Trial Outcomes & Findings for A 24-week Open-Label, Phase 3b Trial With a 28-week Extension to Evaluate the Efficacy and Safety of Saxagliptin Co-administered With Dapagliflozin Compared to Insulin Glargine in Subjects withType 2 Diabetes Who Have Glycemic Control on Metformin (NCT NCT02551874)
NCT ID: NCT02551874
Last Updated: 2018-12-11
Results Overview
To examine whether the mean change from baseline in HbA1c with co-administered saxagliptin 5 mg and dapagliflozin 10 mg plus metformin with or without SU is noninferior (noninferiority margin of 0.3%) to titrated insulin glargine plus metformin with or without SU after 24 weeks of open-label treatment.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
650 participants
Primary outcome timeframe
Baseline and Week 24
Results posted on
2018-12-11
Participant Flow
This study was conducted at 112 centers in 11 countries from 20 Oct 2015 to 10 Nov 2017. There were 2 data cut-offs for this study: 8 May 2017 for analyses of the short-term study period (after 24 weeks of open-label treatment) and 10 Nov 2017 for analyses of the short-term plus long-term study period (after 52 weeks of open-label treatment).
The study duration was up to 56 weeks, consisting of a 2-week screening period, 2-week lead-in period, 24-week short-term treatment period, and 28-week long-term treatment period.
Participant milestones
| Measure |
Dapagliflozin + Saxagliptin + Metformin
Subjects received dapagliflozin 10 milligrams (mg) and saxagliptin 5 mg, administered orally once daily (QD) in the morning for the 52-week treatment period (24-week short-term period and 28-week long term period).
Subjects continued to receive their stable dose of metformin with or without sulfonylurea (SU) throughout the study.
|
Titrated Insulin + Metformin
Subjects were to administer insulin glargine subcutaneously QD at the same time every day for the 52-week treatment period (24-week short-term period and 28-week long term period), following investigator instructions and training. All subjects started with an initial dose of 0.2 units/kilogram (kg) body weight or at least 10 units of insulin per day. Subjects self-titrated the dose of insulin glargine over the first 8 weeks of the study based on daily glucose monitoring. The investigator had the discretion to modify insulin dose based on his/her assessment between Week 8 and Week 12 with the goal to reach an acceptable and stable insulin dose by Week 12.
Subjects continued to receive their stable dose of metformin with or without SU throughout the study.
|
|---|---|---|
|
Overall Study
STARTED
|
324
|
326
|
|
Overall Study
Received Treatment in Short-term Study
|
324
|
319
|
|
Overall Study
Entered Long-term Study
|
306
|
294
|
|
Overall Study
Received Treatment in Long-term Study
|
295
|
284
|
|
Overall Study
COMPLETED
|
296
|
287
|
|
Overall Study
NOT COMPLETED
|
28
|
39
|
Reasons for withdrawal
| Measure |
Dapagliflozin + Saxagliptin + Metformin
Subjects received dapagliflozin 10 milligrams (mg) and saxagliptin 5 mg, administered orally once daily (QD) in the morning for the 52-week treatment period (24-week short-term period and 28-week long term period).
Subjects continued to receive their stable dose of metformin with or without sulfonylurea (SU) throughout the study.
|
Titrated Insulin + Metformin
Subjects were to administer insulin glargine subcutaneously QD at the same time every day for the 52-week treatment period (24-week short-term period and 28-week long term period), following investigator instructions and training. All subjects started with an initial dose of 0.2 units/kilogram (kg) body weight or at least 10 units of insulin per day. Subjects self-titrated the dose of insulin glargine over the first 8 weeks of the study based on daily glucose monitoring. The investigator had the discretion to modify insulin dose based on his/her assessment between Week 8 and Week 12 with the goal to reach an acceptable and stable insulin dose by Week 12.
Subjects continued to receive their stable dose of metformin with or without SU throughout the study.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
0
|
2
|
|
Overall Study
Pregnancy
|
0
|
1
|
|
Overall Study
Reason not reported
|
10
|
4
|
|
Overall Study
Did not receive randomized treatment
|
0
|
7
|
|
Overall Study
Did not enter long-term study
|
18
|
25
|
Baseline Characteristics
A 24-week Open-Label, Phase 3b Trial With a 28-week Extension to Evaluate the Efficacy and Safety of Saxagliptin Co-administered With Dapagliflozin Compared to Insulin Glargine in Subjects withType 2 Diabetes Who Have Glycemic Control on Metformin
Baseline characteristics by cohort
| Measure |
Dapagliflozin + Saxagliptin + Metformin
n=324 Participants
Subjects received dapagliflozin 10 mg and saxagliptin 5 mg, administered orally QD in the morning for the 52-week treatment period (24-week short-term period and 28-week long term period).
Subjects continued to receive their stable dose of metformin with or without SU throughout the study.
|
Titrated Insulin + Metformin
n=319 Participants
Subjects were to administer insulin glargine subcutaneously QD at the same time every day for the 52-week treatment period (24-week short-term period and 28-week long term period), following investigator instructions and training. All subjects started with an initial dose of 0.2 units/kg body weight or at least 10 units of insulin per day. Subjects self-titrated the dose of insulin glargine over the first 8 weeks of the study based on daily glucose monitoring. The investigator had the discretion to modify insulin dose based on his/her assessment between Week 8 and Week 12 with the goal to reach an acceptable and stable insulin dose by Week 12.
Subjects continued to receive their stable dose of metformin with or without SU throughout the study.
|
Total
n=643 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
55.7 Years
STANDARD_DEVIATION 9.52 • n=5 Participants
|
55.3 Years
STANDARD_DEVIATION 9.63 • n=7 Participants
|
55.5 Years
STANDARD_DEVIATION 9.57 • n=5 Participants
|
|
Sex: Female, Male
Female
|
148 Participants
n=5 Participants
|
148 Participants
n=7 Participants
|
296 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
176 Participants
n=5 Participants
|
171 Participants
n=7 Participants
|
347 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
American Indian Or Alaska Native
|
12 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
12 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black Or African American
|
28 Participants
n=5 Participants
|
35 Participants
n=7 Participants
|
63 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian Or Other Pacific Islander
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
9 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
263 Participants
n=5 Participants
|
254 Participants
n=7 Participants
|
517 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline and Week 24Population: The randomized subjects data set consisted of all randomized subjects who received at least 1 dose of study medication.
