Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

A Study of Continuous Subcutaneous Insulin Infusion (CSII) Pump Function in Subjects With Type 1 Diabetes With Recombinant Human Hyaluronidase (rHuPH20) (HALO-117-406)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03662334
Recruitment Status : Completed
First Posted : September 7, 2018
Results First Posted : February 1, 2019
Last Update Posted : February 1, 2019
Sponsor:
Information provided by (Responsible Party):
Halozyme Therapeutics

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Triple (Participant, Care Provider, Investigator);   Primary Purpose: Treatment
Condition Type 1 Diabetes Mellitus
Interventions Drug: Rapid Acting insulin with pre-treatment of rHuPH20
Device: Sham injection
Enrollment 14
Recruitment Details  
Pre-assignment Details All three parts (Parts 1, 2, and 3) of this exploratory study were to use a cross-over design that would maximize efficiency while minimizing sample size. Only Part 2 of this study was conducted; thus, all 14 participants were enrolled in Part 2 only.
Arm/Group Title Hyaluronidase Human Injection/Sham Injection Sham Injection/Hyaluronidase Human Injection
Hide Arm/Group Description Participants received pretreatment of 1 milliliter (mL) hyaluronidase human injection on Day 1 of Treatment Period 1. After a 3- to 7-day washout period, participants received pretreatment of 1 mL sham injection on Day 1 of Treatment Period 2. Participants received pretreatment of 1 mL sham injection on Day 1 of Treatment Period 1. After a 3- to 7-day washout period, participants received pretreatment of 1 mL hyaluronidase human injection on Day 1 of Treatment Period 2.
Period Title: Part 1: Treatment Period 1
Started 0 0
Completed 0 0
Not Completed 0 0
Period Title: Part 1: Treatment Period 2
Started 0 0
Completed 0 0
Not Completed 0 0
Period Title: Part 2: Treatment Period 1 (2 Days)
Started 7 [1] 7 [1]
Completed 7 7
Not Completed 0 0
[1]
Part 1 of the study was not conducted. Participants were enrolled starting with Part 2.
Period Title: Part 2: Treatment Period 2 (2 Days)
Started 7 7
Completed 6 7
Not Completed 1 0
Reason Not Completed
Intended Changes to Clamp Procedure             1             0
Period Title: Part 3: Treatment Period 1
Started 0 [1] 0 [1]
Completed 0 0
Not Completed 0 0
[1]
Part 3 of the study was not conducted. No participants were enrolled in this part of the study.
Period Title: Part 3: Treatment Period 2
Started 0 0
Completed 0 0
Not Completed 0 0
Arm/Group Title Hyaluronidase Human Injection/Sham Injection Sham Injection/Hyaluronidase Human Injection Total
Hide Arm/Group Description Participants received pretreatment of 1 milliliter (mL) hyaluronidase human injection on Day 1 of Treatment Period 1. After a 3- to 7-day washout period, participants received pretreatment of 1 mL sham injection on Day 1 of Treatment Period 2. Participants received pretreatment of 1 mL sham injection on Day 1 of Treatment Period 1. After a 3- to 7-day washout period, participants received pretreatment of 1 mL hyaluronidase human injection on Day 1 of Treatment Period 2. Total of all reporting groups
Overall Number of Baseline Participants 7 7 14
Hide Baseline Analysis Population Description
Baseline data were collected in members of the Safety Population, comprised of all randomized participants exposed to at least one dose of study drug.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 7 participants 7 participants 14 participants
43.6  (8.90) 40.4  (14.84) 42.0  (11.87)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 7 participants 7 participants 14 participants
Female
2
  28.6%
2
  28.6%
4
  28.6%
Male
5
  71.4%
5
  71.4%
10
  71.4%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
White or Caucasian Number Analyzed 7 participants 7 participants 14 participants
7
 100.0%
7
 100.0%
14
 100.0%
1.Primary Outcome
Title Part 1: Area Under the Curve (AUC) of Glucose Infusion Rate (GIR) From 0-6 Hours
Hide Description [Not Specified]
Time Frame 0-6 hours
Hide Outcome Measure Data
Hide Analysis Population Description
The study was stopped early, prior to enrolling the planned 24 participants. As a result, data were not collected for analysis of this outcome measure. Only Part 2 of the study was conducted.
