Ignite Creation Date:
2025-12-24 @ 3:20 PM
Ignite Modification Date:
2026-02-26 @ 6:28 AM
Study NCT ID:
NCT03096392
Status:
COMPLETED
Last Update Posted:
2018-07-31
First Post:
2017-03-01
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison of Hepatic Directed Vesicle (HDV)-Insulin Lispro Versus Insulin Lispro to Further Improve Glycemic Control
Sponsor:
Diasome Pharmaceuticals
Organization:
Study Overview
Official Title:
A Randomized Controlled Comparison of Hepatic Directed Vesicle (HDV)-Insulin Lispro Versus Insulin Lispro Alone to Further Improve Glycemic Control in Type 1 Diabetes Mellitus Subjects With Good Glycemic Control
Status:
COMPLETED
Status Verified Date:
2017-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Multi-Center, double blind, active comparator controlled multiple dose safety, tolerability and efficacy study
Detailed Description:
This is a double blind, active comparator controlled multiple dose safety, tolerability and efficacy study comparing HDV insulin lispro with insulin lispro in 40 Type 1 Diabetes Mellitus Subjects with Good Glycemic Control, with specific focus on time in range (70-180 mg/dL). Subjects will be screened and then monitored with one week of baseline CGM. They will then be randomized to one of two treatment groups: (A) six weeks of treatment with HDV-lispro (B) six weeks of treatment with insulin lispro diluted with sterile water alone.
All subjects will use insulin glargine or insulin degludec for basal insulin coverage throughout the trial. Fasting glucose goals will be 70-120 mg/dL, with recommendations for dosage adjustments made twice weekly according to a simple dosing algorithm based on mean fasting glucose values during the previous 3-4 days.
Subjects will receive standard diabetes education refresher training at the beginning of the trial, including review of insulin dose administration and titration, carbohydrate counting (or other dietary planning as deemed appropriate by the investigator), avoidance of hypoglycemia, and management of exercise and stress.
Post meal (60-90 min after start of meal) goals will be \<140 mg/dL. A test meal study (standardized liquid test meal) to be conducted at the beginning of treatment (baseline study) and at the end of the six week treatment period (treatment comparison study). Subjects will also perform blinded continuous glucose monitoring during 4 weeks of study (i.e weeks 1,3,5 and 7 of study)
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.
All subjects will use insulin glargine or insulin degludec for basal insulin coverage throughout the trial. Fasting glucose goals will be 70-120 mg/dL, with recommendations for dosage adjustments made twice weekly according to a simple dosing algorithm based on mean fasting glucose values during the previous 3-4 days.
Subjects will receive standard diabetes education refresher training at the beginning of the trial, including review of insulin dose administration and titration, carbohydrate counting (or other dietary planning as deemed appropriate by the investigator), avoidance of hypoglycemia, and management of exercise and stress.
Post meal (60-90 min after start of meal) goals will be \<140 mg/dL. A test meal study (standardized liquid test meal) to be conducted at the beginning of treatment (baseline study) and at the end of the six week treatment period (treatment comparison study). Subjects will also perform blinded continuous glucose monitoring during 4 weeks of study (i.e weeks 1,3,5 and 7 of study)
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: