Type 2 Diabetes MellitusPhase 1NCT02915250
A Trial to Compare Post Prandial Blood Glucose Control of BioChaperone® Combo With Humalog® Mix25 and With Simultaneous Injections of Humalog® and Lantus® in Subjects With Type 2 Diabetes
A Phase 1 study testing BioChaperone® Combo, Humalog® Mix25 and Humalog® in people with Type 2 Diabetes Mellitus, run by Adocia at 2 sites in Germany.
Trial summary
This is a two-centre, randomised, double-blind, double-dummy, 3-treatment, 3-period cross-over study using a standardised solid meal test in subjects with type 2 diabetes to investigate postprandial glucose control of BioChaperone® Combo compared with Humalog® Mix25 and with simultaneous subcutaneous injections of… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Type 2 Diabetes Mellitus
- What is being tested?
- BioChaperone® Combo, Humalog® Mix25 and Humalog®
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 36 participants
- Where
- 2 sitesGermany
- Study dates
- Oct 2016to Jun 2017
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female subject aged 18-70 years (both inclusive)
- Type 2 diabetes mellitus (as diagnosed clinically) for ≥ 12 months
- HbA1c level between 7.5% and 9.5% (both inclusive)
- Body mass index between 20.0 and 40.0 kg/m2 (both inclusive)
- Treated with once daily injections with insulin glargine U-100 for ≥ 3 months prior to screening
Who cannot join
- Type 1 diabetes mellitus
- Known or suspected allergy to the IMPs or related products
- Previous participation in this trial. Participation is defined as randomised.
- Receipt of any medicinal product in clinical development within 60 days prior to this trial.
- Clinically significant abnormal haematology, biochemistry, urinalysis or coagulation screening tests, as judged by the Investigator considering the underlying disease
- Supine blood pressure at screening outside the range of 90-160 mmHg for systolic or 50-95 mmHg for diastolic and/or resting supine heart rate outside the range 50-90 beats per minute. This exclusion criterion also pertains to subjects being on antihypertensives.
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- Current treatment with premixed or intermediate insulin products, or with long acting insulins other than insulin glargine U-100. The use of short or rapid acting prandial insulin products will be allowed provided their use has been stable for ≥ 3 months prior to screening.
- Use of GLP-1 receptor agonists or oral antidiabetic drugs (OADs) other than stable intake of metformin alone or metformin in combination with a DPP-4 inhibitor within 4 weeks prior to screening
- Women of child bearing potential not willing to use contraceptive methods.
Trial locations and contacts
2 sites in 1 country.
About this study
Official title: A Randomised, Double-blind, Double-dummy, Three-period Cross-over Trial to Compare Post Prandial Blood Glucose Control of BioChaperone® Combo With Humalog® Mix25 and With Simultaneous Injections of Humalog® and Lantus® in Subjects With Type 2 Diabetes
This is a two-centre, randomised, double-blind, double-dummy, 3-treatment, 3-period cross-over study using a standardised solid meal test in subjects with type 2 diabetes to investigate postprandial glucose control of BioChaperone® Combo compared with Humalog® Mix25 and with simultaneous subcutaneous injections of Humalog® and Lantus® during three separate dosing visits.
Read the detailed description
This is a two-centre, randomised, double-blind, double-dummy, 3-treatment, 3-period cross-over study using a standardised solid meal test in subjects with type 2 diabetes to investigate postprandial glucose control of BioChaperone® Combo compared with Humalog® Mix25 and with simultaneous subcutaneous injections of Humalog® and Lantus® during three separate dosing visits.
Furthermore, this study aims to compare the pharmacokinetic (PK) profiles of the three different study treatments.
During each dosing visit, subjects will be given 3 doses of IMP on three consecutive days (Day 1, Day 2 and Day 3). Dosing on Day 2 and Day 3 will be followed by a standardised solid meal test.
