Comparative Glucose Clamp Study of Wockhardt's Human Isophane Insulin With Novolin N,in Healthy Subjects

NCT00772265 | Completed Phase 1

• 1 other identifier: WosulinN/PK-PD/HV/FDA/10/v3
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Diabetes

Keywords

Bioequivalence; pharmacokinetic; Pharmacodynamic; Isophane insulin

Outcome Measures

Primary Outcomes (1)

• Mean AUC0-24h and Cmax

  Visit 2 and 3

Secondary Outcomes (1)

• PK endpts: AUC0-4h, AUC0-6h, AUC0-12h, AUC6-12h, AUC6-24h,tmax,and elimination rate constant. PD endpoints: AUCGIR0-4h, AUCGIR0-6h, AUCGIR0-12h,AUCGIR0-24h, AUCGIR6-12h, AUCGIR6-24h, GIRmax and tGIRmax Safety : AEs,haematology,biochem,phy exam.

  Visit 2,3 and 4

Study Arms (2)

Wosulin N

EXPERIMENTAL

Wosulin N, Isophane insulin for injection (Recombinant Human Insulin)(100 IU/mL), cartridges 3.0 mL

Biological: Wosulin N

Novolin N

ACTIVE COMPARATOR

Novolin N, Isophane insulin for injection (Recominant Human Insulin)(100IU/ml),cartridges 3.0ml.

Biological: Novolin N

Interventions

Wosulin N BIOLOGICAL

Total Dose per subject will be 0.4IU/Kg given Subcutaneously.

Wosulin N

Novolin N BIOLOGICAL

Total dose per subject will be 0.4 IU/Kg given Subcutaneously.

Novolin N

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 more than 18 and less than 45 years.
• 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 27.0 kg/m2, inclusive.
• Non-smoker, defined as no nicotine consumption for at least one year.
• Signed and dated informed consent obtained before any trial-related activities. (Trial-related activities are any procedure that would not have been performed during normal management of the subject.)

You may not qualify if:

• Previous participation in this trial or other clinical trials within the last 30 days.
• Pregnant, breast-feeding or intention of becoming pregnant or not using adequate contraceptive measures (defined as intrauterine device (IUD) that has been in place for at least 3 months, double barrier contraception, sterilization or abstinence, or oral contraceptive pill, which should have been taken without difficulty for at least 3 months, or an approved hormonal implant).
• Clinically significant abnormal haematology or biochemistry screening tests, as judged by the Investigator. In particular, subjects with elevated liver enzymes (AST or ALT \> 2 times the upper limit of normal) or impaired renal function (elevated serum creatinine values above the upper limit of normal) will not be allowed to enter the trial.
• 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 (haemoglobin below the lower limit of normal) or hemoglobinopathy will not be allowed to enter the trial.
• History of alcohol or drug abuse in the past five years and/or any positive test for drugs of abuse at screening.
• Any positive reaction of drugs of abuse.
• Hepatitis B or C or HIV positive.
• Use of prescription drugs within 3 weeks preceding the first dosing of insulin, except for oral contraceptives/hormonal implants.
• Use of any insulin product for therapeutic purposes in the past.
• Use of non-prescription drugs, except routine vitamins, within 3 weeks prior to the first dose of the test drug. Occasional use of acetaminophen is permitted.
• Mental incapacity, unwillingness or language barriers precluding adequate understanding or co-operation.
• Blood donation of more than 500 ml 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 product or related products.

Sponsors & Collaborators

• Wockhardt: lead

Study Sites (1)

Profil Institute for clinical Research

Chula Vista, California, 91911, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus

Interventions

Isophane Insulin, Human

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Insulin, Isophane; Insulin, Long-Acting; Insulins; Pancreatic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Insulin, Regular, Human; Insulin; Proinsulin; Peptides; Amino Acids, Peptides, and Proteins

Study Officials

• Heidi Guthrie

  Profil Institute for Clinical Research, Inc.

  STUDY CHAIR

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: October 14, 2008
• First Posted: October 15, 2008
• Study Start: September 1, 2010
• Primary Completion: March 1, 2011
• Study Completion: April 1, 2011
• Last Updated: December 27, 2012

Record last verified: 2012-12

Locations

US (1)