Trial Outcomes & Findings for Saxagliptin Compared to Glimepiride in Elderly Type 2 Diabetes Patients, With Inadequate Glycemic Control on Metformin (NCT NCT01006603)
NCT ID: NCT01006603
Last Updated: 2013-11-28
Results Overview
Defined as obtained on or before the 8th day after the last dosing day, as determined by central laboratory. Safety analysis set. Confirmed hypoglycaemia defined as: any event defined as either a symptomatic event with blood glucose level \<3 mmol/L (\<54 mg/dL) and no need for external assistance, or an asymptomatic blood glucose measurement \<3 mmol/L (\<54 mg/dL). Major (or severe) hypoglycaemia defined as: symptomatic events requiring external assistance due to severe impairment in consciousness or behaviour, with or without blood glucose level \<3 mmol/L (\<54 mg/dL), but with prompt recovery after glucose or glucagon administration. These events may be associated with sufficient neuroglycopenia to induce seizure or coma. Plasma glucose measurements may not be available during such an event, but neurological recovery, attributable to the restoration of plasma glucose to normal, was considered sufficient evidence that the event was induced by a low plasma glucose concentration.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
957 participants
Primary outcome timeframe
From week 0 to week 52.
Results posted on
2013-11-28
Participant Flow
In total, 152 study centres in 13 countries recruited patients in this study. The first patient was enrolled in the study on 20 October 2009, and the last patient completed the study on 14 June 2012. 957 subjects were enrolled. 753 were deemed eligible for lead-in and 720 were randomized.
A 2-week single-blind (to patient only) placebo lead-in period occurred from Week -2 to Week 0. Patients were from this period on,counselled on dietary and lifestyle modifications according to usual clinical routine. They were given a glucometer to check their plasma glucose at home at least every second day.
Participant milestones
| Measure |
Saxagliptin 5 mg
Saxagliptin 5 mg, oral tablet, once daily
|
Glimepiride 1 - 6 mg
Glimepiride : 1, 2, 3, 4 or 6 mg, oral encapsulated tablet, once daily
|
|---|---|---|
|
Overall Study
STARTED
|
360
|
360
|
|
Overall Study
COMPLETED
|
289
|
285
|
|
Overall Study
NOT COMPLETED
|
71
|
75
|
Reasons for withdrawal
| Measure |
Saxagliptin 5 mg
Saxagliptin 5 mg, oral tablet, once daily
|
Glimepiride 1 - 6 mg
Glimepiride : 1, 2, 3, 4 or 6 mg, oral encapsulated tablet, once daily
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
17
|
19
|
|
Overall Study
Lost to Follow-up
|
0
|
1
|
|
Overall Study
Safety reason
|
1
|
1
|
|
Overall Study
Protocol Violation
|
1
|
3
|
|
Overall Study
Incorrect enrolment
|
0
|
2
|
|
Overall Study
Adverse Event
|
15
|
7
|
|
Overall Study
Death
|
1
|
1
|
|
Overall Study
Study specific discontinuation criteria
|
33
|
34
|
|
Overall Study
Other
|
3
|
7
|
Baseline Characteristics
Saxagliptin Compared to Glimepiride in Elderly Type 2 Diabetes Patients, With Inadequate Glycemic Control on Metformin
Baseline characteristics by cohort
| Measure |
Saxagliptin 5 mg
n=360 Participants
Saxagliptin 5 mg, oral tablet, once daily
|
Glimepiride 1 - 6 mg
n=360 Participants
Glimepiride 1, 2, 3, 4 or 6 mg, oral encapsulated tablet, once daily
|
Total
n=720 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
360 Participants
n=5 Participants
|
360 Participants
n=7 Participants
|
720 Participants
n=5 Participants
|
|
Age Continuous
|
72.5 years
STANDARD_DEVIATION 5.72 • n=5 Participants
|
72.7 years
STANDARD_DEVIATION 5.44 • n=7 Participants
|
72.6 years
STANDARD_DEVIATION 5.58 • n=5 Participants
|
|
Sex: Female, Male
Female
|
143 Participants
n=5 Participants
|
132 Participants
n=7 Participants
|
275 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
217 Participants
n=5 Participants
|
228 Participants
n=7 Participants
|
445 Participants
n=5 Participants
|
|
Region of Enrollment
Greece
|
21 participants
n=5 Participants
|
18 participants
n=7 Participants
|
39 participants
n=5 Participants
|
|
Region of Enrollment
Finland
|
24 participants
n=5 Participants
|
19 participants
n=7 Participants
|
43 participants
n=5 Participants
|
|
Region of Enrollment
Spain
|
31 participants
n=5 Participants
|
25 participants
n=7 Participants
|
56 participants
n=5 Participants
|
|
Region of Enrollment
Austria
|
30 participants
n=5 Participants
|
15 participants
n=7 Participants
|
45 participants
n=5 Participants
|
|
Region of Enrollment
United Kingdom
|
39 participants
n=5 Participants
|
49 participants
n=7 Participants
|
88 participants
n=5 Participants
|
|
Region of Enrollment
Italy
|
12 participants
n=5 Participants
|
12 participants
n=7 Participants
|
24 participants
n=5 Participants
|
|
Region of Enrollment
France
|
11 participants
n=5 Participants
|
13 participants
n=7 Participants
|
24 participants
n=5 Participants
|
|
Region of Enrollment
Hungary
|
9 participants
n=5 Participants
|
9 participants
n=7 Participants
|
18 participants
n=5 Participants
|
|
Region of Enrollment
Mexico
|
10 participants
n=5 Participants
|
7 participants
n=7 Participants
|
17 participants
n=5 Participants
|
|
Region of Enrollment
Denmark
|
16 participants
n=5 Participants
|
17 participants
n=7 Participants
|
33 participants
n=5 Participants
|
|
Region of Enrollment
Germany
|
44 participants
n=5 Participants
|
55 participants
n=7 Participants
|
99 participants
n=5 Participants
|
|
Region of Enrollment
Norway
|
47 participants
n=5 Participants
|
59 participants
n=7 Participants
|
106 participants
n=5 Participants
|
|
Region of Enrollment
Sweden
|
66 participants
n=5 Participants
|
62 participants
n=7 Participants
|
128 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: From week 0 to week 52.Population: Safety analysis set (a subset of the randomised analysis set including patients who took at least one investigational product dose).
