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OpT2mise Glucose Control in Type 2 Diabetes Mellitus (DM) With Insulin Pump Therapy (OpT2mise)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Medtronic
ClinicalTrials.gov Identifier:
NCT01182493
First received: August 11, 2010
Last updated: February 17, 2016
Last verified: February 2016
Results First Received: February 17, 2016  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Diabetes Mellitus, Type 2
Intervention: Device: Insulin Pump (Medtronic Minimed Paradigm® VEO)

  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
36 hospitals, tertiary care centres, and referal centres participated: eight in Canada, 23 in Europe and Israel, two in South Africa, and three in the USA. The study started in December 2010, and the fi nal data collection date for the primary outcome measure was in February 2014

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Insulin Pump Treatment

Patients will get an insulin pump

Insulin Pump (Medtronic Minimed Paradigm® VEO): The pump delivers insulin as specified by the patient.

Insulin Treatment With MDI patients treated with Multiple Daily Injections (MDI); basal/bolus therapy with rapid- and long-acting analogs with at least 3 injections per day

Participant Flow:   Overall Study
    Insulin Pump Treatment   Insulin Treatment With MDI
STARTED   168   163 
COMPLETED   152   156 
NOT COMPLETED   16   7 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Insulin Pump Treatment

Patients will get an insulin pump

Insulin Pump (Medtronic Minimed Paradigm® VEO): The pump delivers insulin as specified by the patient

Insulin Treatment With MDI patients treated with Multiple Daily Injections (MDI); basal/bolus therapy with rapid- and long-acting analogs with at least 3 injections per day
Total Total of all reporting groups

Baseline Measures
   Insulin Pump Treatment   Insulin Treatment With MDI   Total 
Overall Participants Analyzed 
[Units: Participants]
 168   163   331 
Age 
[Units: Participants]
     
<=18 years   0   0   0 
Between 18 and 65 years   168   163   331 
>=65 years   0   0   0 
Age 
[Units: Years]
Mean (Standard Deviation)
 55.5  (9.7)   56.4  (9.5)   56.0  (9.6) 
Gender 
[Units: Participants]
     
Female   74   77   151 
Male   94   86   180 
HbA1c 
[Units: %]
Mean (Standard Deviation)
 9.0  (0.75)   9.0  (0.75)   9.0  (0.75) 


  Outcome Measures

1.  Primary:   Between Group Difference in HbA1c When Comparing CSII to MDI   [ Time Frame: 6 months ]

2.  Secondary:   Change in Glycemic Variability   [ Time Frame: 6 months ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

3.  Secondary:   Safety   [ Time Frame: 6 months treatment and 6 months follow-up ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   Yes

4.  Secondary:   Change in Postprandial Glycemia   [ Time Frame: 6 months ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

5.  Secondary:   Quality of Life and Treatment Satisfaction   [ Time Frame: 6 months ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

6.  Secondary:   Change in Body Weight or BMI, Lipids and Blood Pressure   [ Time Frame: 6 months ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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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
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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 Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Prof. Yves Reznik
Organization: CHU Caen
phone: +33231064585
e-mail: reznik-y@chu-caen.fr


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Medtronic
ClinicalTrials.gov Identifier: NCT01182493     History of Changes
Other Study ID Numbers: EUR05 / CEP234
Study First Received: August 11, 2010
Results First Received: February 17, 2016
Last Updated: February 17, 2016
Health Authority: Austria: Agency for Health and Food Safety
Austria: Ethikkommission
Canada: Ethics Review Committee
Canada: Health Canada
Czech Republic: Ethics Committee
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
France: Comité consultatif sur le traitement de l'information en matière de recherche dans le domaine de la santé
France: Direction Générale de la Santé
France: Institutional Ethical Committee
France: Agence Nationale de Sécurité du Médicament et des produits de santé
France: The Commission nationale de l’informatique et des libertés
Germany: Ethics Commission
Germany: Federal Institute for Drugs and Medical Devices
Hungary: Institutional Ethics Committee
Hungary: National Institute for Quality and Organizational Development in Healthcare and Medicines
Hungary: Research Ethics Medical Committee
Hungary: Scientific and Medical Research Council Ethics Committee
Israel: Ethics Commission
Israel: Israeli Health Ministry Pharmaceutical Administration
Israel: Ministry of Health
Italy: Ethics Committee
Italy: National Institute of Health
Macedonia: Ethics Committee
Macedonia: Ministry of Health
Netherlands: Independent Ethics Committee
Netherlands: Dutch Health Care Inspectorate
Netherlands: Medical Ethics Review Committee (METC)
Serbia: Ethics Committee
South Africa: Human Research Ethics Committee
South Africa: National Health Research Ethics Council
Spain: Ethics Committee
Spain: Ministry of Health
United States: Institutional Review Board