Trial Outcomes & Findings for Study to Evaluate Safety and Efficacy of Dapagliflozin in Patients With Type 2 Diabetes Mellitus Aged 10-24 Years (NCT NCT02725593)
NCT ID: NCT02725593
Last Updated: 2022-02-23
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
72 participants
Primary outcome timeframe
Baseline to Week 24
Results posted on
2022-02-23
Participant Flow
Participants took part in the study at 42 study centres in 7 countries worldwide.
Participant milestones
| Measure |
Dapagliflozin 10mg/ Dapagliflozin 10mg
Dapagliflozin (10 mg) tablet administered orally, once daily for the 24 week double-blinded treatment period. The participants then continued to receive Dapagliflozin (10 mg) once daily for a further 28 weeks in the open label long term-extension.
|
Placebo/ Dapagliflozin 10mg
Matching placebo tablet administered orally, once daily for the 24 weeks double-blinded treatment period. The participants then received Dapagliflozin (10 mg), orally, once daily for a further 28 weeks in the open label long-term extension.
|
|---|---|---|
|
Blinded Treatment Period
STARTED
|
39
|
33
|
|
Blinded Treatment Period
Received Treatment
|
39
|
33
|
|
Blinded Treatment Period
COMPLETED
|
34
|
27
|
|
Blinded Treatment Period
NOT COMPLETED
|
5
|
6
|
|
Long Term Extension
STARTED
|
33
|
27
|
|
Long Term Extension
COMPLETED
|
32
|
24
|
|
Long Term Extension
NOT COMPLETED
|
1
|
3
|
Reasons for withdrawal
| Measure |
Dapagliflozin 10mg/ Dapagliflozin 10mg
Dapagliflozin (10 mg) tablet administered orally, once daily for the 24 week double-blinded treatment period. The participants then continued to receive Dapagliflozin (10 mg) once daily for a further 28 weeks in the open label long term-extension.
|
Placebo/ Dapagliflozin 10mg
Matching placebo tablet administered orally, once daily for the 24 weeks double-blinded treatment period. The participants then received Dapagliflozin (10 mg), orally, once daily for a further 28 weeks in the open label long-term extension.
|
|---|---|---|
|
Blinded Treatment Period
Withdrawal by Subject
|
4
|
3
|
|
Blinded Treatment Period
Withdrawal by Parent/Guardian
|
0
|
2
|
|
Blinded Treatment Period
Lost to Follow-up
|
1
|
1
|
|
Long Term Extension
Withdrawal by Subject
|
1
|
3
|
Baseline Characteristics
Study to Evaluate Safety and Efficacy of Dapagliflozin in Patients With Type 2 Diabetes Mellitus Aged 10-24 Years
Baseline characteristics by cohort
| Measure |
Dapagliflozin 10mg/ Dapagliflozin 10mg
n=39 Participants
Dapagliflozin (10 mg) tablet administered orally, once daily for the 24 week double-blinded treatment period. The participants then continued to receive Dapagliflozin (10 mg) once daily for a further 28 weeks in the open label long term-extension.
|
Placebo/ Dapagliflozin 10mg
n=33 Participants
Matching placebo tablet administered orally, once daily for the 24 weeks double-blinded treatment period. The participants then received Dapagliflozin (10 mg), orally, once daily for a further 28 weeks in the open label long-term extension.
|
Total
n=72 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
16.1 Years
STANDARD_DEVIATION 3.3 • n=5 Participants
|
16.2 Years
STANDARD_DEVIATION 3.6 • n=7 Participants
|
16.1 Years
STANDARD_DEVIATION 3.4 • n=5 Participants
|
|
Age, Customized
≥10 and ≤15
|
16 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
30 Participants
n=5 Participants
|
|
Age, Customized
>15 and <18
|
13 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
|
Age, Customized
≥18 and <25
|
10 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
24 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
43 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
15 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
29 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
12 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
26 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
47 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
28 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
44 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
8 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or other Pacific Islander
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
0 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Geographic Region
North America
|
16 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
32 Participants
n=5 Participants
|
|
Geographic Region
Latin America
|
7 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Geographic Region
Europe
|
16 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
|
Geographic Region
Asia/Pacific
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline to Week 24Population: Full analysis set: All participants who were randomized and assigned to a treatment group, with baseline and at least one-post baseline value, prior to rescue therapy initiation or discontinuation from study treatment.