Defined as obtained on or before the 8th day after the last dosing day, as determined by central laboratory. Safety analysis set. Confirmed hypoglycaemia defined as: any event defined as either a symptomatic event with blood glucose level \<3 mmol/L (\<54 mg/dL) and no need for external assistance, or an asymptomatic blood glucose measurement \<3 mmol/L (\<54 mg/dL). Major (or severe) hypoglycaemia defined as: symptomatic events requiring external assistance due to severe impairment in consciousness or behaviour, with or without blood glucose level \<3 mmol/L (\<54 mg/dL), but with prompt recovery after glucose or glucagon administration. These events may be associated with sufficient neuroglycopenia to induce seizure or coma. Plasma glucose measurements may not be available during such an event, but neurological recovery, attributable to the restoration of plasma glucose to normal, was considered sufficient evidence that the event was induced by a low plasma glucose concentration.
Outcome measures
| Measure |
Saxagliptin 5 mg
n=359 Participants
Saxagliptin 5 mg, oral tablet, once daily
|
Glimepiride 1 - 6 mg
n=359 Participants
Glimepiride 1, 2, 3, 4 or 6 mg, oral encapsulated tablet, once daily
|
|---|---|---|
|
Proportion of Patients Reaching HbA1c <7% After 52 Weeks of Treatment Without Confirmed or Severe Hypoglycaemia.
All patients
|
37.9 percentage of participants
|
38.2 percentage of participants
|
|
Proportion of Patients Reaching HbA1c <7% After 52 Weeks of Treatment Without Confirmed or Severe Hypoglycaemia.
patients aged <75 years (n=217, n=216)
|
39.2 percentage of participants
|
33.3 percentage of participants
|
|
Proportion of Patients Reaching HbA1c <7% After 52 Weeks of Treatment Without Confirmed or Severe Hypoglycaemia.
patients aged ≥75 years (n=142, n=143)
|
35.9 percentage of participants
|
45.5 percentage of participants
|
SECONDARY outcome
Timeframe: From week 0 to week 52.Population: Safety analysis set (a subset of the randomised analysis set including patients who took at least one investigational product dose).
Hypoglyceamic event defined as, Confirmed hypoglycaemia: any event defined as either a symptomatic event with blood glucose level \<3 mmol/L (\<54 mg/dL) and no need for external assistance, or an asymptomatic blood glucose measurement \<3 mmol/L (\<54 mg/dL). Major (or severe) hypoglycaemia: symptomatic events requiring external assistance due to severe impairment in consciousness or behaviour, with or without blood glucose level \<3 mmol/L (\<54 mg/dL), but with prompt recovery after glucose or glucagon administration. These events may be associated with sufficient neuroglycopenia to induce seizure or coma. Plasma glucose measurements may not be available during such an event, but neurological recovery, attributable to the restoration of plasma glucose to normal, was considered sufficient evidence that the event was induced by a low plasma glucose concentration. Safety analysis set.
Outcome measures
| Measure |
Saxagliptin 5 mg
n=359 Participants
Saxagliptin 5 mg, oral tablet, once daily
|
Glimepiride 1 - 6 mg
n=359 Participants
Glimepiride 1, 2, 3, 4 or 6 mg, oral encapsulated tablet, once daily
|
|---|---|---|
|
Proportion of Patients Having Experienced at Least One Hypoglycaemic Event (Confirmed or Severe) Over the 52-week Double-blind Treatment Period.
|
1.1 percentage of patients
|
15.3 percentage of patients
|
SECONDARY outcome
Timeframe: From week 0 to week 52.Population: The number of subjects with non-missing baseline and Week 52 (LOCF) values in the full analysis set (defined as the subset of patients in the randomized analysis set who took at least one randomised IP dose and have non-missing baseline and post-baseline efficacy data for at least one variable).
