Clinical trial NCT01434186: 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
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Diabetes Mellitus, Type 2
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
Collaborators: name: Bristol-Myers Squibb
First posted: 2011-09-14
Enrollment: 32
Sex: ALL
Minimum age (years): 10
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Detailed 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

Eligibility criteria: 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

Primary outcomes:
measure: Mean Change in HbA1c From Baseline to Week 16
timeFrame: 16 week short term treatment period
Secondary outcomes:
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Research Site
state: California
city: Tallahassee
country: United States
facility: Research Site
state: Florida
city: Dearborn
country: United States
facility: Research Site
state: Michigan
city: St. Paul
country: United States
facility: Research Site
state: Minnesota
city: Mineola
country: United States
facility: Research Site
state: New York
city: Cleveland
country: United States
facility: Research Site
state: Ohio
city: Memphis
country: United States
facility: Research Site
state: Tennessee
city: Namur
country: Belgium
facility: Research Site
city: Calgary
country: Canada
facility: Research Site
state: Alberta
city: Bangalore
country: India
facility: Research Site
city: Aguascalientes
country: Mexico
facility: Research Site
city: Meridas
country: Mexico
facility: Research Site
city: Monterrey
country: Mexico
facility: Research Site
city: Veracruz
country: Mexico
facility: Research Site
city: Taichung
country: Taiwan
facility: Research Site
city: Leicester
country: United Kingdom
facility: Research Site
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References: