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

This study has been completed.
Information provided by (Responsible Party):
Medtronic Identifier:
First received: August 11, 2010
Last updated: February 17, 2016
Last verified: February 2016
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 Intervention Phase
Diabetes Mellitus, Type 2
Device: Insulin Pump (Medtronic Minimed Paradigm® VEO)
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: OpT2mise Glucose Control in Type 2 DM With Insulin Pump Therapy

Resource links provided by NLM:

Further study details as provided by Medtronic:

Primary Outcome Measures:
  • Between Group Difference in HbA1c When Comparing CSII to MDI [ Time Frame: 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

Secondary Outcome Measures:
  • Change in Glycemic Variability [ Time Frame: 6 months ]
    Glycemic parameters calculated from blinded CGM data: Measure of the Average glucose/day; AUC in hypo- (≤70mg/dL) and in hyperglycemia (≥180 mg/dL; Time spent in hypo- (≤70mg/dL) and hyperglycemia (≥180 mg/dL); Mean Amplitude of Glycemic Excursions (MAGE) is the most common measure of the volatility of blood glucose levels; Standard deviation

  • Safety [ Time Frame: 6 months treatment and 6 months follow-up ]
    Severe hypoglycemia incidence; Diabetic Ketoacidosis incidence and Diabetes related hospitalizations

  • Change in Postprandial Glycemia [ Time Frame: 6 months ]
    Change in mean postprandial hyperglycemia 0 to 2 hours post meal, defined as ≥180 mg/dl and measured by SMBG

  • Quality of Life and Treatment Satisfaction [ Time Frame: 6 months ]
  • Change in Body Weight or BMI, Lipids and Blood Pressure [ Time Frame: 6 months ]

Enrollment: 495
Study Start Date: December 2010
Study Completion Date: August 2014
Primary Completion Date: February 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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 first 6-months phase (2-arms parallel) will be followed by another 6-months continuation phase (single cross-over of the MDI arm alone switching to CSII).


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

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
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, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01182493

  Hide Study Locations
United States, Georgia
Atlanta Diabetes Associates
Atlanta, Georgia, United States, 30318
United States, New York
Albany Medical College
Albany, New York, United States, 12208
SUNY Upstate Medical University
Syracuse, New York, United States, 13210
City hopital Vienna-Hieting
Vienna, Austria, 1130
Canada, Alberta
Clinical Professor Department of Medicine University of Calgary
Calgary, Alberta, Canada, T3B 0M3
Canada, British Columbia
Endocrinologist, 202-301 Columbia Street East
New Westminster, British Columbia, Canada, V3L 3W5
416-1033 Davie St
Vancouver, British Columbia, Canada, V6E 1M7
Canada, Newfoundland and Labrador
Health Science Centre
St. John's, Newfoundland and Labrador, Canada, A1B 3V6
Canada, Ontario
LMC Endocrinology Centre
Oakville, Ontario, Canada, L6H 3P1
Canadian Centre for Research on Diabetes
Smiths' Falls, Ontario, Canada, K7A 4W8
Toronto General Hsopital
Toronto, Ontario, Canada, M5G 2C4
Canada, Quebec
McGill University, McGill Nutrition and Food Science Centre
Montreal, Quebec, Canada, H3A 1A1
CHU Côte de Nacre
Caen, France, 14033
CHU - Ste Marguerite
Marseille, France, 13274
Hopital Lapeyronie
Montpellier, France, 34295
CHU de Nancy
Nancy, France, 54500
CHU Strasbourg
Strasbourg, France, 67091
CHU Toulouse Rangueil
Toulouse, France, 31059
Fachklinik Bad Heilbrunn
Bad Heilbrunn, Germany, 83670
Zentrum für Diabetes und Gefäßerkrankungen
Münster, Germany, 48145
Péterfy Hospital and Emergency Center Diabetes Outpatient Clinic
Budapest, Hungary, 1076
Soroka University Medical Center
Beer-Sheva, Israel, 84105
Diabetic Clinic
Jerusalem, Israel, 93106
Chaim Sheba Medical center Endocrinology unit
Tel Hashomer - Ramat Gan, Israel, 5262
Assaf- Harofeh Medical Center
Zerifin, Israel, 70300
Università degli Studi di Bari - Policlinico Universitario
Bari, Italy, 70124
Universita di Perugia - Ospedale S.M. Della Misericordia
Perugia, Italy, 06132
University La Sapienza - Policlinico
Roma, Italy, 00161
Macedonia, The Former Yugoslav Republic of
University Clinic of Endocrinology
Skopje, Macedonia, The Former Yugoslav Republic of, 1000
IJsselland Ziekenhuis Poli Interne geneeskunde
Capelle a/d IJssel, Netherlands, 2906
Maxima Medisch Centrum
Eindhoven, Netherlands, 5600
Bethesda Diabetes Research Center
Hoogeveen, Netherlands, 7900
Clinic for Endocrinology, Diabetes and Metabolic Diseases
Belgrade, Serbia, 11 000
South Africa
Centre for Diabetes and Endocrinology
Johannesburg, South Africa, 2198
Dr.Garcjan Podgorski
Port Elizabeth, South Africa, 6001
ICMDM Hospital Clínic i Universitari
Barcelona, Spain, 08036
Sponsors and Collaborators
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

Additional Information:
Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Medtronic Identifier: NCT01182493     History of Changes
Other Study ID Numbers: EUR05 / CEP234
Study First Received: August 11, 2010
Results First Received: February 17, 2016
Last Updated: February 17, 2016
Individual Participant Data  
Plan to Share IPD: No

Keywords provided by Medtronic:
Diabetes Mellitus
pump therapy

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Insulin, Globin Zinc
Hypoglycemic Agents
Physiological Effects of Drugs processed this record on May 22, 2017