Measured as the difference between the last on-treatment value (defined as obtained before or on the 8th day after the last dosing date), and the last pre-randomisation HbA1c value, as determined by central laboratory. Full analysis set.
Outcome measures
| Measure |
Saxagliptin 5 mg
n=353 Participants
Saxagliptin 5 mg, oral tablet, once daily
|
Glimepiride 1 - 6 mg
n=345 Participants
Glimepiride 1, 2, 3, 4 or 6 mg, oral encapsulated tablet, once daily
|
|---|---|---|
|
Change From Baseline to Week 52 in HbA1c.
|
-0.44 % of glycosylated hemoglobin
Interval -0.51 to -0.37
|
-0.64 % of glycosylated hemoglobin
Interval -0.71 to -0.57
|
SECONDARY outcome
Timeframe: From week 0 to week 52Population: The number of subjects with non-missing baseline and Week 52 (LOCF) values in the full analysis set (defined as the subset of patients in the randomized analysis set who took at least one randomised IP dose and have non-missing baseline and post-baseline efficacy data for at least one variable).
Proportion of patients with their last on-treatment value (defined as obtained before or on the 8th day after the last dosing date), as determined by central laboratory, below the specified limits. Full analysis set.
Outcome measures
| Measure |
Saxagliptin 5 mg
n=356 Participants
Saxagliptin 5 mg, oral tablet, once daily
|
Glimepiride 1 - 6 mg
n=353 Participants
Glimepiride 1, 2, 3, 4 or 6 mg, oral encapsulated tablet, once daily
|
|---|---|---|
|
Proportion of Patients Achieving a Therapeutic Glycaemic Response at Week 52 Defined as HbA1c <7.0%
|
44.7 percentage of responders
|
54.7 percentage of responders
|
SECONDARY outcome
Timeframe: From week 0 to week 52Population: The number of subjects with non-missing baseline and Week 52 (LOCF) values in the full analysis set (defined as the subset of patients in the randomized analysis set who took at least one randomised IP dose and have non-missing baseline and post-baseline efficacy data for at least one variable).
Measured as the difference between the last on-treatment value (defined as obtained before or on the first day after the last dosing date)and the last pre-randomisation fasting plasma glucose value, as determined by central laboratory. Full analysis set.
Outcome measures
| Measure |
Saxagliptin 5 mg
n=344 Participants
Saxagliptin 5 mg, oral tablet, once daily
|
Glimepiride 1 - 6 mg
n=339 Participants
Glimepiride 1, 2, 3, 4 or 6 mg, oral encapsulated tablet, once daily
|
|---|---|---|
|
Change From Baseline to Week 52 in Fasting Plasma Glucose (FPG)
|
-0.73 mmol/L
Interval -0.89 to -0.57
|
-1.29 mmol/L
Interval -1.45 to -1.13
|
SECONDARY outcome
Timeframe: From week 0 to week 52Population: The number of subjects with non-missing baseline and Week 52 (LOCF) values in the full analysis set (defined as the subset of patients in the randomized analysis set who took at least one randomised IP dose and have non-missing baseline and post-baseline efficacy data for at least one variable).
Measured as the difference between the last on-treatment value (defined as obtained before or on the first day after the last dosing date) and the last pre-randomisation fasting plasma insulin value, as determined by central laboratory. Full analysis set.
Outcome measures
| Measure |
Saxagliptin 5 mg
n=312 Participants
Saxagliptin 5 mg, oral tablet, once daily
|
Glimepiride 1 - 6 mg
n=309 Participants
Glimepiride 1, 2, 3, 4 or 6 mg, oral encapsulated tablet, once daily
|
|---|---|---|
|
Change From Baseline to Week 52 in Insulin
|
-2.0 µU/mL
Interval -3.1 to -1.0
|
-0.6 µU/mL
Interval -1.6 to 0.5
|
SECONDARY outcome
Timeframe: From week 0 to week 52Population: The number of subjects with non-missing baseline and Week 52 (LOCF) values in the full analysis set (defined as the subset of patients in the randomized analysis set who took at least one randomised IP dose and have non-missing baseline and post-baseline efficacy data for at least one variable).
β-cell function as estimated by the homeostasis model assessment (HOMA) model. Value is derived from FPG and fasting insulin; fasting insulin values below 2.074 μU/mL or above 57.595 μU/mL and FPG values below 3 mmol/L or above 25 mmol/L are excluded (as restricted by the calculation method used). Full analysis set.
