Trial Outcomes & Findings for Efficacy Study of Pioglitazone Compared to Glimepiride on Coronary Atherosclerotic Disease Progression in Subjects With Type 2 Diabetes Mellitus (NCT NCT00225277)
NCT ID: NCT00225277
Last Updated: 2012-02-28
Results Overview
The nominal change from baseline in percent atheroma volume for all slices of anatomically comparable segments of the target coronary artery. Assessment completed at the Week 72 visit or Final Visit if treatment was prematurely discontinued.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
547 participants
Primary outcome timeframe
Baseline and Final Visit (up to 72 weeks)
Results posted on
2012-02-28
Participant Flow
Subjects were enrolled at 97 sites in the United States, Canada, Argentina and Chile from 21 July 2003 to 18 October 2007.
The participant flow results below do not include 4 subjects who were randomized but did not receive drug. Subjects participating in this study were enrolled in Pioglitazone or Glimepiride once daily (QD) treatment group.
Participant milestones
| Measure |
Pioglitazone QD
Subjects received up to 45 mg Pioglitazone (dose optimized for glucose control) for up to 72 weeks.
|
Glimepiride QD
Subjects received up to 4 mg Glimepiride (dose optimized for glucose control) for up to 72 weeks.
|
|---|---|---|
|
Overall Study
STARTED
|
274
|
273
|
|
Overall Study
COMPLETED
|
177
|
178
|
|
Overall Study
NOT COMPLETED
|
97
|
95
|
Reasons for withdrawal
| Measure |
Pioglitazone QD
Subjects received up to 45 mg Pioglitazone (dose optimized for glucose control) for up to 72 weeks.
|
Glimepiride QD
Subjects received up to 4 mg Glimepiride (dose optimized for glucose control) for up to 72 weeks.
|
|---|---|---|
|
Overall Study
Adverse Event
|
30
|
34
|
|
Overall Study
Lack of Efficacy
|
4
|
1
|
|
Overall Study
Lost to Follow-up
|
4
|
6
|
|
Overall Study
Physician Decision
|
6
|
8
|
|
Overall Study
Protocol Violation
|
6
|
3
|
|
Overall Study
Withdrawal by Subject
|
40
|
34
|
|
Overall Study
Other
|
7
|
9
|
Baseline Characteristics
Efficacy Study of Pioglitazone Compared to Glimepiride on Coronary Atherosclerotic Disease Progression in Subjects With Type 2 Diabetes Mellitus
Baseline characteristics by cohort
| Measure |
Pioglitazone QD
n=270 Participants
Subjects received up to 45 mg Pioglitazone (dose optimized for glucose control) for up to 72 weeks.
|
Glimepiride QD
n=273 Participants
Subjects received up to 4 mg Glimepiride (dose optimized for glucose control) for up to 72 weeks.
|
Total
n=543 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
|
189 Participants
n=5 Participants
|
193 Participants
n=7 Participants
|
382 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
81 Participants
n=5 Participants
|
80 Participants
n=7 Participants
|
161 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
84 Participants
n=5 Participants
|
93 Participants
n=7 Participants
|
177 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
186 Participants
n=5 Participants
|
180 Participants
n=7 Participants
|
366 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
63 Participants
n=5 Participants
|
71 Participants
n=7 Participants
|
134 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
207 Participants
n=5 Participants
|
202 Participants
n=7 Participants
|
409 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Native American
|
3 participants
n=5 Participants
|
10 participants
n=7 Participants
|
13 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
12 participants
n=5 Participants
|
16 participants
n=7 Participants
|
28 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
30 participants
n=5 Participants
|
27 participants
n=7 Participants
|
57 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
225 participants
n=5 Participants
|
220 participants
n=7 Participants
|
445 participants
n=5 Participants
|
|
Family History of Coronary Artery Disease
Male Relative History
|
91 Participants
n=5 Participants
|
77 Participants
n=7 Participants
|
168 Participants
n=5 Participants
|
|
Family History of Coronary Artery Disease
Female Relative History
|
60 Participants
n=5 Participants
|
59 Participants
n=7 Participants
|
119 Participants
n=5 Participants
|
|
Family History of Coronary Artery Disease
No Family History
|
119 Participants
n=5 Participants
|
137 Participants
n=7 Participants
|
256 Participants
n=5 Participants
|
|
Body Mass Index
|
32.08 Kg/m squared
FULL_RANGE 5.264 • n=5 Participants
|
32.03 Kg/m squared
FULL_RANGE 5.233 • n=7 Participants
|
32.05 Kg/m squared
FULL_RANGE 0 • n=5 Participants
|
|
Duration of Coronary Artery Disease
|
40.4 Months
FULL_RANGE 65.10 • n=5 Participants
|
40.5 Months
FULL_RANGE 67.20 • n=7 Participants
|
40.4 Months
FULL_RANGE 0 • n=5 Participants
|
|
Duration of Diabetes Mellitus
|
98.0 Months
FULL_RANGE 100.25 • n=5 Participants
|
96.3 Months
FULL_RANGE 89.51 • n=7 Participants
|
97.1 Months
FULL_RANGE 0 • n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline and Final Visit (up to 72 weeks)Population: N at baseline included subjects who had both a baseline value and a final visit value. Baseline value is the last observation before first dose of study medication.