Arm/Group Title Hyaluronidase Human Injection/Sham Injection Sham Injection/Hyaluronidase Human Injection
Hide Arm/Group Description:
Participants received pretreatment of 1 milliliter (mL) hyaluronidase human injection on Day 1 of Treatment Period 1. After a 3- to 7-day washout period, participants received pretreatment of 1 mL sham injection on Day 1 of Treatment Period 2.
Participants received pretreatment of 1 mL sham injection on Day 1 of Treatment Period 1. After a 3- to 7-day washout period, participants received pretreatment of 1 mL hyaluronidase human injection on Day 1 of Treatment Period 2.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
2.Primary Outcome
Title Part 2: Time to Reduction in Plasma Glucose by 80 Milligrams Per Deciliter (mg/dL) Following CSII Bolus
Hide Description Time to reduction is reported as the maximum time it took for any participant receiving each treatment sequence to achieve a reduction in plasma glucose by 80 mg/dL. During the course of the study, it became difficult to establish a stable hyperglycemic plateau with a target glucose level of 220 mg/dL, even after adjusting several operational parameters. The study was stopped early, prior to enrolling the planned 24 participants for Part 2. Thus, analysis for this endpoint was not conducted. Raw data (as a maximum) are reported.
Time Frame 0-10 hours
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population: all randomized participants exposed to at least one dose of study drug
Arm/Group Title Hyaluronidase Human Injection/Sham Injection Sham Injection/Hyaluronidase Human Injection
Hide Arm/Group Description:
Participants received pretreatment of 1 milliliter (mL) hyaluronidase human injection on Day 1 of Treatment Period 1. After a 3- to 7-day washout period, participants received pretreatment of 1 mL sham injection on Day 1 of Treatment Period 2.
Participants received pretreatment of 1 mL sham injection on Day 1 of Treatment Period 1. After a 3- to 7-day washout period, participants received pretreatment of 1 mL hyaluronidase human injection on Day 1 of Treatment Period 2.
Overall Number of Participants Analyzed 7 7
Measure Type: Number
Unit of Measure: hours
First Intervention 5.58 5.23
Second Intervention 4.63 5.32
3.Primary Outcome
Title Part 3: Time to Achieve Plasma Glucose >90 mg/dL After Release of Hypoglycemic CSII Clamp
Hide Description [Not Specified]
Time Frame 0-12 hours
Hide Outcome Measure Data
Hide Analysis Population Description
The study was stopped early, prior to enrolling the planned 24 participants. As a result, data were not collected for analysis of this outcome measure. Only Part 2 of the study was conducted.
Arm/Group Title Hyaluronidase Human Injection/Sham Injection Sham Injection/Hyaluronidase Human Injection
Hide Arm/Group Description:
Participants received pretreatment of 1 milliliter (mL) hyaluronidase human injection on Day 1 of Treatment Period 1. After a 3- to 7-day washout period, participants received pretreatment of 1 mL sham injection on Day 1 of Treatment Period 2.
Participants received pretreatment of 1 mL sham injection on Day 1 of Treatment Period 1. After a 3- to 7-day washout period, participants received pretreatment of 1 mL hyaluronidase human injection on Day 1 of Treatment Period 2.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
4.Secondary Outcome
Title Part 1: Time-action Profile, Assessed by GIR in Euglycemic Participants
Hide Description [Not Specified]
Time Frame up to approximately 10 hours
Hide Outcome Measure Data
Hide Analysis Population Description
The study was stopped early, prior to enrolling the planned 24 participants. As a result, data were not collected for analysis of this outcome measure. Only Part 2 of the study was conducted.
