Status:
COMPLETED
OpT2mise Glucose Control in Type 2 Diabetes Mellitus (DM) With Insulin Pump Therapy
Lead Sponsor:
Medtronic Diabetes
Conditions:
Diabetes Mellitus, Type 2
Eligibility:
All Genders
30-75 years
Phase:
NA
Brief Summary
The purpose of this study is to evaluate the comparative effectiveness of insulin pump therapy versus multiple daily injections in insulin-taking type 2 Diabetes Mellitus who are sub optimally control...
Detailed Description
The type of study is interventional post-market release. All the devices under investigation have CE mark, and are used within intended use. This study has been designed to be prospective randomized ...
Eligibility Criteria
Inclusion
- Inclusion Criteria at screening:
- Diagnosed with type 2 DM, as per Investigator discretion
- HbA1c (DCCT-standard) must be ≥ 8.0% and ≤12% as evidenced by central lab value taken at screening
- Insulin resistance defined as required daily dose between 0.5-1.8 U/Kg or a maximum of 220 units of insulin per day
- Aged 30 to 75 years old (inclusive)
- On MDI regimen (basal/bolus regimen with long-acting insulin and rapid acting analogs) defined as ≥ 3 injections per day for at least 3 months prior signing the informed consent
- Ability to comply with technology, according to Investigator's judgment
- Patients must be willing to undergo all study procedures
- Female patients of child-bearing potential must be using adequate contraception means as assessed by Investigator
- at randomisation:
- Diagnosed with type 2 DM, as per Investigator discretion
- HbA1c (DCCT-standard) must be ≥ 8.0% and ≤12% as evidenced by central lab value
- Insulin resistance defined as required daily dose between 0.7-1.8 U/Kg or a maximum of 220 units of insulin per day
- On MDI (basal/bolus regimen with long-acting insulin and rapid acting analogs) defined as ≥ 3 injections per day
- Ability to comply with technology, according to Investigator's judgment
- ≥ 2.5 SMBG per day on average, as reported in Carelink clinical during the run-in phase.
- Patients must be willing to undergo all study procedures
- Female patients of child-bearing potential must be using adequate contraception means as assessed by Investigator
- Exclusion Criteria :
- Subject has a history (≥ 2 events) of hypoglycemic seizure or hypoglycemic coma within the last 6 months
- Subject is pregnant as assessed by a pregnancy test with central laboratory, or plans to become pregnant during the course of the study
- Participation in another interventional clinical study, on-going or completed less than 3 months prior to signature of Patient Informed Consent.
- Subject has proliferative retinopathy or sight threatening maculopathy
- Subject has
- an acute coronary syndrome (myocardial infarction or unstable angina) within 12 months OR
- coronary artery revascularization by bypass surgery or stenting within 3 months OR
- a transient ischemic attack (TIA) or cerebrovascular accident (CVA) within 3 months OR
- hospitalization for heart failure within 3 months or current New York Functional Class III or IV OR
- current 2nd or 3rd degree heart block OR
- symptomatic ventricular rhythm disturbances OR
- thromboembolic disease within the last 3 months OR
- 2nd degree Mobitz type II or 3rd degree heart block
- Subject with renal impairment expressed as estimated glomerular filtration rate (eGFR) using the Modification of Diet in Renal Disease (MDRD) formula \< 30 ml/min as demonstrated by the screening central laboratory value at the time of enrollment
- Subject has taken oral or injectable steroids within the last 30 days
- Systolic blood pressure on screening visit is \> 180 mmHg
- Diastolic blood pressure on screening visit is \> 110 mmHg
- Any other disease (eg active cancer under treatment) or condition including abnormalities found on the screening tests, that in the opinion of the Investigator, may preclude him/her from participating in the study
- Taking any medication prescribed for weight loss
- Alcohol or drug abuse, other than nicotine, at the investigator's discretion
- Use of a GLP-1 agonist or pramlintide (Symlin)
Exclusion
Key Trial Info
Start Date :
December 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2014
Estimated Enrollment :
331 Patients enrolled
Trial Details
Trial ID
NCT01182493
Start Date
December 1 2010
End Date
August 1 2014
Last Update
March 12 2018
Active Locations (36)
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1
Atlanta Diabetes Associates
Atlanta, Georgia, United States, 30318
2
Albany Medical College
Albany, New York, United States, 12208
3
SUNY Upstate Medical University
Syracuse, New York, United States, 13210
4
City hopital Vienna-Hieting
Vienna, Austria, 1130