Study on the Effects on Blood Glucose Following Intradermal and Subcutaneous Dosing of Insulin in Diabetic Patients

NCT01120444 | Completed Phase 1

• 1 other identifier: BDT-09-ADC004
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to compare the effects of bolus delivery of insulin when delivered either intradermally (in the skin) or subcutaneously (under the skin) in diabetics.

Conditions

Diabetes

Keywords

Diabetes; Insulin; Blood Glucose

Outcome Measures

Primary Outcomes (1)

• Blood Glucose

  To compare between the ID and SC routes the relative PD times "in-range" (70-180 mg/dL) for glycemic excursions following two types of standardized meals and three dose ranges (optimum dose and +/- 30%).

  12-14 hours

Secondary Outcomes (1)

• Insulin levels

  12-14 hours

Study Arms (2)

Subcutaneous delivery of insulin

ACTIVE COMPARATOR

A bolus dose of insulin will be given subcutaneously just prior to a standardized meal.

Device: Subcutaneous delivery of insulin using Disetronic Accu-Chek Rapid D infusion set

Intradermal delivery of insulin

EXPERIMENTAL

A bolus dose of insulin will be given intradermally just prior to a standardized meal

Device: BD Research Catheter with 34G x 1.5 mm needle

Interventions

BD Research Catheter with 34G x 1.5 mm needle DEVICE

bolus injection of insulin given intradermal prior to standardized meal

Intradermal delivery of insulin

Subcutaneous delivery of insulin using Disetronic Accu-Chek Rapid D infusion set DEVICE

bolus delivery of insulin given subcutaneously prior to standardized meal

Also known as: Disetronic Accu-Chek Rapid D infusion set - 6mm cannula

Subcutaneous delivery of insulin

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (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 or multiple daily injections ("basal-bolus") 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
• 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 \>1.2 mg/dl) 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 \>3x, 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) as judged by the investigator (RRsyst. \>140 mmHg, RRdiast. \> 90 mmHg)
• Mental incapacity, unwillingness or language barriers precluding adequate understanding or co-operation Current addiction to alcohol or substances of abuse as determined by the investigator
• Allergy to plaster/adhesive

Sponsors & Collaborators

• Becton, Dickinson and Company: lead

Study Sites (1)

Profil Institute of Clinical Research

Neuss, D41460, Germany

Location

MeSH Terms

Conditions

Diabetes Mellitus; Insulin Resistance

Interventions

Needles; Cannula

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Equipment and Supplies; Catheters

Study Officials

• Christoph Kapitza, MD

  Profil Institute of Research

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: May 7, 2010
• First Posted: May 11, 2010
• Study Start: April 1, 2010
• Primary Completion: October 1, 2010
• Study Completion: October 1, 2010
• Last Updated: April 18, 2011

Record last verified: 2011-04

Locations

DE (1)