Diabetes Mellitus, Type 1Phase 2NCT03096392
Comparison of Hepatic Directed Vesicle (HDV)-Insulin Lispro Versus Insulin Lispro to Further Improve Glycemic Control
A Phase 2 study testing HDV insulin lispro 100 UNT/ML and Insulin Lispro 100 UNT/ML in people with Diabetes Mellitus, Type 1, run by Diasome Pharmaceuticals at 5 sites in United States.
Trial summary
Multi-Center, double blind, active comparator controlled 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
- Diabetes Mellitus, Type 1
- What is being tested?
- HDV insulin lispro 100 UNT/ML and Insulin Lispro 100 UNT/ML
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 5 sitesUnited States
- Study dates
- 18 Apr 2017to 18 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
- Male or female of age 18 to 65 years, inclusive. Females of child-bearing potential must use a standard and effective means of birth control for the duration of the study
- T1DM ≥12 months
- C-peptide <0.6 ng/mL (single retest allowed)
- Treatment with rapid analog insulin for the previous 6 months and willing to use insulin vial and syringe to deliver rapid acting insulin during the study
- Currently using either insulin glargine (U100 only) or insulin degludec for basal insulin therapy for at least 4 weeks prior to study
- Not using insulin pump delivery systems during the previous 3 months
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- Familiarity with continuous glucose monitoring (CGM) technology; subjects need to be not currently using CGM; subjects will NOT use unblinded CGM during the treatment period of the trial
- Willingness to use insulin lispro as the analog bolus insulin during the study period
- BMI ≥18.0 kg/m2 and ≤35.0 kg/m2
- 6.9%≤A1C≤7.9% (single retest allowed)
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
- 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.
- As judged by the Investigator, clinically significant findings in routine laboratory data
- Use of drugs that may interfere with the interpretation of trial results or are known to cause clinically relevant interference with insulin action, glucose utilization, or recovery from hypoglycemia
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- Use of oral anti-diabetic or non-insulin anti-diabetic injection therapies (e.g. SGLT-2 inhibitors, pramlintide, GLP-1 agonists, etc.) during the 4 weeks prior to randomization
- Current smokers; if a former smoker, no tobacco products (inhaled, oral or buccal) for the previous 3 months
- Use of e-cigarettes or other nicotine-containing products for the previous 3 months
- Current addiction to alcohol or substances of abuse as determined by the Investigator.
- Pregnancy, breast-feeding, the intention of becoming pregnant, or not using adequate contraceptive measures (adequate contraceptive measures consist of sterilization, intra-uterine device [IUD], oral or injectable contraceptives, barrier methods or abstinence as per investigator discretion).
- Mental incapacity, unwillingness, or language barriers precluding adequate understanding or cooperation in this study
- Symptomatic gastroparesis.
- Receipt of any investigational drug within 4 weeks of Visit 2 in this study
- Any condition (intrinsic or extrinsic) that in the judgment of the Investigator will interfere with trial participation or evaluation of data
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Barbara Davis Center for Diabetes, University of Colorado
Aurora, Colorado, 80045
Texas Diabetes and Endocrinology
Austin, Texas, 78731
Texas Diabetes and Endocrinology
Austin, Texas, 78749
Baptist Diabetes Associates
Miami, Florida, 33156
Lucas Research, Inc.
Morehead City, North Carolina, 28557
About this study
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
Multi-Center, double blind, active comparator controlled multiple dose safety, tolerability and efficacy study
Read the 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.
- Conditions
- Diabetes Mellitus, Type 1
- Being tested
- HDV insulin lispro 100 UNT/ML, Insulin Lispro 100 UNT/ML
- Medical subject headings
- Diabetes Mellitus, Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HDV insulin lispro 100 UNT/MLDrug
Also called Hepatic Directed Vesicle insulin lispro 100 UNT/ML
HDV is the active excipient, added to insulin lispro. HDV binds to a portion of the insulin lispro.
Insulin Lispro 100 UNT/MLDrug
Also called Humalog
Sterile Water for Injection is added to the insulin lispro, to dilute the insulin lispro equal to the HDV insulin lispro
| Study group | Role | What they receive |
|---|---|---|
| HDV insulin lispro 100 UNT/mL | Experimental | insulin lispro with 0.8 ml HDV added to a 10 ml vial of insulin lispro, injected subcutaneous before meals as needed. Study duration of 7 weeks (6 weeks of treatment) Receives: Drug: HDV insulin lispro 100 UNT/ML |
| insulin lispro 100 UNT/ML | Active comparator | insulin lispro with 0.8 ml sterile water for injection added to a 10 ml vial of insulin lispro, injected subcutaneous before meals as needed. Study duration of 7 weeks (6 weeks of treatment) Receives: Drug: Insulin Lispro 100 UNT/ML |
What is being measured
The primary outcome is the main question the study is designed to answer.
