OpT2mise Glucose Control in Type 2 Diabetes Mellitus (DM) With Insulin Pump Therapy
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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).
Condition | Intervention | Phase |
---|---|---|
Diabetes Mellitus, Type 2 |
Device: Insulin Pump (Medtronic Minimed Paradigm® VEO) |
Phase 4 |
Study Type: | Interventional |
Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: 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 ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]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 commom measure of the volatility of blood glucose levels; Standard deviation
- Safety [ Time Frame: 6 months treatment and 6 months follow-up ] [ Designated as safety issue: Yes ]Severe hypoglycemia incidence; Diabetic Ketoacidosis incidence and Diabetes related hospitalizations
- Change in postprandial glycemia [ Time Frame: 6 months ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]
- Change in body weight or BMI, Lipids and blood pressure [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Estimated Enrollment: | 400 |
Study Start Date: | December 2010 |
Estimated Study Completion Date: | June 2013 |
Estimated Primary Completion Date: | December 2012 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
Experimental: Insulin Pump Treatment |
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); EC8857 Rev.1, valid until 19.07.2013
|
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
|
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 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).
Ages Eligible for Study: | 30 Years to 75 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
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
- Age between 30-75 years old
- 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
Inclusion Criteria 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
- Age between 30-75 years old
- 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
- 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)
Contact: Sarah Runzis | (+41-21) 802-7028 | sarah.runzis@medtronic.com |
Show 30 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 |
No publications provided
Responsible Party: | Medtronic |
ClinicalTrials.gov Identifier: | NCT01182493 History of Changes |
Other Study ID Numbers: | EUR05 / CEP234 |
Study First Received: | August 11, 2010 |
Last Updated: | March 19, 2012 |
Health Authority: | France: Institutional Ethical Committee Israel: Ethics Commission Spain: Ethics Committee Germany: Ethics Commission Germany: Federal Institute for Drugs and Medical Devices Austria: Agency for Health and Food Safety Austria: Ethikkommission Canada: Ethics Review Committee Canada: Health Canada |
Keywords provided by Medtronic:
Diabetes Mellitus MDI pump therapy |
Additional relevant MeSH terms:
Diabetes Mellitus Diabetes Mellitus, Type 2 Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases |
Insulin Hypoglycemic Agents Physiological Effects of Drugs Pharmacologic Actions |
ClinicalTrials.gov processed this record on October 17, 2012