To examine whether the mean change from baseline in HbA1c with co-administered saxagliptin 5 mg and dapagliflozin 10 mg plus metformin with or without SU is noninferior (noninferiority margin of 0.3%) to titrated insulin glargine plus metformin with or without SU after 24 weeks of open-label treatment.
Outcome measures
| Measure |
Dapagliflozin + Saxagliptin + Metformin
n=319 Participants
Subjects received dapagliflozin 10 mg and saxagliptin 5 mg, administered orally QD in the morning for the 52-week treatment period (24-week short-term period and 28-week long term period).
Subjects continued to receive their stable dose of metformin with or without SU throughout the study.
|
Titrated Insulin + Metformin
n=312 Participants
Subjects were to administer insulin glargine subcutaneously QD at the same time every day for the 52-week treatment period (24-week short-term period and 28-week long term period), following investigator instructions and training. All subjects started with an initial dose of 0.2 units/kg body weight or at least 10 units of insulin per day. Subjects self-titrated the dose of insulin glargine over the first 8 weeks of the study based on daily glucose monitoring. The investigator had the discretion to modify insulin dose based on his/her assessment between Week 8 and Week 12 with the goal to reach an acceptable and stable insulin dose by Week 12.
Subjects continued to receive their stable dose of metformin with or without SU throughout the study.
|
|---|---|---|
|
Mean Change From Baseline in HbA1c at Week 24
|
-1.67 % HbA1c
Interval -1.79 to -1.55
|
-1.54 % HbA1c
Interval -1.66 to -1.42
|
SECONDARY outcome
Timeframe: Baseline and Week 24Population: The number of participants is the number of subjects in the randomized subject data set with non-missing baseline assessments and at least one post-baseline assessment.
To compare the mean change from baseline in total body weight with co-administered saxagliptin 5 mg and dapagliflozin 10 mg plus metformin with or without SU versus titrated insulin glargine plus metformin with or without SU after 24 weeks of open-label treatment
Outcome measures
| Measure |
Dapagliflozin + Saxagliptin + Metformin
n=319 Participants
Subjects received dapagliflozin 10 mg and saxagliptin 5 mg, administered orally QD in the morning for the 52-week treatment period (24-week short-term period and 28-week long term period).
Subjects continued to receive their stable dose of metformin with or without SU throughout the study.
|
Titrated Insulin + Metformin
n=313 Participants
Subjects were to administer insulin glargine subcutaneously QD at the same time every day for the 52-week treatment period (24-week short-term period and 28-week long term period), following investigator instructions and training. All subjects started with an initial dose of 0.2 units/kg body weight or at least 10 units of insulin per day. Subjects self-titrated the dose of insulin glargine over the first 8 weeks of the study based on daily glucose monitoring. The investigator had the discretion to modify insulin dose based on his/her assessment between Week 8 and Week 12 with the goal to reach an acceptable and stable insulin dose by Week 12.
Subjects continued to receive their stable dose of metformin with or without SU throughout the study.
|
|---|---|---|
|
Mean Change From Baseline in Total Body Weight at Week 24
|
-1.50 kg
Interval -1.89 to -1.11
|
2.14 kg
Interval 1.75 to 2.54
|
SECONDARY outcome
Timeframe: Baseline and Week 24Population: The randomized subject data set consisted of all randomized subjects who received at least 1 dose of study medication.
Hypoglycemia defined as plasma glucose ≤70 mg/dL (3.9 mmol/L)
Outcome measures
| Measure |
Dapagliflozin + Saxagliptin + Metformin
n=324 Participants
Subjects received dapagliflozin 10 mg and saxagliptin 5 mg, administered orally QD in the morning for the 52-week treatment period (24-week short-term period and 28-week long term period).
Subjects continued to receive their stable dose of metformin with or without SU throughout the study.
|
Titrated Insulin + Metformin
n=319 Participants
Subjects were to administer insulin glargine subcutaneously QD at the same time every day for the 52-week treatment period (24-week short-term period and 28-week long term period), following investigator instructions and training. All subjects started with an initial dose of 0.2 units/kg body weight or at least 10 units of insulin per day. Subjects self-titrated the dose of insulin glargine over the first 8 weeks of the study based on daily glucose monitoring. The investigator had the discretion to modify insulin dose based on his/her assessment between Week 8 and Week 12 with the goal to reach an acceptable and stable insulin dose by Week 12.
Subjects continued to receive their stable dose of metformin with or without SU throughout the study.
|
|---|---|---|
|
Percentage of Subjects With Confirmed Hypoglycaemia at Week 24
|
21.3 Adjusted % Participants
Interval 17.03 to 26.22
|
38.4 Adjusted % Participants
Interval 32.94 to 44.07
|
SECONDARY outcome
Timeframe: Baseline and Week 24Population: The randomized subject data set consisted of all randomized subjects who received at least 1 dose of study medication.
To compare the percentage of subjects achieving a therapeutic glycemic response, defined as HbA1c \<7.0%, without any reported hypoglycemia, with co-administered saxagliptin 5 mg and dapagliflozin 10 mg plus metformin with or without SU versus titrated insulin glargine plus metformin with or without SU after 24 weeks of open-label treatment.
Outcome measures
| Measure |
Dapagliflozin + Saxagliptin + Metformin
n=324 Participants
Subjects received dapagliflozin 10 mg and saxagliptin 5 mg, administered orally QD in the morning for the 52-week treatment period (24-week short-term period and 28-week long term period).
Subjects continued to receive their stable dose of metformin with or without SU throughout the study.
|
Titrated Insulin + Metformin
n=319 Participants
Subjects were to administer insulin glargine subcutaneously QD at the same time every day for the 52-week treatment period (24-week short-term period and 28-week long term period), following investigator instructions and training. All subjects started with an initial dose of 0.2 units/kg body weight or at least 10 units of insulin per day. Subjects self-titrated the dose of insulin glargine over the first 8 weeks of the study based on daily glucose monitoring. The investigator had the discretion to modify insulin dose based on his/her assessment between Week 8 and Week 12 with the goal to reach an acceptable and stable insulin dose by Week 12.