Outcome measures
| Measure |
Saxagliptin 5 mg
n=240 Participants
Saxagliptin 5 mg, oral tablet, once daily
|
Glimepiride 1 - 6 mg
n=247 Participants
Glimepiride 1, 2, 3, 4 or 6 mg, oral encapsulated tablet, once daily
|
|---|---|---|
|
Change From Baseline to Week 52 in β-cell Function (as Measured by Homeostasis Model Assessment-β [HOMA-β]
|
3.83 percentage of change from baseline
Interval 0.79 to 6.88
|
16.22 percentage of change from baseline
Interval 13.23 to 19.2
|
Adverse Events
Saxagliptin 5 mg
Serious events: 41 serious events
Other events: 130 other events
Deaths: 0 deaths
Glimepiride 1 - 6 mg
Serious events: 32 serious events
Other events: 129 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Saxagliptin 5 mg
n=359 participants at risk
Saxagliptin 5 mg, oral tablet, once daily
|
Glimepiride 1 - 6 mg
n=359 participants at risk
Glimepiride 1, 2, 3, 4 or 6 mg, oral encapsulated tablet, once daily
|
|---|---|---|
|
Blood and lymphatic system disorders
ANAEMIA
|
0.28%
1/359
The at Risk population includes only those randomized subjects who took at least one dose of study drug.
|
0.00%
0/359
The at Risk population includes only those randomized subjects who took at least one dose of study drug.
|
|
Blood and lymphatic system disorders
LYMPHADENOPATHY
|
0.00%
0/359
The at Risk population includes only those randomized subjects who took at least one dose of study drug.
|
0.28%
1/359
The at Risk population includes only those randomized subjects who took at least one dose of study drug.
|
|
Cardiac disorders
CARDIAC FAILURE
|
0.28%
1/359
The at Risk population includes only those randomized subjects who took at least one dose of study drug.
|
0.84%
3/359
The at Risk population includes only those randomized subjects who took at least one dose of study drug.
|
|
Cardiac disorders
MYOCARDIAL INFARCTION
|
0.84%
3/359
The at Risk population includes only those randomized subjects who took at least one dose of study drug.
|
0.28%
1/359
The at Risk population includes only those randomized subjects who took at least one dose of study drug.
|
|
Cardiac disorders
ACUTE MYOCARDIAL INFARCTION
|
0.00%
0/359
The at Risk population includes only those randomized subjects who took at least one dose of study drug.
|
0.56%
2/359
The at Risk population includes only those randomized subjects who took at least one dose of study drug.
|
|
Cardiac disorders
ATRIAL FIBRILLATION
|
0.56%
2/359
The at Risk population includes only those randomized subjects who took at least one dose of study drug.
|
0.28%
1/359
The at Risk population includes only those randomized subjects who took at least one dose of study drug.
|
|
Cardiac disorders
ANGINA PECTORIS
|
0.28%
1/359
The at Risk population includes only those randomized subjects who took at least one dose of study drug.
|
0.28%
1/359
The at Risk population includes only those randomized subjects who took at least one dose of study drug.
|
|
Cardiac disorders
ANGINA UNSTABLE
|
0.28%
1/359
The at Risk population includes only those randomized subjects who took at least one dose of study drug.
|
0.00%
0/359
The at Risk population includes only those randomized subjects who took at least one dose of study drug.
|
|
Cardiac disorders
ISCHAEMIC CARDIOMYOPATHY
|
0.28%
1/359
The at Risk population includes only those randomized subjects who took at least one dose of study drug.
|
0.00%
0/359
The at Risk population includes only those randomized subjects who took at least one dose of study drug.
|
|
Cardiac disorders
PERICARDITIS
|
0.28%
1/359
The at Risk population includes only those randomized subjects who took at least one dose of study drug.
|
0.00%
0/359
The at Risk population includes only those randomized subjects who took at least one dose of study drug.
|
|
Cardiac disorders
TACHYCARDIA
|
0.00%
0/359
The at Risk population includes only those randomized subjects who took at least one dose of study drug.
|
0.28%
1/359
The at Risk population includes only those randomized subjects who took at least one dose of study drug.
|
|
Gastrointestinal disorders
EPIGASTRIC DISCOMFORT
|
0.28%
1/359
The at Risk population includes only those randomized subjects who took at least one dose of study drug.
|
0.00%
0/359
The at Risk population includes only those randomized subjects who took at least one dose of study drug.
|
|
Gastrointestinal disorders
HIATUS HERNIA
|
0.28%
1/359
The at Risk population includes only those randomized subjects who took at least one dose of study drug.
|
0.00%
0/359
The at Risk population includes only those randomized subjects who took at least one dose of study drug.
|
|
Gastrointestinal disorders
INGUINAL HERNIA
|
0.28%
1/359
The at Risk population includes only those randomized subjects who took at least one dose of study drug.
|
0.00%
0/359
The at Risk population includes only those randomized subjects who took at least one dose of study drug.
|
|
Gastrointestinal disorders
MELAENA
|
0.28%
1/359
The at Risk population includes only those randomized subjects who took at least one dose of study drug.
