Trial Outcomes & Findings for A Comparison of Two Treatment Strategies in Older Participants With Type 2 Diabetes Mellitus (T2DM) (NCT NCT02072096)
NCT ID: NCT02072096
Last Updated: 2019-10-09
Results Overview
Failed to reach and maintain HbA1c target, without clinically significant hypoglycemia, is defined as having 2 consecutive HbA1c \> upper limit of HbA1c target over 12 weeks starting from Week 24 for participants with HbA1c data beyond Week 24, or Week 24 HbA1c \> upper limit of HbA1c target for participants without HbA1c data beyond Week 24. Clinically significant hypoglycemia is defined as any severe hypoglycemia or repeated hypoglycemia interrupting participants activities or sleep and associated with blood glucose ≤3.9 millimole per liter (mmol/L), or repeated asymptomatic hypoglycemia associated with blood glucose \<3.0 mmol/L. Success is defined as lacking of failure.
Recruitment status
TERMINATED
Study phase
PHASE4
Target enrollment
192 participants
Primary outcome timeframe
Baseline to last participant visit (up to 72 weeks)
Results posted on
2019-10-09
Participant Flow
Participants completed the first 24 weeks of the study at which time the study was stopped and interim analysis was triggered to assess feasibility. Treatment continued per protocol until study termination and participants discontinued at the next office study visit. Data was assessed from Baseline to last participant visit, up to 72 weeks.
Participant milestones
| Measure |
Strategy A (Glucose-Dependent)
Participants may receive oral and injectable therapies (glucagon-like peptide-1 receptor agonists \[GLP-1 RA\]) that exert a glucose-dependent mode of action. Medications allowed in this arm include: metformin, pioglitazone, acarbose, linagliptin, sitagliptin, liraglutide, exenatide once weekly (QW), and exenatide twice daily (BID). Choice of therapy is based on investigator's discretion. Treatment used in label. Treatment may last up to 72 weeks.
|
Strategy B (Reference)
Participants will receive glimepiride and may receive basal insulin glargine as a first line injectable therapy. Medications allowed in this arm include: glimepiride, metformin, pioglitazone, acarbose, linagliptin, sitagliptin and basal insulin glargine. Choice of therapy is based on investigator's discretion. Treatment used in label. Insulin glargine is titrated according to treatment algorithm. Treatment may last up to 72 weeks.
|
|---|---|---|
|
Overall Study
STARTED
|
99
|
93
|
|
Overall Study
Received at Least One Dose of Study Drug
|
98
|
93
|
|
Overall Study
COMPLETED
|
14
|
15
|
|
Overall Study
NOT COMPLETED
|
85
|
78
|
Reasons for withdrawal
| Measure |
Strategy A (Glucose-Dependent)
Participants may receive oral and injectable therapies (glucagon-like peptide-1 receptor agonists \[GLP-1 RA\]) that exert a glucose-dependent mode of action. Medications allowed in this arm include: metformin, pioglitazone, acarbose, linagliptin, sitagliptin, liraglutide, exenatide once weekly (QW), and exenatide twice daily (BID). Choice of therapy is based on investigator's discretion. Treatment used in label. Treatment may last up to 72 weeks.
|
Strategy B (Reference)
Participants will receive glimepiride and may receive basal insulin glargine as a first line injectable therapy. Medications allowed in this arm include: glimepiride, metformin, pioglitazone, acarbose, linagliptin, sitagliptin and basal insulin glargine. Choice of therapy is based on investigator's discretion. Treatment used in label. Insulin glargine is titrated according to treatment algorithm. Treatment may last up to 72 weeks.
|
|---|---|---|
|
Overall Study
Lack of Efficacy
|
18
|
29
|
|
Overall Study
Protocol Violation
|
7
|
7
|
|
Overall Study
Withdrawal by Subject
|
5
|
7
|
|
Overall Study
Adverse Event
|
5
|
2
|
|
Overall Study
No Reason Provided
|
4
|
2
|
|
Overall Study
Death
|
2
|
0
|
|
Overall Study
Physician Decision
|
0
|
1
|
|
Overall Study
Study Terminated by Sponsor
|
43
|
30
|
|
Overall Study
Lost to Follow-up
|
1
|
0
|
Baseline Characteristics
A Comparison of Two Treatment Strategies in Older Participants With Type 2 Diabetes Mellitus (T2DM)
Baseline characteristics by cohort
| Measure |
Strategy A (Glucose-Dependent)
n=99 Participants
Participants may receive oral and injectable therapies (glucagon-like peptide-1 receptor agonists \[GLP-1 RA\]) that exert a glucose-dependent mode of action. Medications allowed in this arm include: metformin, pioglitazone, acarbose, linagliptin, sitagliptin, liraglutide, exenatide once weekly (QW), and exenatide twice daily (BID). Choice of therapy is based on investigator's discretion. Treatment used in label. Treatment may last up to 72 weeks.
|
Strategy B (Reference)
n=93 Participants
Participants will receive glimepiride and may receive basal insulin glargine as a first line injectable therapy. Medications allowed in this arm include: glimepiride, metformin, pioglitazone, acarbose, linagliptin, sitagliptin and basal insulin glargine. Choice of therapy is based on investigator's discretion. Treatment used in label. Insulin glargine dose is titrated according to treatment algorithm. Treatment may last up to 72 weeks.
|
Total
n=192 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
70.7 years
STANDARD_DEVIATION 5.3 • n=5 Participants
|
70.7 years
STANDARD_DEVIATION 4.4 • n=7 Participants
|
70.7 years
STANDARD_DEVIATION 4.9 • n=5 Participants
|
|
Sex: Female, Male
Female
|
43 Participants
n=5 Participants
|
34 Participants
n=7 Participants
|
77 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
56 Participants
n=5 Participants
|
59 Participants
n=7 Participants
|
115 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
35 Participants
n=5 Participants
|
32 Participants
n=7 Participants
|
67 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
63 Participants
n=5 Participants
|
59 Participants
n=7 Participants
|
122 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
6 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
93 Participants
n=5 Participants
|
81 Participants
n=7 Participants
|
174 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
Austria
|
18 participants
n=5 Participants
|
14 participants
n=7 Participants
|
32 participants
n=5 Participants
|
|
Region of Enrollment
Puerto Rico
|
23 participants
n=5 Participants
|
16 participants
n=7 Participants
|
39 participants
n=5 Participants
|
|
Region of Enrollment
United States
|
29 participants
n=5 Participants
|
35 participants
n=7 Participants
|
64 participants
n=5 Participants
|
|
Region of Enrollment
United Kingdom
|
10 participants
n=5 Participants
|
11 participants
n=7 Participants
|
21 participants
n=5 Participants
|
|
Region of Enrollment
Germany
|
19 participants
n=5 Participants
|
17 participants
n=7 Participants
|
36 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline to last participant visit (up to 72 weeks)Population: All participants who received at least one dose of study drug.
Failed to reach and maintain HbA1c target, without clinically significant hypoglycemia, is defined as having 2 consecutive HbA1c \> upper limit of HbA1c target over 12 weeks starting from Week 24 for participants with HbA1c data beyond Week 24, or Week 24 HbA1c \> upper limit of HbA1c target for participants without HbA1c data beyond Week 24. Clinically significant hypoglycemia is defined as any severe hypoglycemia or repeated hypoglycemia interrupting participants activities or sleep and associated with blood glucose ≤3.9 millimole per liter (mmol/L), or repeated asymptomatic hypoglycemia associated with blood glucose \<3.0 mmol/L. Success is defined as lacking of failure.
Outcome measures
| Measure |
Strategy A (Glucose-Dependent)
n=98 Participants
Participants may receive oral and injectable therapies (glucagon-like peptide-1 receptor agonists \[GLP-1 RA\]) that exert a glucose-dependent mode of action. Medications allowed in this arm include: metformin, pioglitazone, acarbose, linagliptin, sitagliptin, liraglutide, exenatide once weekly (QW), and exenatide twice daily (BID). Choice of therapy is based on investigator's discretion. Treatment used in label. Treatment may last up to 72 weeks.
|
Strategy B (Reference)
n=93 Participants
Participants will receive glimepiride and may receive basal insulin glargine as a first line injectable therapy. Medications allowed in this arm include: glimepiride, metformin, pioglitazone, acarbose, linagliptin, sitagliptin and basal insulin glargine. Choice of therapy is based on investigator's discretion. Treatment used in label. Dose titrated by treatment algorithm. Treatment may last up to 72 weeks.
|
|---|---|---|
|
Percentage of Participants Achieving and Maintaining Individualized Glycated Hemoglobin A1c (HbA1c) Targets Without Clinically Significant Hypoglycemia
|
64.5 percentage of participants
Interval 54.4 to 73.4
|
54.9 percentage of participants
Interval 44.6 to 64.9
|
SECONDARY outcome
Timeframe: Baseline to last participant visit (up to 72 weeks)Population: All participants who received at least one dose of study drug.
