Pharmacology of Insulin Injected With Jet-injection in Diabetes

NCT01438632 | Completed Phase 4 DMC

• 1 other identifier: PKPD_INSJ_2
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

A previous study showed that absorption and glucose-lowering action of rapid-acting insulin analogues occurred twice as fast when these analogues were administered by jet injection technology rather than by conventional insulin pen in healthy non-diabetic subjects. This study investigates if the rapid-acting insulin analogue aspart (Novorapid®) injected with jet-injection or a conventional insulin pen prior to a standardised meal in patients with diabetes shows the same difference in the pharmacokinetic and pharmacodynamic profile.

Conditions

Diabetes Mellitus

Keywords

Insulin action; Jet injector; Diabetes Mellitus; Pharmacodynamics; Pharmacokinetics; Insulin analogs; Insulin aspart

Outcome Measures

Primary Outcomes (1)

• BG-AUC0-2h (mmol•min-1•l-1): area under the baseline-subtracted plasma glucose concentration time-curve from time 0 to 2 h after insulin injection and meal ingestion.

  based on plasma glucose levels during the first two hours of the 6-hour post-meal study duration

  2 days (2 hours per day)

Secondary Outcomes (11)

• BGmax (mmol/l): maximal glucose excursion after insulin injection and meal ingestion

  2 days (6 hours each day)

• T-BGmax (min): time to maximal glucose excursion after insulin injection and meal ingestion

  2 days (6 hours per day)

• BG-AUC0-6h (mmol•min-1•l-1): area under the baseline-subtracted plasma glucose concentration time-curve from time 0 to 6 h after insulin injection and meal ingestion

  2 days (6 hours each day)

• T-BGBL (min): time until plasma glucose has returned to baseline values after insulin injection and meal ingestion

  2 days (6 hours per day)

• T-INSmax (min): time to maximal insulin concentration (C-INSmax)

  2 days (6 hours per day)

Study Arms (2)

jet injector

EXPERIMENTAL

Jet injectors deliver insulin at a high velocity (typically \>100m/s) across the skin in the subcutaneous tissue, without the use of a needle

Device: jet injection device

conventional insulin pen

ACTIVE COMPARATOR

Device: jet injection device

Interventions

jet injection device DEVICE

Rapid-acting insulin analogue aspart (Novorapid®) administration by means of a jet injector or a conventional insulin pen in the subcutaneous tissue. Dosage of insulin will be determined by the normal dosage of insulin used by the patient before breakfast.

Also known as: Jet injector: InsuJet™ from the European Pharma Group, Insulin device: NovoPen® 3 from Novo Nordisk

conventional insulin pen; jet injector

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Body-mass index 18-32 kg/m2
• Stable glycaemic control with HbA1c 6.0-9.0%
• Duration of diabetes \>1 year
• Insulin use at least once daily or with subcutaneous pump
• Blood pressure \<160/90 mmHg

You may not qualify if:

• Inability to provide informed consent
• Requirement of \<8 units of rapid-acting insulin (analogue) before meals
• Chronic use of sulphonylurea derivatives, GLP-1 based treatments, acarbose or thiazolidinediones
• Treatment with prednisolone, non-steroidal anti-inflammatory drugs (NSAIDs), immunosuppressive agents, cytostatic drugs, hormone therapy except insulin, thyroid supplementation and oral anticonceptives
• Known allergy to aspart insulin
• Symptomatic diabetic neuropathy
• History of a major cardiovascular disease event (myocardial infarction, stroke, symptomatic peripheral artery disease, coronary bypass surgery, percutaneous coronary or peripheral artery angioplasty) in the past 6 months
• Pregnancy or the intention to become pregnant

Sponsors & Collaborators

• Radboud University Medical Center: lead
• European Pharma Group (EPG): collaborator

Study Sites (1)

Department of general internal medicine 463, section Diabetes, Radboud University Nijmegen Medical Centre

Nijmegen, Gelderland, 6500 HB, Netherlands

Location

Related Publications (3)

• Mitragotri S. Current status and future prospects of needle-free liquid jet injectors. Nat Rev Drug Discov. 2006 Jul;5(7):543-8. doi: 10.1038/nrd2076.

  PMID: 16816837 BACKGROUND

• Rave K, Klein O, Frick AD, Becker RH. Advantage of premeal-injected insulin glulisine compared with regular human insulin in subjects with type 1 diabetes. Diabetes Care. 2006 Aug;29(8):1812-7. doi: 10.2337/dc06-0383.

  PMID: 16873785 BACKGROUND

• Engwerda EE, Abbink EJ, Tack CJ, de Galan BE. Improved pharmacokinetic and pharmacodynamic profile of rapid-acting insulin using needle-free jet injection technology. Diabetes Care. 2011 Aug;34(8):1804-8. doi: 10.2337/dc11-0182. Epub 2011 Jun 29.

  PMID: 21715522 BACKGROUND

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Bastiaan E de Galan, MD, PhD

  Radboud University Nijmegen Medical Centre, Department of general internal medicine 463, section Diabetes

  STUDY DIRECTOR

• Elsemiek EC Engwerda, BSc

  Department of general internal medicine 463, section Diabetes, Radboud University Nijmegen Medical Centre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 19, 2011
• First Posted: September 22, 2011
• Study Start: September 1, 2011
• Primary Completion: May 1, 2012
• Study Completion: July 1, 2012
• Last Updated: March 12, 2013

Record last verified: 2011-08

Locations

NL (1)