Trial Outcomes & Findings for 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 (NCT NCT01434186)
NCT ID: NCT01434186
Last Updated: 2017-04-18
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
32 participants
Primary outcome timeframe
16 week short term treatment period
Results posted on
2017-04-18
Participant Flow
Of 32 subjects enrolled, 7 subjects entered the lead-in period. Of these 7 subjects, 6 were randomized
Participant milestones
| Measure |
Placebo
Placebo matching saxagliptin
|
Saxagliptin
saxagliptin 2.5 or 5 mg according to body weight
|
|---|---|---|
|
Overall Study
STARTED
|
2
|
4
|
|
Overall Study
COMPLETED
|
2
|
4
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
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
Baseline characteristics by cohort
| Measure |
Placebo
n=2 Participants
Placebo matching saxagliptin
|
Saxagliptin
n=4 Participants
saxagliptin 2.5 or 5 mg according to body weight
|
Total
n=6 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
2 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 16 week short term treatment periodOutcome measures
| Measure |
Saxagliptin
n=4 Participants
Saxagliptin 2.5 mg or 5 mg according to bodyweight
|
Placebo
n=2 Participants
Saxagliptin matching placebo
|
|---|---|---|
|
Mean Change in HbA1c From Baseline to Week 16
|
-1.0 percentage
Standard Deviation 0.62
|
0.9 percentage
Standard Deviation 0.14
|
Adverse Events
Placebo
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Saxagliptin
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Placebo
n=2 participants at risk
Placebo matching saxagliptin
|
Saxagliptin
n=4 participants at risk
saxagliptin 2.5 or 5 mg according to body weight
|
|---|---|---|
|
Nervous system disorders
Headache
|
0.00%
0/2 • 52 week
|
50.0%
2/4 • Number of events 3 • 52 week
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/2 • 52 week
|
25.0%
1/4 • 52 week
|
|
Gastrointestinal disorders
ABDOMINAL PAIN UPPER
|
0.00%
0/2 • 52 week
|
25.0%
1/4 • 52 week
|
|
Respiratory, thoracic and mediastinal disorders
OROPHARYNGEAL PAIN
|
0.00%
0/2 • 52 week
|
25.0%
1/4 • 52 week
|
|
Infections and infestations
Pharyngitis Streptococcal
|
0.00%
0/2 • 52 week
|
25.0%
1/4 • 52 week
|
|
Nervous system disorders
Dizziness
|
0.00%
0/2 • 52 week
|
25.0%
1/4 • 52 week
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/2 • 52 week
|
25.0%
1/4 • 52 week
|
|
Infections and infestations
Pharyngitis bacterial
|
0.00%
0/2 • 52 week
|
25.0%
1/4 • 52 week
|
|
Injury, poisoning and procedural complications
LACERATION
|
50.0%
1/2 • 52 week
|
0.00%
0/4 • 52 week
|
|
Investigations
URINE OUTPUT INCREASED
|
50.0%
1/2 • 52 week
|
0.00%
0/4 • 52 week
|
|
Reproductive system and breast disorders
MENSTRUATION IRREGULAR
|
50.0%
1/2 • 52 week
|
0.00%
0/4 • 52 week
|
Additional Information
Eva Johnsson, Clinical Science Lead, GLOBAL_MEDICINES_DEV
AstraZeneca AB, S-151 85 Södertälje, Sweden
Phone: +46 31 7762484
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place