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

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ClinicalTrials.gov Identifier: NCT01182493
Recruitment Status : Completed
First Posted : August 16, 2010
Results First Posted : March 15, 2016
Last Update Posted : March 12, 2018
Sponsor:
Information provided by (Responsible Party):
Medtronic Diabetes

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Diabetes Mellitus, Type 2
Intervention: Device: Insulin Pump (Medtronic Minimed Paradigm® VEO)

  Participant Flow

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

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]
Count of Participants
     
<=18 years      0   0.0%      0   0.0%      0   0.0% 
Between 18 and 65 years      168 100.0%      163 100.0%      331 100.0% 
>=65 years      0   0.0%      0   0.0%      0   0.0% 
Age 
[Units: Years]
Mean (Standard Deviation)
 55.5  (9.7)   56.4  (9.5)   56.0  (9.6) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      74  44.0%      77  47.2%      151  45.6% 
Male      94  56.0%      86  52.8%      180  54.4% 
HbA1c 
[Units: % of glycosylated hemoglobin]
Mean (Standard Deviation)
 9.0  (0.75)   9.0  (0.76)   9.0  (0.75) 


  Outcome Measures

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

2.  Secondary:   Change in Glycemic Variability - AUC in Hypo (≤70mg/dL)   [ Time Frame: 6 months ]

3.  Secondary:   Safety - Severe Hypoglycemia Incidence   [ Time Frame: 6 months ]

4.  Secondary:   Change in Glycemic Variability - AUC in Hyper (≥180mg/dL)   [ Time Frame: 6 months ]

5.  Secondary:   Quality of Life and Treatment Satisfaction - Results From Diabetes Treatment Satisfaction Questionnaire (DTSQ)   [ Time Frame: 6 months ]

6.  Secondary:   Change in Body Weight   [ Time Frame: 6 months ]

7.  Secondary:   Safety - Diabetic Ketoacidosis Incidence   [ Time Frame: 6 Months ]


  Serious Adverse Events


  Other Adverse Events


  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
No text entered.


  More Information

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 Diabetes
ClinicalTrials.gov Identifier: NCT01182493     History of Changes
Other Study ID Numbers: EUR05 / CEP234
First Submitted: August 11, 2010
First Posted: August 16, 2010
Results First Submitted: February 17, 2016
Results First Posted: March 15, 2016
Last Update Posted: March 12, 2018