Arm/Group Title Hyaluronidase Human Injection/Sham Injection Sham Injection/Hyaluronidase Human Injection
Hide Arm/Group Description:
Participants received pretreatment of 1 milliliter (mL) hyaluronidase human injection on Day 1 of Treatment Period 1. After a 3- to 7-day washout period, participants received pretreatment of 1 mL sham injection on Day 1 of Treatment Period 2.
Participants received pretreatment of 1 mL sham injection on Day 1 of Treatment Period 1. After a 3- to 7-day washout period, participants received pretreatment of 1 mL hyaluronidase human injection on Day 1 of Treatment Period 2.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
5.Secondary Outcome
Title Part 1: Mean Maximum Concentration (Cmax)
Hide Description [Not Specified]
Time Frame up to approximately 22 hours
Hide Outcome Measure Data
Hide Analysis Population Description
The study was stopped early, prior to enrolling the planned 24 participants. As a result, data were not collected for analysis of this outcome measure. Only Part 2 of the study was conducted.
Arm/Group Title Hyaluronidase Human Injection/Sham Injection Sham Injection/Hyaluronidase Human Injection
Hide Arm/Group Description:
Participants received pretreatment of 1 milliliter (mL) hyaluronidase human injection on Day 1 of Treatment Period 1. After a 3- to 7-day washout period, participants received pretreatment of 1 mL sham injection on Day 1 of Treatment Period 2.
Participants received pretreatment of 1 mL sham injection on Day 1 of Treatment Period 1. After a 3- to 7-day washout period, participants received pretreatment of 1 mL hyaluronidase human injection on Day 1 of Treatment Period 2.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
6.Secondary Outcome
Title Part 1: Time to Achieve Maximum Concentration (Tmax)
Hide Description [Not Specified]
Time Frame up to approximately 22 hours
Hide Outcome Measure Data
Hide Analysis Population Description
The study was stopped early, prior to enrolling the planned 24 participants. As a result, data were not collected for analysis of this outcome measure. Only Part 2 of the study was conducted.
Arm/Group Title Hyaluronidase Human Injection/Sham Injection Sham Injection/Hyaluronidase Human Injection
Hide Arm/Group Description:
Participants received pretreatment of 1 milliliter (mL) hyaluronidase human injection on Day 1 of Treatment Period 1. After a 3- to 7-day washout period, participants received pretreatment of 1 mL sham injection on Day 1 of Treatment Period 2.
Participants received pretreatment of 1 mL sham injection on Day 1 of Treatment Period 1. After a 3- to 7-day washout period, participants received pretreatment of 1 mL hyaluronidase human injection on Day 1 of Treatment Period 2.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
7.Secondary Outcome
Title Part 1: Early Time to 50% Maximum Serum Insulin Concentration (t50%) Max
Hide Description [Not Specified]
Time Frame up to approximately 22 hours
Hide Outcome Measure Data
Hide Analysis Population Description
The study was stopped early, prior to enrolling the planned 24 participants. As a result, data were not collected for analysis of this outcome measure. Only Part 2 of the study was conducted.
Arm/Group Title Hyaluronidase Human Injection/Sham Injection Sham Injection/Hyaluronidase Human Injection
Hide Arm/Group Description:
Participants received pretreatment of 1 milliliter (mL) hyaluronidase human injection on Day 1 of Treatment Period 1. After a 3- to 7-day washout period, participants received pretreatment of 1 mL sham injection on Day 1 of Treatment Period 2.
Participants received pretreatment of 1 mL sham injection on Day 1 of Treatment Period 1. After a 3- to 7-day washout period, participants received pretreatment of 1 mL hyaluronidase human injection on Day 1 of Treatment Period 2.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
8.Secondary Outcome
Title Part 1: Time to 50% of Total AUC (AUC0-last)
Hide Description [Not Specified]
Time Frame up to approximately 22 hours
Hide Outcome Measure Data
Hide Analysis Population Description
The study was stopped early, prior to enrolling the planned 24 participants. As a result, data were not collected for analysis of this outcome measure. Only Part 2 of the study was conducted.