The nominal change from baseline in percent atheroma volume for all slices of anatomically comparable segments of the target coronary artery. Assessment completed at the Week 72 visit or Final Visit if treatment was prematurely discontinued.
Outcome measures
| Measure |
Pioglitazone QD
n=179 Participants
Subjects received up to 45 mg Pioglitazone (dose optimized for glucose control) for up to 72 weeks.
|
Glimepiride QD
n=181 Participants
Subjects received up to 4 mg Glimepiride (dose optimized for glucose control) for up to 72 weeks.
|
|---|---|---|
|
Nominal Change From Baseline in Percent Atheroma Volume
Baseline
|
40.592 Percent volume
Standard Error 0.6925
|
40.016 Percent volume
Standard Error 0.6663
|
|
Nominal Change From Baseline in Percent Atheroma Volume
Nominal Change from Baseline
|
-0.161 Percent volume
Standard Error 0.2095
|
0.725 Percent volume
Standard Error 0.2017
|
SECONDARY outcome
Timeframe: Baseline and Final Visit (up to 72 weeks)Population: N at baseline included subjects who had both a baseline value and a final visit value. Baseline value is the last observation before first dose of study medication.
The nominal change in normalized total atheroma volume as measured by the average of plaque areas for all slices of anatomically comparable segments of the target coronary artery multiplied by the mean number of matched slices in the population. Assessment completed at the Week 72 visit or Final Visit if treatment was prematurely discontinued.
Outcome measures
| Measure |
Pioglitazone QD
n=179 Participants
Subjects received up to 45 mg Pioglitazone (dose optimized for glucose control) for up to 72 weeks.
|
Glimepiride QD
n=181 Participants
Subjects received up to 4 mg Glimepiride (dose optimized for glucose control) for up to 72 weeks.
|
|---|---|---|
|
Nominal Change From Baseline in Normalized Total Atheroma Volume
Baseline
|
206.579 Percent volume
Standard Error 7.2778
|
217.619 Percent volume
Standard Error 7.0030
|
|
Nominal Change From Baseline in Normalized Total Atheroma Volume
Nominal Change from Baseline
|
-5.528 Percent volume
Standard Error 1.5989
|
-1.480 Percent volume
Standard Error 1.5370
|
SECONDARY outcome
Timeframe: Up to 72 weeksPopulation: Kaplan-Meier methodology was used to estimate time to event for each composite endpoint. P-value comparing survival function between groups was based on log-rank test. Time to first occurrence of cardiovascular events/hospitalizations had non-estimable medians due to very low event rates. Number of participants experiencing events are presented.
Due to low event rates, number of subjects experiencing any of the composite endpoint A cardiovascular events is being reported instead of time to first occurrence. Endpoint A conditions listed in Limitations and Caveats section.
Outcome measures
| Measure |
Pioglitazone QD
n=270 Participants
Subjects received up to 45 mg Pioglitazone (dose optimized for glucose control) for up to 72 weeks.
|
Glimepiride QD
n=273 Participants
Subjects received up to 4 mg Glimepiride (dose optimized for glucose control) for up to 72 weeks.
|
|---|---|---|
|
Number of Subjects Experiencing Any of the Composite Endpoint A Cardiovascular Events
|
5 Participants
Interval 0.0 to 0.0
|
6 Participants
Interval 0.0 to 0.0
|
SECONDARY outcome
Timeframe: Up to 72 weeksPopulation: Kaplan-Meier methodology was used to estimate time to event for each composite endpoint. P-value comparing survival function between groups was based on log-rank test. Time to first occurrence of cardiovascular events/hospitalizations had non-estimable medians due to very low event rates. Number of participants experiencing events are presented.