- Conditions
- Type 2 Diabetes Mellitus
- Being tested
- BioChaperone® Combo, Humalog® Mix25, Humalog®, Lantus®, Placebo
- 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® ComboDrug
Injection of BioChaperone® Combo
Humalog® Mix25Drug
Injection of Humalog® Mix25
Humalog®Drug
Injection of Humalog®
Lantus®Drug
Injection of Lantus®
PlaceboDrug
Injection of 0.9% NaCl
| Study group | Role | What they receive |
|---|---|---|
| BioChaperone® Combo | Experimental | Individualised single subcutaneous of BioChaperone® Combo + injection of placebo (0.9% NaCl) to ensure the double dummy Receives: Drug: BioChaperone® Combo; Drug: Placebo |
| Humalog® Mix25 | Active comparator | Individualised single subcutaneous of Humalog® Mix25 + injection of placebo (0.9% NaCl) to ensure the double dummy Receives: Drug: Humalog® Mix25; Drug: Placebo |
| Humalog® and Lantus® | Active comparator | Individualised simultaneous subcutaneous injections Receives: Drug: Humalog®; Drug: Lantus® |
What is being measured
The primary outcome is the main question the study is designed to answer.
Delta AUC BG 0-2h (area under the blood glucose concentration-time curve)
Mean of incremental areas under the blood glucose concentration-time curve from 0-2 hours after a standardised meal on Day 2 and Day 3
Measured: From 0 to 2 hours
Secondary outcomes (10)
Partial delta AUCs BG and total AUCs BG
Partial incremental AUCs BG and total AUCs BG in the 0-6 time range
Measured: From 0 to 6 hours
Mean and mean change from baseline of blood glucose at different time points
Measured: From 0 to 6 hours
Delta BGmax and delta BGmin
Maximum and minimum blood glucose excursions after a standardised meal
Measured: From 0 to 6 hours
BGmax and BGmin
Maximum and minimum blood glucose concentrations after a standardised meal
Measured: From 0 to 6 hours
AUC Insulin
Partial areas under the insulins plasma concentration time curve
Measured: From 0 to 24 hours
Cmax Insulin
Maximum observed plasma insulins concentration
Measured: From 0 to 6 hours
tmax Insulin
Time to maximum observed plasma insulins concentration
Measured: From 0 to 6 hours
Adverse Events
Measured: Up to 12 weeks (maximum duration of subject's participation)
Local tolerability
Measured: Up to 12 weeks (maximum duration of subject's participation)
Hypoglycaemic events
Measured: Up to 12 weeks (maximum duration of subject's participation)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2016 (estimated)
- Study startOct 2016
- Primary completionJun 2017
- Study completionJun 2017
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, Investigator, Outcomes assessor
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Adocia
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Leona Plum-Mörschel, MD, Principal investigator, Profil Mainz GmbH & Co KG
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02915250
- Sponsor's protocol ID
- BC3-CT022
- Status last verified
- Jun 2017
- First submitted
- 21 Sep 2016
- Last updated
- 29 Jun 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised, Double-blind, Double-dummy, Three-period Cross-over Trial to Compare Post Prandial Blood Glucose Control of BioChaperone® Combo With Humalog® Mix25 and With Simultaneous Injections of Humalog® and Lantus® in Subjects With Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT02915250
- Acronym / sponsor ID
- BC3-CT022
- Conditions
- Type 2 Diabetes Mellitus
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- AdociaIndustry (pharma, biotech, devices)
- Study start
- Oct 2016 (actual)
- Primary completion
- Jun 2017 (actual)
- Study completion
- Jun 2017 (actual)
- First posted
- 26 Sep 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 two-centre, randomised, double-blind, double-dummy, 3-treatment, 3-period cross-over study using a standardised solid meal test in subjects with type 2 diabetes to investigate postprandial glucose control of BioChaperone® Combo compared with Humalog® Mix25 and with simultaneous subcutaneous injections of Humalog® and Lantus® during three separate dosing visits.
