NCT01182493

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

OpT2mise Glucose Control in Type 2 DM With Insulin Pump Therapy

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 331 (actual)
• Sponsor: Medtronic MiniMed, Inc. · Industry
• Sex: All
• Age: 30 Years – 75 Years
• Healthy volunteers: Not accepted

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 controlled with multiple daily injections (MDI).

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 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 study phase is a 6-months phase with 2-arms parallel design.

Conditions

• Diabetes Mellitus, Type 2

Interventions

Type	Name	Description
DEVICE	Insulin Pump (Medtronic Minimed Paradigm® VEO)	The pump delivers insulin as specified by the patient

Timeline

• Start date: 2010-12-01
• Primary completion: 2014-02-01
• Completion: 2014-08-01
• First posted: 2010-08-16
• Last updated: 2018-03-12
• Results posted: 2016-03-15

Locations

36 sites across 13 countries: United States, Austria, Canada, France, Germany, Hungary, Israel, Italy, Netherlands, North Macedonia, Serbia, South Africa, Spain