Subjects continued to receive their stable dose of metformin with or without SU throughout the study.
|
|---|---|---|
|
Percentage of Subjects Achieving a Therapeutic Glycemic Response, Without Hypoglycaemia, at Week 24
|
20.9 Adjusted % Participants
Interval 16.69 to 25.83
|
13.1 Adjusted % Participants
Interval 9.72 to 17.33
|
SECONDARY outcome
Timeframe: Baseline and Week 24Population: The randomized subject data set consisted of all randomized subjects who received at least 1 dose of study medication.
To examine whether the percentage of subjects achieving a therapeutic glycemic response, defined as HbA1c \<7.0%, with co-administered saxagliptin 5 mg and dapagliflozin 10 mg plus metformin with or without SU is noninferior (noninferiority margin of 10%) to titrated insulin glargine plus metformin with or without SU after 24 weeks of open-label treatment.
Outcome measures
| Measure |
Dapagliflozin + Saxagliptin + Metformin
n=324 Participants
Subjects received dapagliflozin 10 mg and saxagliptin 5 mg, administered orally QD in the morning for the 52-week treatment period (24-week short-term period and 28-week long term period).
Subjects continued to receive their stable dose of metformin with or without SU throughout the study.
|
Titrated Insulin + Metformin
n=319 Participants
Subjects were to administer insulin glargine subcutaneously QD at the same time every day for the 52-week treatment period (24-week short-term period and 28-week long term period), following investigator instructions and training. All subjects started with an initial dose of 0.2 units/kg body weight or at least 10 units of insulin per day. Subjects self-titrated the dose of insulin glargine over the first 8 weeks of the study based on daily glucose monitoring. The investigator had the discretion to modify insulin dose based on his/her assessment between Week 8 and Week 12 with the goal to reach an acceptable and stable insulin dose by Week 12.
Subjects continued to receive their stable dose of metformin with or without SU throughout the study.
|
|---|---|---|
|
Percentage of Subjects Achieving a Therapeutic Glycemic Response at Week 24
|
33.2 Adjusted % Participants
Interval 28.0 to 38.79
|
33.5 Adjusted % Participants
Interval 28.28 to 39.26
|
SECONDARY outcome
Timeframe: Baseline and Week 2Population: The randomized subject data set consisted of all randomized subjects who received at least 1 dose of study medication.
Change from baseline in the mean value of 24-hour glucose readings measured by Continuous Glucose Monitoring with co-administered saxagliptin 5 mg and dapagliflozin 10 mg plus metformin with or without SU is noninferior to titrated insulin glargine plus metformin with or without SU after 2 weeks of open-label treatment.
Outcome measures
| Measure |
Dapagliflozin + Saxagliptin + Metformin
n=133 Participants
Subjects received dapagliflozin 10 mg and saxagliptin 5 mg, administered orally QD in the morning for the 52-week treatment period (24-week short-term period and 28-week long term period).
Subjects continued to receive their stable dose of metformin with or without SU throughout the study.
|
Titrated Insulin + Metformin
n=133 Participants
Subjects were to administer insulin glargine subcutaneously QD at the same time every day for the 52-week treatment period (24-week short-term period and 28-week long term period), following investigator instructions and training. All subjects started with an initial dose of 0.2 units/kg body weight or at least 10 units of insulin per day. Subjects self-titrated the dose of insulin glargine over the first 8 weeks of the study based on daily glucose monitoring. The investigator had the discretion to modify insulin dose based on his/her assessment between Week 8 and Week 12 with the goal to reach an acceptable and stable insulin dose by Week 12.
Subjects continued to receive their stable dose of metformin with or without SU throughout the study.
|
|---|---|---|
|
Change From Baseline in the Mean Value of 24-hour Glucose at Week 2
|
-48.53 mg/deciliter (dL)
Interval -53.47 to -43.59
|
-28.54 mg/deciliter (dL)
Interval -33.47 to -23.61
|
Adverse Events
Dapagliflozin + Saxagliptin + Metformin
Serious events: 20 serious events
Other events: 55 other events
Deaths: 2 deaths
Titrated Insulin + Metformin
Serious events: 13 serious events
Other events: 73 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Dapagliflozin + Saxagliptin + Metformin
n=324 participants at risk
Subjects received dapagliflozin 10 mg and saxagliptin 5 mg, administered orally QD in the morning for the 52-week treatment period (24-week short-term period and 28-week long term period).
Subjects continued to receive their stable dose of metformin with or without SU throughout the study.
|
Titrated Insulin + Metformin
n=319 participants at risk
Subjects were to administer insulin glargine subcutaneously QD at the same time every day for the 52-week treatment period (24-week short-term period and 28-week long term period), following investigator instructions and training. All subjects started with an initial dose of 0.2 units/kg body weight or at least 10 units of insulin per day. Subjects self-titrated the dose of insulin glargine over the first 8 weeks of the study based on daily glucose monitoring. The investigator had the discretion to modify insulin dose based on his/her assessment between Week 8 and Week 12 with the goal to reach an acceptable and stable insulin dose by Week 12.
Subjects continued to receive their stable dose of metformin with or without SU throughout the study.
|
|---|---|---|
|
Infections and infestations
Sepsis
|
0.00%
0/324 • From baseline (Day 1) up to Week 52 (24-week short-term treatment period + 28-week long-term treatment period).
Adverse event (AE) data is reported for the treated subject data set, and included AEs with an onset date on or after the date of first dose of short-term study treatment and up to and including 30 days following the date of last dose of short-term + long-term study treatment.
|
0.31%
1/319 • Number of events 1 • From baseline (Day 1) up to Week 52 (24-week short-term treatment period + 28-week long-term treatment period).
Adverse event (AE) data is reported for the treated subject data set, and included AEs with an onset date on or after the date of first dose of short-term study treatment and up to and including 30 days following the date of last dose of short-term + long-term study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
0.31%
1/324 • Number of events 1 • From baseline (Day 1) up to Week 52 (24-week short-term treatment period + 28-week long-term treatment period).
Adverse event (AE) data is reported for the treated subject data set, and included AEs with an onset date on or after the date of first dose of short-term study treatment and up to and including 30 days following the date of last dose of short-term + long-term study treatment.
|
0.00%
0/319 • From baseline (Day 1) up to Week 52 (24-week short-term treatment period + 28-week long-term treatment period).
