Type 1 Diabetes MellitusPhase 1/2NCT02739906
A Trial to Investigate Post Prandial Blood Glucose Control With Fast-acting Human Insulin HinsBet® Compared to Insulin Lispro (Humalog®) and Regular Human Insulin (Huminsulin® Normal) After Ingestion of a Standardized Meal in Subjects With T1DM
A Phase 1/2 study testing BioChaperone Human Insulin (HinsBet®), Insulin Lispro (Humalog®) and Regular human insulin (Huminsulin® Normal) in people with Type 1 Diabetes Mellitus, run by Adocia at 2 sites in Germany.
Trial summary
This is a 2 centres, randomised, double blind, three-treatment, three-period cross-over trial in subjects with type 1 diabetes mellitus. Each subject will be administered individualised single subcutaneous doses of BioChaperone Human Insulin (HinsBet®), insulin lispro (Humalog®) and regular human insulin (Huminsulin®… Read more about this study
- Who is it for?
- Ages 18 to 64 years
- Conditions the study is for
- Type 1 Diabetes Mellitus
- What is being tested?
- BioChaperone Human Insulin (HinsBet®), Insulin Lispro (Humalog®) and Regular human insulin (Huminsulin® Normal)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 2 sitesGermany
- Study dates
- Apr 2016to Aug 2016
- Phase
- Phase 1/2
- 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 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Male or female subject aged 18-64 years (both inclusive).
- Type 1 diabetes mellitus (as diagnosed clinically) >= 12 months.
- Treated with multiple daily insulin injections or CSII >= 12 months.
- Current total daily insulin treatment < 1.2 (I)U/kg/day.
- Current total daily bolus insulin treatment < 0.7 (I)U/kg/day.
- BMI 18.5-28.0 kg/m^2 (both inclusive).
- HbA1c <= 9.0 % by local laboratory analysis
- Fasting C-peptide <= 0.30 nmol/L.
Who cannot join
- Known or suspected hypersensitivity to IMPs or related products.
- Type 2 diabetes mellitus.
- Previous participation in this trial. Participation is defined as randomised.
- Participation in any clinical trial within 3 months prior to this trial.
- Clinically significant abnormal haematology, coagulation, biochemistry, lipids, or urinalysis screening tests, as judged by the Investigator considering the underlying disease.
- Presence of clinically significant acute gastrointestinal symptoms (e.g. nausea, vomiting, heartburn or diarrhoea), as judged by the Investigator.
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- Known slowing of gastric emptying and or gastrointestinal surgery that in the opinion of the Investigator might change gastrointestinal motility and food absorption.
- Unusual meal habits and special diet requirements or unwillingness to eat the food provided in the trial.
- Females of childbearing potential who are pregnant, breast-feeding or intend to become pregnant or are not using highly effective contraceptive methods
Trial locations and contacts
2 sites in 1 country.
About this study
Official title: A Randomised, Double Blind, Three-period Cross-over Trial to Investigate Post Prandial Blood Glucose Control With Fast-acting Human Insulin HinsBet® Compared to Insulin Lispro (Humalog®) and Regular Human Insulin (Huminsulin® Normal) After Ingestion of a Standardized Meal in Subjects With Type 1 Diabetes Mellitus (T1DM)
This is a 2 centres, randomised, double blind, three-treatment, three-period cross-over trial in subjects with type 1 diabetes mellitus.
Each subject will be administered individualised single subcutaneous doses of BioChaperone Human Insulin (HinsBet®), insulin lispro (Humalog®) and regular human insulin (Huminsulin® Normal) immediately before ingesting a standardised mixed meal.
Following trial drug administration, PK and PD assessments will be carried until 6 hours after start of the standardized test meal.
The total trial duration for an individual subject will be up to 11 weeks.
- Conditions
- Type 1 Diabetes Mellitus
- Being tested
- BioChaperone Human Insulin (HinsBet®), Insulin Lispro (Humalog®), Regular human insulin (Huminsulin® Normal)
- 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.
BioChaperone Human Insulin (HinsBet®)Drug
BioChaperone Human Insulin (HinsBet®) individualised single subcutaneous injection followed by test meal intake
Insulin Lispro (Humalog®)Drug
Insulin Lispro (Humalog®) individualised single subcutaneous injection followed by test meal intake
Regular human insulin (Huminsulin® Normal)Drug
Regular human insulin (Huminsulin® Normal) individualised single subcutaneous injection followed by test meal intake
| Study group | Role | What they receive |
|---|---|---|
| HinsBet® | Experimental | Not described Receives: Drug: BioChaperone Human Insulin (HinsBet®) |
| Humalog® | Active comparator | Not described Receives: Drug: Insulin Lispro (Humalog®) |
| Huminsulin® Normal | Active comparator | Not described Receives: Drug: Regular human insulin (Huminsulin® Normal) |
What is being measured
The primary outcome is the main question the study is designed to answer.