Outcome measures
| Measure |
Strategy A (Glucose-Dependent)
n=98 Participants
Participants may receive oral and injectable therapies (glucagon-like peptide-1 receptor agonists \[GLP-1 RA\]) that exert a glucose-dependent mode of action. Medications allowed in this arm include: metformin, pioglitazone, acarbose, linagliptin, sitagliptin, liraglutide, exenatide once weekly (QW), and exenatide twice daily (BID). Choice of therapy is based on investigator's discretion. Treatment used in label. Treatment may last up to 72 weeks.
|
Strategy B (Reference)
n=93 Participants
Participants will receive glimepiride and may receive basal insulin glargine as a first line injectable therapy. Medications allowed in this arm include: glimepiride, metformin, pioglitazone, acarbose, linagliptin, sitagliptin and basal insulin glargine. Choice of therapy is based on investigator's discretion. Treatment used in label. Dose titrated by treatment algorithm. Treatment may last up to 72 weeks.
|
|---|---|---|
|
Percentage of Participants Requiring Alternative Treatment Due to Glycemic Failure of First Line Injectable Therapy
|
21 percentage of participants
|
13 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline to last participant visit (up to 72 weeks)Population: All participants who received at least one dose of study drug.
Outcome measures
| Measure |
Strategy A (Glucose-Dependent)
n=98 Participants
Participants may receive oral and injectable therapies (glucagon-like peptide-1 receptor agonists \[GLP-1 RA\]) that exert a glucose-dependent mode of action. Medications allowed in this arm include: metformin, pioglitazone, acarbose, linagliptin, sitagliptin, liraglutide, exenatide once weekly (QW), and exenatide twice daily (BID). Choice of therapy is based on investigator's discretion. Treatment used in label. Treatment may last up to 72 weeks.
|
Strategy B (Reference)
n=93 Participants
Participants will receive glimepiride and may receive basal insulin glargine as a first line injectable therapy. Medications allowed in this arm include: glimepiride, metformin, pioglitazone, acarbose, linagliptin, sitagliptin and basal insulin glargine. Choice of therapy is based on investigator's discretion. Treatment used in label. Dose titrated by treatment algorithm. Treatment may last up to 72 weeks.
|
|---|---|---|
|
Number of Participants With Total Hypoglycemia and Other Categories of Hypoglycemia
Relative Hypoglycemia
|
1 Participants
|
6 Participants
|
|
Number of Participants With Total Hypoglycemia and Other Categories of Hypoglycemia
Total Hypoglycemia
|
10 Participants
|
50 Participants
|
|
Number of Participants With Total Hypoglycemia and Other Categories of Hypoglycemia
Severe Hypoglycemia
|
0 Participants
|
0 Participants
|
|
Number of Participants With Total Hypoglycemia and Other Categories of Hypoglycemia
Clinically Significant Hypoglycemia
|
0 Participants
|
1 Participants
|
|
Number of Participants With Total Hypoglycemia and Other Categories of Hypoglycemia
Symptomatic Hypoglycemia
|
5 Participants
|
34 Participants
|
|
Number of Participants With Total Hypoglycemia and Other Categories of Hypoglycemia
Asymptomatic Hypoglycemia
|
8 Participants
|
30 Participants
|
|
Number of Participants With Total Hypoglycemia and Other Categories of Hypoglycemia
Probable Symptomatic Hypoglycemia
|
0 Participants
|
7 Participants
|
|
Number of Participants With Total Hypoglycemia and Other Categories of Hypoglycemia
Unspecified Hypoglycemia
|
2 Participants
|
7 Participants
|
|
Number of Participants With Total Hypoglycemia and Other Categories of Hypoglycemia
Nocturnal Hypoglycemia
|
4 Participants
|
10 Participants
|
SECONDARY outcome
Timeframe: Baseline, Week 72Population: All participants who received at least one dose of study drug and had evaluable baseline and post-baseline urinary albumin to creatinine ratio.
The Urinary Albumin to Creatinine Ratio is used in addition to Estimated Glomerular Filtration Rate (eGFR) to measure the incidence and progression of diabetic kidney disease.
Outcome measures
| Measure |
Strategy A (Glucose-Dependent)
n=80 Participants
Participants may receive oral and injectable therapies (glucagon-like peptide-1 receptor agonists \[GLP-1 RA\]) that exert a glucose-dependent mode of action. Medications allowed in this arm include: metformin, pioglitazone, acarbose, linagliptin, sitagliptin, liraglutide, exenatide once weekly (QW), and exenatide twice daily (BID). Choice of therapy is based on investigator's discretion. Treatment used in label. Treatment may last up to 72 weeks.
|
Strategy B (Reference)
n=83 Participants
Participants will receive glimepiride and may receive basal insulin glargine as a first line injectable therapy. Medications allowed in this arm include: glimepiride, metformin, pioglitazone, acarbose, linagliptin, sitagliptin and basal insulin glargine. Choice of therapy is based on investigator's discretion. Treatment used in label. Dose titrated by treatment algorithm. Treatment may last up to 72 weeks.
|
|---|---|---|
|
Change From Baseline of Urinary Albumin to Creatinine Ratio
|
1.85 milligram per millimole (mg/mmol)
Standard Deviation 22.99
|
1.85 milligram per millimole (mg/mmol)
Standard Deviation 16.46
|
SECONDARY outcome
Timeframe: Baseline, Week 72Population: All participants who received at least one dose of study drug and had evaluable baseline and post-baseline BMI data.
Outcome measures
| Measure |
Strategy A (Glucose-Dependent)
n=96 Participants
Participants may receive oral and injectable therapies (glucagon-like peptide-1 receptor agonists \[GLP-1 RA\]) that exert a glucose-dependent mode of action. Medications allowed in this arm include: metformin, pioglitazone, acarbose, linagliptin, sitagliptin, liraglutide, exenatide once weekly (QW), and exenatide twice daily (BID). Choice of therapy is based on investigator's discretion. Treatment used in label. Treatment may last up to 72 weeks.
|
Strategy B (Reference)
n=93 Participants
Participants will receive glimepiride and may receive basal insulin glargine as a first line injectable therapy. Medications allowed in this arm include: glimepiride, metformin, pioglitazone, acarbose, linagliptin, sitagliptin and basal insulin glargine. Choice of therapy is based on investigator's discretion. Treatment used in label. Dose titrated by treatment algorithm. Treatment may last up to 72 weeks.
|
|---|---|---|
|
Change From Baseline in Body Mass Index (BMI)
|
-0.47 kilogram per square meter (kg/m^2)
Standard Deviation 1.56
|
0.20 kilogram per square meter (kg/m^2)
Standard Deviation 2.91
|
SECONDARY outcome
Timeframe: Baseline, Week 72Population: All participants who received at least one dose of study drug and had evaluable baseline and post-baseline eGFR data.
The eGFR is used in addition to the Urinary Albumin to Creatinine Ratio to measure the incidence and progression of diabetic kidney disease.
Outcome measures
| Measure |
Strategy A (Glucose-Dependent)
n=85 Participants
Participants may receive oral and injectable therapies (glucagon-like peptide-1 receptor agonists \[GLP-1 RA\]) that exert a glucose-dependent mode of action. Medications allowed in this arm include: metformin, pioglitazone, acarbose, linagliptin, sitagliptin, liraglutide, exenatide once weekly (QW), and exenatide twice daily (BID). Choice of therapy is based on investigator's discretion. Treatment used in label. Treatment may last up to 72 weeks.
|
Strategy B (Reference)
n=85 Participants
Participants will receive glimepiride and may receive basal insulin glargine as a first line injectable therapy. Medications allowed in this arm include: glimepiride, metformin, pioglitazone, acarbose, linagliptin, sitagliptin and basal insulin glargine. Choice of therapy is based on investigator's discretion. Treatment used in label. Dose titrated by treatment algorithm. Treatment may last up to 72 weeks.
|
|---|---|---|
|
Change From Baseline of Estimated Glomerular Filtration Rate (eGFR)
|
-5.00 milliliter per minute/1.73 square meter
Standard Deviation 13.64
|
-5.88 milliliter per minute/1.73 square meter
Standard Deviation 10.95
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline, Week 72Population: Unable to conduct change from baseline analysis due to study closure and lack of endpoint data.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline, Week 72Population: Unable to conduct change from baseline analysis due to study closure and lack of endpoint data.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline, Week 72Population: Unable to conduct change from baseline analysis due to study closure and lack of endpoint data.
