NCT01434186

Brief Summary

To evaluate the efficacy, safety, tolerability, of Saxagliptin (BMS-477118) in combination with Metformin in pediatric patients with type 2 diabetes

Trial Health

93
On Track

Trial Health Score

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

Enrollment
32

participants targeted

Target at below P25 for phase_3 diabetes-mellitus-type-2

Timeline
Completed

Started May 2012

Longer than P75 for phase_3 diabetes-mellitus-type-2

Geographic Reach
7 countries

16 active sites

Status
completed

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

First Submitted

Initial submission to the registry

September 13, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 14, 2011

Completed
8 months until next milestone

Study Start

First participant enrolled

May 1, 2012

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2016

Completed
1 year until next milestone

Results Posted

Study results publicly available

April 18, 2017

Completed
Last Updated

April 18, 2017

Status Verified

March 1, 2017

Enrollment Period

3.9 years

First QC Date

September 13, 2011

Results QC Date

March 7, 2017

Last Update Submit

March 7, 2017

Conditions

Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (1)

  • Mean Change in HbA1c From Baseline to Week 16

    16 week short term treatment period

Study Arms (2)

Arm 1: Saxagliptin +Metformin XR/IR

EXPERIMENTAL

Saxagliptin Tablet, 2.5 mg, or Saxagliptin Tablet, 5 mg, (based on subject's weight) Metformin XR/IR 1000 mg-2000 mg

Drug: Metformin IRDrug: Metformin XRDrug: Saxagliptin

Arm 2: Placebo +Metformin XR/IR

PLACEBO COMPARATOR

Placebo matching saxagliptin 0 mg Metformin XR/IR 1000 mg - 2000 mg

Drug: Placebo matching with SaxagliptinDrug: Metformin IRDrug: Metformin XR

Interventions

Placebo matching with SaxagliptinDRUG

Tablet, Oral, 0.0 mg, Daily, Day 1 through week 52

Arm 2: Placebo +Metformin XR/IR
Metformin IRDRUG

Tablet, Oral, 1000 mg -2000 mg, Daily , Day 1 through week 52

Arm 1: Saxagliptin +Metformin XR/IRArm 2: Placebo +Metformin XR/IR
Metformin XRDRUG

Tablet, Oral, 1000 mg -2000 mg, Daily, Day 1 through week 52

Arm 1: Saxagliptin +Metformin XR/IRArm 2: Placebo +Metformin XR/IR
SaxagliptinDRUG

Saxagliptin Tablet, 2.5 mg, or Saxagliptin Tablet, 5 mg, (based on subject's weight)

Also known as: BMS-477118
Arm 1: Saxagliptin +Metformin XR/IR

Eligibility Criteria

Age10 Years - 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Male and female patients eligible if 10 years of age, up to 17 years and 30 weeks of age at the time of screening
  • Previously diagnosed as having type 2 diabetes
  • HbA1c ≥7.0% and ≤10.5%
  • Body weight ≥ 30 kg
  • Stable dose of metformin (≥ 1000mg - ≤ 2000mg) for a minimum of 2 months
  • Women must have a negative serum or urine pregnancy test
  • Women must not be breastfeeding

You may not qualify if:

  • Current use of anti-diabetic medications or use within the specified timeframe prior to screening (Exception: Metformin)
  • Fasting plasma glucose (FPG) \> 255 mg/dL
  • Diabetic ketoacidosis (DKA) within 6 months of study entry
  • Abnormal renal function
  • Active liver disease
  • Anemia
  • An abnormal Thyroid Stimulating Hormone (TSH)
  • Creatinine kinase (CK) ≥ 3X ULN

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (16)

Research Site

Los Angeles, California, United States

Location

Research Site

Tallahassee, Florida, United States

Location

Research Site

Dearborn, Michigan, United States

Location

Research Site

Saint Paul, Minnesota, United States

Location

Research Site

Mineola, New York, United States

Location

Research Site

Cleveland, Ohio, United States

Location

Research Site

Memphis, Tennessee, United States

Location

Research Site

Namur, Belgium

Location

Research Site

Calgary, Alberta, Canada

Location

Research Site

Bangalore, India

Location

Research Site

Aguascalientes, Mexico

Location

Research Site

Meridas, Mexico

Location

Research Site

Monterrey, Mexico

Location

Research Site

Veracruz, Mexico

Location

Research Site

Taichung, Taiwan

Location

Research Site

Leicester, United Kingdom

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

saxagliptin

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Results Point of Contact

Title
Eva Johnsson, Clinical Science Lead, GLOBAL_MEDICINES_DEV
Organization
AstraZeneca AB, S-151 85 Södertälje, Sweden
Eva.Johnsson@astrazeneca.com
+46 31 7762484

Study Officials

  • Bristol-Myers Squibb

    Bristol-Myers Squibb

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 13, 2011

First Posted

September 14, 2011

Study Start

May 1, 2012

Primary Completion

April 1, 2016

Study Completion

April 1, 2016

Last Updated

April 18, 2017

Results First Posted

April 18, 2017

Record last verified: 2017-03

Locations

IN(1)BE(1)ME(4)TW(1)US(7)GB(1)CA(1)