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Efficacy Study of Pioglitazone Compared to Glimepiride on Coronary Atherosclerotic Disease Progression in Subjects With Type 2 Diabetes Mellitus (PERISCOPE)
This study has been completed.
Study NCT00225277   Information provided by Takeda Global Research & Development Center, Inc.
First Received: September 21, 2005   Last Updated: September 23, 2009   History of Changes
Study Type: Interventional
Study Design: Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment
Condition: Diabetes Mellitus
Interventions: Drug: Pioglitazone
Drug: Glimepiride

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Subjects were enrolled at 97 sites in the United States, Canada, Argentina and Chile from 21 July 2003 to 18 October 2007.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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.

Reporting Groups
  Description
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.

Participant Flow:   Overall Study
  Pioglitazone QD Glimepiride QD
STARTED   274[1]   273[2]
COMPLETED   177     178  
NOT COMPLETED   97     95  
      Adverse Event               30                 34  
      Lack of Efficacy               4                 1  
      Lost to Follow-up               4                 6  
      Physician Decision               6                 8  
      Protocol Violation               6                 3  
      Withdrawal by Subject               40                 34  
      Other               7                 9  
[1] 274 subjects randomized, but four subjects did not receive drug.
[2] Mean treatment durations were 56.3 weeks (glimepiride) and 56.5 weeks (pioglitazone).



  Baseline Characteristics
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Reporting Groups
  Description
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.

Baseline Measures
  Pioglitazone QD Glimepiride QD Total
Number of Participants  
[units: participants]
 		270 273 543
Age  
[units: participants]
 		     
<=18 years 0 0 0
Between 18 and 65 years 189 193 382
>=65 years 81 80 161
Gender  
[units: participants]
 		     
Female 84 93 177
Male 186 180 366
Ethnicity (NIH/OMB)  
[units: Participants]
 		     
Hispanic or Latino 63 71 134
Not Hispanic or Latino 207 202 409
Unknown or Not Reported 0 0 0
Race/Ethnicity, Customized  
[units: participants]
 		     
Native American 3 10 13
Asian 12 16 28
Black or African American 30 27 57
White 225 220 445
Family History of Coronary Artery Disease[1]
[units: Participants]
 		     
Male Relative History 91 77 168
Female Relative History 60 59 119
No Family History 119 137 256
Body Mass Index[2]
[units: Kg/m squared]
Mean ( Full Range ) 		32.08
( 21.1 to 49.3 )		 32.03
( 19.7 to 47.9 )		 32.05
( 19.7 to 49.3 )
Duration of Coronary Artery Disease[3]
[units: Months]
Mean ( Full Range ) 		40.4
( 0 to 378 )		 40.5
( 0 to 468 )		 40.4
( 0 to 468 )
Duration of Diabetes Mellitus[4]
[units: Months]
Mean ( Full Range ) 		98.0
( 0 to 624 )		 96.3
( 0 to 556 )		 97.1
( 0 to 624 )
[1] Was first degree male or female relative diagnosed with Coronary Artery Disease at age < 55 years or < 65 years, respectively?
[2] The mean for total was calculated as the weighted average of the means of the two treatment arms.
[3] The mean for total was calculated as the weighted average of the means of the two treatment arms.
[4] The mean for total was calculated as the weighted average of the means of the two treatment arms.



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Nominal Change From Baseline in Percent Atheroma Volume   [ Baseline and Final Visit (up to 72 weeks) ]
  Show Outcome Measure 1

2.  Secondary:   Nominal Change From Baseline in Normalized Total Atheroma Volume   [ Baseline and Final Visit (up to 72 weeks) ]
  Show Outcome Measure 2

3.  Secondary:   Number of Subjects Experiencing Any of the Composite Endpoint A Cardiovascular Events   [ Up to 72 weeks ]
  Show Outcome Measure 3

4.  Secondary:   Number of Subjects Experiencing Any of the Composite Endpoint B Cardiovascular Events   [ Up to 72 weeks ]
  Show Outcome Measure 4

5.  Secondary:   Number of Subjects Experiencing Any of the Composite Endpoint C Cardiovascular Events   [ Up to 72 weeks ]
  Show Outcome Measure 5

6.  Other Pre-specified:   Number of Cardiovascular Events as Adjudicated by the Clinical Endpoint Committee   [ Up to 72 weeks ]
  Show Outcome Measure 6


  Serious Adverse Events
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Reporting Groups
  Description
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.

