Clinical trial NCT01182493: OpT2mise Glucose Control in Type 2 Diabetes Mellitus (DM) With Insulin Pump Therapy
Official title: OpT2mise Glucose Control in Type 2 DM With Insulin Pump Therapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus, Type 2
Keywords: Diabetes Mellitus
MDI
pump therapy
Lead sponsor: Medtronic Diabetes
Sponsor class: INDUSTRY
First posted: 2010-08-16
Enrollment: 331
Sex: ALL
Minimum age (years): 30
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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)

Primary outcomes:
measure: Between Group Difference in HbA1c When Comparing CSII to MDI
timeFrame: baseline and 6 months
Secondary outcomes:
measure: Change in Glycemic Variability - AUC in Hypo (≤70mg/dL)
timeFrame: 6 months
measure: Safety - Severe Hypoglycemia Incidence
timeFrame: 6 months
measure: Change in Glycemic Variability - AUC in Hyper (≥180mg/dL)
timeFrame: 6 months
measure: Quality of Life and Treatment Satisfaction - Results From Diabetes Treatment Satisfaction Questionnaire (DTSQ)
timeFrame: 6 months
measure: Change in Body Weight
timeFrame: 6 months
measure: Safety - Diabetic Ketoacidosis Incidence
timeFrame: 6 Months
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Atlanta Diabetes Associates
state: Georgia
city: Albany
country: United States
facility: Albany Medical College
state: New York
city: Syracuse
country: United States
facility: SUNY Upstate Medical University
state: New York
city: Vienna
country: Austria
facility: City hopital Vienna-Hieting
city: Calgary
country: Canada
facility: Clinical Professor Department of Medicine University of Calgary
state: Alberta
city: New Westminster
country: Canada
facility: Endocrinologist, 202-301 Columbia Street East
state: British Columbia
city: Vancouver
country: Canada
facility: 416-1033 Davie St
state: British Columbia
city: St. John's
country: Canada
facility: Health Science Centre
state: Newfoundland and Labrador
city: Oakville
country: Canada
facility: LMC Endocrinology Centre
state: Ontario
city: Smiths' Falls
country: Canada
facility: Canadian Centre for Research on Diabetes
state: Ontario
city: Toronto
country: Canada
facility: Toronto General Hsopital
state: Ontario
city: Montreal
country: Canada
facility: McGill University, McGill Nutrition and Food Science Centre
state: Quebec
city: Caen
country: France
facility: CHU Côte de Nacre
city: Marseille
country: France
facility: CHU - Ste Marguerite
city: Montpellier
country: France
facility: Hopital Lapeyronie
city: Nancy
country: France
facility: CHU de Nancy
city: Strasbourg
country: France
facility: CHU Strasbourg
city: Toulouse
country: France
facility: CHU Toulouse Rangueil
city: Bad Heilbrunn
country: Germany
facility: Fachklinik Bad Heilbrunn
city: Münster
country: Germany
facility: Zentrum für Diabetes und Gefäßerkrankungen
city: Budapest
country: Hungary
facility: Péterfy Hospital and Emergency Center Diabetes Outpatient Clinic
city: Beer-Sheva
country: Israel
facility: Soroka University Medical Center
city: Jerusalem
country: Israel
facility: Diabetic Clinic
city: Tel Hashomer - Ramat Gan
country: Israel
facility: Chaim Sheba Medical center Endocrinology unit
city: Zerifin
country: Israel
facility: Assaf- Harofeh Medical Center
city: Bari
country: Italy
facility: Università degli Studi di Bari - Policlinico Universitario
city: Perugia
country: Italy
facility: Universita di Perugia - Ospedale S.M. Della Misericordia
city: Roma
country: Italy
facility: University La Sapienza - Policlinico
city: Skopje
country: Macedonia, The Former Yugoslav Republic of
facility: University Clinic of Endocrinology
city: Capelle A/d IJssel
country: Netherlands
facility: IJsselland Ziekenhuis Poli Interne geneeskunde
city: Eindhoven
country: Netherlands
facility: Maxima Medisch Centrum
city: Hoogeveen
country: Netherlands
facility: Bethesda Diabetes Research Center
city: Belgrade
country: Serbia
facility: Clinic for Endocrinology, Diabetes and Metabolic Diseases
city: Johannesburg
country: South Africa
facility: Centre for Diabetes and Endocrinology
city: Port Elizabeth
country: South Africa
facility: Dr.Garcjan Podgorski
city: Barcelona
country: Spain
facility: ICMDM Hospital Clínic i Universitari
Study officials:
affiliation: Chaim Sheba Medical Center, Tel Hashomer, Israel
name: Ohad Cohen, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: ICMDM Hospital Clínic i, Barcelona, Spain
name: Ignacio Conget, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: CHU Côte de Nacre, France
name: Yves Reznic, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: FRCPC, FACE LMC Endocrinology Centres, Canada
name: Ronnie Aronson, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.