Trial Outcomes & Findings for Evaluate Efficacy and Safety in Japanese Subjects With Type 2 Diabetes Mellitus (NCT NCT01294423)
NCT ID: NCT01294423
Last Updated: 2014-07-24
Results Overview
To compare change from baseline in HbA1c achieved with each dose of dapagliflozin versus placebo after 24 weeks double-blind treatment.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
261 participants
Primary outcome timeframe
From Baseline to Week 24
Results posted on
2014-07-24
Participant Flow
First participant enrolled: 25 Feb 2011. Last participant completed 24 week period: 12 Mar 2012. 354 participant were enrolled in 30 Japanese centers. 261 participants were randomized. Japanese men or women aged \>= 20 years with inadequate glycemic control (HbA1c 6.5% to 10.0%) with diet and exercise.
Wash-out period was applicable only for participants with ongoing anti-diabetic treatment at enrolment. Drug-naive participants skip the period and directly proceed to a placebo lead-in period.
Participant milestones
| Measure |
Dapagliflozin 5 mg
Dapagliflozin : Dapagliflozin 5mg/matching placebo for Dapagliflozin 10mg oral dose
|
Dapagliflozin 10 mg
Dapagliflozin : Dapagliflozin 10mg/matching placebo for Dapagliflozin 5mg oral dose
|
Placebo
Placebo : Matching placebo for Dapagliflozin 5mg/10mg oral dose
|
|---|---|---|---|
|
Overall Study
STARTED
|
86
|
88
|
87
|
|
Overall Study
COMPLETED
|
81
|
79
|
79
|
|
Overall Study
NOT COMPLETED
|
5
|
9
|
8
|
Reasons for withdrawal
| Measure |
Dapagliflozin 5 mg
Dapagliflozin : Dapagliflozin 5mg/matching placebo for Dapagliflozin 10mg oral dose
|
Dapagliflozin 10 mg
Dapagliflozin : Dapagliflozin 10mg/matching placebo for Dapagliflozin 5mg oral dose
|
Placebo
Placebo : Matching placebo for Dapagliflozin 5mg/10mg oral dose
|
|---|---|---|---|
|
Overall Study
Adverse Event
|
1
|
2
|
3
|
|
Overall Study
Withdrawal by Subject
|
1
|
2
|
2
|
|
Overall Study
subject no longer meets study criteria
|
2
|
5
|
2
|
|
Overall Study
poor/non-compliance
|
1
|
0
|
1
|
Baseline Characteristics
Evaluate Efficacy and Safety in Japanese Subjects With Type 2 Diabetes Mellitus
Baseline characteristics by cohort
| Measure |
Dapagliflozin 5 mg
n=86 Participants
Dapagliflozin : Dapagliflozin 5mg/matching placebo for Dapagliflozin 10mg oral dose
|
Dapagliflozin 10 mg
n=88 Participants
Dapagliflozin : Dapagliflozin 10mg/matching placebo for Dapagliflozin 5mg oral dose
|
Placebo
n=87 Participants
Placebo : Matching placebo for Dapagliflozin 5mg/10mg oral dose
|
Total
n=261 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
58.6 years
STANDARD_DEVIATION 10.41 • n=5 Participants
|
57.5 years
STANDARD_DEVIATION 9.29 • n=7 Participants
|
60.4 years
STANDARD_DEVIATION 9.65 • n=5 Participants
|
58.9 years
STANDARD_DEVIATION 9.83 • n=4 Participants
|
|
Age, Customized
< 65 years
|
59 participants
n=5 Participants
|
67 participants
n=7 Participants
|
55 participants
n=5 Participants
|
181 participants
n=4 Participants
|
|
Age, Customized
65 - <75 years
|
23 participants
n=5 Participants
|
20 participants
n=7 Participants
|
29 participants
n=5 Participants
