Comparative Glucose Clamp Study of Wockhardt's Insulin Human Regular for Injection and Actrapid, in Healthy Subjects.

NCT00719108 | Completed Phase 1

• 1 other identifier: WosulinR/PK-PD/HV/EMEA/2008/v2
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this trial is to demonstrate bioequivalence of Wosulin R to Actrapid with regard to its total and to its maximum serum insulin concentrations.

Conditions

Diabetes

Keywords

Diabetes, Healthy Volunteers

Outcome Measures

Primary Outcomes (1)

• The area under the GIR-time curve at steady state from 240 to 300 minutes (AUCGIR-SS)

  Visit 2 and 3

Secondary Outcomes (1)

• PD Endpoints: Area under the GIR-time curve from 0 to 7 hours, GlR at steady state. PK Endpoints: AUCINS-SS, AUCINS0-7h, CLtot, VSS, t1/2 ,Terminal rate constant Safety Endpoints: AE, Lab assessments, Vital signs, Phy Exam, ECG & Hypoglycemia.

  Visit 2 , 3 and 4

Study Arms (2)

Wosulin R

EXPERIMENTAL

Wosulin R, Regular insulin for injection (Recombinant Human Insulin) (100 IU/mL)in vials 10.0 ml

Biological: Wosulin R

Actrapid

ACTIVE COMPARATOR

Actrapid, Regular insulin for injection (Recombinant Human Insulin) (100 IU/mL)in vials 10.0 ml

Biological: Actrapid

Interventions

Wosulin R BIOLOGICAL

Total dose per subject will be 0.3 IU/Kg given IV over 5 hrs.

Wosulin R

Actrapid BIOLOGICAL

Total dose per subject will be 0.3 IU/Kg given IV over 5 hrs.

Actrapid

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy male or female subject
• Age between 18 and 45 years (both inclusive)
• Considered generally healthy upon completion of medical history, physical examination and biochemical investigations as judged by the Investigator.
• Body Mass Index (BMI) between 18.0 and 35.0 kg/m2 (both inclusive)
• Non-smoker, defined as no nicotine consumption for at least one year.
• Signed and dated informed consent obtained before any trial-related activities.

You may not qualify if:

• Previous participation in this trial or other clinical trials within the last 3 months.
• Pregnant, breast-feeding or intention of becoming pregnant or not using adequate contraceptive measures.
• Clinically significant abnormal hematology or biochemistry screening tests, as judged by the Investigator.
• Any serious systemic infectious disease during the four weeks prior to the first dose of test drug, as judged by the Investigator.
• History of any illness that, in the opinion of the Investigator, might confound the results of the trial or pose risk in administering the trial drug to the subject. In particular, subjects with significant cardiovascular disease, anemia (below the lower limit of normal) or hemoglobinopathy will not be allowed to enter the trial.
• History of alcohol or drug abuse within the past 5 years and/or any positive test for drugs of abuse at screening.
• Positive test for hepatitis B or C or HIV positive at screening or in the past.
• Use of prescription drugs within 3 weeks preceding the first dosing of insulin, except for oral contraceptives/hormonal implants.
• Use of any insulin product in the past.
• Use of non-prescription drugs, except routine vitamins, within 2 weeks prior to the first dose of the test drug. Occasional use of acetaminophen will be permitted.
• Blood donation of more than 500 mL (or considerable blood loss) within the last 12 weeks.
• History of multiple and/or severe allergies to drugs or foods or a history of severe anaphylactic reaction.
• Known or suspected allergy to trial products or related products.
• Mental incapacity, unwillingness or language barriers precluding adequate understanding or co-operation.

Sponsors & Collaborators

• Wockhardt: lead

Study Sites (1)

Profil Institute for Clinical Research Inc.

Chula Vista, California, 91911, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus

Interventions

Insulin

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Proinsulin; Insulins; Pancreatic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Study Officials

• Marcus Hompesch, MD

  Profil Institute of Clinical Research

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 18, 2008
• First Posted: July 21, 2008
• Study Start: July 1, 2008
• Primary Completion: September 1, 2008
• Study Completion: September 1, 2008
• Last Updated: December 27, 2012

Record last verified: 2012-12

Locations

US (1)