Pharmacokinetics/Dynamics of Basal (Continuous) Insulin Infusion Administered Either Intradermally or Subcutaneously

NCT01061216 | Completed Phase 1

• 2 other identifiers: BDT-09-ADC0032009-016164-36
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

The primary objective of this study will be to assess the PK/PD responsiveness of basal ID administered insulin compared to SC, and to determine the safety and local tolerability of extended (two six-hour periods) microneedle insulin delivery (MID) infusion. The primary endpoint will be the PK response to changes in rapid-acting insulin basal infusion rate. Faster PK transitions coupled with faster PD responsiveness could provide clinical benefit, compared to current subcutaneous insulin infusion. In addition, for nocturnal basal pumping, more rapid insulin offset could decrease the occurrence rate and severity of hypoglycemic episodes.

Conditions

Diabetes Mellitus, Type 1; Diabetes Mellitus, Type 2

Keywords

Diabetes; Insulin Therapy; Blood Glucose; Basal insulin; Diabetics

Outcome Measures

Primary Outcomes (1)

• Insulin measurements will be used to compute PK model parameters: absorption rate(s) and elimination rate using an appropriate transport model.

  20 hours

Secondary Outcomes (3)

• Pharmacodynamic glycemic parameters will be as follows: time from insulin infusion onset to glycemic nadir; time from test insulin shutoff to return to baseline glucose; amount of additional drop in blood glucose following test insulin infusion shutoff

  20 hours

• Evidence of safety and tolerability of intradermally infused insulin

  26 hours

• Feasibility of RCS for longer-term ID infusion

  16 hours

Study Arms (2)

Intradermal insulin infusion (ID)

EXPERIMENTAL

Device: Intradermal insulin delivery: BD Research Catheter Set

Subcutaneous insulin infusion (SC)

ACTIVE COMPARATOR

Device: Subcutaneous insulin delivery:ACCU-CHEK Rapid-D Infusion Set

Interventions

Intradermal insulin delivery: BD Research Catheter Set DEVICE

1 unit/hr rapid acting insulin delivered intradermally for 6 hours 4 hour washout period (no insulin delivered) 2 units/hr rapid acting insulin delivered intradermally for 6 hours 4 hour washout period (no insulin delivered)

Intradermal insulin infusion (ID)

Subcutaneous insulin delivery:ACCU-CHEK Rapid-D Infusion Set DEVICE

1 unit per hour of rapid acting insulin infusion for 6 hours 4 hour washout (no insulin delivered) 2 unit per hour of rapid acting insulin infusion for 6 hours 4 hour washout (no insulin delivered)

Also known as: ACCU-CHEK, Rapid-D Infusion Set (Disetronic, USA)

Subcutaneous insulin infusion (SC)

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: male
• 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 subject)
• Type 1 Diabetes mellitus, according to clinical judgment / ADA / WHO-definition (Diabetes Care 2003; 26: 5-20) for at least 1 year
• Current treatment:Insulin Pump
• Age in the range of greater than or equal to 18 and less than or equal to 55 years
• Body mass index (BMI) less than or equal to 32 kg/m²
• HbA1c less than or equal to 9.0 %
• 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 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, subjects with GOT/GPT \>3x, thrombocyte count \<100/nL, INR \>1.3, PTT \>50 sec. will not be permitted to enter the study.
• 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 months prior to 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 medical treatment having existed for at least three month prior 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

Sponsors & Collaborators

• Becton, Dickinson and Company: lead

Study Sites (1)

Profil Institut für Stoffwechselforschung GmbH

Neuss, D-41460, Germany

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1; Diabetes Mellitus, Type 2; Diabetes Mellitus

Condition Hierarchy (Ancestors)

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

Study Officials

• Christoph Kapitza, Dr. med.

  Profil Institut für Stoffwechselforschung GmbH

  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: January 29, 2010
• First Posted: February 3, 2010
• Study Start: January 1, 2010
• Primary Completion: March 1, 2010
• Study Completion: March 1, 2010
• Last Updated: March 10, 2010

Record last verified: 2010-03

Locations

DE (1)