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Type 1 Diabetes MellitusPhase 1NCT02514954

Postprandial Blood Glucose Control With BioChaperone® Combo and Insulin Lispro (Humalog®) Mix 25 in People With Type 1 Diabetes Mellitus

A Phase 1 study testing Biochaperone® Combo and Humalog® Mix25 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

Each subject will be randomly allocated to a sequence of two treatments applied at two separate dosing visits. At each dosing visit subjects will be injected with individualised doses of either BioChaperone® Combo or Humalog® Mix 25 immediately before ingesting a standardised mixed meal [(t=0 min) start of the meal]. 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® Combo and Humalog® Mix25
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
28 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 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.
  • Usual Insulin bolus dose between 0.8 and 2 (I)U per 10 g CH (both inclusive). Expecting prandial insulin dose range for standardised meal test between 5 and 12 (I)U.
  • BMI 18.5-28.0 kg/m^2 (both inclusive).
  • HbA1c <= 9.0% by local laboratory analysis
  • Fasting C-peptide <= 0.3 nmol/L.

Who cannot join

  • Known or suspected hypersensitivity to trial products 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, 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.
Show all 9Show fewer
  • 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.
  • Women of child bearing potential, not willing to use contraceptive methods.

Trial locations and contacts

1 site in 1 country.

Germany1 site

  • Profil Institut für Stoffwechselforschung GmbH

    Neuss, 41460

Other trials in Germany

About this study

Each subject will be randomly allocated to a sequence of two treatments applied at two separate dosing visits. At each dosing visit subjects will be injected with individualised doses of either BioChaperone® Combo or Humalog® Mix 25 immediately before ingesting a standardised mixed meal [(t=0 min) start of the meal]. Insulin doses will be identical at both dosing visits of one individual and will be administered subcutaneously in the abdominal region. Subjects will be asked to consume a standardised meal (e.g. pizza) for dinner at home in the evening before each dosing visit. Subjects will attend the clinical site in a fasted state in the morning of each dosing day and stay at the clinical trial centre until 10-hour after dosing (standardised test-meal procedure has been terminated after 6h). The two dosing visits will be separated by a wash-out period of 5-15 days.

Being tested
Biochaperone® Combo, Humalog® Mix25
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® ComboDrug

    Subcutaneous injection of an individualized dose

  • Humalog® Mix25Drug

    Subcutaneous injection of an individualized dose

Study groups in NCT02514954
Study groupRoleWhat they receive
BioChaperone® ComboExperimental1 single dose 400 U/mL
Receives: Drug: Biochaperone® Combo
Humalog® Mix25Active comparator1 single dose 100 U/mL
Receives: Drug: Humalog® Mix25

What is being measured

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

  1. Delta AUCBG,0-2h

    Incremental area under the blood glucose concentration-time curve from 0-2 hours after a standardised meal

    Measured: 2 hours

Secondary outcomes (9)

  1. Delta AUCBG,0-6h

    Incremental area under the blood glucose concentration-time curve from 0-6 hours after a standardised meal

    Measured: 6 hours

  2. BGmax

    Maximum blood glucose concentration after a standardised meal (0-6 hours)

    Measured: 6 hours

  3. tBGmax

    Time to maximum blood glucose concentration after a standardised meal (0-6 hours)

    Measured: 6 hours

  4. AUCLisp,0-6h,

    Area under the plasma insulin lispro concentration-time curve from 0-6 hours

    Measured: 6 hours

  5. AUCGlarg,0-6h

    Area under the plasma insulin glargine concentration-time curve from 0-6 hours

    Measured: 6 hours

  6. Cmax,Lisp

    Maximum observed plasma insulin lispro concentration

    Measured: 6 hours

  7. Cmax,Glarg

    Maximum observed plasma insulin glargine concentration

    Measured: 6 hours

  8. Adverse events

    Number of adverse events

    Measured: Up to 7 weeks

  9. Local tolerability

    Number and intensity of injection site reactions

    Measured: Up to 7 weeks

Timeline

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

  1. First posted4 Aug 2015 (estimated)
  2. Study startJul 2015
  3. Primary completionNov 2015
  4. Study completionNov 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
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
28 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02514954
Sponsor's protocol ID
BC3-CT019
Status last verified
Nov 2015
First submitted
29 Jul 2015
Last updated
6 Nov 2015
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Biochaperone® Combo and Humalog® Mix25 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 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 6 Nov 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?

Delta AUCBG,0-2h (time frame: 2 hours). 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 NCT02514954.

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 6 Nov 2015.

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