|
0.00%
0/359
The at Risk population includes only those randomized subjects who took at least one dose of study drug.
|
|
Gastrointestinal disorders
SUBILEUS
|
0.00%
0/359
The at Risk population includes only those randomized subjects who took at least one dose of study drug.
|
0.28%
1/359
The at Risk population includes only those randomized subjects who took at least one dose of study drug.
|
|
General disorders
CHEST PAIN
|
0.28%
1/359
The at Risk population includes only those randomized subjects who took at least one dose of study drug.
|
0.00%
0/359
The at Risk population includes only those randomized subjects who took at least one dose of study drug.
|
|
General disorders
DEATH
|
0.00%
0/359
The at Risk population includes only those randomized subjects who took at least one dose of study drug.
|
0.28%
1/359
The at Risk population includes only those randomized subjects who took at least one dose of study drug.
|
|
General disorders
DEVICE DISLOCATION
|
0.28%
1/359
The at Risk population includes only those randomized subjects who took at least one dose of study drug.
|
0.00%
0/359
The at Risk population includes only those randomized subjects who took at least one dose of study drug.
|
|
General disorders
INFLAMMATION
|
0.28%
1/359
The at Risk population includes only those randomized subjects who took at least one dose of study drug.
|
0.00%
0/359
The at Risk population includes only those randomized subjects who took at least one dose of study drug.
|
|
Hepatobiliary disorders
CHOLECYSTITIS
|
0.28%
1/359
The at Risk population includes only those randomized subjects who took at least one dose of study drug.
|
0.00%
0/359
The at Risk population includes only those randomized subjects who took at least one dose of study drug.
|
|
Immune system disorders
ANAPHYLACTIC SHOCK
|
0.28%
1/359
The at Risk population includes only those randomized subjects who took at least one dose of study drug.
|
0.00%
0/359
The at Risk population includes only those randomized subjects who took at least one dose of study drug.
|
|
Infections and infestations
PNEUMONIA
|
0.84%
3/359
The at Risk population includes only those randomized subjects who took at least one dose of study drug.
|
0.84%
3/359
The at Risk population includes only those randomized subjects who took at least one dose of study drug.
|
|
Infections and infestations
APPENDICITIS
|
0.28%
1/359
The at Risk population includes only those randomized subjects who took at least one dose of study drug.
|
0.00%
0/359
The at Risk population includes only those randomized subjects who took at least one dose of study drug.
|
|
Infections and infestations
DIVERTICULITIS
|
0.00%
0/359
The at Risk population includes only those randomized subjects who took at least one dose of study drug.
|
0.28%
1/359
The at Risk population includes only those randomized subjects who took at least one dose of study drug.
|
|
Infections and infestations
GASTROENTERITIS
|
0.00%
0/359
The at Risk population includes only those randomized subjects who took at least one dose of study drug.
|
0.28%
1/359
The at Risk population includes only those randomized subjects who took at least one dose of study drug.
|
|
Infections and infestations
GASTROENTERITIS NOROVIRUS
|
0.00%
0/359
The at Risk population includes only those randomized subjects who took at least one dose of study drug.
|
0.28%
1/359
The at Risk population includes only those randomized subjects who took at least one dose of study drug.
|
|
Infections and infestations
INFECTIOUS PLEURAL EFFUSION
|
0.00%
0/359
The at Risk population includes only those randomized subjects who took at least one dose of study drug.
|
0.28%
1/359
The at Risk population includes only those randomized subjects who took at least one dose of study drug.
|
|
Infections and infestations
LABYRINTHITIS
|
0.00%
0/359
The at Risk population includes only those randomized subjects who took at least one dose of study drug.
|
0.28%
1/359
The at Risk population includes only those randomized subjects who took at least one dose of study drug.
|
|
Infections and infestations
PYELONEPHRITIS
|
0.28%
1/359
The at Risk population includes only those randomized subjects who took at least one dose of study drug.
|
0.00%
0/359
The at Risk population includes only those randomized subjects who took at least one dose of study drug.
|
|
Infections and infestations
RESPIRATORY TRACT INFECTION
|
0.00%
0/359
The at Risk population includes only those randomized subjects who took at least one dose of study drug.
|
0.28%
1/359
The at Risk population includes only those randomized subjects who took at least one dose of study drug.
|
|
Infections and infestations
URINARY TRACT INFECTION
|
0.00%
0/359
The at Risk population includes only those randomized subjects who took at least one dose of study drug.
|
0.28%
1/359
The at Risk population includes only those randomized subjects who took at least one dose of study drug.
|
|
Infections and infestations
UROSEPSIS
|
0.28%
1/359
The at Risk population includes only those randomized subjects who took at least one dose of study drug.
|
0.00%
0/359
The at Risk population includes only those randomized subjects who took at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
LUMBAR VERTEBRAL FRACTURE
|
0.56%
2/359
The at Risk population includes only those randomized subjects who took at least one dose of study drug.