Outcome measures
Outcome data not reported
Adverse Events
Strategy A (Glucose-Dependent)
Serious events: 15 serious events
Other events: 82 other events
Deaths: 0 deaths
Strategy B (Reference)
Serious events: 14 serious events
Other events: 74 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Strategy A (Glucose-Dependent)
n=98 participants at risk
Participants may receive oral and injectable therapies (glucagon-like peptide-1 receptor agonists \[GLP-1 RA\]) that exert a glucose-dependent mode of action. Medications allowed in this arm include: metformin, pioglitazone, acarbose, linagliptin, sitagliptin, liraglutide, exenatide once weekly (QW), and exenatide twice daily (BID). Choice of therapy is based on investigator's discretion. Treatment used in label. Treatment may last up to 72 weeks.
|
Strategy B (Reference)
n=93 participants at risk
Participants will receive glimepiride and may receive basal insulin glargine as a first line injectable therapy. Medications allowed in this arm include: glimepiride, metformin, pioglitazone, acarbose, linagliptin, sitagliptin and basal insulin glargine. Choice of therapy is based on investigator's discretion. Treatment used in label. Dose titrated by treatment algorithm. Treatment may last up to 72 weeks.
|
|---|---|---|
|
Cardiac disorders
Acute myocardial infarction
|
1.0%
1/98 • Number of events 1
All participants who received at least one dose of study drug.
|
0.00%
0/93
All participants who received at least one dose of study drug.
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/98
All participants who received at least one dose of study drug.
|
2.2%
2/93 • Number of events 2
All participants who received at least one dose of study drug.
|
|
Cardiac disorders
Cardiac failure congestive
|
1.0%
1/98 • Number of events 1
All participants who received at least one dose of study drug.
|
1.1%
1/93 • Number of events 1
All participants who received at least one dose of study drug.
|
|
Cardiac disorders
Microvascular coronary artery disease
|
1.0%
1/98 • Number of events 1
All participants who received at least one dose of study drug.
|
0.00%
0/93
All participants who received at least one dose of study drug.
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/98
All participants who received at least one dose of study drug.
|
2.2%
2/93 • Number of events 2
All participants who received at least one dose of study drug.
|
|
Ear and labyrinth disorders
Vertigo
|
1.0%
1/98 • Number of events 1
All participants who received at least one dose of study drug.
|
0.00%
0/93
All participants who received at least one dose of study drug.
|
|
Eye disorders
Retinal vascular thrombosis
|
1.0%
1/98 • Number of events 1
All participants who received at least one dose of study drug.
|
0.00%
0/93
All participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Gastritis
|
1.0%
1/98 • Number of events 1
All participants who received at least one dose of study drug.
|
0.00%
0/93
All participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Lower gastrointestinal haemorrhage
|
0.00%
0/98
All participants who received at least one dose of study drug.
|
1.1%
1/93 • Number of events 1
All participants who received at least one dose of study drug.
|
|
General disorders
Chest pain
|
1.0%
1/98 • Number of events 1
All participants who received at least one dose of study drug.
|
0.00%
0/93
All participants who received at least one dose of study drug.
|
|
Hepatobiliary disorders
Cholecystitis chronic
|
1.0%
1/98 • Number of events 1
All participants who received at least one dose of study drug.
|
0.00%
0/93
All participants who received at least one dose of study drug.
|
|
Infections and infestations
Appendicitis
|
0.00%
0/98
All participants who received at least one dose of study drug.
|
1.1%
1/93 • Number of events 1
All participants who received at least one dose of study drug.
|
|
Infections and infestations
Cellulitis
|
1.0%
1/98 • Number of events 1
All participants who received at least one dose of study drug.
|
0.00%
0/93
All participants who received at least one dose of study drug.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/98
All participants who received at least one dose of study drug.
|
1.1%
1/93 • Number of events 1
All participants who received at least one dose of study drug.
|
|
Infections and infestations
Respiratory tract infection
|
0.00%
0/98
All participants who received at least one dose of study drug.
|
1.1%
1/93 • Number of events 1
All participants who received at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/98
All participants who received at least one dose of study drug.
|
1.1%
1/93 • Number of events 1
All participants who received at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
Muscle rupture
|
0.00%
0/98
All participants who received at least one dose of study drug.
|
1.1%
1/93 • Number of events 1
All participants who received at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
Rib fracture
|
1.0%
1/98 • Number of events 1
All participants who received at least one dose of study drug.
|
0.00%
0/93
All participants who received at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
1.0%
1/98 • Number of events 1
All participants who received at least one dose of study drug.
|
0.00%
0/93
All participants who received at least one dose of study drug.
|
|
Investigations
Hepatic enzyme increased
|
1.0%
1/98 • Number of events 1
All participants who received at least one dose of study drug.
|
0.00%
0/93
All participants who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
1.0%
1/98 • Number of events 1
All participants who received at least one dose of study drug.
|
0.00%
0/93
All participants who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.00%
0/98
All participants who received at least one dose of study drug.
|
1.1%
1/93 • Number of events 1
All participants who received at least one dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Benign neoplasm of spinal cord
|
0.00%
0/98
All participants who received at least one dose of study drug.
|
1.1%
1/93 • Number of events 1
All participants who received at least one dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Benign ovarian tumour
|
0.00%
0/98
All participants who received at least one dose of study drug.
|
1.1%
1/93 • Number of events 1
All participants who received at least one dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostatic adenoma
|
0.00%
0/98
All participants who received at least one dose of study drug.
|
1.1%
1/93 • Number of events 1
All participants who received at least one dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma of lung
|
1.0%
1/98 • Number of events 1
All participants who received at least one dose of study drug.
|
0.00%
0/93
All participants who received at least one dose of study drug.
|
|
Nervous system disorders
Carotid artery stenosis
|
1.0%
1/98 • Number of events 2
All participants who received at least one dose of study drug.
|
0.00%
0/93
All participants who received at least one dose of study drug.
|
|
Nervous system disorders
Cerebrovascular accident
|
2.0%
2/98 • Number of events 2
All participants who received at least one dose of study drug.
|
0.00%
0/93
All participants who received at least one dose of study drug.
|
|
Nervous system disorders
Syncope
|
1.0%
1/98 • Number of events 1
All participants who received at least one dose of study drug.
|
0.00%
0/93
All participants who received at least one dose of study drug.
|
|
Nervous system disorders
Transient ischaemic attack
|
1.0%
1/98 • Number of events 1
All participants who received at least one dose of study drug.
|
0.00%
0/93
All participants who received at least one dose of study drug.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/98
All participants who received at least one dose of study drug.
|
1.1%
1/93 • Number of events 1
All participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
1.0%
1/98 • Number of events 1
All participants who received at least one dose of study drug.
|
0.00%
0/93
All participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
1.0%
1/98 • Number of events 1
All participants who received at least one dose of study drug.
|
0.00%
0/93
All participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
1.0%
1/98 • Number of events 1
All participants who received at least one dose of study drug.
|
0.00%
0/93
All participants who received at least one dose of study drug.
|
Other adverse events
| Measure |
Strategy A (Glucose-Dependent)
n=98 participants at risk
Participants may receive oral and injectable therapies (glucagon-like peptide-1 receptor agonists \[GLP-1 RA\]) that exert a glucose-dependent mode of action. Medications allowed in this arm include: metformin, pioglitazone, acarbose, linagliptin, sitagliptin, liraglutide, exenatide once weekly (QW), and exenatide twice daily (BID). Choice of therapy is based on investigator's discretion. Treatment used in label. Treatment may last up to 72 weeks.
|
Strategy B (Reference)
n=93 participants at risk
Participants will receive glimepiride and may receive basal insulin glargine as a first line injectable therapy. Medications allowed in this arm include: glimepiride, metformin, pioglitazone, acarbose, linagliptin, sitagliptin and basal insulin glargine. Choice of therapy is based on investigator's discretion. Treatment used in label. Dose titrated by treatment algorithm. Treatment may last up to 72 weeks.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
1.0%
1/98 • Number of events 1
All participants who received at least one dose of study drug.
|
2.2%
2/93 • Number of events 2
All participants who received at least one dose of study drug.
|
|
Blood and lymphatic system disorders
Iron deficiency anaemia
|
0.00%
0/98
All participants who received at least one dose of study drug.
|
1.1%
1/93 • Number of events 1
All participants who received at least one dose of study drug.
