Feasibility Study of the Effect of Intra-Dermal Insulin Injection on Blood Glucose Levels After Eating - Tabular View

Tracking Information

First Received Date ^ICMJE

October 12, 2007

Last Updated Date

August 21, 2008

Start Date ^ICMJE

September 2007

Primary Completion Date

December 2007 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Area Under Curve (AUC) of the blood glucose (BG) profile after the meal, with and without baseline correction. [ Time Frame: 90 mins ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Area Under Curve (AUC) of the blood glucose (BG) profile after the meal, with and without baseline correction. [ Time Frame: 90 mins ]

Change History

Complete list of historical versions of study NCT00553488 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Maximal BG (BGmax) [ Time Frame: Approximately 4 hours per injection ] [ Designated as safety issue: No ]
Total BG-AUC0-4 h [ Time Frame: Approximately 4 hrs per injection ] [ Designated as safety issue: No ]
Minimal BG (BGmin, time to BGmin (tBGmin) [ Time Frame: Approximately 4 hrs per injection ] [ Designated as safety issue: No ]
Insulin pharmacokinetics [ Time Frame: Approximately 4 hrs per injection ] [ Designated as safety issue: No ]
Number and seriousness of adverse events [ Time Frame: Approximately 4 hrs per injections ] [ Designated as safety issue: Yes ]
Vital signs, examination of insulin application [ Time Frame: Approximately 4 hrs per injection ] [ Designated as safety issue: No ]
Time to BGmax (tBGmax) [ Time Frame: Approximately 4 hours per injection ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

• Maximal BG (BGmax) • time to BGmax (tBGmax) • total BG-AUC0-4 h • Minimal BG (BGmin) • time to BGmin (tBGmin) • Insulin pharmacokinetics • Number and seriousness of adverse events • Vital signs, examination of insulin application [ Time Frame: Approximately 4 hours per injection ]

Descriptive Information

Brief Title ^ICMJE

Feasibility Study of the Effect of Intra-Dermal Insulin Injection on Blood Glucose Levels After Eating

Official Title ^ICMJE

A Mono Center Open Labeled, Randomized Study Examining the Effects of Intra-Dermal vs Subcutaneous Application of Regular Insulin or Rapid Acting Insulin Analogue on Postprandial Glycemic Excursions in Patients With Type 1 Diabetes

Brief Summary

This study is to determine the effect of intra-dermal (ID) administration of regular and of rapid-acting insulin, before eating, on blood glucose levels for several hours after a standard meal (a mixed, liquid meal). Insulin will also be given normally, subcutaneously, for control or comparison purposes. The hypothesis or expectation is that ID insulin will work more quickly and control blood glucose levels better than SC injection.

Detailed Description

Previous studies have shown that intra-dermal (ID) insulin administration results in a more rapid onset of action in comparison to subcutaneous (SC) administration as measured by glucose infusion rate (GIR) under glucose clamp conditions.The aim of this study is to investigate whether ID administration of regular human insulin or rapid-acting insulin analogue leads to reduced postprandial glycemic excursions in comparison to SC application under highly standardized experimental conditions. Effects on the occurrence of hypoglycemia will also be investigated, as well as pK and pD comparisons between different insulin formulations administered ID. This is a mono-center, open-label, randomized, 5-period crossover study in patients with type 1 diabetes

Study Phase

Phase II

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Open Label, Active Control, Crossover Assignment, Pharmacokinetics/Dynamics Study

Condition ^ICMJE

Diabetes Mellitus, Type 1

Intervention ^ICMJE

Drug: Regular insulin (Humulin)
Drug: Insulin lispro (Humalog)

Study Arms / Comparison Groups

Active Comparator: Regular insulin SC at -17 mins
Active Comparator: Regular insulin ID at -17 mins
Active Comparator: Regular insulin ID at -2 mins
Active Comparator: Insulin lispro given SC at -2 mins
Experimental: Insulin lispro given ID at -2 mins

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

January 2008

Primary Completion Date

December 2007 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Type 1 diabetes for 1-15 years, on multiple daily injections (MDI) or insulin pump (CSII) in stable control with HbA1c <= 9.0%.
Able to attend clinic for 5 different days

Exclusion Criteria:

BMI > 32 kg/m2
Evidence of gastroparesis or impaired renal function or lipodystrophy

Gender

Male

Ages

18 Years to 55 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Germany

Administrative Information

NCT ID ^ICMJE

NCT00553488

Responsible Party

Laurence Hirsch, Vice-President, Global Medical Affairs, Diabetes Care, BD

Study ID Numbers ^ICMJE

BDT-ADD-07-002, EudraCT number 2007-003924-39

Study Sponsor ^ICMJE

Becton, Dickinson and Company

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator:

Christoph Kapitza, MD

Profil Institut fur Stoffwechselforschung GmbH

Information Provided By

Becton, Dickinson and Company

Verification Date

August 2008

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP