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Release of Post Marketing Requirement for this study. Terminated November 2013.
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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Metformin + Saxagliptin + Saxagliptin/Metformin XR FDC | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Metformin immediate release (IR) | Drug | Tablet, Oral, 1000 mg, twice daily, 1 day |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 \ |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bristol-Myers Squibb | Bristol-Myers Squibb | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Osborne Research Center | Little Rock | Arkansas | 72201 | United States | ||
| Axis Clinical Trials |
A total of 4 participants were enrolled. Two participants were treated and completed the study prior to the termination of the study.
Upon approval of Kombiglyze™ XR, the Food and Drug Administration (FDA) required the conduct of this clinical pharmacology study in pediatric patients as a post-marketing requirement (PMR). Study was initiated February 2013. On 14-Nov-13, the FDA issued a letter stating release from this PMR, thus the study was terminated prior to completion.
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| ID | Title | Description |
|---|---|---|
| FG000 | Metformin + Saxagliptin + Saxagliptin/Metformin XR FDC | Each participant received one dose of a 5 mg saxagliptin tablet once a day (QD) and a 1000 mg Glucophage® immediate release (IR) tablet twice a day (BID) on Day 1. On Days 2 through 6, participants received a 1000 mg tablet of Glucophage® IR BID, and on Day 7, participants received one dose of two 2.5 mg saxagliptin/1000 mg metformin extended release (XR) fixed dose combination (FDC) tablets. Finally, on Day 8 participants received four 500 mg Glucophage® IR tablets QD. All study drugs were administered with food. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Enrollment |
|
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| Saxagliptin | Drug | Tablet, Oral, 5 mg, single-dose, 1 day |
|
| Metformin IR | Drug | Tablet, Oral, 1000 mg, twice daily, 5 days |
|
|
| Saxagliptin/Metformin XR FDC | Drug | Tablet, Oral, 2.5 mg Saxagliptin/1000 mg Metformin extended release (XR), Single-dose of 2 tablets. Fixed dose combination (FDC). |
|
| Metformin XR | Drug | Tablet, Oral, 500 mg, Single-dose of 4 tablets |
|
|
| Day 1 to Day 8 |
| 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 |
| COMPLETED |
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| NOT COMPLETED |
|
|
| Treated |
|
All participants who received at least one dose of study drug.
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| ID | Title | Description |
|---|---|---|
| BG000 | Metformin + Saxagliptin + Saxagliptin/Metformin XR FDC | Each participant received one dose of a 5 mg saxagliptin tablet once a day (QD) and a 1000 mg Glucophage® IR tablet twice a day (BID) on Day 1. On Days 2 through 6, participants received a 1000 mg tablet of Glucophage® IR BID, and on Day 7, participants received one dose of two 2.5 mg saxagliptin/1000 mg metformin XR FDC tablets. Finally, on Day 8 participants received four 500 mg Glucophage® IR tablets QD. All study drugs were administered with food. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median | Full Range | years |
| ||||||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| |||||||||||||||||||||||
| Race/Ethnicity, Customized | Number | participants |
| |||||||||||||||||||||||
| Region of Enrollment | Number | participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | All participants who received at least one dose of study drug. | Posted | Number | participants | 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 \ | Participants who received at least one dose of study drug. | Posted | Number | participants | Day 1 to Day 8 |
|
Day 1 up to Day 8, plus 30 days.
Study initiated February 2013 and was terminated November 2013. Last patient, last visit was June 2013.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Metformin + Saxagliptin + Saxagliptin/Metformin XR FDC | Each participant received one dose of a 5 mg saxagliptin tablet once a day (QD) and a 1000 mg Glucophage® IR tablet twice a day (BID) on Day 1. On Days 2 through 6, participants received a 1000 mg tablet of Glucophage® IR BID, and on Day 7, participants received one dose of two 2.5 mg saxagliptin/1000 mg metformin XR FDC tablets. Finally, on Day 8 participants received four 500 mg Glucophage® IR tablets QD. All study drugs were administered with food. | 0 | 2 | 2 | 2 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Headache | Nervous system disorders | MedDRA 16.1 | Non-systematic Assessment |
|
Due to the small number of participants (2), the primary endpoints, pharmacokinetic parameters, were not calculated.
Bristol-Myers Squibb Co. agreements with investigators vary; constant is our right to embargo communications regarding trial results prior to public release for a period ≤60 days from submittal for review. We will not prohibit investigators from publishing, but will prohibit the disclosure of previously undisclosed confidential information other than study results, and request postponement of single-center publications until after disclosure of the clinical trial's primary publication.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Bristol-Myers Squibb Study Director | Bristol-Myers Squibb | Clinical.Trials@bms.com |
| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| D008687 | Metformin |
| C502994 | saxagliptin |
| ID | Term |
|---|---|
| D001645 | Biguanides |
| D006146 | Guanidines |
| D000578 | Amidines |
| D009930 | Organic Chemicals |
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| Title | Measurements |
|---|---|
|
| SAE |
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| Death |
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