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

NCT ID: NCT01182493

Last Updated: 2018-03-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 331 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-12-31
• Study Completion Date: 2014-08-31

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).

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Insulin Pump Treatment

Patients will get an insulin pump

Group Type: EXPERIMENTAL

Insulin Pump (Medtronic Minimed Paradigm® VEO)

Intervention Type: DEVICE

The pump delivers insulin as specified by the patient

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Insulin Pump (Medtronic Minimed Paradigm® VEO)

The pump delivers insulin as specified by the patient

Intervention Type: DEVICE

Other Intervention Names

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

Eligibility Criteria

Inclusion Criteria

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)

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Medtronic Diabetes

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ohad Cohen, MD

Role: PRINCIPAL_INVESTIGATOR

Chaim Sheba Medical Center, Tel Hashomer, Israel

Ignacio Conget, MD

Role: PRINCIPAL_INVESTIGATOR

ICMDM Hospital Clínic i, Barcelona, Spain

Yves Reznic, MD

Role: PRINCIPAL_INVESTIGATOR

CHU Côte de Nacre, France

Ronnie Aronson, MD

Role: PRINCIPAL_INVESTIGATOR

FRCPC, FACE LMC Endocrinology Centres, Canada

Locations

Atlanta Diabetes Associates

Atlanta, Georgia, United States

Albany Medical College

Albany, New York, United States

SUNY Upstate Medical University

Syracuse, New York, United States

City hopital Vienna-Hieting

Vienna, , Austria

Clinical Professor Department of Medicine University of Calgary

Calgary, Alberta, Canada

Endocrinologist, 202-301 Columbia Street East

New Westminster, British Columbia, Canada

416-1033 Davie St

Vancouver, British Columbia, Canada

Health Science Centre

St. John's, Newfoundland and Labrador, Canada

LMC Endocrinology Centre

Oakville, Ontario, Canada

Canadian Centre for Research on Diabetes

Smiths Falls, Ontario, Canada

Toronto General Hsopital

Toronto, Ontario, Canada

McGill University, McGill Nutrition and Food Science Centre

Montreal, Quebec, Canada

CHU Côte de Nacre

Caen, , France

CHU - Ste Marguerite

Marseille, , France

Hopital Lapeyronie

Montpellier, , France

CHU de Nancy

Nancy, , France

CHU Strasbourg

Strasbourg, , France

CHU Toulouse Rangueil

Toulouse, , France

Fachklinik Bad Heilbrunn

Bad Heilbrunn, , Germany

Zentrum für Diabetes und Gefäßerkrankungen

Münster, , Germany

Péterfy Hospital and Emergency Center Diabetes Outpatient Clinic

Budapest, , Hungary

Soroka University Medical Center

Beersheba, , Israel

Diabetic Clinic

Jerusalem, , Israel

Chaim Sheba Medical center Endocrinology unit

Tel Hashomer - Ramat Gan, , Israel

Assaf- Harofeh Medical Center

Ẕerifin, , Israel

Università degli Studi di Bari - Policlinico Universitario

Bari, , Italy

Universita di Perugia - Ospedale S.M. Della Misericordia

Perugia, , Italy

University La Sapienza - Policlinico

Roma, , Italy

IJsselland Ziekenhuis Poli Interne geneeskunde

Capelle aan den IJssel, , Netherlands

Maxima Medisch Centrum

Eindhoven, , Netherlands

Bethesda Diabetes Research Center

Hoogeveen, , Netherlands

University Clinic of Endocrinology

Skopje, , North Macedonia

Clinic for Endocrinology, Diabetes and Metabolic Diseases

Belgrade, , Serbia

Centre for Diabetes and Endocrinology

Johannesburg, , South Africa

Dr.Garcjan Podgorski

Port Elizabeth, , South Africa

ICMDM Hospital Clínic i Universitari

Barcelona, , Spain

Countries

United States; Austria; Canada; France; Germany; Hungary; Israel; Italy; Netherlands; North Macedonia; Serbia; South Africa; Spain

References

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.

Reference Type: DERIVED

PMID: 29215299 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 28374511 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 24998009 (View on PubMed)

Related Links

http://www.thelancet.com/journals/lancet/article/PIIS0140-6736(14)61037-0/abstract

Publication of primary endpoints in the Lancet

Other Identifiers

EUR05 / CEP234

Identifier Type: -

Identifier Source: org_study_id