Outcome measures
| Measure |
Dapagliflozin 10mg/ Dapagliflozin 10mg
n=31 Participants
Dapagliflozin (10 mg) tablet administered orally, once daily for the 24 week double-blinded treatment period. The participants then continued to receive Dapagliflozin (10 mg) once daily for a further 28 weeks in the open label long term-extension.
|
Placebo/ Dapagliflozin 10mg
n=23 Participants
Matching placebo tablet administered orally, once daily for the 24 weeks double-blinded treatment period. The participants then received Dapagliflozin (10 mg), orally, once daily for a further 28 weeks in the open label long-term extension.
|
|---|---|---|
|
Adjusted Change From Baseline in Glycated Haemoglobin (HbA1c) at Week 24
|
-0.25 Percentage of HbA1c
Standard Error 0.30
|
0.50 Percentage of HbA1c
Standard Error 0.34
|
SECONDARY outcome
Timeframe: Baseline to Week 24Population: Full analysis set: All participants who were randomized and assigned to a treatment group, with baseline and at least one-post baseline value, prior to rescue therapy initiation or discontinuation from study treatment.
Outcome measures
| Measure |
Dapagliflozin 10mg/ Dapagliflozin 10mg
n=31 Participants
Dapagliflozin (10 mg) tablet administered orally, once daily for the 24 week double-blinded treatment period. The participants then continued to receive Dapagliflozin (10 mg) once daily for a further 28 weeks in the open label long term-extension.
|
Placebo/ Dapagliflozin 10mg
n=23 Participants
Matching placebo tablet administered orally, once daily for the 24 weeks double-blinded treatment period. The participants then received Dapagliflozin (10 mg), orally, once daily for a further 28 weeks in the open label long-term extension.
|
|---|---|---|
|
Adjusted Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24
|
-0.07 mmol/L
Standard Error 0.53
|
0.72 mmol/L
Standard Error 0.61
|
SECONDARY outcome
Timeframe: Baseline to Week 24Population: Full analysis set: All participants who were randomized and assigned to a treatment group.
Outcome measures
| Measure |
Dapagliflozin 10mg/ Dapagliflozin 10mg
n=39 Participants
Dapagliflozin (10 mg) tablet administered orally, once daily for the 24 week double-blinded treatment period. The participants then continued to receive Dapagliflozin (10 mg) once daily for a further 28 weeks in the open label long term-extension.
|
Placebo/ Dapagliflozin 10mg
n=33 Participants
Matching placebo tablet administered orally, once daily for the 24 weeks double-blinded treatment period. The participants then received Dapagliflozin (10 mg), orally, once daily for a further 28 weeks in the open label long-term extension.
|
|---|---|---|
|
Percentage of Participants Who Required Glycemic Rescue Medication or Permanently Discontinued Treatment Due to Lack of Glycemic Control
|
5.1 Percentage of participants
|
9.1 Percentage of participants
|
SECONDARY outcome
Timeframe: Baseline to Week 24Population: Full analysis set: All participants who were randomized and assigned to a treatment group, with HbA1c \>=7% at baseline, with baseline and at least one-post baseline value, prior to rescue therapy initiation or discontinuation from study treatment.
Outcome measures
| Measure |
Dapagliflozin 10mg/ Dapagliflozin 10mg
n=28 Participants
Dapagliflozin (10 mg) tablet administered orally, once daily for the 24 week double-blinded treatment period. The participants then continued to receive Dapagliflozin (10 mg) once daily for a further 28 weeks in the open label long term-extension.
|
Placebo/ Dapagliflozin 10mg
n=24 Participants
Matching placebo tablet administered orally, once daily for the 24 weeks double-blinded treatment period. The participants then received Dapagliflozin (10 mg), orally, once daily for a further 28 weeks in the open label long-term extension.