Detailed description
This is a two-centre, randomised, double-blind, double-dummy, 3-treatment, 3-period cross-over study using a standardised solid meal test in subjects with type 2 diabetes to investigate postprandial glucose control of BioChaperone® Combo compared with Humalog® Mix25 and with simultaneous subcutaneous injections of Humalog® and Lantus® during three separate dosing visits.
Furthermore, this study aims to compare the pharmacokinetic (PK) profiles of the three different study treatments.
During each dosing visit, subjects will be given 3 doses of IMP on three consecutive days (Day 1, Day 2 and Day 3). Dosing on Day 2 and Day 3 will be followed by a standardised solid meal test.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| BioChaperone® Combo | Experimental | Drug: BioChaperone® Combo, Drug: PlaceboIndividualised single subcutaneous of BioChaperone® Combo + injection of placebo (0.9% NaCl) to ensure the double dummy |
| Humalog® Mix25 | Active comparator | Drug: Humalog® Mix25, Drug: PlaceboIndividualised single subcutaneous of Humalog® Mix25 + injection of placebo (0.9% NaCl) to ensure the double dummy |
| Humalog® and Lantus® | Active comparator | Drug: Humalog®, Drug: Lantus®Individualised simultaneous subcutaneous injections |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Male or female subject aged 18-70 years (both inclusive)
- Type 2 diabetes mellitus (as diagnosed clinically) for ≥ 12 months
- HbA1c level between 7.5% and 9.5% (both inclusive)
- Body mass index between 20.0 and 40.0 kg/m2 (both inclusive)
- Treated with once daily injections with insulin glargine U-100 for ≥ 3 months prior to screening
Key exclusion criteria (9 listed)
- Type 1 diabetes mellitus
- Known or suspected allergy to the IMPs or related products
- Previous participation in this trial. Participation is defined as randomised.
- Receipt of any medicinal product in clinical development within 60 days prior to this trial.
- Clinically significant abnormal haematology, biochemistry, urinalysis or coagulation 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® ComboInjection of BioChaperone® Combo | Drug | BioChaperone® Combo |
| Humalog® Mix25Injection of Humalog® Mix25 | Drug | Humalog® Mix25 |
| Humalog®Injection of Humalog® | Drug | Humalog® and Lantus® |
| Lantus®Injection of Lantus® | Drug | Humalog® and Lantus® |
| PlaceboInjection of 0.9% NaCl | Drug | BioChaperone® Combo, Humalog® Mix25 |
Primary outcome
Delta AUC BG 0-2h (area under the blood glucose concentration-time curve)
Time frame: From 0 to 2 hours
Mean of incremental areas under the blood glucose concentration-time curve from 0-2 hours after a standardised meal on Day 2 and Day 3
10 secondary outcomes
Partial delta AUCs BG and total AUCs BG
Time frame: From 0 to 6 hours
Mean and mean change from baseline of blood glucose at different time points
Time frame: From 0 to 6 hours
Delta BGmax and delta BGmin
Time frame: From 0 to 6 hours
BGmax and BGmin
Time frame: From 0 to 6 hours
AUC Insulin
Time frame: From 0 to 24 hours
Cmax Insulin
Time frame: From 0 to 6 hours
tmax Insulin
Time frame: From 0 to 6 hours
Adverse Events
Time frame: Up to 12 weeks (maximum duration of subject's participation)
Local tolerability
Time frame: Up to 12 weeks (maximum duration of subject's participation)
Hypoglycaemic events
Time frame: Up to 12 weeks (maximum duration of subject's participation)
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 Jun 2017.
- 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.
Leona Plum-Mörschel, MD principal investigator
Profil Mainz GmbH & Co KG
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® Combo, Humalog® Mix25 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 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 29 Jun 2017. 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?
Delta AUC BG 0-2h (area under the blood glucose concentration-time curve) (time frame: From 0 to 2 hours). 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 Jun 2017.