Type 2 Diabetes MellitusPhase 1NCT02514850
A Trial to Compare the Pharmacodynamic and Pharmacokinetic Properties 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 1 site in Germany.
Trial summary
This is a single centre, randomised, double-blind, double-dummy, 3-treatment, 3-period cross-over, euglycaemic clamp study in subjects with type 2 diabetes on stable insulin treatment. Read more about this study
- Who is it for?
- Ages 18 to 64 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
- 24 participants
- Where
- 1 siteGermany
- Study dates
- Jul 2015to Nov 2015
- 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 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Type 2 diabetes mellitus (as diagnosed clinically) for ≥ 12 months
- HbA1c levels ≤ 9.0%
- Total insulin dose of < 1.2 U/kg/day
- Body mass index between 20.0 and 35.0 kg/m2 (both inclusive)
- Body weight ≤ 125.0 kg
- Fasting serum C-peptide ≤ 1 nmol/L
- Treated with a stable insulin regimen for ≥ 3 months prior to screening
Who cannot join
- Type 1 diabetes mellitus
- Known or suspected allergy to the trial products or related products
- 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, biochemistry, lipids, or urinalysis 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
- Use of GLP-1 receptor agonists or oral antidiabetic drugs (OADs) other than stable intake of metformin within 4 weeks prior to screening
- Women of child bearing potential, not willing to use contraceptive methods
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomised, Single Dose, Double-blind, Double-dummy, Three-period Cross-over Trial to Compare the Pharmacodynamic and Pharmacokinetic Properties of Biochaperone® Combo With Humalog® Mix25 and With Simultaneous Injections of Humalog® and Lantus® in Subjects With Type 2 Diabetes
This is a single centre, randomised, double-blind, double-dummy, 3-treatment, 3-period cross-over, euglycaemic clamp study in subjects with type 2 diabetes on stable insulin treatment. Each subject will be randomly allocated to a treatment sequence and will be administered single subcutaneous doses of 0.8 U/kg Biochaperone® Combo, 0.8 U/kg Humalog® Mix25 or simultaneous subcutaneous injections of 0.2 U/kg Humalog® and 0.6 U/kg Lantus® during three separate dosing visits.
- 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
HumalogDrug
Injection of Humalog
LantusDrug
Injection of Lantus
PlaceboDrug
Injection of saline 0.9% solution
| Study group | Role | What they receive |
|---|---|---|
| Biochaperone Combo | Experimental | single subcutaneous injection of 0.8 U/kg + injection of placebo (0.9% NaCl) to ensure the double dummy Receives: Drug: Biochaperone Combo; Drug: Placebo |
| Humalog Mix25 | Active comparator | single subcutaneous dose of 0.8 U/kg + injection of placebo (0.9% NaCl) to ensure the double dummy Receives: Drug: Humalog Mix25; Drug: Placebo |
| Humalog and Lantus | Active comparator | simultaneous subcutaneous injections of 0.2 U/kg Humalog and 0.6 U/kg Lantus Receives: Drug: Humalog; Drug: Lantus |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under the glucose infusion rate curve (AUCGIR) 12-30h (mg/kg)
Area under the glucose infusion rate curve from 12 hours to 30 hours
Measured: from 12h to 30 hours
Secondary outcomes (10)
AUCGIR 0-last (mg/kg)
Area under the glucose infusion rate curve from 0 hours until the end of clamp
Measured: Up to 30 hours
GIRmax (mg/kg/min)
Maximum glucose infusion rate
Measured: Up to 30 hours
tGIRmax
Time to maximum glucose infusion rate
Measured: Up to 30 hours
AUCLis 0-30h
Area under the insulin lispro plasma concentration time curve
Measured: Up to 30 hours
AUCGla 0-30h
Area under the insulin glargine plasma concentration time curve
Measured: Up to 30 hours
tmax Gla
Time to maximum insulin glargine plasma concentration
Measured: Up to 30 hours
tmax Lis
Time to maximum insulin lispro plasma concentration
Measured: Up to 30 hours
Adverse events
Number of adverse events
Measured: Up to 9 weeks
Hypoglycaemic episodes
Number of Hypoglycaemic episodes
Measured: Up to 9 weeks
Local tolerability
Number and intensity of injection site reactions
Measured: Up to 9 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2015 (estimated)
- Study startJul 2015
- Primary completionNov 2015
- Study completionNov 2015
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
