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

Study Description

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Brief 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).

Condition or disease	Intervention/treatment	Phase
Diabetes Mellitus, Type 2	Device: Insulin Pump (Medtronic Minimed Paradigm® VEO)	Not Applicable

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.

Study Design

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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

Arms and Interventions

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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

Outcome Measures

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Primary Outcome Measures :

1. 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

Secondary Outcome Measures :

1. 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
2. Safety - Severe Hypoglycemia Incidence [ Time Frame: 6 months ]
   Severe hypoglycemia incidence during the study
3. 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
4. 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
5. 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
6. Safety - Diabetic Ketoacidosis Incidence [ Time Frame: 6 Months ]
   Diabetic Ketoacidosis incidence during the study

Eligibility Criteria

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Ages Eligible for Study:	30 Years to 75 Years (Adult, Older Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria at screening:

1. Diagnosed with type 2 DM, as per Investigator discretion
2. HbA1c (DCCT-standard) must be ≥ 8.0% and ≤12% as evidenced by central lab value taken at screening
3. Insulin resistance defined as required daily dose between 0.5-1.8 U/Kg or a maximum of 220 units of insulin per day
4. Aged 30 to 75 years old (inclusive)
5. 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
6. Ability to comply with technology, according to Investigator's judgment
7. Patients must be willing to undergo all study procedures
8. Female patients of child-bearing potential must be using adequate contraception means as assessed by Investigator

at randomisation:

1. Diagnosed with type 2 DM, as per Investigator discretion
2. HbA1c (DCCT-standard) must be ≥ 8.0% and ≤12% as evidenced by central lab value
3. Insulin resistance defined as required daily dose between 0.7-1.8 U/Kg or a maximum of 220 units of insulin per day
4. On MDI (basal/bolus regimen with long-acting insulin and rapid acting analogs) defined as ≥ 3 injections per day
5. Ability to comply with technology, according to Investigator's judgment
6. ≥ 2.5 SMBG per day on average, as reported in Carelink clinical during the run-in phase.
7. Patients must be willing to undergo all study procedures
8. Female patients of child-bearing potential must be using adequate contraception means as assessed by Investigator

Exclusion Criteria :

1. Subject has a history (≥ 2 events) of hypoglycemic seizure or hypoglycemic coma within the last 6 months
2. Subject is pregnant as assessed by a pregnancy test with central laboratory, or plans to become pregnant during the course of the study
3. Participation in another interventional clinical study, on-going or completed less than 3 months prior to signature of Patient Informed Consent.
4. Subject has proliferative retinopathy or sight threatening maculopathy

5. 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
6. 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
7. Subject has taken oral or injectable steroids within the last 30 days
8. Systolic blood pressure on screening visit is > 180 mmHg
9. Diastolic blood pressure on screening visit is > 110 mmHg
10. 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
11. Taking any medication prescribed for weight loss
12. Alcohol or drug abuse, other than nicotine, at the investigator's discretion
13. Use of a GLP-1 agonist or pramlintide (Symlin)

Contacts and Locations

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  Show 36 Study Locations

Sponsors and Collaborators

Medtronic Diabetes

Investigators

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

More Information

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Additional Information:

Publication of primary endpoints in the Lancet 

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Metzger M, Castañeda J, Reznik Y, Giorgino F, Conget I, Aronson R, de Portu S, Runzis S, Lee SW, Cohen O. Factors associated with improved glycemic control following continuous subcutaneous insulin infusion therapy in patients with type 2 diabetes uncontrolled with bolus-basal insulin regimens: An analysis from the OpT2mise randomized trial. Diabetes Obes Metab. 2017 Oct;19(10):1490-1494. doi: 10.1111/dom.12960. Epub 2017 Jul 25.

Reznik Y, Cohen O, Aronson R, Conget I, Runzis S, Castaneda J, Lee SW; OpT2mise Study Group. Insulin pump treatment compared with multiple daily injections for treatment of type 2 diabetes (OpT2mise): a randomised open-label controlled trial. Lancet. 2014 Oct 4;384(9950):1265-72. doi: 10.1016/S0140-6736(14)61037-0. Epub 2014 Jul 2.

Responsible Party:	Medtronic Diabetes
ClinicalTrials.gov Identifier:	NCT01182493 History of Changes
Other Study ID Numbers:	EUR05 / CEP234
First Posted:	August 16, 2010
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