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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Medtronic
ClinicalTrials.gov Identifier:
NCT01182493
First received: August 11, 2010
Last updated: July 17, 2014
Last verified: July 2014
  Purpose

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
Endpoint Classification: Efficacy Study
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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: Yes ]
    Severe hypoglycemia incidence; Diabetic Ketoacidosis incidence and Diabetes related hospitalizations

  • Change in postprandial glycemia [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
  • Change in body weight or BMI, Lipids and blood pressure [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Enrollment: 495
Study Start Date: December 2010
Estimated 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).

  Eligibility

Ages Eligible for Study:   30 Years to 75 Years
Genders Eligible for Study:   Both
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
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 ClinicalTrials.gov identifier: NCT01182493

  Show 36 Study Locations
Sponsors and Collaborators
Medtronic
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

Additional Information:
No publications provided by Medtronic

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Medtronic
ClinicalTrials.gov Identifier: NCT01182493     History of Changes
Other Study ID Numbers: EUR05 / CEP234
Study First Received: August 11, 2010
Last Updated: July 17, 2014
Health Authority: Austria: Agency for Health and Food Safety
Austria: Ethikkommission
Canada: Ethics Review Committee
Canada: Health Canada
Czech Republic: Ethics Committee
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
France: Comité consultatif sur le traitement de l'information en matière de recherche dans le domaine de la santé
France: Direction Générale de la Santé
France: Institutional Ethical Committee
France: Agence Nationale de Sécurité du Médicament et des produits de santé
France: The Commission nationale de l’informatique et des libertés
Germany: Ethics Commission
Germany: Federal Institute for Drugs and Medical Devices
Hungary: Institutional Ethics Committee
Hungary: National Institute for Quality and Organizational Development in Healthcare and Medicines
Hungary: Research Ethics Medical Committee
Hungary: Scientific and Medical Research Council Ethics Committee
Israel: Ethics Commission
Israel: Israeli Health Ministry Pharmaceutical Administration
Israel: Ministry of Health
Italy: Ethics Committee
Italy: National Institute of Health
Macedonia: Ethics Committee
Macedonia: Ministry of Health
Netherlands: Independent Ethics Committee
Netherlands: Dutch Health Care Inspectorate
Netherlands: Medical Ethics Review Committee (METC)
Serbia: Ethics Committee
South Africa: Human Research Ethics Committee
South Africa: National Health Research Ethics Council
Spain: Ethics Committee
Spain: Ministry of Health
United States: Institutional Review Board

Keywords provided by Medtronic:
Diabetes Mellitus
MDI
pump therapy

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Endocrine System Diseases
Glucose Metabolism Disorders
Metabolic Diseases
Insulin
Insulin, Globin Zinc
Hypoglycemic Agents
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on October 23, 2014