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
1.0%
1/98 • Number of events 1
All participants who received at least one dose of study drug.
|
0.00%
0/93
All participants who received at least one dose of study drug.
|
|
Blood and lymphatic system disorders
Nephrogenic anaemia
|
1.0%
1/98 • Number of events 1
All participants who received at least one dose of study drug.
|
0.00%
0/93
All participants who received at least one dose of study drug.
|
|
Cardiac disorders
Aortic valve stenosis
|
0.00%
0/98
All participants who received at least one dose of study drug.
|
1.1%
1/93 • Number of events 1
All participants who received at least one dose of study drug.
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/98
All participants who received at least one dose of study drug.
|
1.1%
1/93 • Number of events 1
All participants who received at least one dose of study drug.
|
|
Cardiac disorders
Cardiac failure
|
0.00%
0/98
All participants who received at least one dose of study drug.
|
1.1%
1/93 • Number of events 1
All participants who received at least one dose of study drug.
|
|
Cardiac disorders
Left ventricular hypertrophy
|
0.00%
0/98
All participants who received at least one dose of study drug.
|
1.1%
1/93 • Number of events 1
All participants who received at least one dose of study drug.
|
|
Cardiac disorders
Mitral valve incompetence
|
0.00%
0/98
All participants who received at least one dose of study drug.
|
1.1%
1/93 • Number of events 1
All participants who received at least one dose of study drug.
|
|
Cardiac disorders
Palpitations
|
2.0%
2/98 • Number of events 2
All participants who received at least one dose of study drug.
|
0.00%
0/93
All participants who received at least one dose of study drug.
|
|
Cardiac disorders
Tachycardia
|
1.0%
1/98 • Number of events 1
All participants who received at least one dose of study drug.
|
0.00%
0/93
All participants who received at least one dose of study drug.
|
|
Congenital, familial and genetic disorders
Type v hyperlipidaemia
|
1.0%
1/98 • Number of events 1
All participants who received at least one dose of study drug.
|
0.00%
0/93
All participants who received at least one dose of study drug.
|
|
Ear and labyrinth disorders
Cerumen impaction
|
1.0%
1/98 • Number of events 1
All participants who received at least one dose of study drug.
|
0.00%
0/93
All participants who received at least one dose of study drug.
|
|
Ear and labyrinth disorders
Sudden hearing loss
|
1.0%
1/98 • Number of events 1
All participants who received at least one dose of study drug.
|
0.00%
0/93
All participants who received at least one dose of study drug.
|
|
Endocrine disorders
Goitre
|
2.0%
2/98 • Number of events 2
All participants who received at least one dose of study drug.
|
3.2%
3/93 • Number of events 3
All participants who received at least one dose of study drug.
|
|
Endocrine disorders
Hyperparathyroidism secondary
|
1.0%
1/98 • Number of events 1
All participants who received at least one dose of study drug.
|
1.1%
1/93 • Number of events 1
All participants who received at least one dose of study drug.
|
|
Endocrine disorders
Hyperthyroidism
|
1.0%
1/98 • Number of events 1
All participants who received at least one dose of study drug.
|
0.00%
0/93
All participants who received at least one dose of study drug.
|
|
Endocrine disorders
Hypothyroidism
|
1.0%
1/98 • Number of events 1
All participants who received at least one dose of study drug.
|
2.2%
2/93 • Number of events 2
All participants who received at least one dose of study drug.
|
|
Endocrine disorders
Primary hypothyroidism
|
1.0%
1/98 • Number of events 1
All participants who received at least one dose of study drug.
|
0.00%
0/93
All participants who received at least one dose of study drug.
|
|
Eye disorders
Diplopia
|
0.00%
0/98
All participants who received at least one dose of study drug.
|
1.1%
1/93 • Number of events 1
All participants who received at least one dose of study drug.
|
|
Eye disorders
Lacrimation increased
|
0.00%
0/98
All participants who received at least one dose of study drug.
|
1.1%
1/93 • Number of events 1
All participants who received at least one dose of study drug.
|
|
Eye disorders
Vision blurred
|
1.0%
1/98 • Number of events 1
All participants who received at least one dose of study drug.
|
0.00%
0/93
All participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Abdominal discomfort
|
1.0%
1/98 • Number of events 1
All participants who received at least one dose of study drug.
|
0.00%
0/93
All participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Abdominal distension
|
4.1%
4/98 • Number of events 4
All participants who received at least one dose of study drug.
|
0.00%
0/93
All participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Abdominal pain
|
2.0%
2/98 • Number of events 2
All participants who received at least one dose of study drug.
|
2.2%
2/93 • Number of events 2
All participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Abdominal pain lower
|
0.00%
0/98
All participants who received at least one dose of study drug.
|
1.1%
1/93 • Number of events 1
All participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
3.1%
3/98 • Number of events 3
All participants who received at least one dose of study drug.
|
2.2%
2/93 • Number of events 2
All participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Anal pruritus
|
1.0%
1/98 • Number of events 1
All participants who received at least one dose of study drug.
|
0.00%
0/93
All participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Barrett's oesophagus
|
1.0%
1/98 • Number of events 1
All participants who received at least one dose of study drug.
|
0.00%
0/93
All participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Constipation
|
2.0%
2/98 • Number of events 2
All participants who received at least one dose of study drug.
|
0.00%
0/93
All participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Dental caries
|
0.00%
0/98
All participants who received at least one dose of study drug.
|
1.1%
1/93 • Number of events 1
All participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Diarrhoea
|
12.2%
12/98 • Number of events 18
All participants who received at least one dose of study drug.
|
6.5%
6/93 • Number of events 6
All participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Dyspepsia
|
1.0%
1/98 • Number of events 1
All participants who received at least one dose of study drug.
|
0.00%
0/93
All participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Flatulence
|
3.1%
3/98 • Number of events 4
All participants who received at least one dose of study drug.
|
1.1%
1/93 • Number of events 1
All participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Food poisoning
|
1.0%
1/98 • Number of events 1
All participants who received at least one dose of study drug.
|
0.00%
0/93
All participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Gastritis
|
1.0%
1/98 • Number of events 1
All participants who received at least one dose of study drug.
|
1.1%
1/93 • Number of events 1
All participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Gastrointestinal disorder
|
1.0%
1/98 • Number of events 1
All participants who received at least one dose of study drug.
|
0.00%
0/93
All participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
2.0%
2/98 • Number of events 2
All participants who received at least one dose of study drug.
|
2.2%
2/93 • Number of events 2
All participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Haemorrhoids
|
1.0%
1/98 • Number of events 1
All participants who received at least one dose of study drug.
|
0.00%
0/93
All participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Hiatus hernia
|
0.00%
0/98
All participants who received at least one dose of study drug.
|
1.1%
1/93 • Number of events 1
All participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Impaired gastric emptying
|
1.0%
1/98 • Number of events 1
All participants who received at least one dose of study drug.
|
0.00%
0/93
All participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Large intestine polyp
|
1.0%
1/98 • Number of events 1
All participants who received at least one dose of study drug.
|
0.00%
0/93
All participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Loose tooth
|
1.0%
1/98 • Number of events 1
All participants who received at least one dose of study drug.
|
0.00%
0/93
All participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Nausea
|
7.1%
7/98 • Number of events 8
All participants who received at least one dose of study drug.
|
3.2%
3/93 • Number of events 3
All participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Toothache
|
3.1%
3/98 • Number of events 3
All participants who received at least one dose of study drug.
|
1.1%
1/93 • Number of events 2
All participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Vomiting
|
3.1%
3/98 • Number of events 5
All participants who received at least one dose of study drug.
|
0.00%
0/93
All participants who received at least one dose of study drug.
|
|
General disorders
Asthenia
|
0.00%
0/98
All participants who received at least one dose of study drug.
|
1.1%
1/93 • Number of events 1
All participants who received at least one dose of study drug.
|
|
General disorders
Chest pain
|
3.1%
3/98 • Number of events 3
All participants who received at least one dose of study drug.
|
1.1%
1/93 • Number of events 1
All participants who received at least one dose of study drug.
|
|
General disorders
Fatigue
|
1.0%
1/98 • Number of events 1
All participants who received at least one dose of study drug.
