OpT2mise Glucose Control in Type 2 Diabetes Mellitus (DM) With Insulin Pump Therapy (OpT2mise)
|Diabetes Mellitus, Type 2||Device: Insulin Pump (Medtronic Minimed Paradigm® VEO)||Phase 4|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
|Official Title:||OpT2mise Glucose Control in Type 2 DM With Insulin Pump Therapy|
- Between Group Difference in HbA1c When Comparing CSII to MDI [ Time Frame: 6 months ]To evaluate change in glycemic control (HbA1c) after 6 months of insulin pump therapy in patients with type 2 DM, as compared to patients on MDI therapy over the same time period
- Change in Glycemic Variability [ Time Frame: 6 months ]Glycemic parameters calculated from blinded CGM data: Measure of the Average glucose/day; AUC in hypo- (≤70mg/dL) and in hyperglycemia (≥180 mg/dL; Time spent in hypo- (≤70mg/dL) and hyperglycemia (≥180 mg/dL); Mean Amplitude of Glycemic Excursions (MAGE) is the most common measure of the volatility of blood glucose levels; Standard deviation
- Safety [ Time Frame: 6 months treatment and 6 months follow-up ]Severe hypoglycemia incidence; Diabetic Ketoacidosis incidence and Diabetes related hospitalizations
- Change in Postprandial Glycemia [ Time Frame: 6 months ]Change in mean postprandial hyperglycemia 0 to 2 hours post meal, defined as ≥180 mg/dl and measured by SMBG
- Quality of Life and Treatment Satisfaction [ Time Frame: 6 months ]
- Change in Body Weight or BMI, Lipids and Blood Pressure [ Time Frame: 6 months ]
|Study Start Date:||December 2010|
|Study Completion Date:||August 2014|
|Primary Completion Date:||February 2014 (Final data collection date for primary outcome measure)|
Experimental: Insulin Pump Treatment
Patients will get an insulin pump
Device: Insulin Pump (Medtronic Minimed Paradigm® VEO)
The pump delivers insulin as specified by the patient
Other Name: Medtronic MiniMed Paradigm® VEO system (MMT-554/754
No Intervention: 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
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 controlled with a single-arm cross-over in the continuation phase.
Four hundred type 2 Multiple Daily Injections (MDI) treated patients will undergo a screening (run-in) phase of 8 weeks. The aim of the screening phase is to eliminate the study effect that might result in a decrease of HbA1c and to make sure that patients, who are failing current MDI therapy, are selected.
After this screening phase, eligible patients will be randomised to receive either Continuous Subcutaneous Insulin Infusion (CSII) treatment or continue MDI treatment. The first 6-months phase (2-arms parallel) will be followed by another 6-months continuation phase (single cross-over of the MDI arm alone switching to CSII).
Please refer to this study by its ClinicalTrials.gov identifier: NCT01182493
Show 36 Study Locations
|Principal Investigator:||Ohad Cohen, MD||Chaim Sheba Medical Center, Tel Hashomer, Israel|
|Principal Investigator:||Ignacio Conget, MD||ICMDM Hospital Clínic i, Barcelona, Spain|
|Principal Investigator:||Yves Reznic, MD||CHU Côte de Nacre, France|
|Principal Investigator:||Ronnie Aronson, MD||FRCPC, FACE LMC Endocrinology Centres, Canada|