Serious Adverse Events
  Pioglitazone QD Glimepiride QD
Total, serious adverse events    
# participants affected 76   77  
Blood and lymphatic system disorders    
Anaemia   † A
      # participants affected / at risk
1/270 (0.37%)  
0/273 (0.00%)  
Cardiac disorders    
Acute Coronary Syndrome   † A
      # participants affected / at risk
0/270 (0.00%)  
3/273 (1.10%)  
Acute Myocardial Infarction   † A
      # participants affected / at risk
2/270 (0.74%)  
1/273 (0.37%)  
Angina Pectoris   † A
      # participants affected / at risk
8/270 (2.96%)  
4/273 (1.47%)  
Angina Unstable   † A
      # participants affected / at risk
4/270 (1.48%)  
3/273 (1.10%)  
Atrial Fibrillation   † A
      # participants affected / at risk
2/270 (0.74%)  
1/273 (0.37%)  
Atrioventricular Block Complete   † A
      # participants affected / at risk
0/270 (0.00%)  
1/273 (0.37%)  
Cardiac Arrest   † A
      # participants affected / at risk
0/270 (0.00%)  
1/273 (0.37%)  
Cardiac Discomfort   † A
      # participants affected / at risk
0/270 (0.00%)  
1/273 (0.37%)  
Cardiac Failure Congestive   † A
      # participants affected / at risk
3/270 (1.11%)  
5/273 (1.83%)  
Cardiac Tamponade   † A
      # participants affected / at risk
0/270 (0.00%)  
1/273 (0.37%)  
Coronary Artery Atherosclerosis   † A
      # participants affected / at risk
1/270 (0.37%)  
1/273 (0.37%)  
Coronary Artery Disease   † A
      # participants affected / at risk
20/270 (7.41%)  
16/273 (5.86%)  
Coronary Artery Insufficiency   † A
      # participants affected / at risk
0/270 (0.00%)  
1/273 (0.37%)  
Coronary Artery Occlusion   † A
      # participants affected / at risk
0/270 (0.00%)  
1/273 (0.37%)  
Coronary Artery Stenosis   † A
      # participants affected / at risk
5/270 (1.85%)  
5/273 (1.83%)  
Myocardial Infarction   † A
      # participants affected / at risk
3/270 (1.11%)  
2/273 (0.73%)  
Ventricular Fibrillation   † A
      # participants affected / at risk
1/270 (0.37%)  
0/273 (0.00%)  
Ventricular Tachycardia   † A
      # participants affected / at risk
1/270 (0.37%)  
0/273 (0.00%)  
Ear and labyrinth disorders    
Vertigo   † A
      # participants affected / at risk
1/270 (0.37%)  
0/273 (0.00%)  
Endocrine disorders    
Hyperaldosteronism   † A
      # participants affected / at risk
1/270 (0.37%)  
0/273 (0.00%)  
Hyperthyroidism   † A
      # participants affected / at risk
1/270 (0.37%)  
0/273 (0.00%)  
Gastrointestinal disorders    
Abdominal Hernia   † A
      # participants affected / at risk
0/270 (0.00%)  
1/273 (0.37%)  
Abdominal Pain   † A
      # participants affected / at risk
1/270 (0.37%)  
1/273 (0.37%)  
Abdominal Strangulated Hernia   † A
      # participants affected / at risk
1/270 (0.37%)  
0/273 (0.00%)  
Anal Haemorrhage   † A
      # participants affected / at risk
0/270 (0.00%)  
1/273 (0.37%)  
Appendiceal Mucocoele   † A
      # participants affected / at risk
0/270 (0.00%)  
1/273 (0.37%)  
Appendicitis Perforated   † A
      # participants affected / at risk
1/270 (0.37%)  
0/273 (0.00%)  
Colitis   † A
      # participants affected / at risk
0/270 (0.00%)  
1/273 (0.37%)  
Constipation   † A
      # participants affected / at risk
0/270 (0.00%)  
1/273 (0.37%)  
Dysphagia   † A
      # participants affected / at risk
1/270 (0.37%)  
0/273 (0.00%)  
Gastrointestinal Haemorrhage   † A
      # participants affected / at risk
0/270 (0.00%)  
1/273 (0.37%)  
Gastrooesophageal Reflux Disease   † A
      # participants affected / at risk
1/270 (0.37%)  
0/273 (0.00%)  
Ruptured Diverticulum of Colon   † A
      # participants affected / at risk
0/270 (0.00%)  
1/273 (0.37%)  
General disorders    
Catheter Site Phlebitis   † A
      # participants affected / at risk
1/270 (0.37%)  
0/273 (0.00%)  
Non-Cardia Chest Pain   † A
      # participants affected / at risk
15/270 (5.56%)  
5/273 (1.83%)  
Hepatobiliary disorders    
Biliary Colic   † A
