NCT00532766

Brief Summary

To evaluate the pharmacokinetic and pharmacodynamic profile of a new human insulin (Jusline) after subcutaneous administration, and to compare this profile with Humulin insulin.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at P25-P50 for not_applicable healthy

Timeline
Completed

Started Nov 2006

Shorter than P25 for not_applicable healthy

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

November 1, 2006

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2007

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

September 19, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 20, 2007

Completed
Last Updated

September 26, 2007

Status Verified

September 1, 2007

First QC Date

September 19, 2007

Last Update Submit

September 24, 2007

Conditions

Healthy

Keywords

Healthy subjects

Outcome Measures

Primary Outcomes (1)

  • To evaluate the pharmacokinetic and pharmacodynamic profile of a new human insulin (Jusline)

Study Arms (1)

2

EXPERIMENTAL

Jusline Humulin

Drug: Jusline

Interventions

JuslineDRUG
Also known as: Humulin
2

Eligibility Criteria

Age18 Years - 35 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy
  • Non-diabetic
  • Age 18-35 year
  • Normal body mass index (BMI 18-25 kg/m2)

You may not qualify if:

  • Diabetics
  • Overweight/obese
  • Anemic, with liver, cardiac, renal or thyroid dysfunction

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Diabetes Center

Riyadh, Riyadh Region, 11461, Saudi Arabia

Location

MeSH Terms

Interventions

Insulin, Regular, Human

Intervention Hierarchy (Ancestors)

InsulinProinsulinInsulinsPancreatic HormonesPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsPeptidesAmino Acids, Peptides, and Proteins

Study Officials

  • Khalid A Al-Rubeaan, MD

    College of Medicine, King Saud University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 19, 2007

First Posted

September 20, 2007

Study Start

November 1, 2006

Study Completion

February 1, 2007

Last Updated

September 26, 2007

Record last verified: 2007-09

Locations

SA(1)