Trial Outcomes & Findings for Study to Evaluate the Efficacy, Safety, Tolerability, and Pharmacokinetics of Saxagliptin as Monotherapy in Pediatric Patients With Type 2 Diabetes (NCT NCT01204775)
NCT ID: NCT01204775
Last Updated: 2017-04-18
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
26 participants
Primary outcome timeframe
16 week short term treatment period
Results posted on
2017-04-18
Participant Flow
Of 26 subjects enrolled, 12 subjects entered the lead in period. Of these 12 subjects, 8 subjects were randomized
Participant milestones
| Measure |
Saxagliptin
Saxagliptin 2.5 mg or 5 mg depending on body weight
|
Placebo
Placebo matching saxagliptin
|
|---|---|---|
|
Overall Study
STARTED
|
4
|
4
|
|
Overall Study
Double-blind Treatment Period
|
4
|
4
|
|
Overall Study
COMPLETED
|
3
|
3
|
|
Overall Study
NOT COMPLETED
|
1
|
1
|
Reasons for withdrawal
| Measure |
Saxagliptin
Saxagliptin 2.5 mg or 5 mg depending on body weight
|
Placebo
Placebo matching saxagliptin
|
|---|---|---|
|
Overall Study
Poor/non-compliance
|
0
|
1
|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
Baseline Characteristics
Study to Evaluate the Efficacy, Safety, Tolerability, and Pharmacokinetics of Saxagliptin as Monotherapy in Pediatric Patients With Type 2 Diabetes
Baseline characteristics by cohort
| Measure |
Saxagliptin
n=4 Participants
Saxagliptin 2.5 mg or 5 mg depending on body weight
|
Placebo
n=4 Participants
Placebo matching saxagliptin
|
Total
n=8 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
4 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
8 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
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
4 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 depending on body weight
|
Placebo
n=4 Participants
Placebo matching saxagliptin
|
|---|---|---|
|
Mean Change in HbA1c From Baseline to Week 16
|
-0.7 percentage
Standard Deviation 0.83
|
0.6 percentage
Standard Deviation 1.53
|
Adverse Events
Placebo
Serious events: 1 serious events
Other events: 3 other events
Deaths: 0 deaths
Saxagliptin
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo
n=4 participants at risk
Placebo matching saxagliptin
|
Saxagliptin
n=4 participants at risk
Saxagliptin 2.5 mg or 5 mg depending on body weight
|
|---|---|---|
|
Infections and infestations
Pneumonia
|
25.0%
1/4 • Number of events 1 • 52 week
16 week double-blind treatment period and 36 week long-term extension period
|
0.00%
0/4 • 52 week
16 week double-blind treatment period and 36 week long-term extension period
|
Other adverse events
| Measure |
Placebo
n=4 participants at risk
Placebo matching saxagliptin
|
Saxagliptin
n=4 participants at risk
Saxagliptin 2.5 mg or 5 mg depending on body weight
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
OROPHARYNGEAL PAIN
|
25.0%
1/4 • 52 week
16 week double-blind treatment period and 36 week long-term extension period
|
50.0%
2/4 • 52 week
16 week double-blind treatment period and 36 week long-term extension period
|
|
Respiratory, thoracic and mediastinal disorders
COUGH
|
25.0%
1/4 • 52 week
16 week double-blind treatment period and 36 week long-term extension period
|
25.0%
1/4 • 52 week
16 week double-blind treatment period and 36 week long-term extension period
|
|
Nervous system disorders
Headache
|
25.0%
1/4 • 52 week
16 week double-blind treatment period and 36 week long-term extension period
|
25.0%
1/4 • 52 week
16 week double-blind treatment period and 36 week long-term extension period
|
|
Skin and subcutaneous tissue disorders
ACNE
|
0.00%
0/4 • 52 week
16 week double-blind treatment period and 36 week long-term extension period
|
25.0%
1/4 • 52 week
16 week double-blind treatment period and 36 week long-term extension period
|
|
Gastrointestinal disorders
DIARRHOEA
|
0.00%
0/4 • 52 week
16 week double-blind treatment period and 36 week long-term extension period
|
25.0%
1/4 • 52 week
16 week double-blind treatment period and 36 week long-term extension period
|
|
Gastrointestinal disorders
VOMITING
|
0.00%
0/4 • 52 week
16 week double-blind treatment period and 36 week long-term extension period
|
25.0%
1/4 • 52 week
16 week double-blind treatment period and 36 week long-term extension period
|
|
Infections and infestations
VIRAL UPPER RESPIRATORY TRACT INFECTION
|
0.00%
0/4 • 52 week
16 week double-blind treatment period and 36 week long-term extension period
|
25.0%
1/4 • 52 week
16 week double-blind treatment period and 36 week long-term extension period
|
|
Injury, poisoning and procedural complications
FALL
|
0.00%
0/4 • 52 week
16 week double-blind treatment period and 36 week long-term extension period
|
25.0%
1/4 • 52 week
