Multi-Center Study Comparing Efficacy and Safety of Frequently Modified Insulin Therapy

This is an interventional treatment trial for Diabetes Mellitus, Type 2 Read More

Inclusion Criteria:

1. 21 to 70 years of age
2. If female, must be of non-childbearing potential or have a negative urine pregnancy test at screening and using adequate method of contraception throughout conduct of the study
3. Clinical diagnosis of Type-2 diabetes for at least 1-year
4. HbA1c 7.5% to 11% inclusive

5. Total daily dose of insulin of 25 units or more (10 units if on Lantus® alone) using one of these insulin regimens:

   • Regimen 1 - a single injection of the long-acting insulin analog Lantus® (Glargine) per day (limited to a daily dose that is no more than 0.7 units per kg of body weight);
   • Regimen 2 - twice daily biphasic insulin (i.e., Humalog® Mix 75/25, NovoLog® Mix 70/30) or pre-mixed insulin (i.e., Humulin® 70/30, Novolin® 70/30);
   • Regimen 3 - a short-acting insulin analog (i.e., Humalog®-Lispro, NovoLog®-Aspart, Apidra®-Glulisine) before each meal and are treated with a single injection of the long-acting insulin analog Lantus® (Glargine) per day and do not utilize an insulin/carbohydrate ratio for calculating their short-acting insulin doses; or
   • Regimen 4 - with a short-acting insulin analog (i.e., Humalog®-Lispro, NovoLog®-Aspart, Apidra®-Glulisine) before each meal and a single injection of the long-acting insulin analog Lantus® (Glargine) per day and utilize an insulin/carbohydrate ratio for calculating their short-acting insulin doses.
6. On same insulin regimen for the previous 3-months
7. May be using other diabetes agents at a stable dose for the last 3-months
8. Signed and dated informed consent document, which contains HIPAA waiver information informing about all of the aspects of the clinical study;

9. Will regularly conduct Self-Monitored Blood Glucose. Prior to randomization must meet the following .

   Minimum number of tests required from all subjects:

   • Basal insulin subjects at least 4 fasting glucose readings/wk
   • Premixed insulin subjects at least 8 readings/wk
   • Basal-bolus insulin therapy subjects at least 16 total readings/wk

10. Willing and able to comply with the scheduled clinical study activities and glucose testing:

    • Basal insulin subjects at least 5 fasting glucose readings/wk
    • Premixed insulin subjects at least 5 pre-breakfast and 5 pre-evening meal readings/wk
    • Basal-bolus insulin therapy subjects at least 20 total readings/wk which include 5 readings before each of the following time points: breakfast, lunch, evening meal and bedtime.

    Note: All subjects may be asked to test during the night if clinically indicated.

11. Participant must have a primary care provider

Exclusion Criteria:

1. History >2 episodes of severe hypoglycemia (see definition below) in the past year, or hypoglycemic unawareness when glucose levels are ≤ 50 mg/dl;
2. Significant physical, psychological, or cognitive impairment that would prohibit adherence to the protocol at the discretion of the PI;
3. Splitting Lantus and taking Lantus twice a day
4. Severe cardiovascular disease including a history of congestive heart failure, unstable angina, myocardial infarction or stroke within the 6-months preceding enrollment;
5. Active anemia w/ hematocrit ≤ 25% in women or 30% in men;
6. Advanced kidney disease Stage 4 (eGFR < 30 ml/min) and above
7. Active cancer or cancer in the past 2-years (except non-melanoma skin cancer)
8. History of significant liver disease including cirrhosis or elevated liver enzymes (e.g., AST and ALT greater than 3 times the upper limit of normal values).
9. BMI > 45 kg/m2
10. Are pregnant, plan to become pregnant during the study period, or are breastfeeding.
11. Have a BGMS that cannot be downloaded.