Adverse event (AE) data is reported for the treated subject data set, and included AEs with an onset date on or after the date of first dose of short-term study treatment and up to and including 30 days following the date of last dose of short-term + long-term study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer female
|
0.31%
1/324 • Number of events 1 • From baseline (Day 1) up to Week 52 (24-week short-term treatment period + 28-week long-term treatment period).
Adverse event (AE) data is reported for the treated subject data set, and included AEs with an onset date on or after the date of first dose of short-term study treatment and up to and including 30 days following the date of last dose of short-term + long-term study treatment.
|
0.00%
0/319 • From baseline (Day 1) up to Week 52 (24-week short-term treatment period + 28-week long-term treatment period).
Adverse event (AE) data is reported for the treated subject data set, and included AEs with an onset date on or after the date of first dose of short-term study treatment and up to and including 30 days following the date of last dose of short-term + long-term study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Endometrial cancer
|
0.31%
1/324 • Number of events 1 • From baseline (Day 1) up to Week 52 (24-week short-term treatment period + 28-week long-term treatment period).
Adverse event (AE) data is reported for the treated subject data set, and included AEs with an onset date on or after the date of first dose of short-term study treatment and up to and including 30 days following the date of last dose of short-term + long-term study treatment.
|
0.00%
0/319 • From baseline (Day 1) up to Week 52 (24-week short-term treatment period + 28-week long-term treatment period).
Adverse event (AE) data is reported for the treated subject data set, and included AEs with an onset date on or after the date of first dose of short-term study treatment and up to and including 30 days following the date of last dose of short-term + long-term study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant melanoma
|
0.31%
1/324 • Number of events 1 • From baseline (Day 1) up to Week 52 (24-week short-term treatment period + 28-week long-term treatment period).
Adverse event (AE) data is reported for the treated subject data set, and included AEs with an onset date on or after the date of first dose of short-term study treatment and up to and including 30 days following the date of last dose of short-term + long-term study treatment.
|
0.00%
0/319 • From baseline (Day 1) up to Week 52 (24-week short-term treatment period + 28-week long-term treatment period).
Adverse event (AE) data is reported for the treated subject data set, and included AEs with an onset date on or after the date of first dose of short-term study treatment and up to and including 30 days following the date of last dose of short-term + long-term study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer
|
0.00%
0/324 • From baseline (Day 1) up to Week 52 (24-week short-term treatment period + 28-week long-term treatment period).
Adverse event (AE) data is reported for the treated subject data set, and included AEs with an onset date on or after the date of first dose of short-term study treatment and up to and including 30 days following the date of last dose of short-term + long-term study treatment.
|
0.31%
1/319 • Number of events 1 • From baseline (Day 1) up to Week 52 (24-week short-term treatment period + 28-week long-term treatment period).
Adverse event (AE) data is reported for the treated subject data set, and included AEs with an onset date on or after the date of first dose of short-term study treatment and up to and including 30 days following the date of last dose of short-term + long-term study treatment.
|
|
Metabolism and nutrition disorders
Diabetic ketoacidosis
|
0.00%
0/324 • From baseline (Day 1) up to Week 52 (24-week short-term treatment period + 28-week long-term treatment period).
Adverse event (AE) data is reported for the treated subject data set, and included AEs with an onset date on or after the date of first dose of short-term study treatment and up to and including 30 days following the date of last dose of short-term + long-term study treatment.
|
0.31%
1/319 • Number of events 1 • From baseline (Day 1) up to Week 52 (24-week short-term treatment period + 28-week long-term treatment period).
Adverse event (AE) data is reported for the treated subject data set, and included AEs with an onset date on or after the date of first dose of short-term study treatment and up to and including 30 days following the date of last dose of short-term + long-term study treatment.
|
|
Nervous system disorders
Ischaemic stroke
|
0.00%
0/324 • From baseline (Day 1) up to Week 52 (24-week short-term treatment period + 28-week long-term treatment period).
Adverse event (AE) data is reported for the treated subject data set, and included AEs with an onset date on or after the date of first dose of short-term study treatment and up to and including 30 days following the date of last dose of short-term + long-term study treatment.
|
0.31%
1/319 • Number of events 1 • From baseline (Day 1) up to Week 52 (24-week short-term treatment period + 28-week long-term treatment period).
Adverse event (AE) data is reported for the treated subject data set, and included AEs with an onset date on or after the date of first dose of short-term study treatment and up to and including 30 days following the date of last dose of short-term + long-term study treatment.
|
|
Eye disorders
Vitreous haemorrhage
|
0.00%
0/324 • From baseline (Day 1) up to Week 52 (24-week short-term treatment period + 28-week long-term treatment period).
Adverse event (AE) data is reported for the treated subject data set, and included AEs with an onset date on or after the date of first dose of short-term study treatment and up to and including 30 days following the date of last dose of short-term + long-term study treatment.
|
0.31%
1/319 • Number of events 1 • From baseline (Day 1) up to Week 52 (24-week short-term treatment period + 28-week long-term treatment period).
Adverse event (AE) data is reported for the treated subject data set, and included AEs with an onset date on or after the date of first dose of short-term study treatment and up to and including 30 days following the date of last dose of short-term + long-term study treatment.
|
|
Cardiac disorders
Coronary artery disease
|
0.93%
3/324 • Number of events 3 • From baseline (Day 1) up to Week 52 (24-week short-term treatment period + 28-week long-term treatment period).
Adverse event (AE) data is reported for the treated subject data set, and included AEs with an onset date on or after the date of first dose of short-term study treatment and up to and including 30 days following the date of last dose of short-term + long-term study treatment.
|
0.31%
1/319 • Number of events 1 • From baseline (Day 1) up to Week 52 (24-week short-term treatment period + 28-week long-term treatment period).
Adverse event (AE) data is reported for the treated subject data set, and included AEs with an onset date on or after the date of first dose of short-term study treatment and up to and including 30 days following the date of last dose of short-term + long-term study treatment.
|
|
Cardiac disorders
Cardiac failure congestive
|
0.62%
2/324 • Number of events 2 • From baseline (Day 1) up to Week 52 (24-week short-term treatment period + 28-week long-term treatment period).
