NCT01811849

Brief Summary

A Double-blind Study of the Pharmacokinetic Properties of BIOD-238 and BIOD-250 Compared to Humalog® in Subjects with Type 1 Diabetes

Trial Health

100
On Track

Trial Health Score

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

Enrollment
12

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Aug 2012

Shorter than P25 for phase_1

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2012

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2012

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

March 13, 2013

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 15, 2013

Completed
Last Updated

March 15, 2013

Status Verified

March 1, 2013

Enrollment Period

4 months

First QC Date

March 13, 2013

Last Update Submit

March 14, 2013

Conditions

Type 1 Diabetes

Keywords

diabetes

Outcome Measures

Primary Outcomes (1)

  • Time to 1/2 maximal insulin concentration

    480 minutes

Secondary Outcomes (4)

  • Time to maximal insulin concentration

    480 minutes

  • Time to 1/2 maximal insulin concentration after peak

    480 minutes

  • Visual analog scale

    30 minutes

  • AUC 0-30 and AUC 0-60

    60 minutes

Study Arms (3)

BIOD-238

EXPERIMENTAL

Subcutaneous injection

Drug: Insulin LISPRO

BIOD-250

EXPERIMENTAL

Subcutaneous injection

Drug: Insulin LISPRO

Humalog

ACTIVE COMPARATOR

Subcutaneous injection

Drug: Insulin LISPRO

Interventions

Insulin LISPRODRUG
BIOD-238

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age: ≥18 to ≤70 years
  • Body Mass Index: ≥18 and ≤35 kg/m2
  • Diagnosed with Type 1 Diabetes Mellitus for at least 1 year

You may not qualify if:

  • Type 2 diabetes mellitus
  • Serum C-peptide \>1.0 ng/mL
  • HbA1c \>10.0%
  • History of hypersensitivity to any of the components in the study medication
  • Treatment with any other investigational drug in the last 30 days before dosing.
  • Current drug or alcohol abuse, or a history of drug or alcohol abuse which in the opinion of the Investigator will impair subject safety, protocol compliance, or interpretation of study results. Caffeine, nicotine or alcohol addiction which might be expected to result in withdrawal symptoms during the course of a study dosing day would fall into this category.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Diabetes Mellitus, Type 1Diabetes Mellitus

Interventions

Insulin Lispro

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Insulin, Short-ActingInsulinsPancreatic HormonesPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsPeptidesAmino Acids, Peptides, and Proteins

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 13, 2013

First Posted

March 15, 2013

Study Start

August 1, 2012

Primary Completion

December 1, 2012

Study Completion

December 1, 2012

Last Updated

March 15, 2013

Record last verified: 2013-03