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

Completed · Not applicable

Conditions studied: Diabetes Mellitus, Type 2

In brief

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 controlled with multiple daily injections (MDI).

Key facts

Study ID

NCT01182493

Run by

Medtronic MiniMed, Inc.

People needed

331

Starts

2010-12-01

Expected to finish

2014-08-01

Last updated by the study team

2018-03-12

Who can join

Age: 30 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may not qualify if…

• 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)

Where it is running

• Atlanta Diabetes Associates — Atlanta, Georgia, United States
• Albany Medical College — Albany, New York, United States
• SUNY Upstate Medical University — Syracuse, New York, United States
• City hopital Vienna-Hieting — Vienna, Austria
• Clinical Professor Department of Medicine University of Calgary — Calgary, Alberta, Canada
• Endocrinologist, 202-301 Columbia Street East — New Westminster, British Columbia, Canada
• 416-1033 Davie St — Vancouver, British Columbia, Canada
• Health Science Centre — St. John's, Newfoundland and Labrador, Canada
• LMC Endocrinology Centre — Oakville, Ontario, Canada
• Canadian Centre for Research on Diabetes — Smiths Falls, Ontario, Canada
• Toronto General Hsopital — Toronto, Ontario, Canada
• McGill University, McGill Nutrition and Food Science Centre — Montreal, Quebec, Canada
• CHU Côte de Nacre — Caen, France
• CHU - Ste Marguerite — Marseille, France
• Hopital Lapeyronie — Montpellier, France
• CHU de Nancy — Nancy, France
• CHU Strasbourg — Strasbourg, France
• CHU Toulouse Rangueil — Toulouse, France
• Fachklinik Bad Heilbrunn — Bad Heilbrunn, Germany
• Zentrum für Diabetes und Gefäßerkrankungen — Münster, Germany
• Péterfy Hospital and Emergency Center Diabetes Outpatient Clinic — Budapest, Hungary
• Soroka University Medical Center — Beersheba, Israel
• Diabetic Clinic — Jerusalem, Israel
• Chaim Sheba Medical center Endocrinology unit — Tel Hashomer - Ramat Gan, Israel
• Assaf- Harofeh Medical Center — Ẕerifin, Israel

Full record on ClinicalTrials.gov

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