21 Day Comparison of Continuous Insulin Infusion Using HDV Insulin to Standard Insulin in Type 1 Diabetes Mellitus
|Type1 Diabetes Mellitus||Drug: HDV insulin lispro 100 UNIT/mL Drug: Insulin Lispro 100 Units/mL||Phase 2|
|Study Design:||Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description:
This is a single center, double blind, active comparator controlled 2-Way crossover multiple dose safety, tolerability and efficacy study.Masking: Participant, Care Provider, Investigator, Outcomes Assessor
Primary Purpose: Treatment
|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|
- Glucose area under the curve [ Time Frame: 21 days ]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
- total units Insulin [ Time Frame: 21 days ]To compare insulin doses (basal, bolus and total) during HDV insulin lispro treatment
|Actual Study Start Date:||May 18, 2017|
|Estimated Study Completion Date:||January 2018|
|Estimated Primary Completion Date:||October 2017 (Final data collection date for primary outcome measure)|
Experimental: HDV insulin lispro 100 UNIT/mL
Hepatic Directed Vesicle (HDV) is the active excipient, added to insulin lispro. HDV binds to a portion of the insulin lispro.
Drug: HDV insulin lispro 100 UNIT/mL
Hepatic Directed Vesicle (HDV) added to commercial insulin lispro
Other Name: HDV Humalog
Active Comparator: Insulin Lispro 100 UNIT/mL
Sterile Water for Injection (SWFI) is added to the insulin lispro, to dilute the insulin lispro equal to the HDV insulin lispro
Drug: Insulin Lispro 100 Units/mL
Sterile Water for Injection added to commercial insulin lispro
Other Name: Humalog
This is a single center, double blind, active comparator controlled 2-Way crossover multiple dose safety, tolerability and efficacy study.
The study will consist of three periods. Total duration will be approximately nine weeks, including a screening period of up to 14 days, a 7-day run-in period and two 21-day treatment periods.
Subjects will be screened and then they will undergo a week of baseline CGM. They will then be randomized to one of two treatment sequences: three weeks of treatment with HDV-lispro followed by three weeks of treatment with insulin lispro diluted with sterile water to match the insulin concentration in HDV-lispro, or the same treatments in the reverse order.
A test meal study (standardized liquid test meal) is to be conducted at the beginning of treatment (baseline study) and at the end of each three week treatment period. As noted above, frequent blood samples will be collected for glucose and insulin levels during the first (baseline study) test meal; during the two test meals performed after the two treatment periods the same sampling for glucose and insulin will be performed, with the addition of collecting samples for glucagon levels.
Subjects will also perform blinded continuous glucose monitoring throughout the entirety of the study (7 weeks).
Throughout study, subjects will be asked to perform frequent self-monitoring of blood glucose (SMBG), at least 6 times per day (before and 60-90 minutes after each meal) during 3 or more days of each week. This will serve as data for therapeutic decision-making as well as for data collection.
Please refer to this study by its ClinicalTrials.gov identifier: NCT03156361
|Contact: Douglas Muchmore, MDfirstname.lastname@example.org|
|Contact: Robert Geho, MBAemail@example.com|
|United States, Georgia|
|Atlanta Diabetes Association||Recruiting|
|Atlanta, Georgia, United States, 30318|
|Contact: Bruce W Bode, MD 404-355-4393|
|Study Director:||Douglas Muchmore, MD||Diasome Pharmaceuticals|