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Terminated Phase 1 Interventional Results available

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

ClinicalTrials.gov ID: NCT01525225

Public ClinicalTrials.gov record NCT01525225. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced May 7, 2026, 1:19 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

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

Study identification

NCT ID
NCT01525225
Recruitment status
Terminated
Study type
Interventional
Phase
Phase 1
Lead sponsor
AstraZeneca
Industry
Enrollment
4 participants

Conditions and interventions

Interventions

  • Metformin IR Drug
  • Metformin XR Drug
  • Metformin immediate release (IR) Drug
  • Saxagliptin Drug
  • Saxagliptin/Metformin XR FDC Drug

Drug

Eligibility (public fields only)

Age range
10 Years to 17 Years
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Aug 31, 2012
Primary completion
May 31, 2013
Completion
May 31, 2013
Last update posted
Jun 21, 2015

2012 – 2013

United States locations

U.S. sites
7
U.S. states
6
U.S. cities
6
Facility City State ZIP Site status
Osborne Research Center Little Rock Arkansas 72201
Axis Clinical Trials Los Angeles California 90036
Kosair Charities Pediatric Clinical Research Unit Louisville Kentucky 40202
The Children'S Mercy Hospital And Clinics Kansas City Missouri 64108
Promedica Toledo Children'S Hospital Toledo Ohio 43606
Promedica Toledo Childrens Hospital Toledo Ohio 43606
Childrens Hospital Of Pittsburgh Of Upmc Pittsburgh Pennsylvania 15224

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT01525225, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Jun 21, 2015 · Synced May 7, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT01525225 live on ClinicalTrials.gov.

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