Adverse event (AE) data is reported for the treated subject data set, and included AEs with an onset date on or after the date of first dose of short-term study treatment and up to and including 30 days following the date of last dose of short-term + long-term study treatment.
|
0.00%
0/319 • From baseline (Day 1) up to Week 52 (24-week short-term treatment period + 28-week long-term treatment period).
Adverse event (AE) data is reported for the treated subject data set, and included AEs with an onset date on or after the date of first dose of short-term study treatment and up to and including 30 days following the date of last dose of short-term + long-term study treatment.
|
|
Cardiac disorders
Acute myocardial infarction
|
0.31%
1/324 • Number of events 1 • From baseline (Day 1) up to Week 52 (24-week short-term treatment period + 28-week long-term treatment period).
Adverse event (AE) data is reported for the treated subject data set, and included AEs with an onset date on or after the date of first dose of short-term study treatment and up to and including 30 days following the date of last dose of short-term + long-term study treatment.
|
0.00%
0/319 • From baseline (Day 1) up to Week 52 (24-week short-term treatment period + 28-week long-term treatment period).
Adverse event (AE) data is reported for the treated subject data set, and included AEs with an onset date on or after the date of first dose of short-term study treatment and up to and including 30 days following the date of last dose of short-term + long-term study treatment.
|
|
Cardiac disorders
Angina unstable
|
0.31%
1/324 • Number of events 1 • From baseline (Day 1) up to Week 52 (24-week short-term treatment period + 28-week long-term treatment period).
Adverse event (AE) data is reported for the treated subject data set, and included AEs with an onset date on or after the date of first dose of short-term study treatment and up to and including 30 days following the date of last dose of short-term + long-term study treatment.
|
0.00%
0/319 • From baseline (Day 1) up to Week 52 (24-week short-term treatment period + 28-week long-term treatment period).
Adverse event (AE) data is reported for the treated subject data set, and included AEs with an onset date on or after the date of first dose of short-term study treatment and up to and including 30 days following the date of last dose of short-term + long-term study treatment.
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/324 • From baseline (Day 1) up to Week 52 (24-week short-term treatment period + 28-week long-term treatment period).
Adverse event (AE) data is reported for the treated subject data set, and included AEs with an onset date on or after the date of first dose of short-term study treatment and up to and including 30 days following the date of last dose of short-term + long-term study treatment.
|
0.31%
1/319 • Number of events 1 • From baseline (Day 1) up to Week 52 (24-week short-term treatment period + 28-week long-term treatment period).
Adverse event (AE) data is reported for the treated subject data set, and included AEs with an onset date on or after the date of first dose of short-term study treatment and up to and including 30 days following the date of last dose of short-term + long-term study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.31%
1/324 • Number of events 1 • From baseline (Day 1) up to Week 52 (24-week short-term treatment period + 28-week long-term treatment period).
Adverse event (AE) data is reported for the treated subject data set, and included AEs with an onset date on or after the date of first dose of short-term study treatment and up to and including 30 days following the date of last dose of short-term + long-term study treatment.
|
0.00%
0/319 • From baseline (Day 1) up to Week 52 (24-week short-term treatment period + 28-week long-term treatment period).
Adverse event (AE) data is reported for the treated subject data set, and included AEs with an onset date on or after the date of first dose of short-term study treatment and up to and including 30 days following the date of last dose of short-term + long-term study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
0.31%
1/324 • Number of events 1 • From baseline (Day 1) up to Week 52 (24-week short-term treatment period + 28-week long-term treatment period).
Adverse event (AE) data is reported for the treated subject data set, and included AEs with an onset date on or after the date of first dose of short-term study treatment and up to and including 30 days following the date of last dose of short-term + long-term study treatment.
|
0.00%
0/319 • From baseline (Day 1) up to Week 52 (24-week short-term treatment period + 28-week long-term treatment period).
Adverse event (AE) data is reported for the treated subject data set, and included AEs with an onset date on or after the date of first dose of short-term study treatment and up to and including 30 days following the date of last dose of short-term + long-term study treatment.
|
|
Skin and subcutaneous tissue disorders
Hidradenitis
|
0.00%
0/324 • From baseline (Day 1) up to Week 52 (24-week short-term treatment period + 28-week long-term treatment period).
Adverse event (AE) data is reported for the treated subject data set, and included AEs with an onset date on or after the date of first dose of short-term study treatment and up to and including 30 days following the date of last dose of short-term + long-term study treatment.
|
0.31%
1/319 • Number of events 1 • From baseline (Day 1) up to Week 52 (24-week short-term treatment period + 28-week long-term treatment period).
Adverse event (AE) data is reported for the treated subject data set, and included AEs with an onset date on or after the date of first dose of short-term study treatment and up to and including 30 days following the date of last dose of short-term + long-term study treatment.
|
|
Renal and urinary disorders
Haematuria
|
0.31%
1/324 • Number of events 1 • From baseline (Day 1) up to Week 52 (24-week short-term treatment period + 28-week long-term treatment period).
Adverse event (AE) data is reported for the treated subject data set, and included AEs with an onset date on or after the date of first dose of short-term study treatment and up to and including 30 days following the date of last dose of short-term + long-term study treatment.
|
0.00%
0/319 • From baseline (Day 1) up to Week 52 (24-week short-term treatment period + 28-week long-term treatment period).
Adverse event (AE) data is reported for the treated subject data set, and included AEs with an onset date on or after the date of first dose of short-term study treatment and up to and including 30 days following the date of last dose of short-term + long-term study treatment.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/324 • From baseline (Day 1) up to Week 52 (24-week short-term treatment period + 28-week long-term treatment period).
Adverse event (AE) data is reported for the treated subject data set, and included AEs with an onset date on or after the date of first dose of short-term study treatment and up to and including 30 days following the date of last dose of short-term + long-term study treatment.
|
0.31%
1/319 • Number of events 1 • From baseline (Day 1) up to Week 52 (24-week short-term treatment period + 28-week long-term treatment period).