|
0.00%
0/93
All participants who received at least one dose of study drug.
|
|
General disorders
Influenza like illness
|
2.0%
2/98 • Number of events 3
All participants who received at least one dose of study drug.
|
2.2%
2/93 • Number of events 2
All participants who received at least one dose of study drug.
|
|
General disorders
Injection site nodule
|
1.0%
1/98 • Number of events 1
All participants who received at least one dose of study drug.
|
0.00%
0/93
All participants who received at least one dose of study drug.
|
|
General disorders
Malaise
|
1.0%
1/98 • Number of events 1
All participants who received at least one dose of study drug.
|
0.00%
0/93
All participants who received at least one dose of study drug.
|
|
General disorders
Oedema
|
6.1%
6/98 • Number of events 7
All participants who received at least one dose of study drug.
|
0.00%
0/93
All participants who received at least one dose of study drug.
|
|
General disorders
Oedema peripheral
|
1.0%
1/98 • Number of events 1
All participants who received at least one dose of study drug.
|
6.5%
6/93 • Number of events 6
All participants who received at least one dose of study drug.
|
|
General disorders
Peripheral swelling
|
1.0%
1/98 • Number of events 1
All participants who received at least one dose of study drug.
|
2.2%
2/93 • Number of events 2
All participants who received at least one dose of study drug.
|
|
General disorders
Pyrexia
|
1.0%
1/98 • Number of events 1
All participants who received at least one dose of study drug.
|
1.1%
1/93 • Number of events 1
All participants who received at least one dose of study drug.
|
|
Immune system disorders
Hypersensitivity
|
0.00%
0/98
All participants who received at least one dose of study drug.
|
1.1%
1/93 • Number of events 1
All participants who received at least one dose of study drug.
|
|
Immune system disorders
Seasonal allergy
|
1.0%
1/98 • Number of events 1
All participants who received at least one dose of study drug.
|
1.1%
1/93 • Number of events 2
All participants who received at least one dose of study drug.
|
|
Infections and infestations
Abscess
|
1.0%
1/98 • Number of events 1
All participants who received at least one dose of study drug.
|
0.00%
0/93
All participants who received at least one dose of study drug.
|
|
Infections and infestations
Acarodermatitis
|
0.00%
0/98
All participants who received at least one dose of study drug.
|
1.1%
1/93 • Number of events 1
All participants who received at least one dose of study drug.
|
|
Infections and infestations
Bronchitis
|
4.1%
4/98 • Number of events 6
All participants who received at least one dose of study drug.
|
2.2%
2/93 • Number of events 2
All participants who received at least one dose of study drug.
|
|
Infections and infestations
Cellulitis
|
1.0%
1/98 • Number of events 1
All participants who received at least one dose of study drug.
|
0.00%
0/93
All participants who received at least one dose of study drug.
|
|
Infections and infestations
Chikungunya virus infection
|
4.1%
4/98 • Number of events 4
All participants who received at least one dose of study drug.
|
5.4%
5/93 • Number of events 5
All participants who received at least one dose of study drug.
|
|
Infections and infestations
Colon gangrene
|
0.00%
0/98
All participants who received at least one dose of study drug.
|
1.1%
1/93 • Number of events 1
All participants who received at least one dose of study drug.
|
|
Infections and infestations
Conjunctivitis
|
0.00%
0/98
All participants who received at least one dose of study drug.
|
1.1%
1/93 • Number of events 1
All participants who received at least one dose of study drug.
|
|
Infections and infestations
Cystitis
|
1.0%
1/98 • Number of events 1
All participants who received at least one dose of study drug.
|
1.1%
1/93 • Number of events 1
All participants who received at least one dose of study drug.
|
|
Infections and infestations
Dermatitis infected
|
1.0%
1/98 • Number of events 1
All participants who received at least one dose of study drug.
|
0.00%
0/93
All participants who received at least one dose of study drug.
|
|
Infections and infestations
Ear infection
|
0.00%
0/98
All participants who received at least one dose of study drug.
|
1.1%
1/93 • Number of events 1
All participants who received at least one dose of study drug.
|
|
Infections and infestations
Erysipelas
|
0.00%
0/98
All participants who received at least one dose of study drug.
|
1.1%
1/93 • Number of events 1
All participants who received at least one dose of study drug.
|
|
Infections and infestations
Fungal infection
|
1.0%
1/98 • Number of events 1
All participants who received at least one dose of study drug.
|
0.00%
0/93
All participants who received at least one dose of study drug.
|
|
Infections and infestations
Fungal skin infection
|
0.00%
0/98
All participants who received at least one dose of study drug.
|
1.1%
1/93 • Number of events 1
All participants who received at least one dose of study drug.
|
|
Infections and infestations
Gastroenteritis
|
1.0%
1/98 • Number of events 1
All participants who received at least one dose of study drug.
|
0.00%
0/93
All participants who received at least one dose of study drug.
|
|
Infections and infestations
Gastroenteritis viral
|
1.0%
1/98 • Number of events 1
All participants who received at least one dose of study drug.
|
2.2%
2/93 • Number of events 2
All participants who received at least one dose of study drug.
|
|
Infections and infestations
Gastrointestinal infection
|
2.0%
2/98 • Number of events 2
All participants who received at least one dose of study drug.
|
0.00%
0/93
All participants who received at least one dose of study drug.
|
|
Infections and infestations
Gingivitis
|
2.0%
2/98 • Number of events 3
All participants who received at least one dose of study drug.
|
0.00%
0/93
All participants who received at least one dose of study drug.
|
|
Infections and infestations
Helicobacter infection
|
1.0%
1/98 • Number of events 1
All participants who received at least one dose of study drug.
|
0.00%
0/93
All participants who received at least one dose of study drug.
|
|
Infections and infestations
Herpes zoster
|
1.0%
1/98 • Number of events 1
All participants who received at least one dose of study drug.
|
1.1%
1/93 • Number of events 1
All participants who received at least one dose of study drug.
|
|
Infections and infestations
Influenza
|
4.1%
4/98 • Number of events 4
All participants who received at least one dose of study drug.
|
3.2%
3/93 • Number of events 3
All participants who received at least one dose of study drug.
|
|
Infections and infestations
Laryngitis
|
1.0%
1/98 • Number of events 1
All participants who received at least one dose of study drug.
|
0.00%
0/93
All participants who received at least one dose of study drug.
|
|
Infections and infestations
Lower respiratory tract infection
|
0.00%
0/98
All participants who received at least one dose of study drug.
|
1.1%
1/93 • Number of events 1
All participants who received at least one dose of study drug.
|
|
Infections and infestations
Lung infection
|
0.00%
0/98
All participants who received at least one dose of study drug.
|
1.1%
1/93 • Number of events 1
All participants who received at least one dose of study drug.
|
|
Infections and infestations
Nasopharyngitis
|
10.2%
10/98 • Number of events 17
All participants who received at least one dose of study drug.
|
17.2%
16/93 • Number of events 18
All participants who received at least one dose of study drug.
|
|
Infections and infestations
Onychomycosis
|
0.00%
0/98
All participants who received at least one dose of study drug.
|
2.2%
2/93 • Number of events 2
All participants who received at least one dose of study drug.
|
|
Infections and infestations
Rhinitis
|
1.0%
1/98 • Number of events 1
All participants who received at least one dose of study drug.
|
1.1%
1/93 • Number of events 1
All participants who received at least one dose of study drug.
|
|
Infections and infestations
Sinusitis
|
3.1%
3/98 • Number of events 3
All participants who received at least one dose of study drug.
|
2.2%
2/93 • Number of events 2
All participants who received at least one dose of study drug.
|
|
Infections and infestations
Staphylococcal abscess
|
1.0%
1/98 • Number of events 1
All participants who received at least one dose of study drug.
|
0.00%
0/93
All participants who received at least one dose of study drug.
|
|
Infections and infestations
Tonsillitis
|
1.0%
1/98 • Number of events 1
All participants who received at least one dose of study drug.
|
1.1%
1/93 • Number of events 1
All participants who received at least one dose of study drug.
|
|
Infections and infestations
Tooth infection
|
0.00%
0/98
All participants who received at least one dose of study drug.
|
1.1%
1/93 • Number of events 1
All participants who received at least one dose of study drug.
|
|
Infections and infestations
Upper respiratory tract infection
|
3.1%
3/98 • Number of events 3
All participants who received at least one dose of study drug.
|
7.5%
7/93 • Number of events 7
All participants who received at least one dose of study drug.
