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Absorption of Insulin Following Subcutaneous Bolus Administration With Different Bolus Durations

Information source: Medical University of Graz
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Type 1 Diabetes

Intervention: Insulin LISPRO (Drug)

Phase: Phase 1

Status: Completed

Sponsored by: Medical University of Graz

Official(s) and/or principal investigator(s):
Thomas R Pieber, MD, Principal Investigator, Affiliation: Medical University of Graz, Internal Medicine, Endocrinology and Metabolism

Summary

To cover meal-related insulin requirements, insulin pumps allow insulin to be delivered at high rates over a short period of time (bolus delivery). The length of this period (bolus duration) usually depends on the chosen bolus size and on the used insulin pump model. This study will evaluate the impact of different bolus durations (i. e., durations commonly employed in commercially available insulin pumps: 2 and 40 seconds for delivering 1 Unit of insulin) on the pharmacokinetic and pharmacodynamic properties of an rapid-acting insulin analogue. Objective: To evaluate in type 1 diabetic patients the pharmacodynamics and pharmacokinetics of rapid-acting insulin (insulin lispro) administered as subcutaneous boluses with different bolus durations. Study design: Single-center, randomized, controlled, two-arm cross-over intervention study Population: Twenty type 1 diabetic subjects Intervention: The investigational treatment is the subcutaneous administration of insulin lispro either as one bolus of 15 IU over a period of 30s or as one bolus of 15 IU over a period of 10 min. Plasma samples to assess pharmacodynamic and pharmacokinetic properties will be taken during an 8-hour clamp experiment. Patients will undergo both investigational treatments in a randomized order; between the two clamp visits there will be a wash-out period of 5-21 days. Main study endpoint: Time to maximum glucose infusion rate

Clinical Details

Official title: Subcutaneous Insulin Absorption Following Bolus Administrations With an Insulin Pump - Comparison of Bolus Administrations With Different Bolus Durations

Study design: Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Basic Science

Primary outcome: tmax(GIR); time to maximum glucose infusion rate

Secondary outcome: GIRmax, maximum glucose infusion rate

Eligibility

Minimum age: 18 Years. Maximum age: 60 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Informed consent obtained after being advised of the nature of the study

- Male or female aged 18-60 years (both inclusive)

- Type 1 diabetes treated with multiple daily insulin injection or continuous

subcutaneous insulin infusion for 12 months

- Fasting C-peptide < 0. 3nmol/L

- Body mass index 20. 0-30. 0 kg/m² (both inclusive)

- HbA1c < 10%

Exclusion Criteria:

- Female of childbearing potential who is pregnant, breast-feeding or intend to become

pregnant or is not using adequate contraceptive methods

- Skin pathology or condition prohibiting needle insertion/insulin administration as

judged by the investigator

- History of bleeding disorder

- Current participation in another clinical study

- Use of insulin lispro >2 weeks

- Significant acute or chronic illness that might interfere with subject safety or

integrity of results as judged by the investigator

- Smoker (defined as >5 cigarettes/d)

- Lipodystrophy

- Current treatment with systemic (oral or i. v.) corticosteroids, monoamine oxidase

(MAO) inhibitors, non-selective beta-blockers, growth hormone, herbal products or non-routine vitamins. Furthermore, thyroid hormones are not allowed unless the use of these has been stable during the past 3 months

- Significant history of alcoholism or drug abuse or a positive result in urine

drug/alcohol screen Study Day Exclusion Criteria:

- Strenuous exercise within the last 24 hours prior to the clamp visit

- Non-fasting (i. e. consumption of food or beverages, other than water, later than

22: 00 hours the evening before the visit) except if slight intake of rapidly absorbable carbohydrates has been necessary in order to prevent hypoglycaemia

- Injection of long-acting insulin (e. g. insulin glargine or insulin detemir) later

than 12: 00 hours (noon), 2 days before the clamp visit

- Injection of NPH insulin or other intermediate-acting insulin products later than

12: 00 hours (noon) on the day before the clamp visit

- Injection of any short acting insulin (aspart, lispro, glulisine) or more than 6 IU

of human insulin between 22: 00 hours and 03: 00 hours the night before the clamp visit

- Injection of any insulin later than 03: 00 hours the night before the clamp visit

- Infusion of any insulin later than 03: 00 hours the night before the clamp visit for

subjects using continuous subcutaneous insulin infusion (CSII)

- Positive result of alcohol breath test

- Any medical condition that, in the opinion of the Investigator, could interfere with

insulin pharmacokinetics and/or glucose metabolism

Locations and Contacts

Medical University of Graz, Graz, Styria A-8036, Austria
Additional Information

Medical University of Graz

Starting date: August 2011
Last updated: February 25, 2014

Page last updated: August 23, 2015

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