NCT01000922

Brief Summary

Evaluation of post-prandial blood glucose excursions after a standardized meal and pre meal injections of individual doses of the study insulins.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
24

participants targeted

Target at below P25 for phase_2 diabetes-mellitus

Timeline
Completed

Started Jun 2006

Geographic Reach
1 country

1 active site

Status
completed

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, 2006

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2008

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

October 21, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 23, 2009

Completed
Last Updated

July 29, 2015

Status Verified

July 1, 2015

Enrollment Period

1.6 years

First QC Date

October 21, 2009

Last Update Submit

July 28, 2015

Conditions

Diabetes Mellitus

Keywords

Mealtime InsulinRapid acting insulinUltra fast VIAjectprandial insulin

Outcome Measures

Primary Outcomes (1)

  • To compare the maximal post prandial blood glucose concentration and the time to maximal post prandial glucose concentration between the different treatments

    8 hours

Secondary Outcomes (1)

  • To compare the ppGlucmax for all treatments, the ppTGluc-max, the AUCGluc 0-180 and the AUCGluc 0-360, CGluc-baseline for all treatments.

    8 hours

Study Arms (6)

Regular Human Insulin

EXPERIMENTAL

Single injection

Drug: Regular Human Insulin

Lispro

EXPERIMENTAL

Single injection

Drug: Lispro

VIAject

EXPERIMENTAL

Single injection

Drug: VIAject

VIAject 50%

EXPERIMENTAL

Single injection

Drug: VIAject 50%

VIAject/Insulin glargine

EXPERIMENTAL

Single injection

Drug: VIAject/Insulin Glargine

Insulin Glargine/VIAject

EXPERIMENTAL

Single injection

Drug: Insulin Glargine/VIAject

Interventions

Regular Human InsulinDRUG

Individual dose of RHI administered subcutaneously

Regular Human Insulin
LisproDRUG

Individual dose of lispro administered subcutaneously

Lispro
VIAjectDRUG

Individual dose of VIAject administered subcutaneously

VIAject
VIAject 50%DRUG

Individual dose of VIAject 50% administered subcutaneously

VIAject 50%
VIAject/Insulin GlargineDRUG

VIAject mixed wiht insulin glargine and administered subcutaneously

VIAject/Insulin glargine
Insulin Glargine/VIAjectDRUG

Individual dose of VIAject and Insulin Glargine administered seperately and subcutaneously

Insulin Glargine/VIAject

Eligibility Criteria

Age19 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Established diagnosis of type 1 diabetes for not less than 5 years
  • HbA1c values of not more than 9%
  • Age: 19 to 70 years
  • Sex: Male or Female
  • Body Mass Index: 18 - 28 kg/m2
  • Informed consent must be obtained in writing for all volunteers.

You may not qualify if:

  • Type 2 Diabetes mellitus.
  • History of hypersensitivity to any of the components in the study medication.
  • History of severe or multiple allergies.
  • Treatment with any other investigational drug in the last 1 month before study entry.
  • Treatment with any concomitant medication that in the judgment of the investigator. would interfere with the study results.
  • Progressive disease likely to prove fatal (e.g. malignancies).
  • Current drug or alcohol abuse, or a history which in the opinion of the Investigator will impair subject safety or protocol compliance.
  • Having a significant cardiovascular, respiratory, gastrointestinal, hepatic, renal, neurological, psychiatric and/or hematological disease as evaluated by the investigator.
  • Blood donation within the last 30 days.
  • A women who is lactating.
  • Pregnant women or women intending to become pregnant during the study.
  • A sexually active woman of childbearing age not actively practicing birth control by using a medically accepted device or therapy.
  • Positive Serology for HIV, Hepatitis B or Hepatitis C.
  • Abnormal ECG, safety lab or physical examination results that are deemed clinically significant by the investigator.
  • A lack of compliance or other reasons which, in the opinion of the investigator, prevent the participation of the subject in the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Profil Institute for Clinical Research, Inc. (PICR)

Chula Vista, California, 91911, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus

Interventions

InsulinInsulin LisproInsulin Glargine

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

ProinsulinInsulinsPancreatic HormonesPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsPeptidesAmino Acids, Peptides, and ProteinsInsulin, Short-ActingInsulin, Long-Acting

Study Officials

  • Marcus Hompesch, MD

    Profil Institute for Clinical Research, Inc.

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 21, 2009

First Posted

October 23, 2009

Study Start

June 1, 2006

Primary Completion

January 1, 2008

Study Completion

January 1, 2008

Last Updated

July 29, 2015

Record last verified: 2015-07

Locations

US(1)