Type 2 Diabetes MellitusPhase 1NCT02562326
A Trial to Investigate the Efficacy, Pharmacokinetics, Safety and Tolerability of BioChaperone Insulin Lispro in Comparison to Humalog® U-100 in Patients With Type 2 Diabetes Mellitus
A Phase 1 study testing BioChaperone insulin lispro and Humalog® in people with Type 2 Diabetes Mellitus, run by Adocia at 2 sites in Germany.
Trial summary
This is a double-blind, randomised, controlled, two-period crossover phase Ib trial using an individualised standard meal with a fixed nutrient ratio in subjects with type 2 diabetes mellitus to investigate post-prandial blood glucose control with BioChaperone insulin lispro compared to insulin lispro (Humalog®, Eli… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Type 2 Diabetes Mellitus
- What is being tested?
- BioChaperone insulin lispro and Humalog®
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 51 participants
- Where
- 2 sitesGermany
- Study dates
- Sep 2015to Jan 2016
- Phase
- Phase 1
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Type 2 diabetes mellitus ≥ 12 months
- Treated with stable multiple daily insulin ≥ 3 months (basal-bolus therapy or only bolus insulin therapy)
- Current total daily insulin treatment <1.2 (I)U/kg/day
- Body Mass Index below or equal to 40.0 kg/m²
- HbA1c ≤ 9.0% by local laboratory analysis
Who cannot join
- Known or suspected hypersensitivity to trial products or related products
- Type 1 diabetes mellitus
- Previous participation in this trial
- The receipt of any investigational product within 60 days prior to this trial
- Clinically significant abnormal haematology, 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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- Presence of renal impairment (Estimated Glomerular filtration Rate (eGFR)<60 milliliters/minute/1.73m²)
- Presence of late diabetic complications and/or acute coronary heart disease.
- 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
- Current treatment with corticosteroids
Trial locations and contacts
2 sites in 1 country.
About this study
Official title: A Randomised, Monocentric, Double-blind, Multiple Daily Dose, Two-period 14 Day Cross-over Trial to Investigate the Efficacy, Pharmacokinetics, Safety and Tolerability of Individualised Doses of BioChaperone Insulin Lispro in Comparison to Humalog® U-100 in Patients With Type 2 Diabetes Mellitus
This is a double-blind, randomised, controlled, two-period crossover phase Ib trial using an individualised standard meal with a fixed nutrient ratio in subjects with type 2 diabetes mellitus to investigate post-prandial blood glucose control with BioChaperone insulin lispro compared to insulin lispro (Humalog®, Eli Lilly and Company) before and after a period of multiple daily dose administrations for 14 days. Each subject will be randomised to a sequence of two treatments, either BioChaperone insulin lispro-Humalog® or Humalog®-BioChaperone insulin lispro. Injections will take place immediately before an individualised standard meal in the morning of day 1, 2, 13, and 14. Insulin doses will be determined at the screening visit. During the outpatient phase the subjects will keep their basal insulin constant (except changes for safety reason). They will self-measure blood glucose at least 4 times daily (pre-prandial and at bedtime). In addition, on two days per outpatient period (Day 5 and 9) blood glucose will be measured 7 times daily (pre-prandial, 2 hours post-prandial and at bedtime).
- Conditions
- Type 2 Diabetes Mellitus
- Being tested
- BioChaperone insulin lispro, Humalog®
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BioChaperone insulin lisproDrug
Injection immediately before the start of the individualised standard meal
Humalog®Drug
Injection immediately before the start of the individualised standard meal
| Study group | Role | What they receive |
|---|---|---|
| BioChaperone insulin lispro | Experimental | Not described Receives: Drug: BioChaperone insulin lispro |
| Humalog® | Active comparator | Not described Receives: Drug: Humalog® |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacodynamics: ΔAUCBG 0-2h
Incremental Area Under Blood Glucose concentration-time Curve from 0-2 hours after a meal (comparison between BioChaperone insulin lispro and insulin lispro)
Measured: 2 hours
Pharmacokinetics: AUClis 0-30min
Area Under the serum insulin Lispro concentration-time Curve 0-30 minutes (comparison between BioChaperone insulin lispro and insulin lispro)
Measured: 30 minutes
Secondary outcomes (7)
AUClisp_0-6h
Area Under the serum insulin Lispro concentration-time Curve from 0-6 hours after bolus dose
Measured: up to 6 hours
Cmax_lisp
Maximum serum insulin lispro Concentration
Measured: up to 6 hours
tmax_lisp
Time to maximum observed serum insulin lispro concentration
Measured: up to 6 hours
CmaxBG
Maximum Blood Glucose after an individualised standard meal
Measured: up to 6 hours
AUCBG_0-6h
Area Under the Curve under the Blood Glucose concentration time curve from 0-6 hours
Measured: up to 6 hours
Adverse Events
Number of Adverse Events
