Comparison of Hepatic Directed Vesicle (HDV)-Insulin Lispro Versus Insulin Lispro to Further Improve Glycemic Control

• Status: Completed
• Trial end date: 2018-03-18
• Target enrollment: 0
• Participant gender: All

Summary

Multi-Center, double blind, active comparator controlled multiple dose safety, tolerability and efficacy study

• 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. Male or female of age 18 to 65 years, inclusive. Females of child-bearing potential must use a standard and effective means of birth control for the duration of the study

2. T1DM ≥12 months

3. C-peptide <0.6 ng/mL (single retest allowed)

4. Treatment with rapid analog insulin for the previous 6 months and willing to use insulin vial and syringe to deliver rapid acting insulin during the study

5. Currently using either insulin glargine (U100 only) or insulin degludec for basal insulin therapy for at least 4 weeks prior to study

6. Not using insulin pump delivery systems during the previous 3 months

7. Familiarity with continuous glucose monitoring (CGM) technology; subjects need to be not currently using CGM; subjects will NOT use unblinded CGM during the treatment period of the trial

8. Willingness to use insulin lispro as the analog bolus insulin during the study period

9. BMI ≥18.0 kg/m2 and ≤35.0 kg/m2

10. 6.9%≤A1C≤7.9% (single retest allowed)

Exclusion Criteria:

1. Known or suspected allergy to any component of any of the study drugs in this trial.

2. A patient who has unstable proliferative retinopathy or maculopathy, and/or severe neuropathy, in particular autonomic neuropathy, as judged by the Investigator

3. As judged by the investigator, clinically significant active disease of the gastrointestinal, cardiovascular (including a history of arrhythmia or conduction delays on ECG), hepatic, neurological, renal, genitourinary, or hematological systems, or uncontrolled hypertension (diastolic blood pressure ≥ 100 mmHg and/or systolic blood pressure ≥ 160 mmHg after 5 minutes in the supine position).

4. History of any illness or disease that in the opinion of the Investigator might confound the results of the trial or pose additional risk in administering the study drugs to the patient.

5. As judged by the Investigator, clinically significant findings in routine laboratory data

6. Use of drugs that may interfere with the interpretation of trial results or are known to cause clinically relevant interference with insulin action, glucose utilization, or recovery from hypoglycemia

7. Use of oral anti-diabetic or non-insulin anti-diabetic injection therapies (e.g. SGLT-2 inhibitors, pramlintide, GLP-1 agonists, etc.) during the 4 weeks prior to randomization

8. Current smokers; if a former smoker, no tobacco products (inhaled, oral or buccal) for the previous 3 months

9. Use of e-cigarettes or other nicotine-containing products for the previous 3 months

10. Current addiction to alcohol or substances of abuse as determined by the Investigator.

11. Pregnancy, breast-feeding, the intention of becoming pregnant, or not using adequate contraceptive measures (adequate contraceptive measures consist of sterilization, intra-uterine device [IUD], oral or injectable contraceptives, barrier methods or abstinence as per investigator discretion).

12. Mental incapacity, unwillingness, or language barriers precluding adequate understanding or cooperation in this study

13. Symptomatic gastroparesis.

14. Receipt of any investigational drug within 4 weeks of Visit 2 in this study

15. Any condition (intrinsic or extrinsic) that in the judgment of the Investigator will interfere with trial participation or evaluation of data