Adverse event (AE) data is reported for the treated subject data set, and included AEs with an onset date on or after the date of first dose of short-term study treatment and up to and including 30 days following the date of last dose of short-term + long-term study treatment.
|
|
Reproductive system and breast disorders
Prostatomegaly
|
0.00%
0/324 • From baseline (Day 1) up to Week 52 (24-week short-term treatment period + 28-week long-term treatment period).
Adverse event (AE) data is reported for the treated subject data set, and included AEs with an onset date on or after the date of first dose of short-term study treatment and up to and including 30 days following the date of last dose of short-term + long-term study treatment.
|
0.31%
1/319 • Number of events 1 • From baseline (Day 1) up to Week 52 (24-week short-term treatment period + 28-week long-term treatment period).
Adverse event (AE) data is reported for the treated subject data set, and included AEs with an onset date on or after the date of first dose of short-term study treatment and up to and including 30 days following the date of last dose of short-term + long-term study treatment.
|
|
General disorders
Inflammation
|
0.00%
0/324 • From baseline (Day 1) up to Week 52 (24-week short-term treatment period + 28-week long-term treatment period).
Adverse event (AE) data is reported for the treated subject data set, and included AEs with an onset date on or after the date of first dose of short-term study treatment and up to and including 30 days following the date of last dose of short-term + long-term study treatment.
|
0.31%
1/319 • Number of events 1 • From baseline (Day 1) up to Week 52 (24-week short-term treatment period + 28-week long-term treatment period).
Adverse event (AE) data is reported for the treated subject data set, and included AEs with an onset date on or after the date of first dose of short-term study treatment and up to and including 30 days following the date of last dose of short-term + long-term study treatment.
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/324 • From baseline (Day 1) up to Week 52 (24-week short-term treatment period + 28-week long-term treatment period).
Adverse event (AE) data is reported for the treated subject data set, and included AEs with an onset date on or after the date of first dose of short-term study treatment and up to and including 30 days following the date of last dose of short-term + long-term study treatment.
|
0.31%
1/319 • Number of events 1 • From baseline (Day 1) up to Week 52 (24-week short-term treatment period + 28-week long-term treatment period).
Adverse event (AE) data is reported for the treated subject data set, and included AEs with an onset date on or after the date of first dose of short-term study treatment and up to and including 30 days following the date of last dose of short-term + long-term study treatment.
|
|
Injury, poisoning and procedural complications
Lisfranc fracture
|
0.31%
1/324 • Number of events 1 • From baseline (Day 1) up to Week 52 (24-week short-term treatment period + 28-week long-term treatment period).
Adverse event (AE) data is reported for the treated subject data set, and included AEs with an onset date on or after the date of first dose of short-term study treatment and up to and including 30 days following the date of last dose of short-term + long-term study treatment.
|
0.00%
0/319 • From baseline (Day 1) up to Week 52 (24-week short-term treatment period + 28-week long-term treatment period).
Adverse event (AE) data is reported for the treated subject data set, and included AEs with an onset date on or after the date of first dose of short-term study treatment and up to and including 30 days following the date of last dose of short-term + long-term study treatment.
|
|
Cardiac disorders
Acute coronary syndrome
|
0.31%
1/324 • Number of events 1 • From baseline (Day 1) up to Week 52 (24-week short-term treatment period + 28-week long-term treatment period).
Adverse event (AE) data is reported for the treated subject data set, and included AEs with an onset date on or after the date of first dose of short-term study treatment and up to and including 30 days following the date of last dose of short-term + long-term study treatment.
|
0.63%
2/319 • Number of events 2 • From baseline (Day 1) up to Week 52 (24-week short-term treatment period + 28-week long-term treatment period).
Adverse event (AE) data is reported for the treated subject data set, and included AEs with an onset date on or after the date of first dose of short-term study treatment and up to and including 30 days following the date of last dose of short-term + long-term study treatment.
|
|
Cardiac disorders
Angina pectoris
|
0.31%
1/324 • Number of events 1 • From baseline (Day 1) up to Week 52 (24-week short-term treatment period + 28-week long-term treatment period).
Adverse event (AE) data is reported for the treated subject data set, and included AEs with an onset date on or after the date of first dose of short-term study treatment and up to and including 30 days following the date of last dose of short-term + long-term study treatment.
|
0.00%
0/319 • From baseline (Day 1) up to Week 52 (24-week short-term treatment period + 28-week long-term treatment period).
Adverse event (AE) data is reported for the treated subject data set, and included AEs with an onset date on or after the date of first dose of short-term study treatment and up to and including 30 days following the date of last dose of short-term + long-term study treatment.
|
|
Gastrointestinal disorders
Femoral hernia incarcerated
|
0.31%
1/324 • Number of events 1 • From baseline (Day 1) up to Week 52 (24-week short-term treatment period + 28-week long-term treatment period).
Adverse event (AE) data is reported for the treated subject data set, and included AEs with an onset date on or after the date of first dose of short-term study treatment and up to and including 30 days following the date of last dose of short-term + long-term study treatment.
|
0.00%
0/319 • From baseline (Day 1) up to Week 52 (24-week short-term treatment period + 28-week long-term treatment period).
Adverse event (AE) data is reported for the treated subject data set, and included AEs with an onset date on or after the date of first dose of short-term study treatment and up to and including 30 days following the date of last dose of short-term + long-term study treatment.
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.31%
1/324 • Number of events 1 • From baseline (Day 1) up to Week 52 (24-week short-term treatment period + 28-week long-term treatment period).
Adverse event (AE) data is reported for the treated subject data set, and included AEs with an onset date on or after the date of first dose of short-term study treatment and up to and including 30 days following the date of last dose of short-term + long-term study treatment.
|
0.00%
0/319 • From baseline (Day 1) up to Week 52 (24-week short-term treatment period + 28-week long-term treatment period).
Adverse event (AE) data is reported for the treated subject data set, and included AEs with an onset date on or after the date of first dose of short-term study treatment and up to and including 30 days following the date of last dose of short-term + long-term study treatment.
|
|
Injury, poisoning and procedural complications
Concussion
|
0.31%
1/324 • Number of events 1 • From baseline (Day 1) up to Week 52 (24-week short-term treatment period + 28-week long-term treatment period).
