Clinical trial NCT02794155 (phase 2, status: completed)
Conditions: type 1 diabetes mellitus
ICD codes: E10.65, E10.9, E10.21, E10.36, E10.41, E10.42, E10.44
Drugs: hdv insulin lispro, insulin lispro
SMILES: [Na+].[Na+].[O-]P([O-])(F)=O, [Na+].[Na+].[O-]P([O-])(F)=O
Eligibility criteria:

        Inclusion Criteria:

          1. Men and women ≥ 18 yrs. of age

          2. Clinical diagnosis of Type 1 diabetes mellitus for at least 12 months

          3. Body Mass Index (BMI) ≤ 35 Kg/m2

          4. Basal insulin includes insulin Glargine or insulin Detemir

          5. Patient should be using bolus insulin defined as 2 to 4 doses of regular human insulin
             or rapid-acting analog at meals

          6. HbA1c ≥ 7.0% and ≤ 10.5%

          7. Fasting C-peptide ≤ 0.5 pmol/mL

          8. Willingness to adhere to protocol and perform all required tests

          9. Willing and able to review and sign the Informed Consent Form.

         10. If child bearing age, must use acceptable form of birth control (ligation, 2 forms of
             birth control)

         11. Willing to wear CGM devices and complete diaries.

        Exclusion Criteria:

          1. Total daily insulin dose ≥ 1.5 IU/kg/day.

          2. History of recent blood transfusions (within previous 3 months), hemoglobinopathies,
             or any other conditions that effect HbA1c measurements

          3. Evidence of serious complications of diabetes (eg, Symptomatic autonomic neuropathy)

          4. Patients who are selected to but are unwilling or unable to participate in the MRI
             evaluation subset. (These patients may still participate in the non-MRI subset).

          5. Significant cardiovascular dysfunction or history within 12 months of Screening, eg,
             congestive heart failure (New York Heart Association Class III or IV), or clinically
             significant arrhythmia, myocardial infarction, cardiac surgery; history of valvular
             heart disease including mild or greater aortic insufficiency, or moderate or greater
             mitral insufficiency; recurrent syncope, transient ischemic attacks, or
             cerebrovascular accident

          6. Impaired liver function with elevated enzymes > 50% above the normal range at
             Screening. Patients with elevated liver enzymes may have the test repeated only at
             Visit 2 on a case-by-case basis at the request of the PI.

          7. Creatinine level > 2 mg/dL for men, and > 1.8 mg/dL for women at Screening.

          8. Patient on low carbohydrate diet, such as Atkins Diet

          9. History of Adrenal supplementation within 3 years of Screening.

         10. History of unawareness or SEVERE recurrent hypoglycemia, defined as a patient who is
             unaware of symptoms of hypoglycemia, or due to autonomic dysfunction, has no inherent
             warnings of hypoglycemia, and therefore requires outside assistance to rectify any
             episodes of hypoglycemia

         11. Patients treated with systemic corticosteroids (Sporadic use of inhaled,
             intraarticular, and topical corticosteroids is not considered systemic).

         12. Patients with triglyceride levels ≥500 mg/dL at Screening.

         13. Patients with a history of cancer within the past 5 years, excluding basal or squamous
             cell carcinoma localized to the skin.

         14. Epilepsy or other physical or medical conditions which could result in non-compliance
             with the study.

         15. Participation in a clinical trial or use of an investigational drug within 30 days
             prior to admission to this study

         16. Unwilling to discontinue use of an insulin pump for the duration of the study.

         17. Women who are pregnant, nursing, or planning to become pregnant during the course of
             the study.

         18. Patients on NPH as their basal insulin.

         19. Positive history of hepatitis A (within 12 months of Screening), or a positive history
             of hepatitis B, hepatitis C, or HIV at Screening.

         20. History of drug addiction and/or alcohol abuse within 12 months of Screening.