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Study to Evaluate the Efficacy, Safety, Tolerability, and Pharmacokinetics of Saxagliptin as Monotherapy in Pediatric Patients With Type 2 Diabetes | Clinical Trials | Clareo Health

COMPLETEDPHASE3

Study to Evaluate the Efficacy, Safety, Tolerability, and Pharmacokinetics of Saxagliptin as Monotherapy in Pediatric Patients With Type 2 Diabetes

A Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy, Safety, Tolerability, and Pharmacokinetics of Saxagliptin (BMS-477118) as Monotherapy in Pediatric Patients With Type 2 Diabetes

NCT01204775•AstraZeneca

View on ClinicalTrials.gov

Summary

The purpose of this study is to evaluate the efficacy, safety, tolerability, of Saxagliptin in pediatric patients with type 2 diabetes.

Eligibility

Age

10 - 17 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•HbA1c ≥7.0% and ≤10.5%
•Body weight ≥ 30 kg.
•BMI \> 85th percentile
•Age and Reproductive Status a) Women of childbearing potential (WOCBP) and men must be using an acceptable method of contraception to avoid pregnancy throughout the study and for up to 4 weeks after the last dose of investigational product in such a manner that the risk of pregnancy is minimized. The decision for appropriate methods to prevent pregnancy should be determined by discussions between the investigator and the study subject.
•b) WOCBP must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of HCG) within 72 hours prior to the start of investigational product. c) Women must not be breastfeeding. d) Sexually active fertile men must use effective birth control if their partners are WOCBP.

Exclusion Criteria

•1. Target Disease Exceptions
•a) Current use of the following medications for the treatment of diabetes, or use within the specified timeframe prior to screening for the study: i) Six months: insulin. ii) Four months: thiazolidinediones. iii) Two months: any other antidiabetic treatment iv) Any previous use of DPP4-inhibitor and/or incretin mimetics b) Current use of prescription or non-prescription weight loss drugs and their use within 3 months of screening.
•2. Medical History and Concurrent Diseases
•a) Significant co-morbidity that, in the opinion of the investigators would preclude participation in the study (eg, current treatment for cancer). b) Previous diagnosis of monogenic etiology of type 2 diabetes such as MODY (maturity onset of diabetes in youth) or secondary diabetes (steroid use, Cushing's disease, acromegaly). c) Significant cardiovascular history. d) History of hemoglobinopathies (sickle cell anemia or thalassemias, sideroblastic anemia). e) History of unstable or rapidly progressive renal disease. f) History of alcohol or drug abuse. g) Psychiatric or cognitive disorder that will, in the opinion of investigators, limit the patient's ability to comply with the study medications and monitoring. h) Administration of any other study drug or participation in a clinical research trial within 30 days of planned enrollment to this study (or a longer period if dictated by local regulatory authorities). i) Any condition, which in the investigator's opinion may render the subject unable to complete the study or may pose significant risk to the subject. j) Immunocompromised individuals such as subjects that have undergone organ transplantation or subjects diagnosed with human immunodeficiency virus. k) Subjects on a commercial weight loss program with ongoing weight loss, or on an intensive exercise program.
•3. Physical and Laboratory Test Findings a) Fasting plasma glucose (FPG) \> 255 mg/dL (14.2 mmol/L) at screening will exclude the patient. b) Diabetic ketoacidosis (DKA) within 6 months of study entr1) Target Disease Exceptions a) Current use of the following medications : i) Six months: insulin. ii) Four months: thiazolidinediones. iii) Two months: any other antidiabetic treatment iv) Any previous use of DPP4-inhibitor and/or incretin mimetics b) Current use of prescription or non-prescription weight loss drugs and their use within 3 months of screening.
•2\) Medical History and Concurrent Diseases
•a) Significant co-morbidity that, in the opinion of the investigators would preclude participation in the study (eg, current treatment for cancer). b) Previous diagnosis of monogenic etiology of type 2 diabetes such as MODY (maturity onset of diabetes in youth) or secondary diabetes (steroid use, Cushing's disease, acromegaly). c) Significant cardiovascular history. d) History of hemoglobinopathies (sickle cell anemia or thalassemias, sideroblastic anemia). e) History of unstable or rapidly progressive renal disease. f) History of alcohol or drug abuse. g) Psychiatric or cognitive disorder that will, in the opinion of investigators, limit the patient's ability to comply with the study medications and monitoring. h) Administration of any other study drug or participation in a clinical research trial within 30 days of planned enrollment to this study (or a longer period if dictated by local regulatory authorities). i) Any condition, which in the investigator's opinion may render the subject unable to complete the study or may pose significant risk to the subject. j) Immunocompromised individuals such as subjects that have undergone organ transplantation or subjects diagnosed with human immunodeficiency virus. k) Subjects on a commercial weight loss program with ongoing weight loss, or on an intensive exercise program. 3) Physical and Laboratory Test Findings
•1. Fasting plasma glucose (FPG) \> 255 mg/dL (14.2 mmol/L) at screening
•2. Diabetic ketoacidosis (DKA) within 6 months of study entry (DKA can occur as a presenting sign of type 2 diabetes in youth).
•3. Abnormal renal function, which is defined as an abnormal creatinine clearance rate as determined by the Schwartz Formula
+7 more criteria

Locations (16)

Research Site

Los Angeles, California, United States

Research Site

San Diego, California, United States

Research Site

Hollywood, Florida, United States

Research Site

Tallahassee, Florida, United States

Research Site

Tampa, Florida, United States

Research Site

Dearborn, Michigan, United States

Research Site

Buffalo, New York, United States

Research Site

Memphis, Tennessee, United States

Research Site

Richmond, Virginia, United States

Research Site

Moscow, Russia

Key Dates

Start Date

June 1, 2011

Primary Completion Date

April 1, 2016

Completion Date

April 1, 2016

Last Updated

April 18, 2017

Enrollment

ACTUAL participants

Conditions

Type 2 Diabetes

Interventions

Saxagliptin

DRUG

Placebo (Saxagliptin)

DRUG

Metformin IR

DRUG

Placebo (Metformin)

DRUG

Metformin (Active Rescue)

DRUG

Feasibility of a Tailored Online Self-compassion Intervention

NCT07051005

Type 1 Diabetes MellitusType 2 Diabetes Mellitus (T2DM)

View study

RECRUITINGPHASE2

Trial Against INtractable Type 2 Diabetes (CAPTAIN-T2D)

NCT07296484

Type 2 DiabetesCortisol Excess

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: April 18, 2017Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Study to Evaluate the Efficacy, Safety, Tolerability, and Pharmacokinetics of Saxagliptin as Monotherapy in Pediatric Patients With Type 2 Diabetes

Inclusion Criteria

Exclusion Criteria

Feasibility of a Tailored Online Self-compassion Intervention

Trial Against INtractable Type 2 Diabetes (CAPTAIN-T2D)

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