BG1h
Blood glucose (BG) concentration 1 hour after start of intake of a standardised meal
Measured: 1 hour
Secondary outcomes (6)
ΔBG1h
Mean change from baseline of blood glucose concentration 1 hour after start of intake of a standardised meal
Measured: 1 hour
AUCBG,0-1h
Area under the blood glucose concentration-time curve from 0-1 hour after a standardised meal
Measured: 1 hour
ΔAUCBG,0-1h
Incremental area under the blood glucose concentration-time curve from 0-1 hour after a standardised meal
Measured: 1 hour
AUCIns,0-1h
Area under the serum insulin concentration-time curve from 0-1 hour
Measured: 1 hour
Adverse Events
Number of Adverse Events
Measured: Up to 11 weeks
Local tolerability (Number of injection site reactions)
Number of injection site reactions
Measured: Up to 11 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2016 (estimated)
- Study startApr 2016
- Primary completionAug 2016
- Study completionAug 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 1 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Adocia
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Oliver Klein, MD, Principal investigator, Profil GmbH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02739906
- Sponsor's protocol ID
- BC3-CT021
- Status last verified
- Aug 2016
- First submitted
- 12 Apr 2016
- Last updated
- 18 Aug 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised, Double Blind, Three-period Cross-over Trial to Investigate Post Prandial Blood Glucose Control With Fast-acting Human Insulin HinsBet® Compared to Insulin Lispro (Humalog®) and Regular Human Insulin (Huminsulin® Normal) After Ingestion of a Standardized Meal in Subjects With Type 1 Diabetes Mellitus (T1DM)
- ClinicalTrials.gov ID
- NCT02739906
- Acronym / sponsor ID
- BC3-CT021
- Conditions
- Type 1 Diabetes Mellitus
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- AdociaIndustry (pharma, biotech, devices)
- Study start
- Apr 2016
- Primary completion
- Aug 2016 (actual)
- Study completion
- Aug 2016 (actual)
- First posted
- 15 Apr 2016 (estimated)
- 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.
This is a 2 centres, randomised, double blind, three-treatment, three-period cross-over trial in subjects with type 1 diabetes mellitus.
Each subject will be administered individualised single subcutaneous doses of BioChaperone Human Insulin (HinsBet®), insulin lispro (Humalog®) and regular human insulin (Huminsulin® Normal) immediately before ingesting a standardised mixed meal.
Following trial drug administration, PK and PD assessments will be carried until 6 hours after start of the standardized test meal.
The total trial duration for an individual subject will be up to 11 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| HinsBet® | Experimental | Drug: BioChaperone Human Insulin (HinsBet®) |
| Humalog® | Active comparator | Drug: Insulin Lispro (Humalog®) |
| Huminsulin® Normal | Active comparator | Drug: Regular human insulin (Huminsulin® Normal) |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Male or female subject aged 18-64 years (both inclusive).
- Type 1 diabetes mellitus (as diagnosed clinically) >= 12 months.
- Treated with multiple daily insulin injections or CSII >= 12 months.
- Current total daily insulin treatment < 1.2 (I)U/kg/day.
- Current total daily bolus insulin treatment < 0.7 (I)U/kg/day.
Key exclusion criteria (9 listed)
- Known or suspected hypersensitivity to IMPs or related products.
- Type 2 diabetes mellitus.
- Previous participation in this trial. Participation is defined as randomised.
- Participation in any clinical trial within 3 months prior to this trial.
- Clinically significant abnormal haematology, coagulation, biochemistry, lipids, or urinalysis screening tests, as judged by the Investigator considering the underlying disease.
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 |
|---|---|---|
| BioChaperone Human Insulin (HinsBet®)BioChaperone Human Insulin (HinsBet®) individualised single subcutaneous injection followed by test meal intake | Drug | HinsBet® |
| Insulin Lispro (Humalog®)Insulin Lispro (Humalog®) individualised single subcutaneous injection followed by test meal intake | Drug | Humalog® |
| Regular human insulin (Huminsulin® Normal)Regular human insulin (Huminsulin® Normal) individualised single subcutaneous injection followed by test meal intake | Drug | Huminsulin® Normal |
Primary outcome
BG1h
Time frame: 1 hour
Blood glucose (BG) concentration 1 hour after start of intake of a standardised meal
6 secondary outcomes
ΔBG1h
Time frame: 1 hour
AUCBG,0-1h
Time frame: 1 hour
ΔAUCBG,0-1h
Time frame: 1 hour
AUCIns,0-1h
Time frame: 1 hour
Adverse Events
Time frame: Up to 11 weeks
Local tolerability (Number of injection site reactions)
Time frame: Up to 11 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 18 Aug 2016.
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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.
Oliver Klein, MD principal investigator
Profil GmbH
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing BioChaperone Human Insulin (HinsBet®), Insulin Lispro (Humalog®) and Regular human insulin (Huminsulin® Normal) in people with Type 1 Diabetes Mellitus, run by Adocia at 2 sites in Germany.
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 9 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 18 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Germany. 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
BG1h (time frame: 1 hour). 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 18 Aug 2016.