Trial Outcomes & Findings for Dapagliflozin DPPIV Inhibitor add-on Study (NCT NCT00984867)
NCT ID: NCT00984867
Last Updated: 2014-06-13
Results Overview
To compare the change from baseline in HbA1c after 24 weeks treatment (LOCF) between dapagliflozin and placebo in patients with type 2 diabetes who are inadequately controlled on sitagliptin alone or on sitagliptin plus metformin.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
833 participants
Primary outcome timeframe
Baseline to Week 24
Results posted on
2014-06-13
Participant Flow
First participant enrolled: 10 Oct 2009. Last participant last visit for 24-week period: 10 Mar 2011. 833 participants were enrolled, 452 randomized and 451 treated in 3 European countries, USA, Argentina and Mexico. Participants with T2DM who showed inadequate glycemic control (7.0% ≤ HbA1c ≤ 10.0% at randomization) on sitagliptin +/- metformin.
During a placebo lead-in period, participants were counselled on dietary and life-style modifications. Participants eligible for the study were stratified according to use of metformin.
Participant milestones
| Measure |
Placebo
Placebo plus sitagliptin alone or in combination with metformin
|
Dapagliflozin
Dapagliflozin 10 mg plus sitagliptin alone or in combination with metformin
|
|---|---|---|
|
Overall Study
STARTED
|
226
|
225
|
|
Overall Study
COMPLETED
|
203
|
208
|
|
Overall Study
NOT COMPLETED
|
23
|
17
|
Reasons for withdrawal
| Measure |
Placebo
Placebo plus sitagliptin alone or in combination with metformin
|
Dapagliflozin
Dapagliflozin 10 mg plus sitagliptin alone or in combination with metformin
|
|---|---|---|
|
Overall Study
Adverse Event
|
3
|
7
|
|
Overall Study
Death
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
13
|
4
|
|
Overall Study
Lost to Follow-up
|
3
|
4
|
|
Overall Study
Poor/non-compliance
|
0
|
1
|
|
Overall Study
Subject no longer meets study criteria
|
1
|
1
|
|
Overall Study
site closing
|
1
|
0
|
|
Overall Study
lack of efficacy and subject compliance
|
1
|
0
|
Baseline Characteristics
Dapagliflozin DPPIV Inhibitor add-on Study
Baseline characteristics by cohort
| Measure |
Placebo
n=224 Participants
Placebo plus sitagliptin alone or in combination with metformin
|
Dapagliflozin
n=223 Participants
Dapagliflozin 10 mg plus sitagliptin alone or in combination with metformin
|
Total
n=447 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
55.0 Years
STANDARD_DEVIATION 10.20 • n=5 Participants
|
54.8 Years
STANDARD_DEVIATION 10.42 • n=7 Participants
|
54.9 Years
STANDARD_DEVIATION 10.30 • n=5 Participants
|
|
Sex: Female, Male
Female
|
106 Participants
n=5 Participants
|
96 Participants
n=7 Participants
|
202 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
118 Participants
n=5 Participants
|
127 Participants
n=7 Participants
|
245 Participants
n=5 Participants
|
|
HbA1c
|
7.97 HbA1c [%]
STANDARD_DEVIATION 0.778 • n=5 Participants
|
7.90 HbA1c [%]
STANDARD_DEVIATION 0.806 • n=7 Participants
|
7.93 HbA1c [%]
STANDARD_DEVIATION 0.792 • n=5 Participants
|
|
Body weight
|
89.23 kg
STANDARD_DEVIATION 20.887 • n=5 Participants
|
91.02 kg
STANDARD_DEVIATION 21.637 • n=7 Participants
|
90.12 kg
STANDARD_DEVIATION 21.259 • n=5 Participants
|
|
FPG
|
162.97 mg/dL
STANDARD_DEVIATION 34.452 • n=5 Participants
|
162.19 mg/dL
STANDARD_DEVIATION 36.825 • n=7 Participants
|
162.58 mg/dL
STANDARD_DEVIATION 35.618 • n=5 Participants
|
|
Seated SBP in subjects with baseline seated SBP ≥130 mmHg
|
139.30 mmHg
STANDARD_DEVIATION 8.507 • n=5 Participants
|
140.46 mmHg
STANDARD_DEVIATION 8.018 • n=7 Participants
|
139.85 mmHg
STANDARD_DEVIATION 8.279 • n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline to Week 24Population: Full Analysis Set, participants with non-missing baseline and Week 24 (LOCF) values
To compare the change from baseline in HbA1c after 24 weeks treatment (LOCF) between dapagliflozin and placebo in patients with type 2 diabetes who are inadequately controlled on sitagliptin alone or on sitagliptin plus metformin.