|
0.00%
0/359
The at Risk population includes only those randomized subjects who took at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
ANKLE FRACTURE
|
0.00%
0/359
The at Risk population includes only those randomized subjects who took at least one dose of study drug.
|
0.28%
1/359
The at Risk population includes only those randomized subjects who took at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
CONCUSSION
|
0.28%
1/359
The at Risk population includes only those randomized subjects who took at least one dose of study drug.
|
0.00%
0/359
The at Risk population includes only those randomized subjects who took at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
CONTUSION
|
0.00%
0/359
The at Risk population includes only those randomized subjects who took at least one dose of study drug.
|
0.28%
1/359
The at Risk population includes only those randomized subjects who took at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
FEMUR FRACTURE
|
0.28%
1/359
The at Risk population includes only those randomized subjects who took at least one dose of study drug.
|
0.00%
0/359
The at Risk population includes only those randomized subjects who took at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
HAND FRACTURE
|
0.28%
1/359
The at Risk population includes only those randomized subjects who took at least one dose of study drug.
|
0.00%
0/359
The at Risk population includes only those randomized subjects who took at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
MUSCLE RUPTURE
|
0.00%
0/359
The at Risk population includes only those randomized subjects who took at least one dose of study drug.
|
0.28%
1/359
The at Risk population includes only those randomized subjects who took at least one dose of study drug.
|
|
Investigations
MEDICAL OBSERVATION
|
0.00%
0/359
The at Risk population includes only those randomized subjects who took at least one dose of study drug.
|
0.28%
1/359
The at Risk population includes only those randomized subjects who took at least one dose of study drug.
|
|
Investigations
WEIGHT DECREASED
|
0.28%
1/359
The at Risk population includes only those randomized subjects who took at least one dose of study drug.
|
0.00%
0/359
The at Risk population includes only those randomized subjects who took at least one dose of study drug.
|
|
Metabolism and nutrition disorders
HYPERKALAEMIA
|
0.28%
1/359
The at Risk population includes only those randomized subjects who took at least one dose of study drug.
|
0.00%
0/359
The at Risk population includes only those randomized subjects who took at least one dose of study drug.
|
|
Metabolism and nutrition disorders
HYPOGLYCAEMIA
|
0.00%
0/359
The at Risk population includes only those randomized subjects who took at least one dose of study drug.
|
0.28%
1/359
The at Risk population includes only those randomized subjects who took at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
ARTHRALGIA
|
0.28%
1/359
The at Risk population includes only those randomized subjects who took at least one dose of study drug.
|
0.00%
0/359
The at Risk population includes only those randomized subjects who took at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
BACK PAIN
|
0.28%
1/359
The at Risk population includes only those randomized subjects who took at least one dose of study drug.
|
0.00%
0/359
The at Risk population includes only those randomized subjects who took at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
INTERVERTEBRAL DISC PROTRUSION
|
0.00%
0/359
The at Risk population includes only those randomized subjects who took at least one dose of study drug.
|
0.28%
1/359
The at Risk population includes only those randomized subjects who took at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
JOINT EFFUSION
|
0.00%
0/359
The at Risk population includes only those randomized subjects who took at least one dose of study drug.
|
0.28%
1/359
The at Risk population includes only those randomized subjects who took at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
OSTEOARTHRITIS
|
0.28%
1/359
The at Risk population includes only those randomized subjects who took at least one dose of study drug.
|
0.00%
0/359
The at Risk population includes only those randomized subjects who took at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
SPINAL COLUMN STENOSIS
|
0.28%
1/359
The at Risk population includes only those randomized subjects who took at least one dose of study drug.
|
0.00%
0/359
The at Risk population includes only those randomized subjects who took at least one dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
BREAST CANCER
|
0.56%
2/359
The at Risk population includes only those randomized subjects who took at least one dose of study drug.
|
0.00%
0/359
The at Risk population includes only those randomized subjects who took at least one dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
BASAL CELL CARCINOMA
|
0.28%
1/359
The at Risk population includes only those randomized subjects who took at least one dose of study drug.
|
0.28%
1/359
The at Risk population includes only those randomized subjects who took at least one dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
BLADDER TRANSITIONAL CELL CARCINOMA
|
0.28%
1/359
The at Risk population includes only those randomized subjects who took at least one dose of study drug.
|
0.00%
0/359
The at Risk population includes only those randomized subjects who took at least one dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
BREAST CANCER IN SITU
|
0.28%
1/359
The at Risk population includes only those randomized subjects who took at least one dose of study drug.
|
0.00%
0/359
The at Risk population includes only those randomized subjects who took at least one dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
COLON CANCER
|
0.28%
1/359
The at Risk population includes only those randomized subjects who took at least one dose of study drug.
|
0.00%
0/359
The at Risk population includes only those randomized subjects who took at least one dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
HEPATIC NEOPLASM MALIGNANT
|
0.28%
1/359
The at Risk population includes only those randomized subjects who took at least one dose of study drug.
