Diabetes Mellitus, Type 2
Conditions
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
Interventions
Tablet, Oral, 0.0 mg, Daily, Day 1 through week 52
DRUGMetformin IR
Tablet, Oral, 1000 mg -2000 mg, Daily , Day 1 through week 52
DRUGMetformin XR
Tablet, Oral, 1000 mg -2000 mg, Daily, Day 1 through week 52
DRUGSaxagliptin
Saxagliptin Tablet, 2.5 mg, or Saxagliptin Tablet, 5 mg, (based on subject's weight)
Sponsors
Bristol-Myers Squibb
AstraZeneca
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
10 Years to 17 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mean Change in HbA1c From Baseline to Week 16 | 16 week short term treatment period |
Countries
Belgium, Canada, India, Mexico, Taiwan, United Kingdom, United States
Participant flow
Pre-assignment details
Of 32 subjects enrolled, 7 subjects entered the lead-in period. Of these 7 subjects, 6 were randomized
Participants by arm
| Arm | Count |
|---|---|
| Placebo Placebo matching saxagliptin | 2 |
| Saxagliptin saxagliptin 2.5 or 5 mg according to body weight | 4 |
| Total | 6 |
Baseline characteristics
| Characteristic | Placebo | Saxagliptin | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 2 Participants | 4 Participants | 6 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Female | 2 Participants | 4 Participants | 6 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 1 / 2 | 4 / 4 |
| serious Total, serious adverse events | 0 / 2 | 0 / 4 |
Outcome results
Primary
Mean Change in HbA1c From Baseline to Week 16
Time frame: 16 week short term treatment period
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Saxagliptin | Mean Change in HbA1c From Baseline to Week 16 | -1.0 percentage | Standard Deviation 0.62 |
| Placebo | Mean Change in HbA1c From Baseline to Week 16 | 0.9 percentage | Standard Deviation 0.14 |