Due to low event rates, number of subjects experiencing any of the composite endpoint B cardiovascular events is being reported instead of time to first occurrence. Endpoint B conditions listed in Limitations and Caveats section.
Outcome measures
| Measure |
Pioglitazone QD
n=270 Participants
Subjects received up to 45 mg Pioglitazone (dose optimized for glucose control) for up to 72 weeks.
|
Glimepiride QD
n=273 Participants
Subjects received up to 4 mg Glimepiride (dose optimized for glucose control) for up to 72 weeks.
|
|---|---|---|
|
Number of Subjects Experiencing Any of the Composite Endpoint B Cardiovascular Events
|
40 Participants
Interval 0.0 to 0.0
|
41 Participants
Interval 0.0 to 0.0
|
SECONDARY outcome
Timeframe: Up to 72 weeksPopulation: Kaplan-Meier methodology was used to estimate time to event for each composite endpoint. P-value comparing survival function between groups was based on log-rank test. Time to first occurrence of cardiovascular events/hospitalizations had non-estimable medians due to very low event rates. Number of participants experiencing events are presented.
Due to low event rates, number of subjects experiencing any of the composite endpoint C cardiovascular events is being reported instead of time to first occurrence. Endpoint C conditions listed in Limitations and Caveats section.
Outcome measures
| Measure |
Pioglitazone QD
n=270 Participants
Subjects received up to 45 mg Pioglitazone (dose optimized for glucose control) for up to 72 weeks.
|
Glimepiride QD
n=273 Participants
Subjects received up to 4 mg Glimepiride (dose optimized for glucose control) for up to 72 weeks.
|
|---|---|---|
|
Number of Subjects Experiencing Any of the Composite Endpoint C Cardiovascular Events
|
11 participants
Interval 0.0 to 0.0
|
13 participants
Interval 0.0 to 0.0
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Up to 72 weeksPopulation: Safety Population
The incidence of cardiovascular events and composite endpoints occurring within 30 days of last dose as adjudicated by the Clinical Endpoint Committee. Abbreviations: PCI: Percutaneous Coronary Intervention; CABG: Coronary Artery Bypass Graft; CHF: Congestive Heart Failure.
Outcome measures
| Measure |
Pioglitazone QD
n=270 Participants
Subjects received up to 45 mg Pioglitazone (dose optimized for glucose control) for up to 72 weeks.
|
Glimepiride QD
n=273 Participants
Subjects received up to 4 mg Glimepiride (dose optimized for glucose control) for up to 72 weeks.
|
|---|---|---|
|
Number of Cardiovascular Events as Adjudicated by the Clinical Endpoint Committee
Nonfatal Myocardial Infarction
|
2 Number of Events
|
4 Number of Events
|
|
Number of Cardiovascular Events as Adjudicated by the Clinical Endpoint Committee
Nonfatal Stroke
|
0 Number of Events
|
1 Number of Events
|
|
Number of Cardiovascular Events as Adjudicated by the Clinical Endpoint Committee
Coronary Revascularization: PCI/CABG counted once
|
29 Number of Events
|
30 Number of Events
|
|
Number of Cardiovascular Events as Adjudicated by the Clinical Endpoint Committee
Coronary Revascularization: PCI
|
25 Number of Events
|
28 Number of Events
|
|
Number of Cardiovascular Events as Adjudicated by the Clinical Endpoint Committee
Coronary Revascularization: CABG
|
5 Number of Events
|
2 Number of Events
|
|
Number of Cardiovascular Events as Adjudicated by the Clinical Endpoint Committee
