Study of HDV Insulin Versus Insulin in Type 1 Diabetes Subjects (ISLE-1)

• Status: Completed
• Trial end date: 2018-06-15
• Target enrollment: 0
• Participant gender: All

Summary

This will be a Phase 2b, multicenter, randomized, double blind, titration clinical study, evaluating the efficacy and safety in the HDV Insulin Lispro Group versus Insulin Lispro Group in patients with type 1 diabetes over a 26 week treatment period. The patients will be randomized using a centrally allocated randomization scheme to 1 of the 2 treatment arms in an overall 2:1 scheme (HDV Insulin Lispro: Insulin Lispro). Both arms will receive the randomized treatment in combination with glargine or detemir. Goal to demonstrate that the efficacy of HDV insulin lispro administered in combination with a basal insulin (HDV Insulin Lispro group) is non-inferior to insulin lispro in combination with a basal insulin (Insulin Lispro group), in effects on glycated hemoglobin (HbA1c) in patients with type 1 diabetes. If non-inferiority is demonstrated, confirm that HDV insulin lispro in combination with a basal insulin (HDV Insulin Lispro group) is superior to insulin lispro in combination with a basal insulin (Insulin Lispro group), in effects on HbA1c in patients with type 1 diabetes (≥ 0.4% decrease in HbA1c).

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Diasome Pharmaceuticals
• Collaborator: Integrium
• Treatments: Insulin; Insulin Lispro; Insulin, Globin Zinc

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.