Type1 Diabetes Mellitus Clinical Trial
Official title:
A Randomized Controlled Trial Comparing 21 Days of Continuous Subcutaneous Insulin Infusion (CSII) Using Hepatic Directed Vesicle (HDV) Insulin to Standard CSII in Type 1 Diabetes Mellitus
Verified date | April 2017 |
Source | Diasome Pharmaceuticals |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Single Center, Double Blind, Active Comparator Controlled 2-Way Crossover Multiple Dose Safety, Tolerability and Efficacy Study
Status | Completed |
Enrollment | 24 |
Est. completion date | March 15, 2018 |
Est. primary completion date | January 15, 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility |
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. |
Country | Name | City | State |
---|---|---|---|
United States | Atlanta Diabetes Association | Atlanta | Georgia |
Lead Sponsor | Collaborator |
---|---|
Diasome Pharmaceuticals | Integrium |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Glucose area under the curve | To evaluate glucose response (incremental AUC) to standardized test meal challenge following 21 days of CSII treatment with HDV insulin lispro versus insulin lispro diluted with sterile water | 21 days | |
Secondary | total units Insulin | To compare insulin doses (basal, bolus and total) during HDV insulin lispro treatment | 21 days |
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