Arm/Group Title Hyaluronidase Human Injection/Sham Injection Sham Injection/Hyaluronidase Human Injection
Hide Arm/Group Description:
Participants received pretreatment of 1 milliliter (mL) hyaluronidase human injection on Day 1 of Treatment Period 1. After a 3- to 7-day washout period, participants received pretreatment of 1 mL sham injection on Day 1 of Treatment Period 2.
Participants received pretreatment of 1 mL sham injection on Day 1 of Treatment Period 1. After a 3- to 7-day washout period, participants received pretreatment of 1 mL hyaluronidase human injection on Day 1 of Treatment Period 2.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
9.Secondary Outcome
Title Part 1: Fractional and Absolute AUC0-1hr
Hide Description [Not Specified]
Time Frame 0 to 1 hour
Hide Outcome Measure Data
Hide Analysis Population Description
The study was stopped early, prior to enrolling the planned 24 participants. As a result, data were not collected for analysis of this outcome measure. Only Part 2 of the study was conducted.
Arm/Group Title Hyaluronidase Human Injection/Sham Injection Sham Injection/Hyaluronidase Human Injection
Hide Arm/Group Description:
Participants received pretreatment of 1 milliliter (mL) hyaluronidase human injection on Day 1 of Treatment Period 1. After a 3- to 7-day washout period, participants received pretreatment of 1 mL sham injection on Day 1 of Treatment Period 2.
Participants received pretreatment of 1 mL sham injection on Day 1 of Treatment Period 1. After a 3- to 7-day washout period, participants received pretreatment of 1 mL hyaluronidase human injection on Day 1 of Treatment Period 2.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
10.Secondary Outcome
Title Part 1: Fractional and Absolute AUC2hr-end
Hide Description [Not Specified]
Time Frame 2 to approximately 22 hours
Hide Outcome Measure Data
Hide Analysis Population Description
The study was stopped early, prior to enrolling the planned 24 participants. As a result, data were not collected for analysis of this outcome measure. Only Part 2 of the study was conducted.
Arm/Group Title Hyaluronidase Human Injection/Sham Injection Sham Injection/Hyaluronidase Human Injection
Hide Arm/Group Description:
Participants received pretreatment of 1 milliliter (mL) hyaluronidase human injection on Day 1 of Treatment Period 1. After a 3- to 7-day washout period, participants received pretreatment of 1 mL sham injection on Day 1 of Treatment Period 2.
Participants received pretreatment of 1 mL sham injection on Day 1 of Treatment Period 1. After a 3- to 7-day washout period, participants received pretreatment of 1 mL hyaluronidase human injection on Day 1 of Treatment Period 2.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
11.Secondary Outcome
Title Part 1: Area Under the Curve From Time Zero to the Last Measureable Concentration (AUC0-last)
Hide Description [Not Specified]
Time Frame up to approximately 22 hours
Hide Outcome Measure Data
Hide Analysis Population Description
The study was stopped early, prior to enrolling the planned 24 participants. As a result, data were not collected for analysis of this outcome measure. Only Part 2 of the study was conducted.
Arm/Group Title Hyaluronidase Human Injection/Sham Injection Sham Injection/Hyaluronidase Human Injection
Hide Arm/Group Description:
Participants received pretreatment of 1 milliliter (mL) hyaluronidase human injection on Day 1 of Treatment Period 1. After a 3- to 7-day washout period, participants received pretreatment of 1 mL sham injection on Day 1 of Treatment Period 2.
Participants received pretreatment of 1 mL sham injection on Day 1 of Treatment Period 1. After a 3- to 7-day washout period, participants received pretreatment of 1 mL hyaluronidase human injection on Day 1 of Treatment Period 2.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
12.Secondary Outcome
Title Part 1: Mean Residence Time (MRT)
Hide Description [Not Specified]
Time Frame up to approximately 22 hours
Hide Outcome Measure Data
Hide Analysis Population Description
The study was stopped early, prior to enrolling the planned 24 participants. As a result, data were not collected for analysis of this outcome measure. Only Part 2 of the study was conducted.