Outcome measures
| Measure |
Placebo
n=223 Participants
Placebo plus sitagliptin alone or in combination with metformin
|
Dapagliflozin
n=223 Participants
Dapagliflozin 10 mg plus sitagliptin alone or in combination with metformin
|
|---|---|---|
|
Adjusted Mean Change in HbA1c Levels
|
0.04 Percent
95% Confidence Interval 0.0509 • Interval -0.06 to 0.14
|
-0.45 Percent
95% Confidence Interval 0.0509 • Interval -0.55 to -0.35
|
SECONDARY outcome
Timeframe: Baseline to Week 24Population: Full Analysis Set, participants with non-missing baseline and Week 24 (LOCF) values
To compare the change in total body weight achieved with dapagliflozin versus placebo from baseline to week 24.
Outcome measures
| Measure |
Placebo
n=224 Participants
Placebo plus sitagliptin alone or in combination with metformin
|
Dapagliflozin
n=223 Participants
Dapagliflozin 10 mg plus sitagliptin alone or in combination with metformin
|
|---|---|---|
|
Adjusted Mean Change in Body Weight
|
-0.26 kg
95% Confidence Interval 0.1741 • Interval -0.6 to 0.09
|
-2.14 kg
95% Confidence Interval 0.1745 • Interval -2.48 to -1.8
|
SECONDARY outcome
Timeframe: Baseline to Week 24Population: Full analysis set, participants with baseline HbA1c \>=8% and Week 24 (LOCF) value
To compare the change in HbA1c in participants with baseline HbA1c ≥8% achieved with dapagliflozin versus placebo from baseline to week 24.
Outcome measures
| Measure |
Placebo
n=99 Participants
Placebo plus sitagliptin alone or in combination with metformin
|
Dapagliflozin
n=94 Participants
Dapagliflozin 10 mg plus sitagliptin alone or in combination with metformin
|
|---|---|---|
|
Adjusted Mean Change in HbA1c in Participants With Baseline HbA1c ≥8%
|
0.03 Percent
95% Confidence Interval 0.0775 • Interval -0.12 to 0.18
|
-0.80 Percent
95% Confidence Interval 0.0797 • Interval -0.96 to -0.65
|
SECONDARY outcome
Timeframe: Baseline to Week 24Population: Full Analysis Set, participants with non-missing baseline and Week 24 (LOCF) values
To compare the change in FPG achieved with dapagliflozin versus placebo from baseline to week 24.
Outcome measures
| Measure |
Placebo
n=222 Participants
Placebo plus sitagliptin alone or in combination with metformin
|
Dapagliflozin
n=222 Participants
Dapagliflozin 10 mg plus sitagliptin alone or in combination with metformin
|
|---|---|---|
|
Adjusted Mean Change in Fasting Plasma Glucose (FPG)
|
3.81 mg/dL
95% Confidence Interval 2.3474 • Interval -0.8 to 8.42
|
-24.11 mg/dL
95% Confidence Interval 2.3474 • Interval -28.73 to -19.5
|
SECONDARY outcome
Timeframe: Baseline to Week 8Population: Full analysis set, participants with baseline SBP\>=130mmHg and Week 8 (LOCF) value
To compare the change in seated systolic blood pressure (SBP) in participants with baseline seated SBP \>=130 achieved with dapagliflozin versus placebo from baseline to week 8.
Outcome measures
| Measure |
Placebo
n=111 Participants
Placebo plus sitagliptin alone or in combination with metformin
|
Dapagliflozin
n=101 Participants
Dapagliflozin 10 mg plus sitagliptin alone or in combination with metformin
|
|---|---|---|
|
Adjusted Mean Change in Seated Systolic Blood Pressure (SBP) in Participants With Baseline SBP>=130 mmHg
|
-5.12 mmHg
95% Confidence Interval 1.0211 • Interval -7.14 to -3.11
|
-5.98 mmHg
95% Confidence Interval 1.0638 • Interval -8.08 to -3.89
|
SECONDARY outcome
Timeframe: Baseline to Week 24Population: Full Analysis Set, participants with non-missing baseline and Week 24 (LOCF) values
To compare the change in 2-hour post liquid meal glucose rise achieved with dapagliflozin versus placebo from baseline to week 24.