Carotid Endarterectomy/Stenting
|
1 Number of Events
|
0 Number of Events
|
|
Number of Cardiovascular Events as Adjudicated by the Clinical Endpoint Committee
Hospitalization for Unstable Angina
|
4 Number of Events
|
2 Number of Events
|
|
Number of Cardiovascular Events as Adjudicated by the Clinical Endpoint Committee
CHF Hospitalization: new/exacerbated counted once
|
4 Number of Events
|
5 Number of Events
|
|
Number of Cardiovascular Events as Adjudicated by the Clinical Endpoint Committee
Hospitalization for New CHF
|
4 Number of Events
|
2 Number of Events
|
|
Number of Cardiovascular Events as Adjudicated by the Clinical Endpoint Committee
Hospitalization for Exacerbated CHF
|
0 Number of Events
|
3 Number of Events
|
|
Number of Cardiovascular Events as Adjudicated by the Clinical Endpoint Committee
Noncardiovascular Mortality
|
0 Number of Events
|
1 Number of Events
|
|
Number of Cardiovascular Events as Adjudicated by the Clinical Endpoint Committee
Cardiovascular Mortality
|
3 Number of Events
|
1 Number of Events
|
|
Number of Cardiovascular Events as Adjudicated by the Clinical Endpoint Committee
Composite Endpoint A
|
5 Number of Events
|
6 Number of Events
|
|
Number of Cardiovascular Events as Adjudicated by the Clinical Endpoint Committee
Composite Endpoint B
|
40 Number of Events
|
41 Number of Events
|
|
Number of Cardiovascular Events as Adjudicated by the Clinical Endpoint Committee
Composite Endpoint C
|
11 Number of Events
|
13 Number of Events
|
Adverse Events
Pioglitazone QD
Serious events: 76 serious events
Other events: 226 other events
Deaths: 0 deaths
Glimepiride QD
Serious events: 77 serious events
Other events: 225 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Pioglitazone QD
Subjects received up to 45 mg Pioglitazone (dose optimized for glucose control) for up to 72 weeks.
|
Glimepiride QD
Subjects received up to 4 mg Glimepiride (dose optimized for glucose control) for up to 72 weeks.
|
|---|---|---|
|
Gastrointestinal disorders
Abdominal Hernia
|
0.00%
0/270
|
0.37%
1/273
|
|
Gastrointestinal disorders
Abdominal Pain
|
0.37%
1/270
|
0.37%
1/273
|
|
Gastrointestinal disorders
Abdominal Strangulated Hernia
|
0.37%
1/270
|
0.00%
0/273
|
|
Injury, poisoning and procedural complications
Accident at Work
|
0.37%
1/270
|
0.00%
0/273
|
|
Cardiac disorders
Acute Coronary Syndrome
|
0.00%
0/270
|
1.1%
3/273
|
|
Cardiac disorders
Acute Myocardial Infarction
|
0.74%
2/270
|
0.37%
1/273
|
|
Respiratory, thoracic and mediastinal disorders
Acute Pulmonary Oedema
|
0.37%
1/270
|
0.00%
0/273
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma
|
0.00%
0/270
|
0.37%
1/273
|
|
Blood and lymphatic system disorders
Anaemia
|
0.37%
1/270
|
0.00%
0/273
|
|
Gastrointestinal disorders
Anal Haemorrhage
|
0.00%
0/270
|
0.37%
1/273
|
|
Cardiac disorders
Angina Pectoris
|
3.0%
8/270
|
1.5%
4/273
|
|
Cardiac disorders
Angina Unstable
|
1.5%
4/270
|
1.1%
3/273
|
|
Vascular disorders
Aortic Stenosis
|
0.37%
1/270
|
0.00%
0/273
|
|
Gastrointestinal disorders
Appendiceal Mucocoele
|
0.00%
0/270
|
0.37%
1/273
|
|
Gastrointestinal disorders
Appendicitis Perforated
|
0.37%
1/270
|
0.00%
0/273
|
|
Respiratory, thoracic and mediastinal disorders
Astma
|
0.00%
0/270
|
0.73%
2/273
|
|
Cardiac disorders
Atrial Fibrillation
|
0.74%
2/270
|
0.37%
1/273
|
