NCT02206568

Brief Summary

To compare the early pharmacokinetic exposure of URAL and insulin lispro (ILisp).

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Jun 2014

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2014

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

July 30, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 1, 2014

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2014

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2014

Completed
Last Updated

July 15, 2020

Status Verified

May 1, 2015

Enrollment Period

2 months

First QC Date

July 30, 2014

Last Update Submit

July 14, 2020

Conditions

Type 1 Diabetes Mellitus

Keywords

diabetes mellitusphase 1insulin lispromale subjects

Outcome Measures

Primary Outcomes (1)

  • Pharmacokinetics of URAL

    Area under the serum insulin lispro concentration-time curve from 0-30 minutes after administration

    1 day

Secondary Outcomes (2)

  • Onset of appearance of serum insulin lispro

    1 day

  • Number of subjects with adverse events

    1 day

Study Arms (1)

URAL vs. Insulin lispro

EXPERIMENTAL

Each subject will randomly be allocated to a treatment sequence consisting of 2 dosing visits during which the subject in a euglycaemic clamp setting will receive either a single dose of insulin lispro or URAL at predefined fixed dose levels in a randomized order.

Drug: URAL

Interventions

URALDRUG
Also known as: Ultra-Rapid-Acting Insulin Lispro
URAL vs. Insulin lispro

Eligibility Criteria

Age18 Years - 65 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Signed informed consent
  • Male subjects age 18-65 years inclusive
  • Type 1 diabetes mellitus diagnosed clinically \>= 12 months
  • Treatment 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
  • Body mass index 18.0-30.0 kg/m2 inclusive
  • HbA1c =\<9.0% by local laboratory analysis (one retest within a week is permitted with the result of the last test being conclusive)
  • C-peptide =\< 0.30 nmol/L

You may not qualify if:

  • Known or suspected hypersensitivity to trial products or related products
  • Previous participation in this trial. .
  • Receipt of any non-marketed investigational product within 3 months
  • Clinically significant abnormal haematology, biochemistry, liver enzymes, or coagulation screening tests
  • Suffer from or history of a life threatening disease or any clinically significant cardiovascular, respiratory, metabolic, renal, hepatic, gastrointestinal, endocrinological, haematological, dermatological, venereal , neurological, psychiatric diseases or other major disorders
  • History of deep leg vein thrombosis or a frequent appearance of deep leg vein thrombosis in 1st degree relatives
  • Cardiac problems defined as decompensated heart failure (New York Heart Association class III and IV) at any time and/or angina pectoris within the last 12 months and/or acute myocardial infarction at any time.
  • Supine blood pressure at screening outside the range of 90-140 mmHg for systolic or 50-90 mmHg for diastolic . Pulse outside 50 to 90 bpm.
  • Clinically significant abnormal ECG at screening.
  • Proliferative retinopathy or maculopathy and/or severe neuropathy, in particular autonomic neuropathy.
  • Any disease or condition that, in the opinion of the Investigator, would represent an unacceptable risk for the subject's safety.
  • Subject positive for HBs-Ag, HCV-Ab
  • Positive result to the screening test for HIV-1 antibodies, HIV-2 antibodies, or HIV-1 antigen according to locally used diagnostic testing.
  • History of multiple and/or severe allergies to drugs or foods or a history of severe anaphylactic reaction.
  • Subject who has donated blood or plasma in the past month or more than 500 mL within 3 months.
  • +10 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Profil Institut fur Stoffwechselforschung GmbH

Neuss, Germany

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

  • Alin Stirban, MD

    Profil Institut fur Stoffwechselforschung GmbH

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 30, 2014

First Posted

August 1, 2014

Study Start

June 1, 2014

Primary Completion

August 1, 2014

Study Completion

September 1, 2014

Last Updated

July 15, 2020

Record last verified: 2015-05

Locations

DE(1)