|
|---|---|---|
|
Percentage of Participants With Baseline Glycated Haemoglobin (HbA1c) >= 7% Who Achieved HbA1c Level < 7% at Week 24
|
25.0 Percentage of participants
|
4.2 Percentage of participants
|
Adverse Events
Dapagliflozin 10mg/ Dapagliflozin 10mg
Serious events: 2 serious events
Other events: 24 other events
Deaths: 0 deaths
Placebo/ Dapagliflozin 10mg
Serious events: 3 serious events
Other events: 19 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Dapagliflozin 10mg/ Dapagliflozin 10mg
n=39 participants at risk
Dapagliflozin (10 mg) tablet administered orally, once daily for the 24 week double-blinded treatment period. The participants then continued to receive Dapagliflozin (10 mg) once daily for a further 28 weeks in the open label long term-extension.
|
Placebo/ Dapagliflozin 10mg
n=33 participants at risk
Matching placebo tablet administered orally, once daily for the 24 weeks double-blinded treatment period. The participants then received Dapagliflozin (10 mg), orally, once daily for a further 28 weeks in the open label long-term extension.
|
|---|---|---|
|
Gastrointestinal disorders
Abdominal pain lower
|
2.6%
1/39 • Number of events 1 • Up to a maximum of 56 weeks
|
0.00%
0/33 • Up to a maximum of 56 weeks
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/39 • Up to a maximum of 56 weeks
|
6.1%
2/33 • Number of events 2 • Up to a maximum of 56 weeks
|
|
Pregnancy, puerperium and perinatal conditions
Abortion spontaneous
|
0.00%
0/39 • Up to a maximum of 56 weeks
|
3.0%
1/33 • Number of events 1 • Up to a maximum of 56 weeks
|
|
Psychiatric disorders
Depression
|
2.6%
1/39 • Number of events 1 • Up to a maximum of 56 weeks
|
0.00%
0/33 • Up to a maximum of 56 weeks
|
Other adverse events
| Measure |
Dapagliflozin 10mg/ Dapagliflozin 10mg
n=39 participants at risk
Dapagliflozin (10 mg) tablet administered orally, once daily for the 24 week double-blinded treatment period. The participants then continued to receive Dapagliflozin (10 mg) once daily for a further 28 weeks in the open label long term-extension.
|
Placebo/ Dapagliflozin 10mg
n=33 participants at risk
Matching placebo tablet administered orally, once daily for the 24 weeks double-blinded treatment period. The participants then received Dapagliflozin (10 mg), orally, once daily for a further 28 weeks in the open label long-term extension.
|
|---|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
5.1%
2/39 • Number of events 2 • Up to a maximum of 56 weeks
|
6.1%
2/33 • Number of events 3 • Up to a maximum of 56 weeks
|
|
Gastrointestinal disorders
Nausea
|
7.7%
3/39 • Number of events 4 • Up to a maximum of 56 weeks
|
0.00%
0/33 • Up to a maximum of 56 weeks
|
|
Gastrointestinal disorders
Toothache
|
2.6%
1/39 • Number of events 1 • Up to a maximum of 56 weeks
|
6.1%
2/33 • Number of events 4 • Up to a maximum of 56 weeks
|
|
Gastrointestinal disorders
Vomiting
|
5.1%
2/39 • Number of events 2 • Up to a maximum of 56 weeks
|
0.00%
0/33 • Up to a maximum of 56 weeks
|
|
General disorders
Fatigue
|
5.1%
2/39 • Number of events 2 • Up to a maximum of 56 weeks
|
3.0%
1/33 • Number of events 2 • Up to a maximum of 56 weeks
|
|
Infections and infestations
Fungal infection
|
5.1%
2/39 • Number of events 3 • Up to a maximum of 56 weeks
|
3.0%
1/33 • Number of events 1 • Up to a maximum of 56 weeks
|
|
Infections and infestations
Gastroenteritis viral
|
5.1%
2/39 • Number of events 2 • Up to a maximum of 56 weeks
|
0.00%
