21 Day Comparison of Continuous Insulin Infusion Using HDV Insulin to Standard Insulin in Type 1 Diabetes Mellitus

• Status: Completed
• Trial end date: 2018-03-15
• Target enrollment: 0
• Participant gender: All

Summary

Single Center, Double Blind, Active Comparator Controlled 2-Way Crossover 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. T1DM ≥12 months

2. C-peptide <0.6 ng/mL (a single re-test is allowable)

3. Treatment with rapid analog insulin by CSII for the previous 6 months

4. Familiarity with continuous glucose monitoring (CGM) technology; subjects nee d not be currently using CGM but should have used it in the past. Personal (unblinded) CGM will NOT be allowed during the study

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

6. Use of MiniMed Paradigm® pump for the previous 6 months. Pumps that employ low glucose suspend technology will NOT be allowed during the study

7. BMI ≥18.0 kg/m2 and ≤35.0 kg/m2

8. A1C≤9.0% (a single re-test is allowable)

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. Use of oral anti-diabetic or non-insulin anti-diabetic injection therapies (e.g. SGLT-2 inhibitors, pramlintide, GLP-1 agonists, etc.)

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

5. 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).

6. 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.