Outcome measures
| Measure |
Placebo
n=197 Participants
Placebo plus sitagliptin alone or in combination with metformin
|
Dapagliflozin
n=205 Participants
Dapagliflozin 10 mg plus sitagliptin alone or in combination with metformin
|
|---|---|---|
|
Adjusted Mean Change in 2-hour Post Liquid Meal Glucose Rise
|
-6.84 mg/dL
95% Confidence Interval 2.5098 • Interval -11.77 to -1.9
|
-21.65 mg/dL
95% Confidence Interval 2.4604 • Interval -26.49 to -16.81
|
SECONDARY outcome
Timeframe: Baseline to Week 24Population: Full Analysis Set, participants with non-missing baseline and Week 24 (LOCF) values
To compare the proportion of participants achieving a therapeutic glycaemic response, defined as a reduction in HbA1c of ≥0.7% compared to baseline, with dapagliflozin versus placebo at week 24. Least Squares Mean represents the percent of participants adjusted for HbA1c baseline value.
Outcome measures
| Measure |
Placebo
n=223 Participants
Placebo plus sitagliptin alone or in combination with metformin
|
Dapagliflozin
n=223 Participants
Dapagliflozin 10 mg plus sitagliptin alone or in combination with metformin
|
|---|---|---|
|
Proportion of Participants Achieving a Therapeutic Glycemic Response Defined as a Reduction in HbA1c of ≥0.7% Compared to Baseline
|
16.6 Percentage of participants
95% Confidence Interval 2.491 • Interval 11.7 to 21.4
|
35.3 Percentage of participants
95% Confidence Interval 3.083 • Interval 29.3 to 41.2
|
Adverse Events
Placebo
Serious events: 9 serious events
Other events: 14 other events
Deaths: 0 deaths
Dapagliflozin
Serious events: 10 serious events
Other events: 9 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo
n=226 participants at risk
Placebo plus sitagliptin alone or in combination with metformin. Safety analysis set.
|
Dapagliflozin
n=225 participants at risk
Dapagliflozin 10 mg plus sitagliptin alone or in combination with metformin. Safety analysis set.
|
|---|---|---|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/226 • 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 plus 4/30 days or up to follow-up visit if earlier, or up to and including the start date of extension period 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.
|
0.44%
1/225 • 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 plus 4/30 days or up to follow-up visit if earlier, or up to and including the start date of extension period 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.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/226 • 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 plus 4/30 days or up to follow-up visit if earlier, or up to and including the start date of extension period 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.
|
0.44%
1/225 • 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 plus 4/30 days or up to follow-up visit if earlier, or up to and including the start date of extension period 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.
|
|
Gastrointestinal disorders
Umbilical hernia
|
0.00%
0/226 • 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 plus 4/30 days or up to follow-up visit if earlier, or up to and including the start date of extension period 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.
|
0.44%
1/225 • 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 plus 4/30 days or up to follow-up visit if earlier, or up to and including the start date of extension period 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.
|
|
Gastrointestinal disorders
Colonic polyp
|
0.44%
1/226 • 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 plus 4/30 days or up to follow-up visit if earlier, or up to and including the start date of extension period 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%
0/225 • 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 plus 4/30 days or up to follow-up visit if earlier, or up to and including the start date of extension period 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.
|
|
General disorders
Device dislocation
|
0.00%
0/226 • 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 plus 4/30 days or up to follow-up visit if earlier, or up to and including the start date of extension period 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.
|
0.44%
1/225 • 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 plus 4/30 days or up to follow-up visit if earlier, or up to and including the start date of extension period 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.
|
|
General disorders
Medical device pain
|
0.00%
0/226 • 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 plus 4/30 days or up to follow-up visit if earlier, or up to and including the start date of extension period 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.
|
0.44%
1/225 • 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 plus 4/30 days or up to follow-up visit if earlier, or up to and including the start date of extension period 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.