Adverse event (AE) data is reported for the treated subject data set, and included AEs with an onset date on or after the date of first dose of short-term study treatment and up to and including 30 days following the date of last dose of short-term + long-term study treatment.
|
0.00%
0/319 • From baseline (Day 1) up to Week 52 (24-week short-term treatment period + 28-week long-term treatment period).
Adverse event (AE) data is reported for the treated subject data set, and included AEs with an onset date on or after the date of first dose of short-term study treatment and up to and including 30 days following the date of last dose of short-term + long-term study treatment.
|
|
Injury, poisoning and procedural complications
Contusion
|
0.31%
1/324 • Number of events 1 • From baseline (Day 1) up to Week 52 (24-week short-term treatment period + 28-week long-term treatment period).
Adverse event (AE) data is reported for the treated subject data set, and included AEs with an onset date on or after the date of first dose of short-term study treatment and up to and including 30 days following the date of last dose of short-term + long-term study treatment.
|
0.31%
1/319 • Number of events 1 • From baseline (Day 1) up to Week 52 (24-week short-term treatment period + 28-week long-term treatment period).
Adverse event (AE) data is reported for the treated subject data set, and included AEs with an onset date on or after the date of first dose of short-term study treatment and up to and including 30 days following the date of last dose of short-term + long-term study treatment.
|
|
Injury, poisoning and procedural complications
Postoperative hernia
|
0.31%
1/324 • Number of events 1 • From baseline (Day 1) up to Week 52 (24-week short-term treatment period + 28-week long-term treatment period).
Adverse event (AE) data is reported for the treated subject data set, and included AEs with an onset date on or after the date of first dose of short-term study treatment and up to and including 30 days following the date of last dose of short-term + long-term study treatment.
|
0.00%
0/319 • From baseline (Day 1) up to Week 52 (24-week short-term treatment period + 28-week long-term treatment period).
Adverse event (AE) data is reported for the treated subject data set, and included AEs with an onset date on or after the date of first dose of short-term study treatment and up to and including 30 days following the date of last dose of short-term + long-term study treatment.
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
0.00%
0/324 • From baseline (Day 1) up to Week 52 (24-week short-term treatment period + 28-week long-term treatment period).
Adverse event (AE) data is reported for the treated subject data set, and included AEs with an onset date on or after the date of first dose of short-term study treatment and up to and including 30 days following the date of last dose of short-term + long-term study treatment.
|
0.31%
1/319 • Number of events 1 • From baseline (Day 1) up to Week 52 (24-week short-term treatment period + 28-week long-term treatment period).
Adverse event (AE) data is reported for the treated subject data set, and included AEs with an onset date on or after the date of first dose of short-term study treatment and up to and including 30 days following the date of last dose of short-term + long-term study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Fibroadenoma of breast
|
0.31%
1/324 • Number of events 1 • From baseline (Day 1) up to Week 52 (24-week short-term treatment period + 28-week long-term treatment period).
Adverse event (AE) data is reported for the treated subject data set, and included AEs with an onset date on or after the date of first dose of short-term study treatment and up to and including 30 days following the date of last dose of short-term + long-term study treatment.
|
0.00%
0/319 • From baseline (Day 1) up to Week 52 (24-week short-term treatment period + 28-week long-term treatment period).
Adverse event (AE) data is reported for the treated subject data set, and included AEs with an onset date on or after the date of first dose of short-term study treatment and up to and including 30 days following the date of last dose of short-term + long-term study treatment.
|
|
Nervous system disorders
Cerebrovascular accident
|
0.00%
0/324 • From baseline (Day 1) up to Week 52 (24-week short-term treatment period + 28-week long-term treatment period).
Adverse event (AE) data is reported for the treated subject data set, and included AEs with an onset date on or after the date of first dose of short-term study treatment and up to and including 30 days following the date of last dose of short-term + long-term study treatment.
|
0.31%
1/319 • Number of events 1 • From baseline (Day 1) up to Week 52 (24-week short-term treatment period + 28-week long-term treatment period).
Adverse event (AE) data is reported for the treated subject data set, and included AEs with an onset date on or after the date of first dose of short-term study treatment and up to and including 30 days following the date of last dose of short-term + long-term study treatment.
|
|
Psychiatric disorders
Depression
|
0.00%
0/324 • From baseline (Day 1) up to Week 52 (24-week short-term treatment period + 28-week long-term treatment period).
Adverse event (AE) data is reported for the treated subject data set, and included AEs with an onset date on or after the date of first dose of short-term study treatment and up to and including 30 days following the date of last dose of short-term + long-term study treatment.
|
0.31%
1/319 • Number of events 1 • From baseline (Day 1) up to Week 52 (24-week short-term treatment period + 28-week long-term treatment period).
Adverse event (AE) data is reported for the treated subject data set, and included AEs with an onset date on or after the date of first dose of short-term study treatment and up to and including 30 days following the date of last dose of short-term + long-term study treatment.
|
|
Psychiatric disorders
Post-traumatic stress disorder
|
0.31%
1/324 • Number of events 1 • From baseline (Day 1) up to Week 52 (24-week short-term treatment period + 28-week long-term treatment period).
Adverse event (AE) data is reported for the treated subject data set, and included AEs with an onset date on or after the date of first dose of short-term study treatment and up to and including 30 days following the date of last dose of short-term + long-term study treatment.
|
0.00%
0/319 • From baseline (Day 1) up to Week 52 (24-week short-term treatment period + 28-week long-term treatment period).
Adverse event (AE) data is reported for the treated subject data set, and included AEs with an onset date on or after the date of first dose of short-term study treatment and up to and including 30 days following the date of last dose of short-term + long-term study treatment.
|
|
Renal and urinary disorders
Urinary bladder polyp
|
0.31%
1/324 • Number of events 1 • From baseline (Day 1) up to Week 52 (24-week short-term treatment period + 28-week long-term treatment period).
Adverse event (AE) data is reported for the treated subject data set, and included AEs with an onset date on or after the date of first dose of short-term study treatment and up to and including 30 days following the date of last dose of short-term + long-term study treatment.
|
0.00%
0/319 • From baseline (Day 1) up to Week 52 (24-week short-term treatment period + 28-week long-term treatment period).