Measured: up to 8 weeks
Local tolerability
Record of injection site reaction
Measured: up to 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2015 (estimated)
- Study startSep 2015
- Primary completionJan 2016
- Study completionJan 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- Adocia
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Eli Lilly and Company
- Responsible party
- Sponsor
- Investigators
- Grit Andersen, MD, Principal investigator, Profil GmbH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02562326
- Sponsor's protocol ID
- BC3-CT014
- Status last verified
- Apr 2016
- First submitted
- 28 Sep 2015
- Last updated
- 29 Apr 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised, Monocentric, Double-blind, Multiple Daily Dose, Two-period 14 Day Cross-over Trial to Investigate the Efficacy, Pharmacokinetics, Safety and Tolerability of Individualised Doses of BioChaperone Insulin Lispro in Comparison to Humalog® U-100 in Patients With Type 2 Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT02562326
- Acronym / sponsor ID
- BC3-CT014
- Conditions
- Type 2 Diabetes Mellitus
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- AdociaIndustry (pharma, biotech, devices)
- Collaborators
- Eli Lilly and Company
- Study start
- Sep 2015
- Primary completion
- Jan 2016 (actual)
- Study completion
- Jan 2016 (actual)
- First posted
- 29 Sep 2015 (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 double-blind, randomised, controlled, two-period crossover phase Ib trial using an individualised standard meal with a fixed nutrient ratio in subjects with type 2 diabetes mellitus to investigate post-prandial blood glucose control with BioChaperone insulin lispro compared to insulin lispro (Humalog®, Eli Lilly and Company) before and after a period of multiple daily dose administrations for 14 days. Each subject will be randomised to a sequence of two treatments, either BioChaperone insulin lispro-Humalog® or Humalog®-BioChaperone insulin lispro. Injections will take place immediately before an individualised standard meal in the morning of day 1, 2, 13, and 14. Insulin doses will be determined at the screening visit. During the outpatient phase the subjects will keep their basal insulin constant (except changes for safety reason). They will self-measure blood glucose at least 4 times daily (pre-prandial and at bedtime). In addition, on two days per outpatient period (Day 5 and 9) blood glucose will be measured 7 times daily (pre-prandial, 2 hours post-prandial and at bedtime).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BioChaperone insulin lispro | Experimental | Drug: BioChaperone insulin lispro |
| Humalog® | Active comparator | Drug: Humalog® |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Type 2 diabetes mellitus ≥ 12 months
- Treated with stable multiple daily insulin ≥ 3 months (basal-bolus therapy or only bolus insulin therapy)
- Current total daily insulin treatment <1.2 (I)U/kg/day
- Body Mass Index below or equal to 40.0 kg/m²
- HbA1c ≤ 9.0% by local laboratory analysis
Key exclusion criteria (11 listed)
- Known or suspected hypersensitivity to trial products or related products
- Type 1 diabetes mellitus
- Previous participation in this trial
- The receipt of any investigational product within 60 days prior to this trial
- Clinically significant abnormal haematology, 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 insulin lisproInjection immediately before the start of the individualised standard meal | Drug | BioChaperone insulin lispro |
| Humalog®Injection immediately before the start of the individualised standard meal | Drug | Humalog® |
Primary outcome
Pharmacodynamics: ΔAUCBG 0-2h
Time frame: 2 hours
Incremental Area Under Blood Glucose concentration-time Curve from 0-2 hours after a meal (comparison between BioChaperone insulin lispro and insulin lispro)
Pharmacokinetics: AUClis 0-30min
Time frame: 30 minutes
Area Under the serum insulin Lispro concentration-time Curve 0-30 minutes (comparison between BioChaperone insulin lispro and insulin lispro)
7 secondary outcomes
AUClisp_0-6h
Time frame: up to 6 hours
Cmax_lisp
Time frame: up to 6 hours
tmax_lisp
Time frame: up to 6 hours
CmaxBG
Time frame: up to 6 hours
AUCBG_0-6h
Time frame: up to 6 hours
Adverse Events
Time frame: up to 8 weeks
Local tolerability
Time frame: up to 8 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 29 Apr 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.
Grit Andersen, 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 study testing BioChaperone insulin lispro and Humalog® in people with Type 2 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 5 inclusion and 11 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 29 Apr 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 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.
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?
Pharmacodynamics: ΔAUCBG 0-2h (time frame: 2 hours). The study lists 2 primary outcomes in all. 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 29 Apr 2016.