|
Cardiac disorders
Atrioventricular Block Complete
|
0.00%
0/270
|
0.37%
1/273
|
|
Reproductive system and breast disorders
Benign Prostatic Hyperplasia
|
0.00%
0/270
|
0.73%
2/273
|
|
Hepatobiliary disorders
Biliary Colic
|
0.00%
0/270
|
0.37%
1/273
|
|
Psychiatric disorders
Bipolar II Disorder
|
0.00%
0/270
|
0.37%
1/273
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder Cancer
|
0.00%
0/270
|
0.37%
1/273
|
|
Investigations
Blood Creatinine Increased
|
0.00%
0/270
|
0.37%
1/273
|
|
Infections and infestations
Bronchitis
|
0.37%
1/270
|
0.73%
2/273
|
|
Infections and infestations
Bronchitis Acute
|
0.37%
1/270
|
0.00%
0/273
|
|
Cardiac disorders
Cardiac Arrest
|
0.00%
0/270
|
0.37%
1/273
|
|
Cardiac disorders
Cardiac Discomfort
|
0.00%
0/270
|
0.37%
1/273
|
|
Cardiac disorders
Cardiac Failure Congestive
|
1.1%
3/270
|
1.8%
5/273
|
|
Cardiac disorders
Cardiac Tamponade
|
0.00%
0/270
|
0.37%
1/273
|
|
Nervous system disorders
Carotid Artery Stenosis
|
0.37%
1/270
|
0.00%
0/273
|
|
General disorders
Catheter Site Phlebitis
|
0.37%
1/270
|
0.00%
0/273
|
|
Infections and infestations
Cellulitis
|
0.37%
1/270
|
0.73%
2/273
|
|
Injury, poisoning and procedural complications
Cerebrospinal Fluid Leakage
|
0.37%
1/270
|
0.00%
0/273
|
|
Nervous system disorders
Cerebrovascular Accident
|
0.00%
0/270
|
0.37%
1/273
|
|
Nervous system disorders
Cerebrovascular Stenosis
|
0.00%
0/270
|
0.37%
1/273
|
|
Musculoskeletal and connective tissue disorders
Cervical Spinal Stenosis
|
0.37%
1/270
|
0.00%
0/273
|
|
Hepatobiliary disorders
Chloelithiasis
|
0.37%
1/270
|
0.00%
0/273
|
|
Hepatobiliary disorders
Cholecystitis
|
0.37%
1/270
|
0.00%
0/273
|
|
Hepatobiliary disorders
Cholecystitis Acute
|
0.00%
0/270
|
0.37%
1/273
|
|
Respiratory, thoracic and mediastinal disorders
Chronic Obstructive Airways Disease Exacerbated
|
0.00%
0/270
|
1.1%
3/273
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/270
|
0.37%
1/273
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/270
|
0.37%
1/273
|
|
Surgical and medical procedures
Coronary Arterial Stent Insertion
|
0.37%
1/270
|
0.00%
0/273
|
|
Cardiac disorders
Coronary Artery Atherosclerosis
|
0.37%
1/270
|
0.37%
1/273
|
|
Cardiac disorders
Coronary Artery Disease
|
7.4%
20/270
|
5.9%
16/273
|
|
Cardiac disorders
Coronary Artery Insufficiency
|
0.00%
0/270
|
0.37%
1/273
|
|
Cardiac disorders
Coronary Artery Occlusion
|
0.00%
0/270
|
0.37%
1/273
|
|
Cardiac disorders
Coronary Artery Stenosis
|
1.9%
5/270
|
1.8%
5/273
|
|
Musculoskeletal and connective tissue disorders
Costochondritis
|
0.00%
0/270
|
0.37%
1/273
|
|
Metabolism and nutrition disorders
Dehydration
|
0.37%
1/270
|
0.00%
0/273
|
|
Injury, poisoning and procedural complications
Device Malfunction
|
0.37%
1/270
|
0.00%
0/273
|
|
Metabolism and nutrition disorders
Diabetes Mellitus Inadequate Control
|
0.00%
0/270
|
0.37%
1/273
|
|
Metabolism and nutrition disorders
Diabetic Foot
|
0.37%
1/270
|
0.00%
0/273
|
|
Infections and infestations
Diabetic Foot Infection
|
0.00%
0/270
|
0.37%
1/273
|
|
Infections and infestations
Diverticulitis
|
0.37%
1/270
|
0.73%
2/273
|
|
Nervous system disorders
Dizziness
|
0.00%
0/270
|
0.37%
1/273
|
|
Gastrointestinal disorders
Dysphagia
|
0.37%
1/270
|
0.00%
0/273
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/270
|
0.37%
1/273
|
|
Musculoskeletal and connective tissue disorders