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Adocia
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ulrike Hövelmann, MD, Principal investigator, Profil Institut Für Stoffwechselfforschung GmbH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02514850
- Sponsor's protocol ID
- BC3-CT018
- Status last verified
- Nov 2015
- First submitted
- 29 Jul 2015
- Last updated
- 2 Dec 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised, Single Dose, Double-blind, Double-dummy, Three-period Cross-over Trial to Compare the Pharmacodynamic and Pharmacokinetic Properties of Biochaperone® Combo With Humalog® Mix25 and With Simultaneous Injections of Humalog® and Lantus® in Subjects With Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT02514850
- Acronym / sponsor ID
- BC3-CT018
- Conditions
- Type 2 Diabetes Mellitus
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- AdociaIndustry (pharma, biotech, devices)
- Study start
- Jul 2015
- Primary completion
- Nov 2015 (actual)
- Study completion
- Nov 2015 (actual)
- First posted
- 4 Aug 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 single centre, randomised, double-blind, double-dummy, 3-treatment, 3-period cross-over, euglycaemic clamp study in subjects with type 2 diabetes on stable insulin treatment. Each subject will be randomly allocated to a treatment sequence and will be administered single subcutaneous doses of 0.8 U/kg Biochaperone® Combo, 0.8 U/kg Humalog® Mix25 or simultaneous subcutaneous injections of 0.2 U/kg Humalog® and 0.6 U/kg Lantus® during three separate dosing visits.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Biochaperone Combo | Experimental | Drug: Biochaperone Combo, Drug: Placebosingle subcutaneous injection of 0.8 U/kg + injection of placebo (0.9% NaCl) to ensure the double dummy |
| Humalog Mix25 | Active comparator | Drug: Humalog Mix25, Drug: Placebosingle subcutaneous dose of 0.8 U/kg + injection of placebo (0.9% NaCl) to ensure the double dummy |
| Humalog and Lantus | Active comparator | Drug: Humalog, Drug: Lantussimultaneous subcutaneous injections of 0.2 U/kg Humalog and 0.6 U/kg Lantus |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Type 2 diabetes mellitus (as diagnosed clinically) for ≥ 12 months
- HbA1c levels ≤ 9.0%
- Total insulin dose of < 1.2 U/kg/day
- Body mass index between 20.0 and 35.0 kg/m2 (both inclusive)
- Body weight ≤ 125.0 kg
Key exclusion criteria (8 listed)
- Type 1 diabetes mellitus
- Known or suspected allergy to the trial products or related products
- 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, 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 ComboInjection of BioChaperone Combo | Drug | Biochaperone Combo |
| Humalog Mix25Injection of Humalog Mix25 | Drug | Humalog Mix25 |
| HumalogInjection of Humalog | Drug | Humalog and Lantus |
| LantusInjection of Lantus | Drug | Humalog and Lantus |
| PlaceboInjection of saline 0.9% solution | Drug | Biochaperone Combo, Humalog Mix25 |
Primary outcome
Area under the glucose infusion rate curve (AUCGIR) 12-30h (mg/kg)
Time frame: from 12h to 30 hours
Area under the glucose infusion rate curve from 12 hours to 30 hours
10 secondary outcomes
AUCGIR 0-last (mg/kg)
Time frame: Up to 30 hours
GIRmax (mg/kg/min)
Time frame: Up to 30 hours
tGIRmax
Time frame: Up to 30 hours
AUCLis 0-30h
Time frame: Up to 30 hours
AUCGla 0-30h
Time frame: Up to 30 hours
tmax Gla
Time frame: Up to 30 hours
tmax Lis
Time frame: Up to 30 hours
Adverse events
Time frame: Up to 9 weeks
Hypoglycaemic episodes
Time frame: Up to 9 weeks
Local tolerability
Time frame: Up to 9 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 2 Dec 2015.
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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.
Ulrike Hövelmann, MD principal investigator
Profil Institut Für Stoffwechselfforschung GmbH
1 site 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 1 site 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 7 inclusion and 8 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 2 Dec 2015. 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 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?
Area under the glucose infusion rate curve (AUCGIR) 12-30h (mg/kg) (time frame: from 12h to 30 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 2 Dec 2015.