Insulin by Jet-injection for Hyperglycemia in Diabetes

NCT01947556 | Completed

• 1 other identifier: PKPD_INSJ_3
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to compare the pharmacokinetic and pharmacodynamic profile of the rapid-acting insulin analogue aspart (Novorapid®) injected subcutaneously by jet-injection to that of the same insulin injected with a conventional pen in the management of hyperglycemia in subjects with diabetes

Conditions

Diabetes Mellitus

Keywords

diabetes; insulin administration; hyperglycaemia; insulin aspart

Outcome Measures

Primary Outcomes (1)

• T-BG≥10

  the time in minutes until plasma glucose concentration has dropped with ≥ 10mmol/l (T-BG≥10).

  participants will be followed for the duration of the study, an expected average of 4 weeks

Secondary Outcomes (9)

• T-BG5 and 8 (min)

  participants will be followed for the duration of the study, an expected average of 4 weeks

• Rfall

  participants will be followed for the duration of the study, an expected average of 4 weeks

• BG-AUC 0-2h

  participants will be followed for the duration of the study, an expected average of 4 weeks

• BG-AUC 0-6h

  participants will be followed for the duration of the study, an expected average of 4 weeks

• C-INSmax (pmol/l)

  participants will be followed for the duration of the study, an expected average of 4 weeks

Other Outcomes (4)

• NRS pain

  participants will be followed for the duration of the study, an expected average of 4 weeks

• hypoglycaemia

  participants will be followed for the duration of the study, an expected average of 4 weeks

• exogenous glucose

  participants will be followed for the duration of the study, an expected average of 4 weeks

Study Arms (2)

insujet is tested first

OTHER

first procedure: experiment with the investigational product (Insujet pen)containing insulin aspart; second procedure: control device (conventional Novopen III insulin pen) contains insulin aspart.

Drug: insulin aspart

insujet is tested second

OTHER

first procedure: experiment with the conventional Novopen III insulin pen containing insulin aspart; second procedure: investigational device (Insujet) contains insulin aspart.

Drug: insulin aspart

Interventions

insulin aspart DRUG

After hyperglycaemia (18-23 mmol/l) has been reached (by decreasing or interrupting exogenous insulin administration 12-24 hours before the experiment), aspart insulin (in a dose of 1.5 times the amount of insulin needed to reduce blood glucose to 6 mmol/l calculated by the insulin-sensitivity factor) will be administered subcutaneously by Insujet pen or conventional insulin pen, on two separate occasions, or vice versa. The injection will be given by the subject under supervision of the research staff.

Also known as: Novorapid

insujet is tested first; insujet is tested second

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• diabetes mellitus type 1 or 2
• Age 18-75 years
• Body-Mass Index ≥25 kg/m2 and ≤40 kg/m2
• Stable glycaemic control with HbA1c ≥48 (6.5%) and ≤86 mmol/mol (10%)
• Insulin treatment according to basal-bolus regimen, i.e. by multiple daily injections at least four times daily, or by subcutaneous insulin pump, for at least 12 months, use of metformin allowed

You may not qualify if:

• Inability to provide informed consent
• Insulin requirement of \<34 or \>200 units per day
• Treatment with systemic corticosteroids, immunosuppressive or cytostatic drugs
• Known allergy to aspart insulin
• Use of oral antidiabetic drugs other than metformin
• 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 previous 6 months
• Pregnancy or the intention to become pregnant
• Renal disease (creatinine \>150 μmol/l or MDRD-GFR \<30 ml/min/1.73m2)
• Liver disease (aspartate aminotransferase or alanine aminotransferase level of more than three times the upper limit of normal range)
• Presence of any other medical condition that might interfere with the study protocol
• anemia

Sponsors & Collaborators

• University Medical Center Nijmegen: lead

Study Sites (1)

Radboud University Nijmegen Medical Centre

Nijmegen, 6500HB, Netherlands

Location

MeSH Terms

Conditions

Diabetes Mellitus; Hyperglycemia

Interventions

Insulin Aspart

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Insulin, Short-Acting; Insulins; Pancreatic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Study Officials

• Bastiaan de Galan, MD PhD

  Radboud University Medical Center

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: September 2, 2013
• First Posted: September 20, 2013
• Study Start: March 1, 2014
• Primary Completion: November 1, 2014
• Study Completion: November 1, 2014
• Last Updated: November 26, 2014

Record last verified: 2014-11

Locations

NL (1)