Improving Glycaemic Control in Malaysian Patients With Type 2 Diabetes Mellitus With Insulin Pump Therapy

This is an interventional treatment trial for Type 2 Diabetes Mellitus focused on measuring insulin pump, basal bolus insulin Read More

Inclusion Criteria:

CRITERIA FOR INCLUSION AT SCREENING

1. Diagnosed with type 2 Diabetes Mellitus, as per Investigator diagnosis
2. HbA1c (DCCT-standard) must be ≥ 9.0% and ≤12%
3. Insulin resistance defined as required daily dose up to 1.5u/kg or a maximum of 200 units insulin per day
4. Aged 20 to 75 years old inclusive
5. On premixed regimen (human or analogue insulin) defined as ≥ 2 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

CRITERIA FOR INCLUSION AT RANDOMISATION

1. Diagnosed with type 2 DM, as per Investigator diagnosis
2. HbA1c (DCCT-standard) must be ≥ 9.0% and ≤12%
3. Insulin resistance defined as required daily dose up to 1.5 U/Kg or a maximum of 200 units per day
4. On premixed regimen (human or analogue insulin) defined as ≥ 2 injections per day for at least 3 months prior signing the informed consent
5. Ability to comply with technology, according to Investigator's judgment
6. ≥ 2.5 SMBG per day on average
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:

CRITERIA FOR EXCLUSION (AT SCREENING AND RANDOMISATION)

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
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 the patient 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 Use of a Glucagon Like Peptide-1 agonist or pramlintide (Symlin®). Glucagon Like Peptide-1 slows gastric emptying, thereby decreasing the rate of glucose absorption. Pramlintide (Symlin®) is a commercially available analogue of amylin, a synergistic partner to insulin.