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

Diabetes Mellitus, Type 2 Clinical Trial

— OpT2mise  

Official title:

OpT2mise Glucose Control in Type 2 DM With Insulin Pump Therapy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01182493
• Other study ID #: EUR05 / CEP234
• Status: Completed
• Phase: N/A
• First received: August 11, 2010
• Last updated: February 6, 2018
• Start date: December 2010
• Est. completion date: August 2014

Study information

• Verified date: February 2018
• Source: Medtronic Diabetes
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 331
• Est. completion date: August 2014
• Est. primary completion date: February 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years to 75 Years

Eligibility

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)

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2

Intervention

Device:
• Insulin Pump (Medtronic Minimed Paradigm® VEO)
The pump delivers insulin as specified by the patient

Locations

Country	Name	City	State
Austria	City hopital Vienna-Hieting	Vienna
Canada	Clinical Professor Department of Medicine University of Calgary	Calgary	Alberta
Canada	McGill University, McGill Nutrition and Food Science Centre	Montreal	Quebec
Canada	Endocrinologist, 202-301 Columbia Street East	New Westminster	British Columbia
Canada	LMC Endocrinology Centre	Oakville	Ontario
Canada	Canadian Centre for Research on Diabetes	Smiths' Falls	Ontario
Canada	Health Science Centre	St. John's	Newfoundland and Labrador
Canada	Toronto General Hsopital	Toronto	Ontario
Canada	416-1033 Davie St	Vancouver	British Columbia
France	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
Germany	Fachklinik Bad Heilbrunn	Bad Heilbrunn
Germany	Zentrum für Diabetes und Gefäßerkrankungen	Münster
Hungary	Péterfy Hospital and Emergency Center Diabetes Outpatient Clinic	Budapest
Israel	Soroka University Medical Center	Beer-Sheva
Israel	Diabetic Clinic	Jerusalem
Israel	Chaim Sheba Medical center Endocrinology unit	Tel Hashomer - Ramat Gan
Israel	Assaf- Harofeh Medical Center	Zerifin
Italy	Università degli Studi di Bari - Policlinico Universitario	Bari
Italy	Universita di Perugia - Ospedale S.M. Della Misericordia	Perugia
Italy	University La Sapienza - Policlinico	Roma
Macedonia, The Former Yugoslav Republic of	University Clinic of Endocrinology	Skopje
Netherlands	IJsselland Ziekenhuis Poli Interne geneeskunde	Capelle A/d IJssel
Netherlands	Maxima Medisch Centrum	Eindhoven
Netherlands	Bethesda Diabetes Research Center	Hoogeveen
Serbia	Clinic for Endocrinology, Diabetes and Metabolic Diseases	Belgrade
South Africa	Centre for Diabetes and Endocrinology	Johannesburg
South Africa	Dr.Garcjan Podgorski	Port Elizabeth
Spain	ICMDM Hospital Clínic i Universitari	Barcelona
United States	Albany Medical College	Albany	New York
United States	Atlanta Diabetes Associates	Atlanta	Georgia
United States	SUNY Upstate Medical University	Syracuse	New York

Sponsors (1)

Lead Sponsor	Collaborator
Medtronic Diabetes

Countries where clinical trial is conducted

United States,  Austria,  Canada,  France,  Germany,  Hungary,  Israel,  Italy,  Macedonia, The Former Yugoslav Republic of,  Netherlands,  Serbia,  South Africa,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Change in Glycemic Variability - AUC in Hypo (=70mg/dL)	Glycemic parameters calculated from blinded CGM data: change in AUC (Area Under the Curve) in hypo- (=70mg/dL), among subjects with available AUC results. Change in hypo AUC = hypo AUC at 6 month - hypo AUC at baseline	6 months
Secondary	Safety - Severe Hypoglycemia Incidence	Severe hypoglycemia incidence during the study	6 months
Secondary	Change in Glycemic Variability - AUC in Hyper (=180mg/dL)	Glycemic parameters calculated from blinded CGM data: change in AUC (Area Under the Curve) in hyper- (=180mg/dL), among subjects with available AUC results. Change in hyper AUC = hyper AUC at 6 month - hyper AUC at baseline	6 months
Secondary	Quality of Life and Treatment Satisfaction - Results From Diabetes Treatment Satisfaction Questionnaire (DTSQ)	Subjects were asked to complete the Diabetes Treatment Satisfaction Questionnaire (DTSQs). Treatment satisfaction is measured by means of the DTSQs, status version (DTSQs, Bradley, 1990). It consists of a six-item scale assessing treatment satisfaction (TS) and two items assessing perceived frequency of hyperglycaemia and hypoglycaemia. The DTSQs items are scored on a scale from 0 to 6. The scale total is computed by adding the six items 1, 4, 5, 6, 7, and 8, to produce the Treatment Satisfaction scale total, which has a min of 0 and a max of 36. Higher score at 6 month compared to baseline represents a better outcome. Change in treatment satisfaction = score at 6 month - score at baseline, among subjects with available satisfaction scores	6 months
Secondary	Change in Body Weight	Change in body weight from randomization to the end of study. Change in body weight = weight at 6 month - weight at baseline, among subjects with available body weight	6 months
Secondary	Safety - Diabetic Ketoacidosis Incidence	Diabetic Ketoacidosis incidence during the study	6 Months

External Links

•   Publication of primary endpoints in the Lancet