Arm/Group Title Hyaluronidase Human Injection/Sham Injection Sham Injection/Hyaluronidase Human Injection
Hide Arm/Group Description:
Participants received pretreatment of 1 milliliter (mL) hyaluronidase human injection on Day 1 of Treatment Period 1. After a 3- to 7-day washout period, participants received pretreatment of 1 mL sham injection on Day 1 of Treatment Period 2.
Participants received pretreatment of 1 mL sham injection on Day 1 of Treatment Period 1. After a 3- to 7-day washout period, participants received pretreatment of 1 mL hyaluronidase human injection on Day 1 of Treatment Period 2.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
13.Secondary Outcome
Title Part 2: Plasma Glucose Concentration Over Time
Hide Description Plasma glucose concentration over time is reported as the maximum concentration for any participant receiving each treatment sequence. During the course of the study, it became difficult to establish a stable hyperglycemic plateau with a target glucose level of 220 mg/dL, even after adjusting several operational parameters. The study was stopped early, prior to enrolling the planned 24 participants for Part 2. Thus, analysis for this endpoint was not conducted. Raw data (as a maximum) are reported.
Time Frame up to approximately 10 hours
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population
Arm/Group Title Hyaluronidase Human Injection/Sham Injection Sham Injection/Hyaluronidase Human Injection
Hide Arm/Group Description:
Participants received pretreatment of 1 milliliter (mL) hyaluronidase human injection on Day 1 of Treatment Period 1. After a 3- to 7-day washout period, participants received pretreatment of 1 mL sham injection on Day 1 of Treatment Period 2.
Participants received pretreatment of 1 mL sham injection on Day 1 of Treatment Period 1. After a 3- to 7-day washout period, participants received pretreatment of 1 mL hyaluronidase human injection on Day 1 of Treatment Period 2.
Overall Number of Participants Analyzed 7 7
Measure Type: Number
Unit of Measure: mg/dL
First Intervention 299 341
Second Intervention 350 445
14.Secondary Outcome
Title Part 2: Insulin Analog Serum Concentration as a Function of Time Following Bolus Insulin Infusion
Hide Description Insulin analog serum concentration is reported as the maximum concentration for any participant receiving each treatment sequence. During the course of the study, it became difficult to establish a stable hyperglycemic plateau with a target glucose level of 220 mg/dL, even after adjusting several operational parameters. The study was stopped early, prior to enrolling the planned 24 participants for Part 2. Thus, analysis for this endpoint was not conducted. Raw data (as a maximum) are reported.
Time Frame up to approximately 10 hours
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population
Arm/Group Title Hyaluronidase Human Injection/Sham Injection Sham Injection/Hyaluronidase Human Injection
Hide Arm/Group Description:
Participants received pretreatment of 1 milliliter (mL) hyaluronidase human injection on Day 1 of Treatment Period 1. After a 3- to 7-day washout period, participants received pretreatment of 1 mL sham injection on Day 1 of Treatment Period 2.
Participants received pretreatment of 1 mL sham injection on Day 1 of Treatment Period 1. After a 3- to 7-day washout period, participants received pretreatment of 1 mL hyaluronidase human injection on Day 1 of Treatment Period 2.
Overall Number of Participants Analyzed 7 7
Measure Type: Number
Unit of Measure: picomolar
First Intervention 1341.8 805.1
Second Intervention 688.5 1092.6
15.Secondary Outcome
Title Part 3: Plasma Glucose Concentration Over Time
Hide Description [Not Specified]
Time Frame up to approximately 12 hours
Hide Outcome Measure Data
Hide Analysis Population Description
The study was stopped early, prior to enrolling the planned 24 participants. As a result, data were not collected for analysis of this outcome measure. Only Part 2 of the study was conducted.
Arm/Group Title Hyaluronidase Human Injection/Sham Injection Sham Injection/Hyaluronidase Human Injection
Hide Arm/Group Description:
Participants received pretreatment of 1 milliliter (mL) hyaluronidase human injection on Day 1 of Treatment Period 1. After a 3- to 7-day washout period, participants received pretreatment of 1 mL sham injection on Day 1 of Treatment Period 2.