Flank Pain
|
0.37%
1/270
|
0.00%
0/273
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/270
|
0.37%
1/273
|
|
Gastrointestinal disorders
Gastrointestinal Haemorrhage
|
0.00%
0/270
|
0.37%
1/273
|
|
Gastrointestinal disorders
Gastrooesophageal Reflux Disease
|
0.37%
1/270
|
0.00%
0/273
|
|
Musculoskeletal and connective tissue disorders
Haemarthrosis
|
0.00%
0/270
|
0.37%
1/273
|
|
Hepatobiliary disorders
Hepatic Function Abnormal
|
0.00%
0/270
|
0.37%
1/273
|
|
Hepatobiliary disorders
Hepatitis
|
0.00%
0/270
|
0.37%
1/273
|
|
Investigations
Hepatitis C Antibody Positive
|
0.37%
1/270
|
0.00%
0/273
|
|
Endocrine disorders
Hyperaldosteronism
|
0.37%
1/270
|
0.00%
0/273
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.37%
1/270
|
0.00%
0/273
|
|
Endocrine disorders
Hyperthyroidism
|
0.37%
1/270
|
0.00%
0/273
|
|
Metabolism and nutrition disorders
Hypoclycaemia
|
0.00%
0/270
|
1.1%
3/273
|
|
Vascular disorders
Hypotension
|
0.37%
1/270
|
0.00%
0/273
|
|
Infections and infestations
Implant Site Infection
|
0.37%
1/270
|
0.00%
0/273
|
|
Injury, poisoning and procedural complications
Incisional Hernia
|
0.00%
0/270
|
0.37%
1/273
|
|
Vascular disorders
Intermittent Claudication
|
0.00%
0/270
|
0.37%
1/273
|
|
Respiratory, thoracic and mediastinal disorders
Interstitial Lung Disease
|
0.00%
0/270
|
0.37%
1/273
|
|
Injury, poisoning and procedural complications
Ligament Injury
|
0.00%
0/270
|
0.37%
1/273
|
|
Infections and infestations
Lobar Pneumonia
|
0.37%
1/270
|
0.00%
0/273
|
|
Musculoskeletal and connective tissue disorders
Localized Osteoarthritis
|
0.37%
1/270
|
0.37%
1/273
|
|
Psychiatric disorders
Mental Disorder
|
0.37%
1/270
|
0.00%
0/273
|
|
Psychiatric disorders
Mental Status Changes
|
0.00%
0/270
|
0.37%
1/273
|
|
Cardiac disorders
Myocardial Infarction
|
1.1%
3/270
|
0.73%
2/273
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Nasal Sinus Cancer
|
0.37%
1/270
|
0.00%
0/273
|
|
General disorders
Non-Cardia Chest Pain
|
5.6%
15/270
|
1.8%
5/273
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Non-Small Cell Lung Cancer
|
0.37%
1/270
|
0.00%
0/273
|
|
Nervous system disorders
Nystagmus
|
0.37%
1/270
|
0.00%
0/273
|
|
Metabolism and nutrition disorders
Obesity
|
0.37%
1/270
|
0.00%
0/273
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Oesophageal Carcinoma
|
0.00%
0/270
|
0.37%
1/273
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.74%
2/270
|
0.00%
0/273
|
|
Vascular disorders
Peripheral Vascular Disorder
|
0.37%
1/270
|
0.37%
1/273
|
|
Respiratory, thoracic and mediastinal disorders
Pleural Effusion
|
0.37%
1/270
|
0.00%
0/273
|
|
Infections and infestations
Pneumonia
|
0.00%
0/270
|
1.8%
5/273
|
|
Infections and infestations
Pneumonia Primary Atypical
|
0.00%
0/270
|
0.37%
1/273
|
|
Injury, poisoning and procedural complications
Post Procedural Haematoma
|
0.37%
1/270
|
0.00%
0/273
|
|
Injury, poisoning and procedural complications
Post Procedural Haemorrhage
|
0.37%
1/270
|
0.37%
1/273
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Oedema
|
0.37%
1/270
|
0.00%
0/273
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal Cell Carcinoma Stage Unspecified
|
0.37%
1/270
|
0.00%
0/273
|
|
Renal and urinary disorders
Renal Failure
|
0.00%
0/270
|
0.37%
1/273
|
|
Injury, poisoning and procedural complications
Road Traffic Accident
|
0.00%
0/270
|
0.37%
