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

NCT01182493 | Completed Results DMC

• 1 other identifier: EUR05 / CEP234
• Study Type: interventional
• Target: 331
• Locations: 13 countries
• Sites: 36

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).

Conditions

Diabetes Mellitus, Type 2

Keywords

Diabetes Mellitus; MDI; pump therapy

Outcome Measures

Primary Outcomes (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

  baseline and 6 months

Secondary Outcomes (6)

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

  6 months

• Safety - Severe Hypoglycemia Incidence

  6 months

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

  6 months

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

  6 months

• Change in Body Weight

  6 months

Study Arms (2)

Insulin Pump Treatment

EXPERIMENTAL

Patients will get an insulin pump

Device: Insulin Pump (Medtronic Minimed Paradigm® VEO)

Insulin treatment with MDI

NO INTERVENTION

patients treated with Multiple Daily Injections (MDI); basal/bolus therapy with rapid- and long-acting analogs with at least 3 injections per day

Interventions

Insulin Pump (Medtronic Minimed Paradigm® VEO) DEVICE

The pump delivers insulin as specified by the patient

Also known as: Medtronic MiniMed Paradigm® VEO system (MMT-554/754

Insulin Pump Treatment

Eligibility Criteria

• Age: 30 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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
• nd 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

Sponsors & Collaborators

• Medtronic Diabetes: lead

Study Sites (36)

Atlanta Diabetes Associates

Atlanta, Georgia, 30318, United States

Location

Albany Medical College

Albany, New York, 12208, United States

Location

SUNY Upstate Medical University

Syracuse, New York, 13210, United States

Location

City hopital Vienna-Hieting

Vienna, 1130, Austria

Location

Clinical Professor Department of Medicine University of Calgary

Calgary, Alberta, T3B 0M3, Canada

Location

Endocrinologist, 202-301 Columbia Street East

New Westminster, British Columbia, V3L 3W5, Canada

Location

416-1033 Davie St

Vancouver, British Columbia, V6E 1M7, Canada

Location

Health Science Centre

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

Location

LMC Endocrinology Centre

Oakville, Ontario, L6H 3P1, Canada

Location

Canadian Centre for Research on Diabetes

Smiths Falls, Ontario, K7A 4W8, Canada

Location

Toronto General Hsopital

Toronto, Ontario, M5G 2C4, Canada

Location

McGill University, McGill Nutrition and Food Science Centre

Montreal, Quebec, H3A 1A1, Canada

Location

CHU Côte de Nacre

Caen, 14033, France

Location

CHU - Ste Marguerite

Marseille, 13274, France

Location

Hopital Lapeyronie

Montpellier, 34295, France

Location

CHU de Nancy

Nancy, 54500, France

Location

CHU Strasbourg

Strasbourg, 67091, France

Location

CHU Toulouse Rangueil

Toulouse, 31059, France

Location

Fachklinik Bad Heilbrunn

Bad Heilbrunn, 83670, Germany

Location

Zentrum für Diabetes und Gefäßerkrankungen

Münster, 48145, Germany

Location

Péterfy Hospital and Emergency Center Diabetes Outpatient Clinic

Budapest, 1076, Hungary

Location

Soroka University Medical Center

Beersheba, 84105, Israel

Location

Diabetic Clinic

Jerusalem, 93106, Israel

Location

Chaim Sheba Medical center Endocrinology unit

Tel Hashomer - Ramat Gan, 5262, Israel

Location

Assaf- Harofeh Medical Center

Ẕerifin, 70300, Israel

Location

Università degli Studi di Bari - Policlinico Universitario

Bari, 70124, Italy

Location

Universita di Perugia - Ospedale S.M. Della Misericordia

Perugia, 06132, Italy

Location

University La Sapienza - Policlinico

Roma, 00161, Italy

Location

IJsselland Ziekenhuis Poli Interne geneeskunde

Capelle aan den IJssel, 2906, Netherlands

Location

Maxima Medisch Centrum

Eindhoven, 5600, Netherlands

Location

Bethesda Diabetes Research Center

Hoogeveen, 7900, Netherlands

Location

University Clinic of Endocrinology

Skopje, 1000, North Macedonia

Location

Clinic for Endocrinology, Diabetes and Metabolic Diseases

Belgrade, 11 000, Serbia

Location

Centre for Diabetes and Endocrinology

Johannesburg, 2198, South Africa

Location

Dr.Garcjan Podgorski

Port Elizabeth, 6001, South Africa

Location

ICMDM Hospital Clínic i Universitari

Barcelona, 08036, Spain

Location

Related Publications (3)

• 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.

  PMID: 29215299 DERIVED

• 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.

  PMID: 28374511 DERIVED

• 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.

  PMID: 24998009 DERIVED

Related Links

• Publication of primary endpoints in the Lancet

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Results Point of Contact

• Title: Prof. Yves Reznik
• Organization: CHU Caen

reznik-y@chu-caen.fr

+33231064585

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 11, 2010
• First Posted: August 16, 2010
• Study Start: December 1, 2010
• Primary Completion: February 1, 2014
• Study Completion: August 1, 2014
• Last Updated: March 12, 2018
• Results First Posted: March 15, 2016

Record last verified: 2018-02

Data Sharing

• IPD Sharing: Will not share

Locations

ZA (2); DE (2); NL (3); CA (8); NO (1); FR (6); IL (4); HU (1); AU (1); US (3); IT (3); SE (1); ES (1)