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Comparative Glucose Clamp Study of Wockhardt's Human Isophane Insulin With Novolin N,in Healthy Subjects
This study is currently recruiting participants.
Verified by Wockhardt, October 2008
Sponsored by: Wockhardt
Information provided by: Wockhardt
ClinicalTrials.gov Identifier: NCT00772265
  Purpose

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.


Condition Intervention Phase
Diabetes
Biological: Isophane insulin for inj. (Recomb Human insulin) (Wosulin N)
Biological: Isophane insulin for inj.(Recomb. Human Insulin) (Novolin N)
Phase I

Drug Information available for: Insulin Dextrose Insulin, isophane
U.S. FDA Resources
Study Type: Interventional
Study Design: Health Services Research, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Active Control, Crossover Assignment
Official Title: A Randomized Single Center Double Blind 2 Period Crossover Glucose Clamp Study to Test for Bioequivalence Between 2 Recombinant Human Isophane Insulins Wockhardt's Human Isophane Insulin Injection100IU/ml With Novolin N in Healthy Subjects

Further study details as provided by Wockhardt:

Primary Outcome Measures:
  • Mean AUC0-24h and Cmax [ Time Frame: Visit 2 and 3 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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. [ Time Frame: Visit 2,3 and 4 ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 56
Study Start Date: September 2008
Estimated Study Completion Date: February 2009
Estimated Primary Completion Date: January 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1: Experimental
Wosulin N, Isophane insulin for injection (Recombinant Human Insulin)(100 IU/mL), cartridges 3.0 mL
Biological: Isophane insulin for inj. (Recomb Human insulin) (Wosulin N)
Total Dose per subject will be 0.4IU/Kg given Subcutaneously.
2: Active Comparator
Novolin N, Isophane insulin for injection (Recominant Human Insulin)(100IU/ml),cartridges 3.0ml.
Biological: Isophane insulin for inj.(Recomb. Human Insulin) (Novolin N)
Total dose per subject will be 0.4 IU/Kg given Subcutaneously.

Detailed Description:

The purpose of this study is is to test for bioequivalence based on AUC0-24h and Cmax between Wosulin N and Novolin® N.The study also compares the pharmacokinetic and pharmacodynamic profiles as well as assessing safety and local tolerability of the two insulin preparations in healthy subjects.

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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.)

Exclusion Criteria:

  • 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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00772265

Contacts
Contact: Dr. Alexa Kollmeier 619.409.1264 alexa.kollmeier@profil-research.com

Locations
United States, California
Profil Institute for clinical Research Recruiting
chula vista, California, United States, 91911
Principal Investigator: Dr. Alexa Kollmeier            
Sponsors and Collaborators
Wockhardt
Investigators
Study Chair: Heidi Guthrie Profil institute for clinical Research
  More Information

Responsible Party: Wockhardt Limited ( Dr.R Jha ,Senior Vice-president - Clinical Research )
Study ID Numbers: WosulinN/PK-PD/HV/FDA/08/v2d1
Study First Received: October 14, 2008
Last Updated: October 14, 2008
ClinicalTrials.gov Identifier: NCT00772265  
Health Authority: United States: Food and Drug Administration

Keywords provided by Wockhardt:
Bioequivalence
pharmacokinetic
Pharmacodynamic
Isophane insulin

Study placed in the following topic categories:
Diabetes Mellitus
Healthy
Insulin, Isophane
Insulin

Additional relevant MeSH terms:
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 14, 2009