Adverse event (AE) data is reported for the treated subject data set, and included AEs with an onset date on or after the date of first dose of short-term study treatment and up to and including 30 days following the date of last dose of short-term + long-term study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.31%
1/324 • Number of events 1 • From baseline (Day 1) up to Week 52 (24-week short-term treatment period + 28-week long-term treatment period).
Adverse event (AE) data is reported for the treated subject data set, and included AEs with an onset date on or after the date of first dose of short-term study treatment and up to and including 30 days following the date of last dose of short-term + long-term study treatment.
|
0.00%
0/319 • From baseline (Day 1) up to Week 52 (24-week short-term treatment period + 28-week long-term treatment period).
Adverse event (AE) data is reported for the treated subject data set, and included AEs with an onset date on or after the date of first dose of short-term study treatment and up to and including 30 days following the date of last dose of short-term + long-term study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.31%
1/324 • Number of events 1 • From baseline (Day 1) up to Week 52 (24-week short-term treatment period + 28-week long-term treatment period).
Adverse event (AE) data is reported for the treated subject data set, and included AEs with an onset date on or after the date of first dose of short-term study treatment and up to and including 30 days following the date of last dose of short-term + long-term study treatment.
|
0.00%
0/319 • From baseline (Day 1) up to Week 52 (24-week short-term treatment period + 28-week long-term treatment period).
Adverse event (AE) data is reported for the treated subject data set, and included AEs with an onset date on or after the date of first dose of short-term study treatment and up to and including 30 days following the date of last dose of short-term + long-term study treatment.
|
|
Infections and infestations
Gangrene
|
0.00%
0/324 • From baseline (Day 1) up to Week 52 (24-week short-term treatment period + 28-week long-term treatment period).
Adverse event (AE) data is reported for the treated subject data set, and included AEs with an onset date on or after the date of first dose of short-term study treatment and up to and including 30 days following the date of last dose of short-term + long-term study treatment.
|
0.31%
1/319 • Number of events 1 • From baseline (Day 1) up to Week 52 (24-week short-term treatment period + 28-week long-term treatment period).
Adverse event (AE) data is reported for the treated subject data set, and included AEs with an onset date on or after the date of first dose of short-term study treatment and up to and including 30 days following the date of last dose of short-term + long-term study treatment.
|
Other adverse events
| Measure |
Dapagliflozin + Saxagliptin + Metformin
n=324 participants at risk
Subjects received dapagliflozin 10 mg and saxagliptin 5 mg, administered orally QD in the morning for the 52-week treatment period (24-week short-term period and 28-week long term period).
Subjects continued to receive their stable dose of metformin with or without SU throughout the study.
|
Titrated Insulin + Metformin
n=319 participants at risk
Subjects were to administer insulin glargine subcutaneously QD at the same time every day for the 52-week treatment period (24-week short-term period and 28-week long term period), following investigator instructions and training. All subjects started with an initial dose of 0.2 units/kg body weight or at least 10 units of insulin per day. Subjects self-titrated the dose of insulin glargine over the first 8 weeks of the study based on daily glucose monitoring. The investigator had the discretion to modify insulin dose based on his/her assessment between Week 8 and Week 12 with the goal to reach an acceptable and stable insulin dose by Week 12.
Subjects continued to receive their stable dose of metformin with or without SU throughout the study.
|
|---|---|---|
|
Infections and infestations
Upper respiratory tract infection
|
5.2%
17/324 • Number of events 24 • From baseline (Day 1) up to Week 52 (24-week short-term treatment period + 28-week long-term treatment period).
Adverse event (AE) data is reported for the treated subject data set, and included AEs with an onset date on or after the date of first dose of short-term study treatment and up to and including 30 days following the date of last dose of short-term + long-term study treatment.
|
7.2%
23/319 • Number of events 26 • From baseline (Day 1) up to Week 52 (24-week short-term treatment period + 28-week long-term treatment period).
Adverse event (AE) data is reported for the treated subject data set, and included AEs with an onset date on or after the date of first dose of short-term study treatment and up to and including 30 days following the date of last dose of short-term + long-term study treatment.
|
|
Infections and infestations
Viral upper respiratory tract infection
|
7.7%
25/324 • Number of events 28 • From baseline (Day 1) up to Week 52 (24-week short-term treatment period + 28-week long-term treatment period).
Adverse event (AE) data is reported for the treated subject data set, and included AEs with an onset date on or after the date of first dose of short-term study treatment and up to and including 30 days following the date of last dose of short-term + long-term study treatment.
|
6.0%
19/319 • Number of events 24 • From baseline (Day 1) up to Week 52 (24-week short-term treatment period + 28-week long-term treatment period).
Adverse event (AE) data is reported for the treated subject data set, and included AEs with an onset date on or after the date of first dose of short-term study treatment and up to and including 30 days following the date of last dose of short-term + long-term study treatment.
|
|
Nervous system disorders
Headache
|
3.7%
12/324 • Number of events 15 • From baseline (Day 1) up to Week 52 (24-week short-term treatment period + 28-week long-term treatment period).
Adverse event (AE) data is reported for the treated subject data set, and included AEs with an onset date on or after the date of first dose of short-term study treatment and up to and including 30 days following the date of last dose of short-term + long-term study treatment.
|
6.9%
22/319 • Number of events 24 • From baseline (Day 1) up to Week 52 (24-week short-term treatment period + 28-week long-term treatment period).
Adverse event (AE) data is reported for the treated subject data set, and included AEs with an onset date on or after the date of first dose of short-term study treatment and up to and including 30 days following the date of last dose of short-term + long-term study treatment.
|
|
Infections and infestations
Influenza
|
2.5%
8/324 • Number of events 8 • From baseline (Day 1) up to Week 52 (24-week short-term treatment period + 28-week long-term treatment period).
Adverse event (AE) data is reported for the treated subject data set, and included AEs with an onset date on or after the date of first dose of short-term study treatment and up to and including 30 days following the date of last dose of short-term + long-term study treatment.
|
5.0%
16/319 • Number of events 16 • From baseline (Day 1) up to Week 52 (24-week short-term treatment period + 28-week long-term treatment period).
Adverse event (AE) data is reported for the treated subject data set, and included AEs with an onset date on or after the date of first dose of short-term study treatment and up to and including 30 days following the date of last dose of short-term + long-term study treatment.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place