|
|
Infections and infestations
Urinary tract infection
|
3.1%
3/98 • Number of events 3
All participants who received at least one dose of study drug.
|
8.6%
8/93 • Number of events 9
All participants who received at least one dose of study drug.
|
|
Infections and infestations
Viral infection
|
2.0%
2/98 • Number of events 2
All participants who received at least one dose of study drug.
|
2.2%
2/93 • Number of events 2
All participants who received at least one dose of study drug.
|
|
Infections and infestations
Vulvitis
|
0.00%
0/98
All participants who received at least one dose of study drug.
|
1.1%
1/93 • Number of events 1
All participants who received at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
Arthropod bite
|
0.00%
0/98
All participants who received at least one dose of study drug.
|
1.1%
1/93 • Number of events 1
All participants who received at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
Arthropod sting
|
1.0%
1/98 • Number of events 2
All participants who received at least one dose of study drug.
|
0.00%
0/93
All participants who received at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
Contusion
|
3.1%
3/98 • Number of events 3
All participants who received at least one dose of study drug.
|
4.3%
4/93 • Number of events 5
All participants who received at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
Eye contusion
|
1.0%
1/98 • Number of events 1
All participants who received at least one dose of study drug.
|
0.00%
0/93
All participants who received at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
Fall
|
3.1%
3/98 • Number of events 3
All participants who received at least one dose of study drug.
|
2.2%
2/93 • Number of events 2
All participants who received at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
Foot fracture
|
0.00%
0/98
All participants who received at least one dose of study drug.
|
1.1%
1/93 • Number of events 1
All participants who received at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
Joint dislocation
|
0.00%
0/98
All participants who received at least one dose of study drug.
|
2.2%
2/93 • Number of events 2
All participants who received at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
Laceration
|
1.0%
1/98 • Number of events 2
All participants who received at least one dose of study drug.
|
4.3%
4/93 • Number of events 5
All participants who received at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
0.00%
0/98
All participants who received at least one dose of study drug.
|
1.1%
1/93 • Number of events 1
All participants who received at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
Limb injury
|
0.00%
0/98
All participants who received at least one dose of study drug.
|
1.1%
1/93 • Number of events 1
All participants who received at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
Meniscus injury
|
2.0%
2/98 • Number of events 2
All participants who received at least one dose of study drug.
|
0.00%
0/93
All participants who received at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
Post procedural haematoma
|
1.0%
1/98 • Number of events 1
All participants who received at least one dose of study drug.
|
0.00%
0/93
All participants who received at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
Radius fracture
|
0.00%
0/98
All participants who received at least one dose of study drug.
|
1.1%
1/93 • Number of events 1
All participants who received at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
Scratch
|
0.00%
0/98
All participants who received at least one dose of study drug.
|
1.1%
1/93 • Number of events 1
All participants who received at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
Skin abrasion
|
0.00%
0/98
All participants who received at least one dose of study drug.
|
1.1%
1/93 • Number of events 1
All participants who received at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
Spinal compression fracture
|
0.00%
0/98
All participants who received at least one dose of study drug.
|
1.1%
1/93 • Number of events 1
All participants who received at least one dose of study drug.
|
|
Investigations
Arteriogram coronary
|
0.00%
0/98
All participants who received at least one dose of study drug.
|
1.1%
1/93 • Number of events 2
All participants who received at least one dose of study drug.
|
|
Investigations
Arthroscopy
|
2.0%
2/98 • Number of events 2
All participants who received at least one dose of study drug.
|
0.00%
0/93
All participants who received at least one dose of study drug.
|
|
Investigations
Aspiration pleural cavity
|
1.0%
1/98 • Number of events 1
All participants who received at least one dose of study drug.
|
0.00%
0/93
All participants who received at least one dose of study drug.
|
|
Investigations
Blood creatinine increased
|
0.00%
0/98
All participants who received at least one dose of study drug.
|
1.1%
1/93 • Number of events 1
All participants who received at least one dose of study drug.
|
|
Investigations
Blood glucose abnormal
|
0.00%
0/98
All participants who received at least one dose of study drug.
|
1.1%
1/93 • Number of events 1
All participants who received at least one dose of study drug.
|
|
Investigations
Blood glucose increased
|
2.0%
2/98 • Number of events 2
All participants who received at least one dose of study drug.
|
1.1%
1/93 • Number of events 1
All participants who received at least one dose of study drug.
|
|
Investigations
Blood pressure diastolic decreased
|
1.0%
1/98 • Number of events 1
All participants who received at least one dose of study drug.
|
0.00%
0/93
All participants who received at least one dose of study drug.
|
|
Investigations
Blood pressure diastolic increased
|
1.0%
1/98 • Number of events 1
All participants who received at least one dose of study drug.
|
1.1%
1/93 • Number of events 1
All participants who received at least one dose of study drug.
|
|
Investigations
Blood pressure systolic decreased
|
1.0%
1/98 • Number of events 1
All participants who received at least one dose of study drug.
|
0.00%
0/93
All participants who received at least one dose of study drug.
|
|
Investigations
Blood pressure systolic increased
|
1.0%
1/98 • Number of events 1
All participants who received at least one dose of study drug.
|
1.1%
1/93 • Number of events 1
All participants who received at least one dose of study drug.
|
|
Investigations
Blood urea increased
|
0.00%
0/98
All participants who received at least one dose of study drug.
|
1.1%
1/93 • Number of events 1
All participants who received at least one dose of study drug.
|
|
Investigations
Blood uric acid
|
1.0%
1/98 • Number of events 1
All participants who received at least one dose of study drug.
|
0.00%
0/93
All participants who received at least one dose of study drug.
|
|
Investigations
Cardiac imaging procedure
|
0.00%
0/98
All participants who received at least one dose of study drug.
|
1.1%
1/93 • Number of events 1
All participants who received at least one dose of study drug.
|
|
Investigations
Catheterisation cardiac
|
0.00%
0/98
All participants who received at least one dose of study drug.
|
1.1%
1/93 • Number of events 1
All participants who received at least one dose of study drug.
|
|
Investigations
Gamma-glutamyltransferase increased
|
0.00%
0/98
All participants who received at least one dose of study drug.
|
1.1%
1/93 • Number of events 1
All participants who received at least one dose of study drug.
|
|
Investigations
Glomerular filtration rate decreased
|
0.00%
0/98
All participants who received at least one dose of study drug.
|
1.1%
1/93 • Number of events 1
All participants who received at least one dose of study drug.
|
|
Investigations
Heart rate increased
|
1.0%
1/98 • Number of events 1
All participants who received at least one dose of study drug.
|
1.1%
1/93 • Number of events 1
All participants who received at least one dose of study drug.
|
|
Investigations
Prostatic specific antigen increased
|
1.0%
1/98 • Number of events 1
All participants who received at least one dose of study drug.
|
0.00%
0/93
All participants who received at least one dose of study drug.
|
|
Investigations
Urine analysis abnormal
|
0.00%
0/98
All participants who received at least one dose of study drug.
|
1.1%
1/93 • Number of events 1
All participants who received at least one dose of study drug.
|
|
Investigations
Weight decreased
|
5.1%
5/98 • Number of events 5
All participants who received at least one dose of study drug.
|
0.00%
0/93
All participants who received at least one dose of study drug.
|
|
Investigations
Weight increased
|
1.0%
1/98 • Number of events 1
All participants who received at least one dose of study drug.
|
0.00%
0/93
All participants who received at least one dose of study drug.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
2.0%
2/98 • Number of events 3
All participants who received at least one dose of study drug.
|
0.00%
0/93
All participants who received at least one dose of study drug.
|
|
Metabolism and nutrition disorders
Dehydration
|
2.0%
2/98 • Number of events 2
All participants who received at least one dose of study drug.
|
0.00%
0/93
All participants who received at least one dose of study drug.
|
|
Metabolism and nutrition disorders
Fructose intolerance
|
1.0%
1/98 • Number of events 1
All participants who received at least one dose of study drug.
|
0.00%
0/93
All participants who received at least one dose of study drug.
|
|
Metabolism and nutrition disorders
Gout
|
0.00%
0/98
All participants who received at least one dose of study drug.
|
3.2%
3/93 • Number of events 3
All participants who received at least one dose of study drug.
|
|
Metabolism and nutrition disorders
Hypercholesterolaemia
|
1.0%
1/98 • Number of events 1
All participants who received at least one dose of study drug.
|
0.00%
0/93
All participants who received at least one dose of study drug.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
4.1%
4/98 • Number of events 4
All participants who received at least one dose of study drug.
|
0.00%
0/93
All participants who received at least one dose of study drug.
|
|
Metabolism and nutrition disorders
Hyperlipidaemia
|
3.1%
3/98 • Number of events 3
All participants who received at least one dose of study drug.
|
1.1%
1/93 • Number of events 1
All participants who received at least one dose of study drug.