|
0.00%
0/359
The at Risk population includes only those randomized subjects who took at least one dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
LUNG CANCER METASTATIC
|
0.00%
0/359
The at Risk population includes only those randomized subjects who took at least one dose of study drug.
|
0.28%
1/359
The at Risk population includes only those randomized subjects who took at least one dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
LYMPHOMA
|
0.28%
1/359
The at Risk population includes only those randomized subjects who took at least one dose of study drug.
|
0.00%
0/359
The at Risk population includes only those randomized subjects who took at least one dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
PANCREATIC CARCINOMA
|
0.28%
1/359
The at Risk population includes only those randomized subjects who took at least one dose of study drug.
|
0.00%
0/359
The at Risk population includes only those randomized subjects who took at least one dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
PROSTATE CANCER
|
0.00%
0/359
The at Risk population includes only those randomized subjects who took at least one dose of study drug.
|
0.28%
1/359
The at Risk population includes only those randomized subjects who took at least one dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
SALIVARY GLAND CANCER
|
0.28%
1/359
The at Risk population includes only those randomized subjects who took at least one dose of study drug.
|
0.00%
0/359
The at Risk population includes only those randomized subjects who took at least one dose of study drug.
|
|
Nervous system disorders
CEREBROVASCULAR ACCIDENT
|
0.00%
0/359
The at Risk population includes only those randomized subjects who took at least one dose of study drug.
|
0.28%
1/359
The at Risk population includes only those randomized subjects who took at least one dose of study drug.
|
|
Nervous system disorders
EPILEPSY
|
0.00%
0/359
The at Risk population includes only those randomized subjects who took at least one dose of study drug.
|
0.28%
1/359
The at Risk population includes only those randomized subjects who took at least one dose of study drug.
|
|
Nervous system disorders
SYNCOPE
|
0.28%
1/359
The at Risk population includes only those randomized subjects who took at least one dose of study drug.
|
0.28%
1/359
The at Risk population includes only those randomized subjects who took at least one dose of study drug.
|
|
Nervous system disorders
TRANSIENT ISCHAEMIC ATTACK
|
0.00%
0/359
The at Risk population includes only those randomized subjects who took at least one dose of study drug.
|
0.28%
1/359
The at Risk population includes only those randomized subjects who took at least one dose of study drug.
|
|
Renal and urinary disorders
CALCULUS BLADDER
|
0.28%
1/359
The at Risk population includes only those randomized subjects who took at least one dose of study drug.
|
0.00%
0/359
The at Risk population includes only those randomized subjects who took at least one dose of study drug.
|
|
Renal and urinary disorders
CALCULUS URETERIC
|
0.00%
0/359
The at Risk population includes only those randomized subjects who took at least one dose of study drug.
|
0.28%
1/359
The at Risk population includes only those randomized subjects who took at least one dose of study drug.
|
|
Renal and urinary disorders
NEUROGENIC BLADDER
|
0.00%
0/359
The at Risk population includes only those randomized subjects who took at least one dose of study drug.
|
0.28%
1/359
The at Risk population includes only those randomized subjects who took at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
CHRONIC OBSTRUCTIVE PULMONARY DISEASE
|
0.28%
1/359
The at Risk population includes only those randomized subjects who took at least one dose of study drug.
|
0.28%
1/359
The at Risk population includes only those randomized subjects who took at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
DYSPNOEA
|
0.00%
0/359
The at Risk population includes only those randomized subjects who took at least one dose of study drug.
|
0.28%
1/359
The at Risk population includes only those randomized subjects who took at least one dose of study drug.
|
|
Surgical and medical procedures
SURGICAL AND MEDICAL PROCEDURES CARDIOVERSION Systematic Assessment 0 359 1 359
|
0.28%
1/359
The at Risk population includes only those randomized subjects who took at least one dose of study drug.
|
0.00%
0/359
The at Risk population includes only those randomized subjects who took at least one dose of study drug.
|
|
Vascular disorders
AORTIC ANEURYSM
|
0.28%
1/359
The at Risk population includes only those randomized subjects who took at least one dose of study drug.
|
0.00%
0/359
The at Risk population includes only those randomized subjects who took at least one dose of study drug.
|
|
Vascular disorders
AORTIC ARTERIOSCLEROSIS
|
0.00%
0/359
The at Risk population includes only those randomized subjects who took at least one dose of study drug.
|
0.28%
1/359
The at Risk population includes only those randomized subjects who took at least one dose of study drug.
|
|
Vascular disorders
CIRCULATORY COLLAPSE
|
0.00%
0/359
The at Risk population includes only those randomized subjects who took at least one dose of study drug.
|
0.28%
1/359
The at Risk population includes only those randomized subjects who took at least one dose of study drug.
|
|
Vascular disorders
PERIPHERAL ARTERIAL OCCLUSIVE DISEASE
|
0.28%
1/359
The at Risk population includes only those randomized subjects who took at least one dose of study drug.