16 week double-blind treatment period and 36 week long-term extension period
|
|
Metabolism and nutrition disorders
HYPERNATRAEMIA
|
0.00%
0/4 • 52 week
16 week double-blind treatment period and 36 week long-term extension period
|
25.0%
1/4 • 52 week
16 week double-blind treatment period and 36 week long-term extension period
|
|
Skin and subcutaneous tissue disorders
ONYCHOLYSIS
|
0.00%
0/4 • 52 week
16 week double-blind treatment period and 36 week long-term extension period
|
25.0%
1/4 • 52 week
16 week double-blind treatment period and 36 week long-term extension period
|
|
Infections and infestations
UPPER RESPIRATORY TRACT INFECTION
|
25.0%
1/4 • 52 week
16 week double-blind treatment period and 36 week long-term extension period
|
25.0%
1/4 • 52 week
16 week double-blind treatment period and 36 week long-term extension period
|
|
Gastrointestinal disorders
ABDOMINAL PAIN
|
25.0%
1/4 • 52 week
16 week double-blind treatment period and 36 week long-term extension period
|
0.00%
0/4 • 52 week
16 week double-blind treatment period and 36 week long-term extension period
|
|
Respiratory, thoracic and mediastinal disorders
EPISTAXIS
|
25.0%
1/4 • 52 week
16 week double-blind treatment period and 36 week long-term extension period
|
0.00%
0/4 • 52 week
16 week double-blind treatment period and 36 week long-term extension period
|
|
Eye disorders
VISION BLURRED
|
25.0%
1/4 • 52 week
16 week double-blind treatment period and 36 week long-term extension period
|
0.00%
0/4 • 52 week
16 week double-blind treatment period and 36 week long-term extension period
|
|
Injury, poisoning and procedural complications
THERMAL BURN
|
25.0%
1/4 • 52 week
16 week double-blind treatment period and 36 week long-term extension period
|
0.00%
0/4 • 52 week
16 week double-blind treatment period and 36 week long-term extension period
|
|
Renal and urinary disorders
POLLAKIURIA
|
25.0%
1/4 • 52 week
16 week double-blind treatment period and 36 week long-term extension period
|
0.00%
0/4 • 52 week
16 week double-blind treatment period and 36 week long-term extension period
|
|
Respiratory, thoracic and mediastinal disorders
NASAL CONGESTION
|
25.0%
1/4 • 52 week
16 week double-blind treatment period and 36 week long-term extension period
|
0.00%
0/4 • 52 week
16 week double-blind treatment period and 36 week long-term extension period
|
|
Skin and subcutaneous tissue disorders
HYPERHIDROSIS
|
25.0%
1/4 • 52 week
16 week double-blind treatment period and 36 week long-term extension period
|
0.00%
0/4 • 52 week
16 week double-blind treatment period and 36 week long-term extension period
|
|
General disorders
PERIPHERAL SWELLING
|
25.0%
1/4 • 52 week
16 week double-blind treatment period and 36 week long-term extension period
|
0.00%
0/4 • 52 week
16 week double-blind treatment period and 36 week long-term extension period
|
|
Musculoskeletal and connective tissue disorders
JOINT SWELLING
|
25.0%
1/4 • 52 week
16 week double-blind treatment period and 36 week long-term extension period
|
0.00%
0/4 • 52 week
16 week double-blind treatment period and 36 week long-term extension period
|
|
Skin and subcutaneous tissue disorders
ERYTHEMA
|
25.0%
1/4 • 52 week
16 week double-blind treatment period and 36 week long-term extension period
|
0.00%
0/4 • 52 week
16 week double-blind treatment period and 36 week long-term extension period
|
|
Respiratory, thoracic and mediastinal disorders
WHEEZING
|
25.0%
1/4 • 52 week
16 week double-blind treatment period and 36 week long-term extension period
|
0.00%
0/4 • 52 week
16 week double-blind treatment period and 36 week long-term extension period
|
|
Gastrointestinal disorders
GASTROOESOPHAGEAL REFLUX DISEASE
|
25.0%
1/4 • 52 week
16 week double-blind treatment period and 36 week long-term extension period
|
0.00%
0/4 • 52 week
16 week double-blind treatment period and 36 week long-term extension period
|
|
Injury, poisoning and procedural complications
LACERATION
|
25.0%
1/4 • 52 week
16 week double-blind treatment period and 36 week long-term extension period
|
0.00%
0/4 • 52 week
16 week double-blind treatment period and 36 week long-term extension period
|
|
Infections and infestations
INFLUENZA
|
25.0%
1/4 • 52 week
16 week double-blind treatment period and 36 week long-term extension period
|
0.00%
0/4 • 52 week
16 week double-blind treatment period and 36 week long-term extension period
|
|
Blood and lymphatic system disorders
LYMPHADENOPATHY
|
25.0%
1/4 • 52 week
16 week double-blind treatment period and 36 week long-term extension period
|
0.00%
0/4 • 52 week
16 week double-blind treatment period and 36 week long-term extension period
|
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