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Type 1 Diabetes MellitusPhase 1NCT02528396

To Investigate the Efficacy and Safety of Individualized Doses of BioChaperone Insulin Lispro in Comparison to Humalog® U-100 in Patients With Type 1 Diabetes Mellitus

A Phase 1 study testing BioChaperone insulin lispro and Humalog® in people with Type 1 Diabetes Mellitus, run by Adocia at 1 site in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This is a double-blind, randomised, controlled, two period crossover phase Ib trial using an individualized standard meal with a fixed nutrient ratio in subjects with type 1 diabetes mellitus to investigate postprandial blood glucose control with BioChaperone insulin lispro compared to Humalog®. 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 insulin lispro and Humalog®
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
36 participants
Where
1 siteGermany
Study dates
Aug 2015to Dec 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 1 diabetes mellitus (as diagnosed clinically) ≥ 12 months
  • Treated with multiple daily insulin injections (no pump users) ≥ 12 months
  • Current total daily insulin treatment <1.2 (I)U/kg/day
  • Body mass index (BMI) 18.5-28.0 kg/m² (both inclusive)
  • HbA1c (N-(1-deoxy)-fructosyl-haemoglobin) ≤ 9.0% by local laboratory analysis
  • Fasting C-peptide ≤ 0.30 nmol/L

Who cannot join

  • Known or suspected hypersensitivity to trial products or related products
  • Type 2 diabetes mellitus
  • Patients using continuous subcutaneous insulin infusion (CSII)
  • Previous participation in this trial. Participation is defined as randomised
  • The receipt of any investigational product 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
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  • Presence of clinically significant acute gastrointestinal symptoms (e.g. nausea, vomiting, heartburn or diarrhoea), as judged by the Investigator
  • 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

Trial locations and contacts

1 site in 1 country.

Germany1 site

  • Profil GmbH

    Neuss, 41460

Other trials in Germany

About this study

Official title: A Randomized, Monocentric, Double-blind, Multiple Daily Dose, Two-period, 14 Day Cross-over Trial to Investigate the Efficacy, Pharmacokinetics, Safety and Tolerability of Individualized Doses of BioChaperone Insulin Lispro in Comparison to Humalog® U-100 in Patients With Type 1 Diabetes Mellitus

This is a double-blind, randomised, controlled, two period crossover phase Ib trial using an individualized standard meal with a fixed nutrient ratio in subjects with type 1 diabetes mellitus to investigate postprandial blood glucose control with BioChaperone insulin lispro compared to Humalog®. The assessments will be conducted before and after a period of multiple daily dose administrations for 14 days. The meal tolerance test will be performed on day 1-3 and on day 14 of each period. Furthermore the study aims at investigating Post-prandial glucose (PPG) profiles with BioChaperone insulin lispro and Humalog® when injected at various injection meal intervals (-15min, 0 minutes, +15 minutes).

Each subject will be randomised to a sequence of two treatments, either BioChaperone insulin lispro-Humalog® or Humalog®-Biochaperone insulin lispro, and three different sequences of injection-meal intervals. A blinded to patient continuous monitoring of glucose (CGM) will be performed during the 14 day treatment periods.

Being tested
BioChaperone insulin lispro, Humalog®
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 insulin lisproDrug

    Injection at t0,or t+15 minutes or t-15minutes with test meal

  • Humalog®Drug

    Injection at t0,or t+15 minutes or t-15minutes with test meal

Study groups in NCT02528396
Study groupRoleWhat they receive
BioChaperone insulin lisproExperimentalNot described
Receives: Drug: BioChaperone insulin lispro
Humalog®Active comparatorNot described
Receives: Drug: Humalog®

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. AUCΔBG0-2h (timepoint 0 = administration of the meal)

    Incremental area under the blood glucose (BG) concentration-time curve from 0-2 hours after a meal on day 1-3 [comparison between treatments Biochaperone insulin lispro vs. lispro (Humalog®)]

    Measured: 2 hours

  2. AUClispro 0-30min (timepoint 0 = time of dosing)

    Area under the serum insulin lispro concentration-time curve from 0-30 minutes after bolus dose on one of days 1, 2 or 3 (comparison between treatments BioChaperone insulin lispro vs. lispro (Humalog®))

    Measured: 30 minutes

Secondary outcomes (7)

  1. AUClispro_0-6h

    Area under the serum insulin lispro concentration-time curve from 0-6 hours after bolus dose

    Measured: 6 Hours

  2. Cmax_lispro

    Maximum serum insulin lispro concentration

    Measured: up to 6 Hours

  3. Tmax_lispro

    Time to maximum observed serum insulin lispro concentration

    Measured: up to 6 Hours

  4. AUCBG_0-6h

    Area under the curve under the blood glucose (BG) concentration time curve from 0-6 hours

    Measured: 6 Hours

  5. ΔBGmax

    Maximum blood glucose (BG) excursion after a standard meal (0-6 hours)

    Measured: 6 Hours

  6. Adverse events

    Number of Adverse events

    Measured: Up to 3 months

  7. Local tolerability injection site reactions

    Injection site reactions over 14 days of exposure

    Measured: 14 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Aug 2015 (estimated)
  2. Study startAug 2015
  3. Primary completionDec 2015
  4. Study completionDec 2015

Resources

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
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
36 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02528396
Sponsor's protocol ID
BC3-CT013
Status last verified
Mar 2016
First submitted
18 Aug 2015
Last updated
16 Mar 2016
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing BioChaperone insulin lispro and Humalog® in people with Type 1 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 6 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 16 Mar 2016. 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?

AUCΔBG0-2h (timepoint 0 = administration of the meal) (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?

On the ClinicalTrials.gov record for NCT02528396.

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 16 Mar 2016.

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