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/226 • 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 plus 4/30 days or up to follow-up visit if earlier, or up to and including the start date of extension period 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.
|
0.44%
1/225 • 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 plus 4/30 days or up to follow-up visit if earlier, or up to and including the start date of extension period 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.
|
|
Cardiac disorders
Angina pectoris
|
0.00%
0/226 • 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 plus 4/30 days or up to follow-up visit if earlier, or up to and including the start date of extension period 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.
|
0.44%
1/225 • 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 plus 4/30 days or up to follow-up visit if earlier, or up to and including the start date of extension period 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.
|
|
Cardiac disorders
Angina unstable
|
0.00%
0/226 • 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 plus 4/30 days or up to follow-up visit if earlier, or up to and including the start date of extension period 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.
|
0.44%
1/225 • 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 plus 4/30 days or up to follow-up visit if earlier, or up to and including the start date of extension period 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.
|
|
Hepatobiliary disorders
Cholecystitis
|
0.00%
0/226 • 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 plus 4/30 days or up to follow-up visit if earlier, or up to and including the start date of extension period 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.
|
0.44%
1/225 • 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 plus 4/30 days or up to follow-up visit if earlier, or up to and including the start date of extension period 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.
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.00%
0/226 • 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 plus 4/30 days or up to follow-up visit if earlier, or up to and including the start date of extension period 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.
|
0.44%
1/225 • 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 plus 4/30 days or up to follow-up visit if earlier, or up to and including the start date of extension period 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.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/226 • 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 plus 4/30 days or up to follow-up visit if earlier, or up to and including the start date of extension period 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.
|
0.44%
1/225 • 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 plus 4/30 days or up to follow-up visit if earlier, or up to and including the start date of extension period 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.
|
|
Infections and infestations
Viral infection
|
0.44%
1/226 • 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 plus 4/30 days or up to follow-up visit if earlier, or up to and including the start date of extension period 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%
0/225 • 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 plus 4/30 days or up to follow-up visit if earlier, or up to and including the start date of extension period 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.
|
|
Musculoskeletal and connective tissue disorders
Rotator cuff syndrome
|
0.00%
0/226 • 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 plus 4/30 days or up to follow-up visit if earlier, or up to and including the start date of extension period 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.
|
0.44%
1/225 • 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 plus 4/30 days or up to follow-up visit if earlier, or up to and including the start date of extension period 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
Arteriosclerosis
|
0.00%
0/226 • 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 plus 4/30 days or up to follow-up visit if earlier, or up to and including the start date of extension period 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.
|
0.44%
1/225 • 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 plus 4/30 days or up to follow-up visit if earlier, or up to and including the start date of extension period 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
Ischaemia
|
0.44%
1/226 • 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 plus 4/30 days or up to follow-up visit if earlier, or up to and including the start date of extension period 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%
0/225 • 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 plus 4/30 days or up to follow-up visit if earlier, or up to and including the start date of extension period 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.
|
|
Injury, poisoning and procedural complications
Upper limb fracture
|
0.44%
1/226 • 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 plus 4/30 days or up to follow-up visit if earlier, or up to and including the start date of extension period 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%
0/225 • 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 plus 4/30 days or up to follow-up visit if earlier, or up to and including the start date of extension period 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.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
0.88%
2/226 • 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 plus 4/30 days or up to follow-up visit if earlier, or up to and including the start date of extension period 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%
0/225 • 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 plus 4/30 days or up to follow-up visit if earlier, or up to and including the start date of extension period 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.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.44%
1/226 • 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 plus 4/30 days or up to follow-up visit if earlier, or up to and including the start date of extension period 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%
0/225 • 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 plus 4/30 days or up to follow-up visit if earlier, or up to and including the start date of extension period 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.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastatic squamous cell carcinoma
|
0.44%
1/226 • 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 plus 4/30 days or up to follow-up visit if earlier, or up to and including the start date of extension period 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%
0/225 • 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 plus 4/30 days or up to follow-up visit if earlier, or up to and including the start date of extension period 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.
|
|
Skin and subcutaneous tissue disorders
Eczema nummular
|
0.44%
1/226 • 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 plus 4/30 days or up to follow-up visit if earlier, or up to and including the start date of extension period 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%
0/225 • 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 plus 4/30 days or up to follow-up visit if earlier, or up to and including the start date of extension period 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 |
Placebo
n=226 participants at risk
Placebo plus sitagliptin alone or in combination with metformin. Safety analysis set.
|
Dapagliflozin
n=225 participants at risk
Dapagliflozin 10 mg plus sitagliptin alone or in combination with metformin. Safety analysis set.
|
|---|---|---|
|
Infections and infestations
Nasopharyngitis
|
6.2%
14/226 • 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 plus 4/30 days or up to follow-up visit if earlier, or up to and including the start date of extension period 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.
|
4.0%
9/225 • 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 plus 4/30 days or up to follow-up visit if earlier, or up to and including the start date of extension period 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