0/33 • Up to a maximum of 56 weeks
|
|
Infections and infestations
Nasopharyngitis
|
12.8%
5/39 • Number of events 5 • Up to a maximum of 56 weeks
|
6.1%
2/33 • Number of events 3 • Up to a maximum of 56 weeks
|
|
Infections and infestations
Pharyngitis streptococcal
|
5.1%
2/39 • Number of events 2 • Up to a maximum of 56 weeks
|
3.0%
1/33 • Number of events 1 • Up to a maximum of 56 weeks
|
|
Infections and infestations
Pharyngotonsillitis
|
0.00%
0/39 • Up to a maximum of 56 weeks
|
6.1%
2/33 • Number of events 2 • Up to a maximum of 56 weeks
|
|
Infections and infestations
Upper respiratory tract infection
|
5.1%
2/39 • Number of events 2 • Up to a maximum of 56 weeks
|
0.00%
0/33 • Up to a maximum of 56 weeks
|
|
Infections and infestations
Urinary tract infection
|
7.7%
3/39 • Number of events 3 • Up to a maximum of 56 weeks
|
3.0%
1/33 • Number of events 1 • Up to a maximum of 56 weeks
|
|
Investigations
Weight increased
|
5.1%
2/39 • Number of events 2 • Up to a maximum of 56 weeks
|
0.00%
0/33 • Up to a maximum of 56 weeks
|
|
Metabolism and nutrition disorders
Dyslipidaemia
|
5.1%
2/39 • Number of events 2 • Up to a maximum of 56 weeks
|
3.0%
1/33 • Number of events 1 • Up to a maximum of 56 weeks
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/39 • Up to a maximum of 56 weeks
|
6.1%
2/33 • Number of events 3 • Up to a maximum of 56 weeks
|
|
Metabolism and nutrition disorders
Hypertriglyceridaemia
|
2.6%
1/39 • Number of events 1 • Up to a maximum of 56 weeks
|
9.1%
3/33 • Number of events 3 • Up to a maximum of 56 weeks
|
|
Metabolism and nutrition disorders
Vitamin D deficiency
|
12.8%
5/39 • Number of events 5 • Up to a maximum of 56 weeks
|
6.1%
2/33 • Number of events 2 • Up to a maximum of 56 weeks
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
5.1%
2/39 • Number of events 2 • Up to a maximum of 56 weeks
|
3.0%
1/33 • Number of events 2 • Up to a maximum of 56 weeks
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
5.1%
2/39 • Number of events 2 • Up to a maximum of 56 weeks
|
0.00%
0/33 • Up to a maximum of 56 weeks
|
|
Nervous system disorders
Dizziness
|
0.00%
0/39 • Up to a maximum of 56 weeks
|
6.1%
2/33 • Number of events 2 • Up to a maximum of 56 weeks
|
|
Nervous system disorders
Headache
|
12.8%
5/39 • Number of events 6 • Up to a maximum of 56 weeks
|
12.1%
4/33 • Number of events 4 • Up to a maximum of 56 weeks
|
|
Renal and urinary disorders
Microalbuminuria
|
2.6%
1/39 • Number of events 1 • Up to a maximum of 56 weeks
|
6.1%
2/33 • Number of events 2 • Up to a maximum of 56 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
5.1%
2/39 • Number of events 2 • Up to a maximum of 56 weeks
|
6.1%
2/33 • Number of events 3 • Up to a maximum of 56 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
10.3%
4/39 • Number of events 4 • Up to a maximum of 56 weeks
|
3.0%
1/33 • Number of events 1 • Up to a maximum of 56 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Sinus congestion
|
5.1%
2/39 • Number of events 2 • Up to a maximum of 56 weeks
|
0.00%
0/33 • Up to a maximum of 56 weeks
|
|
Skin and subcutaneous tissue disorders
Rash
|
5.1%
2/39 • Number of events 2 • Up to a maximum of 56 weeks
|
3.0%
1/33 • Number of events 1 • Up to a maximum of 56 weeks
|
|
Vascular disorders
Hypertension
|
5.1%
2/39 • Number of events 2 • Up to a maximum of 56 weeks
|
3.0%
1/33 • Number of events 2 • Up to a maximum of 56 weeks
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place