne Research Center, Little Rock, Arkansas, 72201, United States|Axis Clinical Trials, Los Angeles, California, 90036, United States|Kosair Charities Pediatric Clinical Research Unit, Louisville, Kentucky, 40202, United States|The Children'S Mercy Hospital And Clinics, Kansas City, Missouri, 64108, United States|Promedica Toledo Children'S Hospital, Toledo, Ohio, 43606, United States|Promedica Toledo Childrens Hospital, Toledo, Ohio, 43606, United States|Childrens Hospital Of Pittsburgh Of Upmc, Pittsburgh, Pennsylvania, 15224, United States
|
| URL: |
https://clinicaltrials.gov/show/NCT01525225
|
