Type1 Diabetes MellitusPhase 2NCT03156361
21 Day Comparison of Continuous Insulin Infusion Using HDV Insulin to Standard Insulin in Type 1 Diabetes Mellitus
A Phase 2 study testing HDV insulin lispro 100 UNIT/mL and Insulin Lispro 100 Units/mL in people with Type1 Diabetes Mellitus, run by Diasome Pharmaceuticals at 1 site in United States.
Trial summary
Single Center, Double Blind, Active Comparator Controlled 2-Way Crossover Multiple Dose Safety, Tolerability and Efficacy Study Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Type1 Diabetes Mellitus
- What is being tested?
- HDV insulin lispro 100 UNIT/mL and Insulin Lispro 100 Units/mL
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- 18 May 2017to 15 Mar 2018
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- T1DM ≥12 months
- C-peptide <0.6 ng/mL (a single re-test is allowable)
- Treatment with rapid analog insulin by CSII for the previous 6 months
- 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
- Willingness to use insulin lispro as the analog insulin during the study period
- Use of MiniMed Paradigm® pump for the previous 6 months. Pumps that employ low glucose suspend technology will NOT be allowed during the study
- BMI ≥18.0 kg/m2 and ≤35.0 kg/m2
- A1C≤9.0% (a single re-test is allowable)
Who cannot join
- Known or suspected allergy to any component of any of the study drugs in this trial.
- A patient who has unstable proliferative retinopathy or maculopathy, and/or severe neuropathy, in particular autonomic neuropathy, as judged by the Investigator.
- Use of oral anti-diabetic or non-insulin anti-diabetic injection therapies (e.g. SGLT-2 inhibitors, pramlintide, GLP-1 agonists, etc.)
- Current smokers; if a former smoker, no tobacco products (inhaled, oral or buccal) for the previous 3 months
- 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).
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Atlanta Diabetes Association
Atlanta, Georgia, 30318
About this study
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
Single Center, Double Blind, Active Comparator Controlled 2-Way Crossover Multiple Dose Safety, Tolerability and Efficacy Study
Read the 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.
- Conditions
- Type1 Diabetes Mellitus
- Being tested
- HDV insulin lispro 100 UNIT/mL, Insulin Lispro 100 Units/mL
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HDV insulin lispro 100 UNIT/mLDrug
Also called HDV Humalog
Hepatic Directed Vesicle (HDV) added to commercial insulin lispro
Insulin Lispro 100 Units/mLDrug
Also called Humalog
Sterile Water for Injection added to commercial insulin lispro
| Study group | Role | What they receive |
|---|---|---|
| HDV insulin lispro 100 UNIT/mL | Experimental | Hepatic Directed Vesicle (HDV) is the active excipient, added to insulin lispro. HDV binds to a portion of the insulin lispro. Receives: Drug: HDV insulin lispro 100 UNIT/mL |
| Insulin Lispro 100 UNIT/mL | Active comparator | Sterile Water for Injection (SWFI) is added to the insulin lispro, to dilute the insulin lispro equal to the HDV insulin lispro Receives: Drug: Insulin Lispro 100 Units/mL |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 21 days
Secondary outcomes (1)
total units Insulin
To compare insulin doses (basal, bolus and total) during HDV insulin lispro treatment
Measured: 21 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2017
- Study start18 May 2017
- Primary completion15 Jan 2018
- Study completion15 Mar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type1 Diabetes MellitusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- This is a single center, double blind, active comparator controlled 2-Way crossover multiple dose safety, tolerability and efficacy study.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Diasome Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Integrium
- Responsible party
- Sponsor
- Investigators
- Douglas Muchmore, MD, Study director, Diasome Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03156361
- Sponsor's protocol ID
- DP 01-2017-02
- Status last verified
- Apr 2017
- First submitted
- 15 May 2017
- Last updated
- 31 Jul 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03156361
- Acronym / sponsor ID
- DP 01-2017-02
- Conditions
- Type1 Diabetes Mellitus
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Diasome PharmaceuticalsIndustry (pharma, biotech, devices)
- Collaborators
- Integrium
- Study start
- 18 May 2017 (actual)
- Primary completion
- 15 Jan 2018 (actual)
- Study completion
- 15 Mar 2018 (actual)
- First posted
- 17 May 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Single Center, Double Blind, Active Comparator Controlled 2-Way Crossover Multiple Dose Safety, Tolerability and Efficacy Study
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- This is a single center, double blind, active comparator controlled 2-Way crossover multiple dose safety, tolerability and efficacy study.
| Arm | Type | Receives |
|---|---|---|
| HDV insulin lispro 100 UNIT/mL | Experimental | Drug: HDV insulin lispro 100 UNIT/mLHepatic Directed Vesicle (HDV) is the active excipient, added to insulin lispro. HDV binds to a portion of the insulin lispro. |
| Insulin Lispro 100 UNIT/mL | Active comparator | Drug: Insulin Lispro 100 Units/mLSterile Water for Injection (SWFI) is added to the insulin lispro, to dilute the insulin lispro equal to the HDV insulin lispro |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- T1DM ≥12 months
- C-peptide <0.6 ng/mL (a single re-test is allowable)
- Treatment with rapid analog insulin by CSII for the previous 6 months
- 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
- Willingness to use insulin lispro as the analog insulin during the study period
Key exclusion criteria (6 listed)
- Known or suspected allergy to any component of any of the study drugs in this trial.
- A patient who has unstable proliferative retinopathy or maculopathy, and/or severe neuropathy, in particular autonomic neuropathy, as judged by the Investigator.
- Use of oral anti-diabetic or non-insulin anti-diabetic injection therapies (e.g. SGLT-2 inhibitors, pramlintide, GLP-1 agonists, etc.)
- Current smokers; if a former smoker, no tobacco products (inhaled, oral or buccal) for the previous 3 months
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HDV insulin lispro 100 UNIT/mLAlso: HDV HumalogHepatic Directed Vesicle (HDV) added to commercial insulin lispro | Drug | HDV insulin lispro 100 UNIT/mL |
| Insulin Lispro 100 Units/mLAlso: HumalogSterile Water for Injection added to commercial insulin lispro | Drug | Insulin Lispro 100 UNIT/mL |
Primary outcome
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
1 secondary outcome
total units Insulin
Time frame: 21 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2018.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Douglas Muchmore, MD study director
Diasome Pharmaceuticals
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing HDV insulin lispro 100 UNIT/mL and Insulin Lispro 100 Units/mL in people with Type1 Diabetes Mellitus, run by Diasome Pharmaceuticals at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Glucose area under the curve (time frame: 21 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jul 2018.