OpT2mise Glucose Control in Type 2 Diabetes Mellitus (DM) With Insulin Pump Therapy (OpT2mise)
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ClinicalTrials.gov Identifier: NCT01182493 |
Recruitment Status
:
Completed
First Posted
: August 16, 2010
Results First Posted
: March 15, 2016
Last Update Posted
: March 12, 2018
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Diabetes Mellitus, Type 2 | Device: Insulin Pump (Medtronic Minimed Paradigm® VEO) | Not Applicable |
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.
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 331 participants |
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 |
Study Start Date : | December 2010 |
Actual Primary Completion Date : | February 2014 |
Actual Study Completion Date : | August 2014 |

Arm | Intervention/treatment |
---|---|
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
|
- Between Group Difference in HbA1c When Comparing CSII to MDI [ Time Frame: baseline and 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 A1c = A1c at 6 month - A1c at baseline
- Change in Glycemic Variability - AUC in Hypo (≤70mg/dL) [ Time Frame: 6 months ]Glycemic parameters calculated from blinded CGM data: change in AUC (Area Under the Curve) in hypo- (≤70mg/dL), among subjects with available AUC results. Change in hypo AUC = hypo AUC at 6 month - hypo AUC at baseline
- Safety - Severe Hypoglycemia Incidence [ Time Frame: 6 months ]Severe hypoglycemia incidence during the study
- Change in Glycemic Variability - AUC in Hyper (≥180mg/dL) [ Time Frame: 6 months ]Glycemic parameters calculated from blinded CGM data: change in AUC (Area Under the Curve) in hyper- (≥180mg/dL), among subjects with available AUC results. Change in hyper AUC = hyper AUC at 6 month - hyper AUC at baseline
- Quality of Life and Treatment Satisfaction - Results From Diabetes Treatment Satisfaction Questionnaire (DTSQ) [ Time Frame: 6 months ]Subjects were asked to complete the Diabetes Treatment Satisfaction Questionnaire (DTSQs). Treatment satisfaction is measured by means of the DTSQs, status version (DTSQs, Bradley, 1990). It consists of a six-item scale assessing treatment satisfaction (TS) and two items assessing perceived frequency of hyperglycaemia and hypoglycaemia. The DTSQs items are scored on a scale from 0 to 6. The scale total is computed by adding the six items 1, 4, 5, 6, 7, and 8, to produce the Treatment Satisfaction scale total, which has a min of 0 and a max of 36. Higher score at 6 month compared to baseline represents a better outcome. Change in treatment satisfaction = score at 6 month - score at baseline, among subjects with available satisfaction scores
- Change in Body Weight [ Time Frame: 6 months ]Change in body weight from randomization to the end of study. Change in body weight = weight at 6 month - weight at baseline, among subjects with available body weight
- Safety - Diabetic Ketoacidosis Incidence [ Time Frame: 6 Months ]Diabetic Ketoacidosis incidence during the study

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 30 Years to 75 Years (Adult, Senior) |
Sexes Eligible for Study: | All |
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
- 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
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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)

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01182493

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 |
Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Medtronic Diabetes |
ClinicalTrials.gov Identifier: | NCT01182493 History of Changes |
Other Study ID Numbers: |
EUR05 / CEP234 |
First Posted: | August 16, 2010 Key Record Dates |
Results First Posted: | March 15, 2016 |
Last Update Posted: | March 12, 2018 |
Last Verified: | February 2018 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Keywords provided by Medtronic Diabetes:
Diabetes Mellitus MDI pump therapy |
Additional relevant MeSH terms:
Diabetes Mellitus Diabetes Mellitus, Type 2 Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases |
Insulin, Globin Zinc Insulin Hypoglycemic Agents Physiological Effects of Drugs |