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
0.00%
0/98
All participants who received at least one dose of study drug.
|
1.1%
1/93 • Number of events 1
All participants who received at least one dose of study drug.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.00%
0/98
All participants who received at least one dose of study drug.
|
1.1%
1/93 • Number of events 8
All participants who received at least one dose of study drug.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/98
All participants who received at least one dose of study drug.
|
1.1%
1/93 • Number of events 1
All participants who received at least one dose of study drug.
|
|
Metabolism and nutrition disorders
Obesity
|
1.0%
1/98 • Number of events 2
All participants who received at least one dose of study drug.
|
0.00%
0/93
All participants who received at least one dose of study drug.
|
|
Metabolism and nutrition disorders
Vitamin d deficiency
|
9.2%
9/98 • Number of events 9
All participants who received at least one dose of study drug.
|
3.2%
3/93 • Number of events 3
All participants who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
4.1%
4/98 • Number of events 4
All participants who received at least one dose of study drug.
|
4.3%
4/93 • Number of events 4
All participants who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
9.2%
9/98 • Number of events 9
All participants who received at least one dose of study drug.
|
11.8%
11/93 • Number of events 11
All participants who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Bursitis
|
1.0%
1/98 • Number of events 1
All participants who received at least one dose of study drug.
|
0.00%
0/93
All participants who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Fibromyalgia
|
0.00%
0/98
All participants who received at least one dose of study drug.
|
1.1%
1/93 • Number of events 1
All participants who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
2.0%
2/98 • Number of events 3
All participants who received at least one dose of study drug.
|
0.00%
0/93
All participants who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
1.0%
1/98 • Number of events 1
All participants who received at least one dose of study drug.
|
0.00%
0/93
All participants who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
1.0%
1/98 • Number of events 1
All participants who received at least one dose of study drug.
|
0.00%
0/93
All participants who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
2.0%
2/98 • Number of events 2
All participants who received at least one dose of study drug.
|
1.1%
1/93 • Number of events 1
All participants who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/98
All participants who received at least one dose of study drug.
|
1.1%
1/93 • Number of events 1
All participants who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
1.0%
1/98 • Number of events 1
All participants who received at least one dose of study drug.
|
0.00%
0/93
All participants who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.00%
0/98
All participants who received at least one dose of study drug.
|
2.2%
2/93 • Number of events 2
All participants who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Osteopenia
|
1.0%
1/98 • Number of events 1
All participants who received at least one dose of study drug.
|
0.00%
0/93
All participants who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
2.0%
2/98 • Number of events 2
All participants who received at least one dose of study drug.
|
1.1%
1/93 • Number of events 1
All participants who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Sjogren's syndrome
|
1.0%
1/98 • Number of events 1
All participants who received at least one dose of study drug.
|
0.00%
0/93
All participants who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Spinal osteoarthritis
|
1.0%
1/98 • Number of events 1
All participants who received at least one dose of study drug.
|
0.00%
0/93
All participants who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Torticollis
|
1.0%
1/98 • Number of events 1
All participants who received at least one dose of study drug.
|
0.00%
0/93
All participants who received at least one dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Acrochordon
|
1.0%
1/98 • Number of events 1
All participants who received at least one dose of study drug.
|
0.00%
0/93
All participants who received at least one dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
0.00%
0/98
All participants who received at least one dose of study drug.
|
1.1%
1/93 • Number of events 1
All participants who received at least one dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Benign neoplasm of adrenal gland
|
0.00%
0/98
All participants who received at least one dose of study drug.
|
1.1%
1/93 • Number of events 1
All participants who received at least one dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon adenoma
|
1.0%
1/98 • Number of events 1
All participants who received at least one dose of study drug.
|
0.00%
0/93
All participants who received at least one dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Seborrhoeic keratosis
|
1.0%
1/98 • Number of events 1
All participants who received at least one dose of study drug.
|
0.00%
0/93
All participants who received at least one dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma
|
0.00%
0/98
All participants who received at least one dose of study drug.
|
1.1%
1/93 • Number of events 1
All participants who received at least one dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Thyroid neoplasm
|
0.00%
0/98
All participants who received at least one dose of study drug.
|
1.1%
1/93 • Number of events 1
All participants who received at least one dose of study drug.
|
|
Nervous system disorders
Amnesia
|
1.0%
1/98 • Number of events 1
All participants who received at least one dose of study drug.
|
0.00%
0/93
All participants who received at least one dose of study drug.
|
|
Nervous system disorders
Autonomic neuropathy
|
0.00%
0/98
All participants who received at least one dose of study drug.
|
1.1%
1/93 • Number of events 1
All participants who received at least one dose of study drug.
|
|
Nervous system disorders
Carotid artery stenosis
|
1.0%
1/98 • Number of events 1
All participants who received at least one dose of study drug.
|
0.00%
0/93
All participants who received at least one dose of study drug.
|
|
Nervous system disorders
Cerebral haemorrhage
|
1.0%
1/98 • Number of events 1
All participants who received at least one dose of study drug.
|
0.00%
0/93
All participants who received at least one dose of study drug.
|
|
Nervous system disorders
Dizziness
|
4.1%
4/98 • Number of events 4
All participants who received at least one dose of study drug.
|
1.1%
1/93 • Number of events 1
All participants who received at least one dose of study drug.
|
|
Nervous system disorders
Headache
|
7.1%
7/98 • Number of events 14
All participants who received at least one dose of study drug.
|
1.1%
1/93 • Number of events 1
All participants who received at least one dose of study drug.
|
|
Nervous system disorders
Paraesthesia
|
1.0%
1/98 • Number of events 1
All participants who received at least one dose of study drug.
|
0.00%
0/93
All participants who received at least one dose of study drug.
|
|
Nervous system disorders
Parkinson's disease
|
1.0%
1/98 • Number of events 1
All participants who received at least one dose of study drug.
|
0.00%
0/93
All participants who received at least one dose of study drug.
|
|
Nervous system disorders
Polyneuropathy
|
1.0%
1/98 • Number of events 1
All participants who received at least one dose of study drug.
|
1.1%
1/93 • Number of events 1
All participants who received at least one dose of study drug.
|
|
Nervous system disorders
Restless legs syndrome
|
1.0%
1/98 • Number of events 1
All participants who received at least one dose of study drug.
|
0.00%
0/93
All participants who received at least one dose of study drug.
|
|
Nervous system disorders
Sciatica
|
1.0%
1/98 • Number of events 1
All participants who received at least one dose of study drug.
|
1.1%
1/93 • Number of events 1
All participants who received at least one dose of study drug.
|
|
Nervous system disorders
Transient ischaemic attack
|
1.0%
1/98 • Number of events 1
All participants who received at least one dose of study drug.
|
0.00%
0/93
All participants who received at least one dose of study drug.
|
|
Nervous system disorders
Tremor
|
1.0%
1/98 • Number of events 1
All participants who received at least one dose of study drug.
|
0.00%
0/93
All participants who received at least one dose of study drug.
|
|
Nervous system disorders
Vascular encephalopathy
|
1.0%
1/98 • Number of events 1
All participants who received at least one dose of study drug.
|
0.00%
0/93
All participants who received at least one dose of study drug.
|
|
Psychiatric disorders
Anxiety
|
1.0%
1/98 • Number of events 1
All participants who received at least one dose of study drug.
|
0.00%
0/93
All participants who received at least one dose of study drug.
|
|
Psychiatric disorders
Confusional state
|
1.0%
1/98 • Number of events 1
All participants who received at least one dose of study drug.
|
0.00%
0/93
All participants who received at least one dose of study drug.
|
|
Psychiatric disorders
Depression
|
1.0%
1/98 • Number of events 1
All participants who received at least one dose of study drug.
|
0.00%
0/93
All participants who received at least one dose of study drug.
|
|
Psychiatric disorders
Food aversion
|
1.0%
1/98 • Number of events 1
All participants who received at least one dose of study drug.
|
0.00%
0/93
All participants who received at least one dose of study drug.
|
|
Psychiatric disorders
Insomnia
|
1.0%
1/98 • Number of events 1
All participants who received at least one dose of study drug.
