NCT01557907

Brief Summary

The primary objective of this study is to investigate if intradermal (in the skin) basal and bolus insulin delivery of a fast acting insulin analog (NovoRapid) as needed to adequately control the blood glucose for a subject with Type 1 Diabetes can be maintained for a period of up to three days and if intradermal delivery of insulin has advantages over standard subcutaneous (under the skin) delivery.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
23

participants targeted

Target at below P25 for phase_1 diabetes

Timeline
Completed

Started Feb 2012

Shorter than P25 for phase_1 diabetes

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2012

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

March 9, 2012

Completed
11 days until next milestone

First Posted

Study publicly available on registry

March 20, 2012

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2012

Completed
Last Updated

July 26, 2012

Status Verified

July 1, 2012

Enrollment Period

3 months

First QC Date

March 9, 2012

Last Update Submit

July 25, 2012

Conditions

Diabetes

Keywords

DiabetesDiabetes MellitusType 1 diabetesInsulin Pump usersIntradermal insulin

Outcome Measures

Primary Outcomes (1)

  • Insulin levels

    Time to peak plasma concentration (Tmax) of insulin delivered intradermally as compared to insulin delivered subcutaneously after a meal bolus.

    0,10,15,20,25,30,35,40,45,50,55,60,65,70,80,90,120,150,180,210,240,300,330,345,360 minutes following each breakfast and lunch meal bolus for the 3 study days

Secondary Outcomes (8)

  • Insulin levels

    0,10,15,20,25,30,35,40,45,50,55,60,65,70,80,90,120,150,180,210,240,300,330,345,360 minutes following each breakfast and lunch meal bolus for the 3 study days

  • Blood Glucose

    0,10,15,20,25,30,35,40,45,50,55,60,65,70,80,90,120,150,180,210,240,300,330,345,360 minutes following each breakfast and lunch meal bolus for the 3 study days

  • Device performance - adhesion

    Evaluated at every timepoint a bolus injection is given

  • Skin thickness using ultrasound

    Upon removal of the device (within 5 minutes)

  • Device performance - Leakage of fluid (insulin) at injection site

    Immediatley before and after each bolus injection and immediatly upon removal of the device at the end of the study period.

  • +3 more secondary outcomes

Study Arms (2)

Intradermal - BD Research Catheter Set

EXPERIMENTAL

Intradermal delivery of insulin (basal and bolus delivery) using the BD Research Catheter Set with 34G x 1.5 mm side-ported needle and the Animas Vibe insulin pump over a three day period.

Device: Intradermal delivery via the BD Research Catheter Set

Subcutaneous - Medtronic Quick-Set

ACTIVE COMPARATOR

Subcutaneous delivery of insulin (basal and bolus delivery) using the Medtronic Quick Set with 6 mm Teflon catheter and the Animas Vibe insulin pump over a three day period.

Device: Subcutaneous delivery via Medtronic Quick-Set

Interventions

Subcutaneous delivery via Medtronic Quick-SetDEVICE

Infusion rates and pre-meal bolus doses will be based on subjects known daily infusion rate and subject's reported insulin to carbohydrate ratio.

Also known as: insulin infusion set
Subcutaneous - Medtronic Quick-Set
Intradermal delivery via the BD Research Catheter SetDEVICE

Infusion rates and pre-meal bolus doses will be based on subjects known daily infusion rate and subject's reported insulin to carbohydrate ratio.

Also known as: microneedles, insulin infusion set
Intradermal - BD Research Catheter Set

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Understood and signed informed consent obtained before any trial-related activities (trial-related activities are any procedures that would not have been performed during normal management of the patient)
  • Type 1 Diabetes mellitus, according to clinical judgment / ADA / WHO-definition (Diabetes Care 2003; 26: 5-20) for at least 1 year.
  • Usage of insulin pump therapy (CSII) with carb counting for at least six months
  • Age in the range of ≥ 18 and ≤ 55 years
  • Body mass index (BMI) ≤ 32 kg/m²
  • HbA1c ≤ 8.0% at screening
  • Using ≤ than 60 U of insulin on a typical day (preferably)
  • Able and willing to adhere to the study procedures for the entire trial period
  • Negative test results for hepatitis C antibodies, hepatitis B surface antigen and HIV at screening.

You may not qualify if:

  • Previous participation in this trial or participation in a clinical trial within 3 months prior to screening examination
  • Any symptoms suggestive of, or a diagnosis or treatment for gastroparesis
  • Abnormalities in renal function (e.g. serum creatinine \> 120 µmmol/L for male, \>100 µmmol/L for female subjects or judged by the investigator that would pose a problem of clearance of injected insulin
  • Proliferative retinopathy or maculopathy that has required acute treatment within the last six months
  • Acute and severe illness apart from diabetes mellitus as judged by the investigator
  • Abnormalities in the laboratory parameters if judged as clinically significant by the investigator. In particular, patients with GOT/GPT \> 3 x upper limit of normal (ULN), thrombocyte count \<100/nL, INR \>1.3, PTT \>50 sec.
  • Clinically significant abnormalities in the ECG
  • Recurrent major hypoglycemia or hypoglycemic unawareness as judged by the investigator
  • Lipodystrophy which in the judgment of the investigator would pose a problem in terms of variability of absorption of injected insulin
  • Use of systemic corticoids for the last three month prior screening examination or treatment with medication known to interfere with glucose metabolism such as non-selective ß-blockers, or mono amine oxidase (MAO) inhibitors, ACE-inhibitors or thiazides, unless such medical treatment has existed for at least three months and is not changing, prior to screening examination
  • Any disease requiring use of anti-coagulants
  • Impaired hepatic or renal functions as judged by the investigator
  • Cardiac problems as judged by the investigator
  • Uncontrolled hypertension (treated or untreated) RRsyst. \>140 mmHg, RRdiast. \> 90 mmHg
  • Mental incapacity, unwillingness or language barriers precluding adequate understanding or co-operation
  • +4 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Profil Institut fur Stoffwechselfforschung GmbH

Neuss, D-41460, Germany

Location

MeSH Terms

Conditions

Diabetes MellitusDiabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

  • Christoph Kapitza, MD

    Profil Institut fur Stoffwechselforschung (GmbH)

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 9, 2012

First Posted

March 20, 2012

Study Start

February 1, 2012

Primary Completion

May 1, 2012

Study Completion

May 1, 2012

Last Updated

July 26, 2012

Record last verified: 2012-07

Locations

DE(1)