|
72 participants
n=4 Participants
|
|
Age, Customized
>= 75 years
|
4 participants
n=5 Participants
|
1 participants
n=7 Participants
|
3 participants
n=5 Participants
|
8 participants
n=4 Participants
|
|
Sex: Female, Male
Female
|
36 Participants
n=5 Participants
|
35 Participants
n=7 Participants
|
35 Participants
n=5 Participants
|
106 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
50 Participants
n=5 Participants
|
53 Participants
n=7 Participants
|
52 Participants
n=5 Participants
|
155 Participants
n=4 Participants
|
|
Region of Enrollment
Japan
|
86 participants
n=5 Participants
|
88 participants
n=7 Participants
|
87 participants
n=5 Participants
|
261 participants
n=4 Participants
|
|
Body Weight
|
65.81 kg
STANDARD_DEVIATION 14.371 • n=5 Participants
|
69.70 kg
STANDARD_DEVIATION 13.821 • n=7 Participants
|
65.96 kg
STANDARD_DEVIATION 12.908 • n=5 Participants
|
67.17 kg
STANDARD_DEVIATION 13.777 • n=4 Participants
|
|
Body Mass Index
|
24.88 kg/m^2
STANDARD_DEVIATION 3.907 • n=5 Participants
|
26.06 kg/m^2
STANDARD_DEVIATION 4.519 • n=7 Participants
|
25.22 kg/m^2
STANDARD_DEVIATION 4.394 • n=5 Participants
|
25.39 kg/m^2
STANDARD_DEVIATION 4.296 • n=4 Participants
|
|
Seated Systolic Blood Pressure
|
122.0 mmHg
STANDARD_DEVIATION 13.01 • n=5 Participants
|
126.2 mmHg
STANDARD_DEVIATION 12.46 • n=7 Participants
|
126.5 mmHg
STANDARD_DEVIATION 14.36 • n=5 Participants
|
124.9 mmHg
STANDARD_DEVIATION 13.41 • n=4 Participants
|
|
HbA1c
|
7.50 Percent
STANDARD_DEVIATION 0.718 • n=5 Participants
|
7.46 Percent
STANDARD_DEVIATION 0.608 • n=7 Participants
|
7.50 Percent
STANDARD_DEVIATION 0.625 • n=5 Participants
|
7.49 Percent
STANDARD_DEVIATION 0.649 • n=4 Participants
|
|
FPG
|
137.5 mg/dL
STANDARD_DEVIATION 24.41 • n=5 Participants
|
138.8 mg/dL
STANDARD_DEVIATION 22.14 • n=7 Participants
|
139.6 mg/dL
STANDARD_DEVIATION 21.63 • n=5 Participants
|
138.6 mg/dL
STANDARD_DEVIATION 22.68 • n=4 Participants
|
PRIMARY outcome
Timeframe: From Baseline to Week 24Population: Full Analysis Set, participants with non-missing baseline and Week 24 (LOCF) values
To compare change from baseline in HbA1c achieved with each dose of dapagliflozin versus placebo after 24 weeks double-blind treatment.
Outcome measures
| Measure |
Dapagliflozin 5 mg
n=86 Participants
Dapagliflozin : Dapagliflozin 5mg/matching placebo for Dapagliflozin 10mg oral dose
|
Dapagliflozin 10 mg
n=87 Participants
Dapagliflozin : Dapagliflozin 10mg/matching placebo for Dapagliflozin 5mg oral dose
|
Placebo
n=86 Participants
Placebo : Matching placebo for Dapagliflozin 5mg/10mg oral dose
|
|---|---|---|---|
|
Adjusted Mean Change in HbA1c Levels
|
-0.41 Percent
Interval -0.53 to -0.29
|
-0.45 Percent
Interval -0.57 to -0.33
|
-0.06 Percent
Interval -0.18 to 0.06
|
SECONDARY outcome
Timeframe: From Baseline to Week 24Population: Full Analysis Set, participants with non-missing baseline and Week 24 (LOCF) values
To compare the change from baseline in fasting plasma glucose (FPG) achieved with each dose of dapagliflozin versus placebo after 24 weeks double-blind treatment.
Outcome measures
| Measure |
Dapagliflozin 5 mg
n=86 Participants
Dapagliflozin : Dapagliflozin 5mg/matching placebo for Dapagliflozin 10mg oral dose
|
Dapagliflozin 10 mg
n=87 Participants
Dapagliflozin : Dapagliflozin 10mg/matching placebo for Dapagliflozin 5mg oral dose
|
Placebo
n=86 Participants
Placebo : Matching placebo for Dapagliflozin 5mg/10mg oral dose
|
|---|---|---|---|
|
Adjusted Mean Change in Fasting Plasma Glucose (FPG)
|
-8.6 mg/dL
Interval -12.9 to -4.3
|
-13.7 mg/dL
Interval -18.0 to -9.5
|
5.8 mg/dL
Interval 1.6 to 10.1
|
SECONDARY outcome
Timeframe: From Baseline to Week 24Population: Full Analysis Set, participants with non-missing baseline and Week 24 (LOCF) values
To compare the change from baseline in total body weight achieved with each dose of dapagliflozin versus placebo after 24 weeks double-blind treatment.
Outcome measures
| Measure |
Dapagliflozin 5 mg
n=86 Participants
Dapagliflozin : Dapagliflozin 5mg/matching placebo for Dapagliflozin 10mg oral dose
|
Dapagliflozin 10 mg
n=88 Participants
Dapagliflozin : Dapagliflozin 10mg/matching placebo for Dapagliflozin 5mg oral dose
|
Placebo
n=87 Participants
Placebo : Matching placebo for Dapagliflozin 5mg/10mg oral dose
|
|---|---|---|---|
|
Adjusted Mean Change in Body Weight
|
-2.13 kg
Interval -2.65 to -1.6
|
-2.22 kg
Interval -2.73 to -1.71
|
-0.84 kg
Interval -1.36 to -0.32
|
Adverse Events
Dapagliflozin 5 mg
Serious events: 0 serious events
Other events: 11 other events
Deaths: 0 deaths
Dapagliflozin 10 mg
Serious events: 1 serious events
Other events: 15 other events
Deaths: 0 deaths
Placebo
Serious events: 1 serious events
Other events: 14 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Dapagliflozin 5 mg
n=86 participants at risk
Dapagliflozin : Dapagliflozin 5mg/matching placebo for Dapagliflozin 10mg oral dose
|
Dapagliflozin 10 mg
n=88 participants at risk
Dapagliflozin : Dapagliflozin 10mg/matching placebo for Dapagliflozin 5mg oral dose
|
Placebo
n=87 participants at risk
Placebo : Matching placebo for Dapagliflozin 5mg/10mg oral dose
|
|---|---|---|---|
|
Injury, poisoning and procedural complications
RIB FRACTURE
|
0.00%
0/86 • Non-serious/serious adverse events on or after the first day and on or prior to the last day of the 24-week double-blind treatment period plus 4/30 days or up to follow-up visit if earlier.
Participants were questioned at each study visit about the occurrence of any health problems and any examination conducted at a study visit was assessed in comparison to the status at study entry.
|
1.1%
1/88 • Non-serious/serious adverse events on or after the first day and on or prior to the last day of the 24-week double-blind treatment period plus 4/30 days or up to follow-up visit if earlier.
Participants were questioned at each study visit about the occurrence of any health problems and any examination conducted at a study visit was assessed in comparison to the status at study entry.
|
0.00%
0/87 • Non-serious/serious adverse events on or after the first day and on or prior to the last day of the 24-week double-blind treatment period plus 4/30 days or up to follow-up visit if earlier.
Participants were questioned at each study visit about the occurrence of any health problems and any examination conducted at a study visit was assessed in comparison to the status at study entry.
|
|
Nervous system disorders
PUTAMEN HAEMORRHAGE
|
0.00%
0/86 • Non-serious/serious adverse events on or after the first day and on or prior to the last day of the 24-week double-blind treatment period plus 4/30 days or up to follow-up visit if earlier.
