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

Completed · Phase 2

Conditions studied: Type1 Diabetes Mellitus

In brief

Single Center, Double Blind, Active Comparator Controlled 2-Way Crossover Multiple Dose Safety, Tolerability and Efficacy Study

Key facts

Study ID

NCT03156361

Run by

Diasome Pharmaceuticals

People needed

24

Starts

2017-05-18

Expected to finish

2018-03-15

Last updated by the study team

2018-07-31

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• T1DM ≥12 months
• C-peptide <0.6 ng/mL (a single re-test is allowable)
• Treatment with rapid analog insulin by CSII for the previous 6 months
• 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
• Willingness to use insulin lispro as the analog insulin during the study period
• Use of MiniMed Paradigm® pump for the previous 6 months. Pumps that employ low glucose suspend technology will NOT be allowed during the study
• BMI ≥18.0 kg/m2 and ≤35.0 kg/m2
• A1C≤9.0% (a single re-test is allowable)

You may not qualify if…

• Known or suspected allergy to any component of any of the study drugs in this trial.
• A patient who has unstable proliferative retinopathy or maculopathy, and/or severe neuropathy, in particular autonomic neuropathy, as judged by the Investigator.
• Use of oral anti-diabetic or non-insulin anti-diabetic injection therapies (e.g. SGLT-2 inhibitors, pramlintide, GLP-1 agonists, etc.)
• Current smokers; if a former smoker, no tobacco products (inhaled, oral or buccal) for the previous 3 months
• 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).
• 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.

Where it is running

• Atlanta Diabetes Association — Atlanta, Georgia, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.