      # participants affected / at risk
0/270 (0.00%)  
1/273 (0.37%)  
Chloelithiasis   † A
      # participants affected / at risk
1/270 (0.37%)  
0/273 (0.00%)  
Cholecystitis   † A
      # participants affected / at risk
1/270 (0.37%)  
0/273 (0.00%)  
Cholecystitis Acute   † A
      # participants affected / at risk
0/270 (0.00%)  
1/273 (0.37%)  
Hepatic Function Abnormal   † A
      # participants affected / at risk
0/270 (0.00%)  
1/273 (0.37%)  
Hepatitis   † A
      # participants affected / at risk
0/270 (0.00%)  
1/273 (0.37%)  
Infections and infestations    
Bronchitis   † A
      # participants affected / at risk
1/270 (0.37%)  
2/273 (0.73%)  
Bronchitis Acute   † A
      # participants affected / at risk
1/270 (0.37%)  
0/273 (0.00%)  
Cellulitis   † A
      # participants affected / at risk
1/270 (0.37%)  
2/273 (0.73%)  
Diabetic Foot Infection   † A
      # participants affected / at risk
0/270 (0.00%)  
1/273 (0.37%)  
Diverticulitis   † A
      # participants affected / at risk
1/270 (0.37%)  
2/273 (0.73%)  
Gastroenteritis   † A
      # participants affected / at risk
0/270 (0.00%)  
1/273 (0.37%)  
Implant Site Infection   † A
      # participants affected / at risk
1/270 (0.37%)  
0/273 (0.00%)  
Lobar Pneumonia   † A
      # participants affected / at risk
1/270 (0.37%)  
0/273 (0.00%)  
Pneumonia   † A
      # participants affected / at risk
0/270 (0.00%)  
5/273 (1.83%)  
Pneumonia Primary Atypical   † A
      # participants affected / at risk
0/270 (0.00%)  
1/273 (0.37%)  
Upper Respiratory Tract Infection   † A
      # participants affected / at risk
0/270 (0.00%)  
1/273 (0.37%)  
Urinary Tract Infection   † A
      # participants affected / at risk
1/270 (0.37%)  
1/273 (0.37%)  
Wound Infeciton   † A
      # participants affected / at risk
1/270 (0.37%)  
0/273 (0.00%)  
Injury, poisoning and procedural complications    
Accident at Work   † A
      # participants affected / at risk
1/270 (0.37%)  
0/273 (0.00%)  
Cerebrospinal Fluid Leakage   † A
      # participants affected / at risk
1/270 (0.37%)  
0/273 (0.00%)  
Device Malfunction   † A
      # participants affected / at risk
1/270 (0.37%)  
0/273 (0.00%)  
Fall   † A
      # participants affected / at risk
0/270 (0.00%)  
1/273 (0.37%)  
Incisional Hernia   † A
      # participants affected / at risk
0/270 (0.00%)  
1/273 (0.37%)  
Ligament Injury   † A
      # participants affected / at risk
0/270 (0.00%)  
1/273 (0.37%)  
Post Procedural Haematoma   † A
      # participants affected / at risk
1/270 (0.37%)  
0/273 (0.00%)  
Post Procedural Haemorrhage   † A
      # participants affected / at risk
1/270 (0.37%)  
1/273 (0.37%)  
Road Traffic Accident   † A
      # participants affected / at risk
0/270 (0.00%)  
1/273 (0.37%)  
Therapeutic Agent Toxicity   † A
      # participants affected / at risk
1/270 (0.37%)  
0/273 (0.00%)  
Investigations    
Blood Creatinine Increased   † A
      # participants affected / at risk
0/270 (0.00%)  
1/273 (0.37%)  
Hepatitis C Antibody Positive   † A
      # participants affected / at risk
1/270 (0.37%)  
0/273 (0.00%)  
Metabolism and nutrition disorders    
Dehydration   † A
      # participants affected / at risk
1/270 (0.37%)  
0/273 (0.00%)  
Diabetes Mellitus Inadequate Control   † A
      # participants affected / at risk
0/270 (0.00%)  
1/273 (0.37%)  
Diabetic Foot   † A
      # participants affected / at risk
1/270 (0.37%)  
0/273 (0.00%)  
Hyperglycaemia   † A
      # participants affected / at risk
1/270 (0.37%)  
0/273 (0.00%)  
Hypoclycaemia   † A
      # participants affected / at risk
0/270 (0.00%)  
3/273 (1.10%)  
Obesity   † A
      # participants affected / at risk
1/270 (0.37%)  
0/273 (0.00%)  
Synovial Cyst   † A
      # participants affected / at risk
0/270 (0.00%)  
1/273 (0.37%)  
Musculoskeletal and connective tissue disorders    
Cervical Spinal Stenosis   † A