1/273
|
|
Gastrointestinal disorders
Ruptured Diverticulum of Colon
|
0.00%
0/270
|
0.37%
1/273
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Small Cell Carcinoma
|
0.00%
0/270
|
0.37%
1/273
|
|
Musculoskeletal and connective tissue disorders
Spinal Column Stenosis
|
0.37%
1/270
|
0.00%
0/273
|
|
Nervous system disorders
Syncope
|
0.37%
1/270
|
0.37%
1/273
|
|
Metabolism and nutrition disorders
Synovial Cyst
|
0.00%
0/270
|
0.37%
1/273
|
|
Injury, poisoning and procedural complications
Therapeutic Agent Toxicity
|
0.37%
1/270
|
0.00%
0/273
|
|
Infections and infestations
Upper Respiratory Tract Infection
|
0.00%
0/270
|
0.37%
1/273
|
|
Infections and infestations
Urinary Tract Infection
|
0.37%
1/270
|
0.37%
1/273
|
|
Cardiac disorders
Ventricular Fibrillation
|
0.37%
1/270
|
0.00%
0/273
|
|
Cardiac disorders
Ventricular Tachycardia
|
0.37%
1/270
|
0.00%
0/273
|
|
Ear and labyrinth disorders
Vertigo
|
0.37%
1/270
|
0.00%
0/273
|
|
Infections and infestations
Wound Infeciton
|
0.37%
1/270
|
0.00%
0/273
|
Other adverse events
| Measure |
Pioglitazone QD
Subjects received up to 45 mg Pioglitazone (dose optimized for glucose control) for up to 72 weeks.
|
Glimepiride QD
Subjects received up to 4 mg Glimepiride (dose optimized for glucose control) for up to 72 weeks.
|
|---|---|---|
|
Cardiac disorders
Angina Pectoris
|
4.4%
12/270
|
11.0%
30/273
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
6.3%
17/270
|
5.5%
15/273
|
|
Gastrointestinal disorders
Diarrhoea
|
4.1%
11/270
|
5.1%
14/273
|
|
Nervous system disorders
Dizziness
|
9.6%
26/270
|
7.3%
20/273
|
|
General disorders
Fatigue
|
6.3%
17/270
|
5.1%
14/273
|
|
Nervous system disorders
Headache
|
7.0%
19/270
|
6.2%
17/273
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
5.6%
15/270
|
5.9%
16/273
|
|
Vascular disorders
Hypertension
|
4.8%
13/270
|
8.8%
24/273
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
15.2%
41/270
|
36.6%
100/273
|
|
Infections and infestations
Influenza
|
5.2%
14/270
|
3.3%
9/273
|
|
Infections and infestations
Nasopharyngitis
|
4.8%
13/270
|
8.1%
22/273
|
|
Gastrointestinal disorders
Nausea
|
5.9%
16/270
|
6.6%
18/273
|
|
General disorders
Non-Cardiac Chest Pain
|
7.8%
21/270
|
9.9%
27/273
|
|
General disorders
Oedema Peripheral
|
17.8%
48/270
|
11.0%
30/273
|
|
Musculoskeletal and connective tissue disorders
Pain In Extremity
|
5.6%
15/270
|
7.0%
19/273
|
|
Infections and infestations
Upper Respiratory Tract Infection
|
5.6%
15/270
|
5.9%
16/273
|
|
Infections and infestations
Urinary Tract Infection
|
6.3%
17/270
|
7.0%
19/273
|
|
Investigations
Weight Increased
|
10.4%
28/270
|
5.5%
15/273
|
Additional Information
Sr. VP Clinical Sciences
Takeda Global Research and Development Center Inc.
Phone: 800-778-2860
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee The sponsor can review results communications prior to public release and can embargo trial results communications up to 150 days to permit actions necessary to preserve sponsor's intellectual property. Sponsor can request changes to the results communication only for the purpose of removing non study related information that is proprietary and confidential to sponsor. Sponsor can require delay of a results communication until the study has been completed at all participating sites.
- Publication restrictions are in place
Restriction type: OTHER