NCT00983775

Brief Summary

The purpose of this study is to compare the pharmacological profile of insulin administered with jet-injection with that of insulin injected with a conventional insulin pen.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
48

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2009

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

First Submitted

Initial submission to the registry

September 21, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 24, 2009

Completed
1 month until next milestone

Study Start

First participant enrolled

November 1, 2009

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2010

Completed
Last Updated

August 11, 2011

Status Verified

September 1, 2009

Enrollment Period

1 year

First QC Date

September 21, 2009

Last Update Submit

August 10, 2011

Conditions

Diabetes Mellitus, Type 1

Keywords

Pharmacokinetic profilePharmacodynamic profileinsulinjet injector

Outcome Measures

Primary Outcomes (1)

  • (time to) maximal glucose infusion rate

    0-8 hours after insulin injection

Secondary Outcomes (1)

  • (time to) maximal insulin concentration

    0-8 hours after insulin injection

Study Arms (3)

healthy low dose insulin

EXPERIMENTAL

16 healthy non-diabetic volunteers. The type of insulin tested will be the rapid-acting insulin analogue insulin aspart (Novorapid®), at a dose of 0.2 units per kg body weight.

Device: jet injector (SQ pen/Novopen III)

healthy high dose insulin

EXPERIMENTAL

16 healthy non-diabetic volunteers. The type of insulin tested will be the rapid-acting insulin analogue insulin aspart (Novorapid®), at a dose of 0.4 units per kg body weight.

Device: jet injector (SQ pen/Novopen III)

type 1 diabetes mellitus

EXPERIMENTAL

16 people with type 1 diabetes mellitus. The type of insulin tested will be the rapid-acting insulin analogue insulin aspart (Novorapid®), at a dose of 0.4 units per kg body weight.

Device: jet injector (SQ pen/Novopen III)

Interventions

jet injector (SQ pen/Novopen III)DEVICE

The rapid-acting insulin analogue insulin aspart (Novorapid®), at a dose of 0.2 units per kg body weight, will be injected subcutaneously. On one experimental day insulin will be injected with the jet injector and placebo with the conventional insulin pen. On the other experimental day insulin will be injected with the conventional insulin pen and placebo with the jet injector.

Also known as: SQ pen, Novopen III
healthy low dose insulin

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Age 18-50 years
  • Body-mass index 18-28 kg/m2
  • Blood pressure \<160/90 mmHg
  • Stable glycaemic control with HbA1c 6.5-9.0% (for patients with type 1 diabetes mellitus)
  • Duration of diabetes \>1 year (for patients with type 1 diabetes mellitus)

You may not qualify if:

  • Inability to provide informed consent
  • Chronic use of medication other than oral contraceptives or thyroid hormone replacement therapy (with stable euthyroidism for at least 3 months)
  • Chronic use of medication other than insulin or low-dose angiotensin-converting enzyme (ACE) inhibitor or angiotensin receptor blocker (ARB) treatment (for patients with type 1 diabetes mellitus)
  • Type 2 diabetes in first-degree relatives (for healthy subjects)
  • History of a major cardiovascular disease event (myocardial infarction, stroke, symptomatic peripheral artery disease, coronary bypass surgery, percutaneous coronary or peripheral artery angioplasty)
  • Pregnancy
  • Macroalbuminuria, i.e. urinary albumin excretion \>200 microg/min in collected urine sample or urinary albumin-to-creatinine ratio \>300 mg/g in spot urine sample (for patients with type 1 diabetes mellitus)
  • Symptomatic diabetic neuropathy (for patients with type 1 diabetes mellitus)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Radboud University Nijmegen Medical Centre

Nijmegen, P.O. Box 9101, 6500 HB, Netherlands

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1Insulin Resistance

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesAutoimmune DiseasesImmune System DiseasesHyperinsulinism

Study Officials

  • Cees J Tack, MD PhD

    Radboud University Medical Center

    STUDY CHAIR

Study Design

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

Study Record Dates

First Submitted

September 21, 2009

First Posted

September 24, 2009

Study Start

November 1, 2009

Primary Completion

November 1, 2010

Study Completion

November 1, 2010

Last Updated

August 11, 2011

Record last verified: 2009-09

Locations

NL(1)