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Pharmacology of Insulin Injected With Jet-Injection

Primary Purpose

Diabetes Mellitus, Type 1

Status
Completed
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
jet injector (SQ pen/Novopen III)
jet injector (SQ pen/Novopen III)
Sponsored by
Radboud University Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetes Mellitus, Type 1 focused on measuring Pharmacokinetic profile, Pharmacodynamic profile, insulin, jet injector

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • 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)

Exclusion Criteria:

  • 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)
  • Proliferative diabetic retinopathy (a history of proliferative retinopathy that was successfully treated with laser coagulopathy is not an exclusion criterion) (for patients with type 1 diabetes mellitus)

Sites / Locations

  • Radboud University Nijmegen Medical Centre

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

healthy low dose insulin

healthy high dose insulin

type 1 diabetes mellitus

Arm Description

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.

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.

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.

Outcomes

Primary Outcome Measures

(time to) maximal glucose infusion rate

Secondary Outcome Measures

(time to) maximal insulin concentration

Full Information

First Posted
September 21, 2009
Last Updated
August 10, 2011
Sponsor
Radboud University Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT00983775
Brief Title
Pharmacology of Insulin Injected With Jet-Injection
Official Title
Pharmacokinetic and Pharmacodynamic Profile of Rapid Acting Insulin Injected by Needle-free Jet-injection
Study Type
Interventional

2. Study Status

Record Verification Date
September 2009
Overall Recruitment Status
Completed
Study Start Date
November 2009 (undefined)
Primary Completion Date
November 2010 (Actual)
Study Completion Date
November 2010 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Radboud University Medical Center

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type 1
Keywords
Pharmacokinetic profile, Pharmacodynamic profile, insulin, jet injector

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
48 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
healthy low dose insulin
Arm Type
Experimental
Arm Description
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.
Arm Title
healthy high dose insulin
Arm Type
Experimental
Arm Description
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.
Arm Title
type 1 diabetes mellitus
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
jet injector (SQ pen/Novopen III)
Other Intervention Name(s)
SQ pen, Novopen III
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
jet injector (SQ pen/Novopen III)
Other Intervention Name(s)
SQ pen, Novopen III
Intervention Description
The rapid-acting insulin analogue insulin aspart (Novorapid®), at a dose of 0.4 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.
Primary Outcome Measure Information:
Title
(time to) maximal glucose infusion rate
Time Frame
0-8 hours after insulin injection
Secondary Outcome Measure Information:
Title
(time to) maximal insulin concentration
Time Frame
0-8 hours after insulin injection

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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) Exclusion Criteria: 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) Proliferative diabetic retinopathy (a history of proliferative retinopathy that was successfully treated with laser coagulopathy is not an exclusion criterion) (for patients with type 1 diabetes mellitus)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Cees J Tack, MD PhD
Organizational Affiliation
Radboud University Medical Center
Official's Role
Study Chair
Facility Information:
Facility Name
Radboud University Nijmegen Medical Centre
City
Nijmegen
State/Province
P.O. Box 9101
ZIP/Postal Code
6500 HB
Country
Netherlands

12. IPD Sharing Statement

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