NCT01525225|TerminatedPhase 1Results

Study Stopped

Release of Post Marketing Requirement for this study. Terminated November 2013.

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

AstraZeneca ClinicalTrials.gov

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1 other identifier

CV181-153

Study Type

interventional

Target

Locations

1 country

Sites

Timeline

RegisteredFeb 2012

StartedSep 2012

CompletionJun 2013

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

Trial Health

Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

participants targeted

Target at below P25 for phase_1 type-2-diabetes-mellitus

Timeline

Completed

Started Sep 2012

Typical duration for phase_1 type-2-diabetes-mellitus

Geographic Reach

1 country

7 active sites

Status

terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

9 months study duration

First Submitted

Initial submission to the registry

January 31, 2012

Completed

2 days until next milestone

First Posted

Study publicly available on registry

February 2, 2012

Completed

7 months until next milestone

Study Start

First participant enrolled

September 1, 2012

Completed

9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2013

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2013

Completed

1.2 years until next milestone

Results Posted

Study results publicly available

August 26, 2014

Completed

Last Updated

June 22, 2015

Status Verified

May 1, 2015

Enrollment Period

9 months

First QC Date

January 31, 2012

Results QC Date

August 11, 2014

Last Update Submit

May 27, 2015

Conditions

Type 2 Diabetes Mellitus

Outcome Measures

Primary Outcomes (1)

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 Outcomes (1)

Number of Participants With Marked Chemistry or Hematology Laboratory Abnormalities
Day 1 to Day 8

Study Arms (1)

Metformin + Saxagliptin + Saxagliptin/Metformin XR FDC

EXPERIMENTAL

Drug: Metformin immediate release (IR)Drug: SaxagliptinDrug: Metformin IRDrug: Saxagliptin/Metformin XR FDCDrug: Metformin XR