Participants received pretreatment of 1 mL sham injection on Day 1 of Treatment Period 1. After a 3- to 7-day washout period, participants received pretreatment of 1 mL hyaluronidase human injection on Day 1 of Treatment Period 2.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
16.Secondary Outcome
Title Part 3: Insulin Analog Serum Concentration as a Function of Time Following Termination of Insulin Infusion
Hide Description [Not Specified]
Time Frame up to approximately 12 hours
Hide Outcome Measure Data
Hide Analysis Population Description
The study was stopped early, prior to enrolling the planned 24 participants. As a result, data were not collected for analysis of this outcome measure. Only Part 2 of the study was conducted.
Arm/Group Title Hyaluronidase Human Injection/Sham Injection Sham Injection/Hyaluronidase Human Injection
Hide Arm/Group Description:
Participants received pretreatment of 1 milliliter (mL) hyaluronidase human injection on Day 1 of Treatment Period 1. After a 3- to 7-day washout period, participants received pretreatment of 1 mL sham injection on Day 1 of Treatment Period 2.
Participants received pretreatment of 1 mL sham injection on Day 1 of Treatment Period 1. After a 3- to 7-day washout period, participants received pretreatment of 1 mL hyaluronidase human injection on Day 1 of Treatment Period 2.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame 155 days
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Hyaluronidase Human Injection Sham Injection
Hide Arm/Group Description Participants received pretreatment of 1 milliliter (mL) hyaluronidase human injection on Day 1 of either Treatment Period 1 or Treatment Period 2. The two periods were separated by a 3- to 7-day washout period. Participants received pretreatment of 1 mL sham injection on Day 1 of either Treatment Period 1 or Treatment Period 2. The two periods were separated by a 3- to 7-day washout period.
All-Cause Mortality
Hyaluronidase Human Injection Sham Injection
Affected / at Risk (%) Affected / at Risk (%)
Total   0/14 (0.00%)   0/14 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
Hyaluronidase Human Injection Sham Injection
Affected / at Risk (%) Affected / at Risk (%)
Total   0/14 (0.00%)   0/14 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Hyaluronidase Human Injection Sham Injection
Affected / at Risk (%) Affected / at Risk (%)
Total   4/14 (28.57%)   2/14 (14.29%) 
Gastrointestinal disorders     
Abdominal Pain Upper * 1  1/14 (7.14%)  0/14 (0.00%) 
General disorders     
Injection Site Pain * 1  2/14 (14.29%)  0/14 (0.00%) 
Injection Site Haematoma * 1  1/14 (7.14%)  0/14 (0.00%) 
Pyrexia * 1  0/14 (0.00%)  1/14 (7.14%) 
Infections and infestations     
Upper Respiratory Tract Infection * 1  0/14 (0.00%)  1/14 (7.14%) 
Metabolism and nutrition disorders     
Hyperglycaemia * 1  1/14 (7.14%)  0/14 (0.00%) 
1
Term from vocabulary, MedDRA (12.0)
*
Indicates events were collected by non-systematic assessment
During the course of the study, it became difficult to establish a stable hyperglycemic plateau with a target glucose level of 220 milligrams per deciliter. The study was stopped early, prior to enrolling the planned 24 participants for Part 2.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
All information obtained as a result of this study or during the conduct of this study will be regarded as confidential. The Investigator agrees to use the information for the purpose of carrying out this study and for no other purpose, unless written permission from the sponsor (Halozyme) is obtained.
Results Point of Contact
Name/Title: Dimitrios Chondros, M.D., Chief Medical Officer
Organization: Halozyme Therapeutics
Phone: 858-794-8889
Responsible Party: Halozyme Therapeutics
ClinicalTrials.gov Identifier: NCT03662334     History of Changes
Other Study ID Numbers: HALO-117-406
First Submitted: August 13, 2018
First Posted: September 7, 2018
Results First Submitted: October 10, 2018
Results First Posted: February 1, 2019
Last Update Posted: February 1, 2019