The amount of time, in minutes, glucose levels are within range (70-180 mg/dL)
evaluate continuous glucose monitoring (CGM) profiles during treatment with HDV insulin lispro versus insulin lispro alone, with specific focus on time in range (70-180 mg/dL)
Measured: 6 weeks
Secondary outcomes (6)
The number of events that blood glucose is equal to or less than 70 mg/dL
evaluate hypoglycemia frequency and severity during treatment with HDV insulin lispro versus insulin lispro alone
Measured: 6 weeks
The number of events blood glucose is less than 54 mg/dL
evaluate hypoglycemia frequency and severity during treatment with HDV insulin lispro versus insulin lispro alone
Measured: 6 weeks
Postprandial glucose levels in mg/dL following test meal challenge
evaluate glucose response to a standardized test meal challenge following six weeks of treatment with HDV insulin lispro versus insulin lispro alone
Measured: 6 weeks
HbA1c levels in percentage (%) at beginning of trial compared to HbA1c levels at the end of the study
evaluate overall glycemic control (A1C) following six weeks of treatment with HDV insulin lispro versus insulin lispro alone
Measured: 6 weeks
Self-Monitoring Blood Glucose (SMBG) results in mg/dL before and after every meal
evaluate self-monitoring of blood glucose (SMBG) values before and after meals during treatment with HDV insulin lispro versus insulin lispro alone
Measured: 6 weeks
Total doses of insulin used (in number of units of insulin injected) during the study
compare insulin doses (prandial, basal and total) during HDV insulin lispro treatment versus insulin lispro alone
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2017
- Study start18 Apr 2017
- Primary completion15 Nov 2017
- Study completion18 Mar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus, Type 1Studies 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
- Parallel groups
- Model description
- Double blind, active comparator controlled (insulin lispro) to HDV insulin lispro, multiple dose safety, tolerability and efficacy study
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Diasome Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Integrium
- Responsible party
- Sponsor
- Investigators
- Douglas B Muchmore, MD, Study director, Chief Medical Officer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03096392
- Sponsor's protocol ID
- DP 01-2017-01
- Status last verified
- Apr 2017
- First submitted
- 1 Mar 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: Not planned
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 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
- ClinicalTrials.gov ID
- NCT03096392
- Acronym / sponsor ID
- DP 01-2017-01
- Conditions
- Diabetes Mellitus, Type 1
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Diasome PharmaceuticalsIndustry (pharma, biotech, devices)
- Collaborators
- Integrium
- Study start
- 18 Apr 2017 (actual)
- Primary completion
- 15 Nov 2017 (actual)
- Study completion
- 18 Mar 2018 (actual)
- First posted
- 30 Mar 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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Double blind, active comparator controlled (insulin lispro) to HDV insulin lispro, multiple dose safety, tolerability and efficacy study
| Arm | Type | Receives |
|---|---|---|
| HDV insulin lispro 100 UNT/mL | Experimental | Drug: HDV insulin lispro 100 UNT/MLinsulin lispro with 0.8 ml HDV added to a 10 ml vial of insulin lispro, injected subcutaneous before meals as needed. Study duration of 7 weeks (6 weeks of treatment) |
| insulin lispro 100 UNT/ML | Active comparator | Drug: Insulin Lispro 100 UNT/MLinsulin lispro with 0.8 ml sterile water for injection added to a 10 ml vial of insulin lispro, injected subcutaneous before meals as needed. Study duration of 7 weeks (6 weeks of treatment) |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Male or female of age 18 to 65 years, inclusive. Females of child-bearing potential must use a standard and effective means of birth control for the duration of the study
- T1DM ≥12 months
- C-peptide <0.6 ng/mL (single retest allowed)
- Treatment with rapid analog insulin for the previous 6 months and willing to use insulin vial and syringe to deliver rapid acting insulin during the study
- Currently using either insulin glargine (U100 only) or insulin degludec for basal insulin therapy for at least 4 weeks prior to study
Key exclusion criteria (15 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
- 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.
- As judged by the Investigator, clinically significant findings in routine laboratory data
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 UNT/MLAlso: Hepatic Directed Vesicle insulin lispro 100 UNT/MLHDV is the active excipient, added to insulin lispro. HDV binds to a portion of the insulin lispro. | Drug | HDV insulin lispro 100 UNT/mL |
| Insulin Lispro 100 UNT/MLAlso: HumalogSterile Water for Injection is added to the insulin lispro, to dilute the insulin lispro equal to the HDV insulin lispro | Drug | insulin lispro 100 UNT/ML |
Primary outcome
The amount of time, in minutes, glucose levels are within range (70-180 mg/dL)
Time frame: 6 weeks
evaluate continuous glucose monitoring (CGM) profiles during treatment with HDV insulin lispro versus insulin lispro alone, with specific focus on time in range (70-180 mg/dL)
6 secondary outcomes
The number of events that blood glucose is equal to or less than 70 mg/dL
Time frame: 6 weeks
The number of events blood glucose is less than 54 mg/dL
Time frame: 6 weeks
Postprandial glucose levels in mg/dL following test meal challenge
Time frame: 6 weeks
HbA1c levels in percentage (%) at beginning of trial compared to HbA1c levels at the end of the study
Time frame: 6 weeks
Self-Monitoring Blood Glucose (SMBG) results in mg/dL before and after every meal
Time frame: 6 weeks
Total doses of insulin used (in number of units of insulin injected) during the study
Time frame: 6 weeks
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. Not planned
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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 B Muchmore, MD study director
Chief Medical Officer
5 sites 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 UNT/ML and Insulin Lispro 100 UNT/ML in people with Diabetes Mellitus, Type 1, run by Diasome Pharmaceuticals at 5 sites 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 10 inclusion and 15 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 5 sites 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?
The amount of time, in minutes, glucose levels are within range (70-180 mg/dL) (time frame: 6 weeks). 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.