      # participants affected / at risk
1/270 (0.37%)  
0/273 (0.00%)  
Costochondritis   † A
      # participants affected / at risk
0/270 (0.00%)  
1/273 (0.37%)  
Flank Pain   † A
      # participants affected / at risk
1/270 (0.37%)  
0/273 (0.00%)  
Haemarthrosis   † A
      # participants affected / at risk
0/270 (0.00%)  
1/273 (0.37%)  
Localized Osteoarthritis   † A
      # participants affected / at risk
1/270 (0.37%)  
1/273 (0.37%)  
Osteoarthritis   † A
      # participants affected / at risk
2/270 (0.74%)  
0/273 (0.00%)  
Spinal Column Stenosis   † A
      # participants affected / at risk
1/270 (0.37%)  
0/273 (0.00%)  
Neoplasms benign, malignant and unspecified (incl cysts and polyps)    
Adenocarcinoma   † A
      # participants affected / at risk
0/270 (0.00%)  
1/273 (0.37%)  
Bladder Cancer   † A
      # participants affected / at risk
0/270 (0.00%)  
1/273 (0.37%)  
Nasal Sinus Cancer   † A
      # participants affected / at risk
1/270 (0.37%)  
0/273 (0.00%)  
Non-Small Cell Lung Cancer   † A
      # participants affected / at risk
1/270 (0.37%)  
0/273 (0.00%)  
Oesophageal Carcinoma   † A
      # participants affected / at risk
0/270 (0.00%)  
1/273 (0.37%)  
Renal Cell Carcinoma Stage Unspecified   † A
      # participants affected / at risk
1/270 (0.37%)  
0/273 (0.00%)  
Small Cell Carcinoma   † A
      # participants affected / at risk
0/270 (0.00%)  
1/273 (0.37%)  
Nervous system disorders    
Carotid Artery Stenosis   † A
      # participants affected / at risk
1/270 (0.37%)  
0/273 (0.00%)  
Cerebrovascular Accident   † A
      # participants affected / at risk
0/270 (0.00%)  
1/273 (0.37%)  
Cerebrovascular Stenosis   † A
      # participants affected / at risk
0/270 (0.00%)  
1/273 (0.37%)  
Dizziness   † A
      # participants affected / at risk
0/270 (0.00%)  
1/273 (0.37%)  
Nystagmus   † A
      # participants affected / at risk
1/270 (0.37%)  
0/273 (0.00%)  
Syncope   † A
      # participants affected / at risk
1/270 (0.37%)  
1/273 (0.37%)  
Psychiatric disorders    
Bipolar II Disorder   † A
      # participants affected / at risk
0/270 (0.00%)  
1/273 (0.37%)  
Mental Disorder   † A
      # participants affected / at risk
1/270 (0.37%)  
0/273 (0.00%)  
Mental Status Changes   † A
      # participants affected / at risk
0/270 (0.00%)  
1/273 (0.37%)  
Renal and urinary disorders    
Renal Failure   † A
      # participants affected / at risk
0/270 (0.00%)  
1/273 (0.37%)  
Reproductive system and breast disorders    
Benign Prostatic Hyperplasia   † A
      # participants affected / at risk
0/270 (0.00%)  
2/273 (0.73%)  
Respiratory, thoracic and mediastinal disorders    
Acute Pulmonary Oedema   † A
      # participants affected / at risk
1/270 (0.37%)  
0/273 (0.00%)  
Astma   † A
      # participants affected / at risk
0/270 (0.00%)  
2/273 (0.73%)  
Chronic Obstructive Airways Disease Exacerbated   † A
      # participants affected / at risk
0/270 (0.00%)  
3/273 (1.10%)  
Interstitial Lung Disease   † A
      # participants affected / at risk
0/270 (0.00%)  
1/273 (0.37%)  
Pleural Effusion   † A
      # participants affected / at risk
1/270 (0.37%)  
0/273 (0.00%)  
Pulmonary Oedema   † A
      # participants affected / at risk
1/270 (0.37%)  
0/273 (0.00%)  
Surgical and medical procedures    
Coronary Arterial Stent Insertion   † A
      # participants affected / at risk
1/270 (0.37%)  
0/273 (0.00%)  
Vascular disorders    
Aortic Stenosis   † A
      # participants affected / at risk
1/270 (0.37%)  
0/273 (0.00%)  
Hypotension   † A
      # participants affected / at risk
1/270 (0.37%)  
0/273 (0.00%)  
Intermittent Claudication   † A
      # participants affected / at risk
0/270 (0.00%)  
1/273 (0.37%)  
Peripheral Vascular Disorder   † A
      # participants affected / at risk
1/270 (0.37%)  
1/273 (0.37%)  
† Indicates events were collected by systematic assessment.
A Term from vocabulary, MedDRA 7.1


