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Diabetes Mellitus, Type 2OpT2miseNCT01182493

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

A study testing Insulin Pump (Medtronic Minimed Paradigm® VEO) in people with Diabetes Mellitus, Type 2, run by Medtronic MiniMed, Inc. at 36 sites in 13 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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). Read more about this study

Who is it for?
Ages 30 to 75 years
Conditions the study is for
Diabetes Mellitus, Type 2
What is being tested?
Insulin Pump (Medtronic Minimed Paradigm® VEO)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
331 participants
Where
36 sitesin 13 countries
Study dates
Dec 2010to Aug 2014
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 30 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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

Who cannot join

  • 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
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  • 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)

Trial locations and contacts

36 sites in 13 countries.

36 sites in 13 countries

Canada8 sites

  • Clinical Professor Department of Medicine University of Calgary

    Calgary, Alberta, T3B 0M3

  • McGill University, McGill Nutrition and Food Science Centre

    Montreal, Quebec, H3A 1A1

  • Endocrinologist, 202-301 Columbia Street East

    New Westminster, British Columbia, V3L 3W5

  • LMC Endocrinology Centre

    Oakville, Ontario, L6H 3P1

  • Canadian Centre for Research on Diabetes

    Smiths Falls, Ontario, K7A 4W8

  • Health Science Centre

    St. John's, Newfoundland and Labrador, A1B 3V6

  • Toronto General Hsopital

    Toronto, Ontario, M5G 2C4

  • 416-1033 Davie St

    Vancouver, British Columbia, V6E 1M7

Other trials in Canada

France6 sites

  • CHU Côte de Nacre

    Caen, 14033

  • CHU - Ste Marguerite

    Marseille, 13274

  • Hopital Lapeyronie

    Montpellier, 34295

  • CHU de Nancy

    Nancy, 54500

  • CHU Strasbourg

    Strasbourg, 67091

  • CHU Toulouse Rangueil

    Toulouse, 31059

Other trials in France

Israel4 sites

  • Soroka University Medical Center

    Beersheba, 84105

  • Diabetic Clinic

    Jerusalem, 93106

  • Chaim Sheba Medical center Endocrinology unit

    Tel Hashomer - Ramat Gan, 5262

  • Assaf- Harofeh Medical Center

    Tsrifin, 70300

Other trials in Israel

United States3 sites

  • Albany Medical College

    Albany, New York, 12208

  • Atlanta Diabetes Associates

    Atlanta, Georgia, 30318

  • SUNY Upstate Medical University

    Syracuse, New York, 13210

Other trials in United States

Italy3 sites

  • Università degli Studi di Bari - Policlinico Universitario

    Bari, 70124

  • Universita di Perugia - Ospedale S.M. Della Misericordia

    Perugia, 06132

  • University La Sapienza - Policlinico

    Roma, 00161

Other trials in Italy

Netherlands3 sites

  • IJsselland Ziekenhuis Poli Interne geneeskunde

    Capelle aan den IJssel, 2906

  • Maxima Medisch Centrum

    Eindhoven, 5600

  • Bethesda Diabetes Research Center

    Hoogeveen, 7900

Other trials in Netherlands

Germany2 sites

  • Fachklinik Bad Heilbrunn

    Bad Heilbrunn, 83670

  • Zentrum für Diabetes und Gefäßerkrankungen

    Münster, 48145

Other trials in Germany

South Africa2 sites

  • Centre for Diabetes and Endocrinology

    Johannesburg, 2198

  • Dr.Garcjan Podgorski

    Port Elizabeth, 6001

Other trials in South Africa

Austria1 site

  • City hopital Vienna-Hieting

    Vienna, 1130

Other trials in Austria

Hungary1 site

  • Péterfy Hospital and Emergency Center Diabetes Outpatient Clinic

    Budapest, 1076

Other trials in Hungary

North Macedonia1 site

  • University Clinic of Endocrinology

    Skopje, 1000

Other trials in North Macedonia

Serbia1 site

  • Clinic for Endocrinology, Diabetes and Metabolic Diseases

    Belgrade, 11 000

Other trials in Serbia

Spain1 site

  • ICMDM Hospital Clínic i Universitari

    Barcelona, 08036

Other trials in Spain

About this study

Official title: OpT2mise Glucose Control in Type 2 DM With Insulin Pump Therapy

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).

Read the 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.

Being tested
Insulin Pump (Medtronic Minimed Paradigm® VEO)
Keywords
Diabetes Mellitus, MDI, pump therapy
Medical subject headings
Diabetes Mellitus, Type 2, Diabetes Mellitus

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Insulin Pump (Medtronic Minimed Paradigm® VEO)Device

    Also called Medtronic MiniMed Paradigm® VEO system (MMT-554/754

    The pump delivers insulin as specified by the patient

Study groups in NCT01182493
Study groupRoleWhat they receive
Insulin Pump TreatmentExperimentalPatients will get an insulin pump
Receives: Device: Insulin Pump (Medtronic Minimed Paradigm® VEO)
Insulin treatment with MDINo interventionpatients treated with Multiple Daily Injections (MDI); basal/bolus therapy with rapid- and long-acting analogs with at least 3 injections per day

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Between Group Difference in HbA1c When Comparing CSII to MDI

    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

    Measured: baseline and 6 months

Secondary outcomes (6)

  1. Change in Glycemic Variability - AUC in Hypo (≤70mg/dL)

    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

    Measured: 6 months

  2. Safety - Severe Hypoglycemia Incidence

    Severe hypoglycemia incidence during the study

    Measured: 6 months

  3. Change in Glycemic Variability - AUC in Hyper (≥180mg/dL)

    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

    Measured: 6 months

  4. Quality of Life and Treatment Satisfaction - Results From Diabetes Treatment Satisfaction Questionnaire (DTSQ)

    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

    Measured: 6 months

  5. Change in Body Weight

    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

    Measured: 6 months

  6. Safety - Diabetic Ketoacidosis Incidence

    Diabetic Ketoacidosis incidence during the study

    Measured: 6 Months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Aug 2010 (estimated)
  2. Study startDec 2010
  3. Primary completionFeb 2014
  4. Study completionAug 2014

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
331 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01182493
Sponsor's protocol ID
EUR05 / CEP234
Acronym
OpT2mise
Status last verified
Feb 2018
First submitted
11 Aug 2010
Last updated
12 Mar 2018
Data monitoring committee
Yes
Individual data sharing
No

Publications

  • Chlup R, Runzis S, Castaneda J, Lee SW, Nguyen X, Cohen O. Complex Assessment of Metabolic Effectiveness of Insulin Pump Therapy in Patients with Type 2 Diabetes Beyond HbA1c Reduction. Diabetes Technol Ther. 2018 Feb;20(2):153-159. doi: 10.1089/dia.2017.0283. Epub 2017 Dec 7.

    PubMed 29215299

  • Metzger M, Castaneda 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.

    PubMed 28374511

  • 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.

    PubMed 24998009

Questions about this trial

What is this clinical trial studying?

A study testing Insulin Pump (Medtronic Minimed Paradigm® VEO) in people with Diabetes Mellitus, Type 2, run by Medtronic MiniMed, Inc. at 36 sites in 13 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 17 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 12 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 36 sites in Canada, France, Israel, United States, Italy and 8 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 15 Mar 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Between Group Difference in HbA1c When Comparing CSII to MDI (time frame: baseline and 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01182493, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Mar 2018.

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