Participants were questioned at each study visit about the occurrence of any health problems and any examination conducted at a study visit was assessed in comparison to the status at study entry.
|
0.00%
0/88 • Non-serious/serious adverse events on or after the first day and on or prior to the last day of the 24-week double-blind treatment period plus 4/30 days or up to follow-up visit if earlier.
Participants were questioned at each study visit about the occurrence of any health problems and any examination conducted at a study visit was assessed in comparison to the status at study entry.
|
1.1%
1/87 • Non-serious/serious adverse events on or after the first day and on or prior to the last day of the 24-week double-blind treatment period plus 4/30 days or up to follow-up visit if earlier.
Participants were questioned at each study visit about the occurrence of any health problems and any examination conducted at a study visit was assessed in comparison to the status at study entry.
|
Other adverse events
| Measure |
Dapagliflozin 5 mg
n=86 participants at risk
Dapagliflozin : Dapagliflozin 5mg/matching placebo for Dapagliflozin 10mg oral dose
|
Dapagliflozin 10 mg
n=88 participants at risk
Dapagliflozin : Dapagliflozin 10mg/matching placebo for Dapagliflozin 5mg oral dose
|
Placebo
n=87 participants at risk
Placebo : Matching placebo for Dapagliflozin 5mg/10mg oral dose
|
|---|---|---|---|
|
Infections and infestations
NASOPHARYNGITIS
|
10.5%
9/86 • Non-serious/serious adverse events on or after the first day and on or prior to the last day of the 24-week double-blind treatment period plus 4/30 days or up to follow-up visit if earlier.
Participants were questioned at each study visit about the occurrence of any health problems and any examination conducted at a study visit was assessed in comparison to the status at study entry.
|
17.0%
15/88 • Non-serious/serious adverse events on or after the first day and on or prior to the last day of the 24-week double-blind treatment period plus 4/30 days or up to follow-up visit if earlier.
Participants were questioned at each study visit about the occurrence of any health problems and any examination conducted at a study visit was assessed in comparison to the status at study entry.
|
10.3%
9/87 • Non-serious/serious adverse events on or after the first day and on or prior to the last day of the 24-week double-blind treatment period plus 4/30 days or up to follow-up visit if earlier.
Participants were questioned at each study visit about the occurrence of any health problems and any examination conducted at a study visit was assessed in comparison to the status at study entry.
|
|
Vascular disorders
HYPERTENSION
|
2.3%
2/86 • Non-serious/serious adverse events on or after the first day and on or prior to the last day of the 24-week double-blind treatment period plus 4/30 days or up to follow-up visit if earlier.
Participants were questioned at each study visit about the occurrence of any health problems and any examination conducted at a study visit was assessed in comparison to the status at study entry.
|
1.1%
1/88 • Non-serious/serious adverse events on or after the first day and on or prior to the last day of the 24-week double-blind treatment period plus 4/30 days or up to follow-up visit if earlier.
Participants were questioned at each study visit about the occurrence of any health problems and any examination conducted at a study visit was assessed in comparison to the status at study entry.
|
5.7%
5/87 • Non-serious/serious adverse events on or after the first day and on or prior to the last day of the 24-week double-blind treatment period plus 4/30 days or up to follow-up visit if earlier.
Participants were questioned at each study visit about the occurrence of any health problems and any examination conducted at a study visit was assessed in comparison to the status at study entry.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee If an Investigator requests permission to publish data from this study any such publication is to be agreed with AstraZeneca (AZ) in advance. The investigator agrees to provide AZ as soon as possible with drafts of proposed publications. Unless otherwise agreed, AZ shall have a period of 60 days from receipt of the proposed final manuscript to review it and may within such time require that submission for publication of the manuscript be delayed in order for AZ to file patent applications.
- Publication restrictions are in place
Restriction type: OTHER