  Other Adverse Events
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Limitations and Caveats
Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
Composite Endpoints A,B,C include cardiovascular mortality, nonfatal MI and nonfatal stroke. In addition, B: coronary revascularization, carotid endarterectomy/stenting, unstable angina hosp. or CHF; C: hospitalization for unstable angina or CHF.  


Results Point of Contact:  
Name/Title: Sr. VP Clinical Sciences
Organization: Takeda Global Research and Development Center Inc.
phone: 800-778-2860
e-mail: clinicaltrialregistry@tpna.com


Publications of Results:
Nissen SE, Nicholls SJ, Wolski K, Nesto R, Kupfer S, Perez A, Jure H, De Larochellière R, Staniloae CS, Mavromatis K, Saw J, Hu B, Lincoff AM, Tuzcu EM; PERISCOPE Investigators. Comparison of pioglitazone vs glimepiride on progression of coronary atherosclerosis in patients with type 2 diabetes: the PERISCOPE randomized controlled trial. JAMA. 2008 Apr 2;299(13):1561-73. Epub 2008 Mar 31.


Responsible Party: Takeda Global Research & Development Center, Inc. ( Sr. VP, Clinical Science )
Study ID Numbers: 01-01-TL-OPI-516
Study First Received: September 21, 2005
Results First Received: October 17, 2008
Last Updated: September 23, 2009
ClinicalTrials.gov Identifier: NCT00225277     History of Changes
Health Authority: United States: Food and Drug Administration;   Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica;   Canada: Health Canada;   Chile: Instituto de Salud Publica de Chile





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