A Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Saxagliptin (BMS-477118) in Combination With Metformin IR or Metformin XR in Pediatric Patients With Type 2 Diabetes Who Have Inadequate Glycemic Control on Metformin Alone

Diabetes Mellitus, Type 2 Clinical Trial

Official title:

A Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Saxagliptin (BMS-477118) in Combination With Metformin IR or Metformin XR in Pediatric Patients With Type 2 Diabetes Who Have Inadequate Glycemic Control on Metformin Alone

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01434186
• Other study ID #: CV181-147
• Secondary ID: 2010-024568-16
• Status: Completed
• Phase: Phase 3
• First received: September 13, 2011
• Last updated: January 19, 2017
• Start date: May 2012
• Est. completion date: April 2016

Study information

• Verified date: January 2017
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Description:

A Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Saxagliptin (BMS-477118) in Combination with Metformin IR or Metformin XR in Pediatric Patients with Type 2 Diabetes who have Inadequate Glycemic Control on Metformin Alone or in Combination with Baseline Insulin Therapy

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: April 2016
• Est. primary completion date: April 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 10 Years to 17 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2

Intervention

Drug:
• Placebo matching with Saxagliptin
Tablet, Oral, 0.0 mg, Daily, Day 1 through week 52
• Metformin IR
Tablet, Oral, 1000 mg -2000 mg, Daily , Day 1 through week 52
• Metformin XR
Tablet, Oral, 1000 mg -2000 mg, Daily, Day 1 through week 52
• Saxagliptin
Saxagliptin Tablet, 2.5 mg, or Saxagliptin Tablet, 5 mg, (based on subject's weight)

Locations

Country	Name	City	State
Belgium	Research Site	Namur
Canada	Research Site	Calgary	Alberta
India	Research Site	Bangalore
Mexico	Research Site	Aguascalientes
Mexico	Research Site	Meridas
Mexico	Research Site	Monterrey
Mexico	Research Site	Veracruz
Taiwan	Research Site	Taichung
United Kingdom	Research Site	Leicester
United States	Research Site	Cleveland	Ohio
United States	Research Site	Dearborn	Michigan
United States	Research Site	Los Angeles	California
United States	Research Site	Memphis	Tennessee
United States	Research Site	Mineola	New York
United States	Research Site	St. Paul	Minnesota
United States	Research Site	Tallahassee	Florida

Sponsors (2)

Lead Sponsor	Collaborator
AstraZeneca	Bristol-Myers Squibb

Countries where clinical trial is conducted

United States,  Belgium,  Canada,  India,  Mexico,  Taiwan,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean change in Glycosylated hemoglobin (HbA1c) in the short term treatment period		Baseline and upto Week 16 (or the last post-baseline measurement prior to Week 16, if no Week 16 assessment is available)
Secondary	Mean change in 2-hour Postprandial Glucose (PPG) Area under the curve (AUC) in the short term treatment period		Baseline and upto Week 16 (or the last post-baseline measurement prior to Week 16, if no Week 16 assessment is available)
Secondary	Mean change in FPG (Fasting plasma glucose) in the short term treatment period		Baseline and upto Week 16 (or the last post-baseline measurement prior to Week 16, if no Week 16 assessment is available)
Secondary	Percent of subjects with HbA1c < 7% in the short term treatment period		At Week 16 (or the last post-baseline measurement prior to Week 16, if no Week 16 assessment is available)

External Links

•   FDA Safety Alerts and Recalls