|
0.00%
0/359
The at Risk population includes only those randomized subjects who took at least one dose of study drug.
|
Other adverse events
| Measure |
Saxagliptin 5 mg
n=359 participants at risk
Saxagliptin 5 mg, oral tablet, once daily
|
Glimepiride 1 - 6 mg
n=359 participants at risk
Glimepiride 1, 2, 3, 4 or 6 mg, oral encapsulated tablet, once daily
|
|---|---|---|
|
Ear and labyrinth disorders
VERTIGO
|
2.5%
9/359
The at Risk population includes only those randomized subjects who took at least one dose of study drug.
|
0.00%
0/359
The at Risk population includes only those randomized subjects who took at least one dose of study drug.
|
|
Gastrointestinal disorders
DIARRHOEA
|
4.2%
15/359
The at Risk population includes only those randomized subjects who took at least one dose of study drug.
|
5.3%
19/359
The at Risk population includes only those randomized subjects who took at least one dose of study drug.
|
|
Gastrointestinal disorders
CONSTIPATION
|
1.1%
4/359
The at Risk population includes only those randomized subjects who took at least one dose of study drug.
|
2.8%
10/359
The at Risk population includes only those randomized subjects who took at least one dose of study drug.
|
|
Gastrointestinal disorders
NAUSEA
|
1.1%
4/359
The at Risk population includes only those randomized subjects who took at least one dose of study drug.
|
2.2%
8/359
The at Risk population includes only those randomized subjects who took at least one dose of study drug.
|
|
Infections and infestations
NASOPHARYNGITIS
|
6.4%
23/359
The at Risk population includes only those randomized subjects who took at least one dose of study drug.
|
9.7%
35/359
The at Risk population includes only those randomized subjects who took at least one dose of study drug.
|
|
Infections and infestations
URINARY TRACT INFECTION
|
3.1%
11/359
The at Risk population includes only those randomized subjects who took at least one dose of study drug.
|
5.0%
18/359
The at Risk population includes only those randomized subjects who took at least one dose of study drug.
|
|
Infections and infestations
BRONCHITIS
|
3.9%
14/359
The at Risk population includes only those randomized subjects who took at least one dose of study drug.
|
1.9%
7/359
The at Risk population includes only those randomized subjects who took at least one dose of study drug.
|
|
Infections and infestations
UPPER RESPIRATORY TRACT INFECTION
|
3.3%
12/359
The at Risk population includes only those randomized subjects who took at least one dose of study drug.
|
3.9%
14/359
The at Risk population includes only those randomized subjects who took at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
CONTUSION
|
2.2%
8/359
The at Risk population includes only those randomized subjects who took at least one dose of study drug.
|
0.00%
0/359
The at Risk population includes only those randomized subjects who took at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
BACK PAIN
|
2.5%
9/359
The at Risk population includes only those randomized subjects who took at least one dose of study drug.
|
5.0%
18/359
The at Risk population includes only those randomized subjects who took at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
ARTHRALGIA
|
4.7%
17/359
The at Risk population includes only those randomized subjects who took at least one dose of study drug.
|
2.5%
9/359
The at Risk population includes only those randomized subjects who took at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
PAIN IN EXTREMITY
|
2.8%
10/359
The at Risk population includes only those randomized subjects who took at least one dose of study drug.
|
2.5%
9/359
The at Risk population includes only those randomized subjects who took at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
MUSCULOSKELETAL PAIN
|
2.5%
9/359
The at Risk population includes only those randomized subjects who took at least one dose of study drug.
|
0.84%
3/359
The at Risk population includes only those randomized subjects who took at least one dose of study drug.
|
|
Nervous system disorders
DIZZINESS
|
1.7%
6/359
The at Risk population includes only those randomized subjects who took at least one dose of study drug.
|
4.7%
17/359
The at Risk population includes only those randomized subjects who took at least one dose of study drug.
|
|
Nervous system disorders
HEADACHE
|
1.7%
6/359
The at Risk population includes only those randomized subjects who took at least one dose of study drug.
|
3.3%
12/359
The at Risk population includes only those randomized subjects who took at least one dose of study drug.
|
|
Nervous system disorders
TREMOR
|
0.28%
1/359
The at Risk population includes only those randomized subjects who took at least one dose of study drug.
|
2.2%
8/359
The at Risk population includes only those randomized subjects who took at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
COUGH
|
2.5%
9/359
The at Risk population includes only those randomized subjects who took at least one dose of study drug.
|
3.6%
13/359
The at Risk population includes only those randomized subjects who took at least one dose of study drug.
|
|
Vascular disorders
HYPERTENSION
|
2.2%
8/359
The at Risk population includes only those randomized subjects who took at least one dose of study drug.
|
3.3%
12/359
The at Risk population includes only those randomized subjects who took at least one dose of study drug.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee No publication or presentation may include any of AZ's confidential information without AZ's prior written approval.
- Publication restrictions are in place
Restriction type: OTHER