Phase 3 Completed N=6 Randomized Double-blind Treatment

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

Type 2 Diabetes Mellitus

Source: ClinicalTrials.gov NCT01434186 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Apr 2017

Primary outcomePrimary: Mean Change in HbA1c From Baseline to Week 16 — -1.0; 0.9 percentage

Summary

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

Outcome Measures

Outcome	Result	p-value
PRIMARY Mean Change in HbA1c From Baseline to Week 16	-1.0; 0.9	—

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

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Data sourced from ClinicalTrials.gov (NCT01434186). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.