|
0.00%
0/93
All participants who received at least one dose of study drug.
|
|
Psychiatric disorders
Sleep disorder
|
1.0%
1/98 • Number of events 1
All participants who received at least one dose of study drug.
|
0.00%
0/93
All participants who received at least one dose of study drug.
|
|
Renal and urinary disorders
Chronic kidney disease
|
2.0%
2/98 • Number of events 2
All participants who received at least one dose of study drug.
|
0.00%
0/93
All participants who received at least one dose of study drug.
|
|
Renal and urinary disorders
Hydronephrosis
|
0.00%
0/98
All participants who received at least one dose of study drug.
|
1.1%
1/93 • Number of events 1
All participants who received at least one dose of study drug.
|
|
Renal and urinary disorders
Hypertonic bladder
|
1.0%
1/98 • Number of events 1
All participants who received at least one dose of study drug.
|
0.00%
0/93
All participants who received at least one dose of study drug.
|
|
Renal and urinary disorders
Microalbuminuria
|
0.00%
0/98
All participants who received at least one dose of study drug.
|
2.2%
2/93 • Number of events 2
All participants who received at least one dose of study drug.
|
|
Renal and urinary disorders
Nephrolithiasis
|
1.0%
1/98 • Number of events 2
All participants who received at least one dose of study drug.
|
0.00%
0/93
All participants who received at least one dose of study drug.
|
|
Renal and urinary disorders
Nocturia
|
1.0%
1/98 • Number of events 1
All participants who received at least one dose of study drug.
|
0.00%
0/93
All participants who received at least one dose of study drug.
|
|
Renal and urinary disorders
Urinary incontinence
|
1.0%
1/98 • Number of events 1
All participants who received at least one dose of study drug.
|
0.00%
0/93
All participants who received at least one dose of study drug.
|
|
Reproductive system and breast disorders
Benign prostatic hyperplasia
|
1.0%
1/98 • Number of events 1
All participants who received at least one dose of study drug.
|
3.2%
3/93 • Number of events 3
All participants who received at least one dose of study drug.
|
|
Reproductive system and breast disorders
Breast mass
|
0.00%
0/98
All participants who received at least one dose of study drug.
|
1.1%
1/93 • Number of events 1
All participants who received at least one dose of study drug.
|
|
Reproductive system and breast disorders
Prostatitis
|
0.00%
0/98
All participants who received at least one dose of study drug.
|
1.1%
1/93 • Number of events 1
All participants who received at least one dose of study drug.
|
|
Reproductive system and breast disorders
Prostatomegaly
|
2.0%
2/98 • Number of events 2
All participants who received at least one dose of study drug.
|
0.00%
0/93
All participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
1.0%
1/98 • Number of events 1
All participants who received at least one dose of study drug.
|
1.1%
1/93 • Number of events 1
All participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
1.0%
1/98 • Number of events 1
All participants who received at least one dose of study drug.
|
1.1%
1/93 • Number of events 2
All participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
4.1%
4/98 • Number of events 4
All participants who received at least one dose of study drug.
|
3.2%
3/93 • Number of events 5
All participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Dry throat
|
1.0%
1/98 • Number of events 1
All participants who received at least one dose of study drug.
|
0.00%
0/93
All participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
1.0%
1/98 • Number of events 1
All participants who received at least one dose of study drug.
|
0.00%
0/93
All participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
3.1%
3/98 • Number of events 3
All participants who received at least one dose of study drug.
|
0.00%
0/93
All participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
1.0%
1/98 • Number of events 1
All participants who received at least one dose of study drug.
|
0.00%
0/93
All participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Emphysema
|
1.0%
1/98 • Number of events 1
All participants who received at least one dose of study drug.
|
0.00%
0/93
All participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/98
All participants who received at least one dose of study drug.
|
1.1%
1/93 • Number of events 1
All participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/98
All participants who received at least one dose of study drug.
|
1.1%
1/93 • Number of events 1
All participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/98
All participants who received at least one dose of study drug.
|
1.1%
1/93 • Number of events 1
All participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory tract congestion
|
1.0%
1/98 • Number of events 1
All participants who received at least one dose of study drug.
|
0.00%
0/93
All participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
0.00%
0/98
All participants who received at least one dose of study drug.
|
1.1%
1/93 • Number of events 1
All participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Sleep apnoea syndrome
|
1.0%
1/98 • Number of events 1
All participants who received at least one dose of study drug.
|
0.00%
0/93
All participants who received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
0.00%
0/98
All participants who received at least one dose of study drug.
|
2.2%
2/93 • Number of events 2
All participants who received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Eczema
|
0.00%
0/98
All participants who received at least one dose of study drug.
|
1.1%
1/93 • Number of events 1
All participants who received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Nail bed inflammation
|
1.0%
1/98 • Number of events 1
All participants who received at least one dose of study drug.
|
0.00%
0/93
All participants who received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Pruritus generalised
|
0.00%
0/98
All participants who received at least one dose of study drug.
|
1.1%
1/93 • Number of events 1
All participants who received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Urticaria contact
|
1.0%
1/98 • Number of events 1
All participants who received at least one dose of study drug.
|
0.00%
0/93
All participants who received at least one dose of study drug.
|
|
Surgical and medical procedures
Cataract operation
|
3.1%
3/98 • Number of events 3
All participants who received at least one dose of study drug.
|
2.2%
2/93 • Number of events 4
All participants who received at least one dose of study drug.
|
|
Surgical and medical procedures
Coronary angioplasty
|
0.00%
0/98
All participants who received at least one dose of study drug.
|
1.1%
1/93 • Number of events 1
All participants who received at least one dose of study drug.
|
|
Surgical and medical procedures
Inguinal hernia repair
|
1.0%
1/98 • Number of events 1
All participants who received at least one dose of study drug.
|
0.00%
0/93
All participants who received at least one dose of study drug.
|
|
Surgical and medical procedures
Large intestinal polypectomy
|
1.0%
1/98 • Number of events 1
All participants who received at least one dose of study drug.
|
0.00%
0/93
All participants who received at least one dose of study drug.
|
|
Surgical and medical procedures
Lens extraction
|
1.0%
1/98 • Number of events 1
All participants who received at least one dose of study drug.
|
0.00%
0/93
All participants who received at least one dose of study drug.
|
|
Surgical and medical procedures
Ptosis repair
|
0.00%
0/98
All participants who received at least one dose of study drug.
|
1.1%
1/93 • Number of events 1
All participants who received at least one dose of study drug.
|
|
Surgical and medical procedures
Tendon sheath lesion excision
|
1.0%
1/98 • Number of events 1
All participants who received at least one dose of study drug.
|
0.00%
0/93
All participants who received at least one dose of study drug.
|
|
Surgical and medical procedures
Tooth extraction
|
0.00%
0/98
All participants who received at least one dose of study drug.
|
1.1%
1/93 • Number of events 1
All participants who received at least one dose of study drug.
|
|
Vascular disorders
Arteriosclerosis
|
1.0%
1/98 • Number of events 1
All participants who received at least one dose of study drug.
|
1.1%
1/93 • Number of events 1
All participants who received at least one dose of study drug.
|
|
Vascular disorders
Essential hypertension
|
1.0%
1/98 • Number of events 1
All participants who received at least one dose of study drug.
|
1.1%
1/93 • Number of events 3
All participants who received at least one dose of study drug.
|
|
Vascular disorders
Hypertension
|
5.1%
5/98 • Number of events 5
All participants who received at least one dose of study drug.
|
4.3%
4/93 • Number of events 5
All participants who received at least one dose of study drug.
|
|
Vascular disorders
Hypotension
|
1.0%
1/98 • Number of events 1
All participants who received at least one dose of study drug.
|
0.00%
0/93
All participants who received at least one dose of study drug.
|
|
Vascular disorders
Peripheral vascular disorder
|
1.0%
1/98 • Number of events 1
All participants who received at least one dose of study drug.
|
0.00%
0/93
All participants who received at least one dose of study drug.
|
|
Vascular disorders
Peripheral venous disease
|
0.00%
0/98
All participants who received at least one dose of study drug.
|
2.2%
2/93 • Number of events 2
All participants who received at least one dose of study drug.
|
|
Vascular disorders
Subclavian artery stenosis
|
1.0%
1/98 • Number of events 1
All participants who received at least one dose of study drug.
|
0.00%
0/93
All participants who received at least one dose of study drug.
|
Additional Information
Chief Medical Officer
Eli Lilly and Company
Phone: 800-545-5979
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place