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

This study is currently recruiting participants.
See Contacts and Locations
Verified April 2017 by Diasome Pharmaceuticals
Sponsor:
Collaborator:
Integrium
Information provided by (Responsible Party):
Diasome Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT03156361
First received: May 15, 2017
Last updated: May 18, 2017
Last verified: April 2017
  Purpose
Single Center, Double Blind, Active Comparator Controlled 2-Way Crossover Multiple Dose Safety, Tolerability and Efficacy Study

Condition Intervention Phase
Type1 Diabetes Mellitus Drug: HDV insulin lispro 100 UNIT/mL Drug: Insulin Lispro 100 Units/mL Phase 2

Study Type: Interventional
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: Quadruple (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

Resource links provided by NLM:


Further study details as provided by Diasome Pharmaceuticals:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • total units Insulin [ Time Frame: 21 days ]
    To compare insulin doses (basal, bolus and total) during HDV insulin lispro treatment


Estimated Enrollment: 24
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)
Arms Assigned Interventions
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

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT03156361

Contacts
Contact: Douglas Muchmore, MD 858-947-8148 dmuchmore@diasome.com
Contact: Robert Geho, MBA 216-444-7110 rgeho@diasome.com

Locations
United States, Georgia
Atlanta Diabetes Association Recruiting
Atlanta, Georgia, United States, 30318
Contact: Bruce W Bode, MD    404-355-4393      
Sponsors and Collaborators
Diasome Pharmaceuticals
Integrium
Investigators
Study Director: Douglas Muchmore, MD Diasome Pharmaceuticals
  More Information

Responsible Party: Diasome Pharmaceuticals
ClinicalTrials.gov Identifier: NCT03156361     History of Changes
Other Study ID Numbers: DP 01-2017-02
Study First Received: May 15, 2017
Last Updated: May 18, 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Insulin, Globin Zinc
Insulin
Insulin Lispro
Hypoglycemic Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on September 21, 2017