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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Wockhardt
ClinicalTrials.gov Identifier:
NCT00772265
First received: October 14, 2008
Last updated: December 26, 2012
Last verified: December 2012
  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: Wosulin N
Biological: Novolin N
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Health Services Research
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

Resource links provided by NLM:


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 ]

Enrollment: 56
Study Start Date: September 2010
Study Completion Date: April 2011
Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Wosulin N
Wosulin N, Isophane insulin for injection (Recombinant Human Insulin)(100 IU/mL), cartridges 3.0 mL
Biological: Wosulin N
Total Dose per subject will be 0.4IU/Kg given Subcutaneously.
Active Comparator: Novolin N
Novolin N, Isophane insulin for injection (Recominant Human Insulin)(100IU/ml),cartridges 3.0ml.
Biological: Novolin N
Total dose per subject will be 0.4 IU/Kg given Subcutaneously.
Other Name: Novolin N

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00772265

Locations
United States, California
Profil Institute for clinical Research
Chula Vista, California, United States, 91911
Sponsors and Collaborators
Wockhardt
Investigators
Study Chair: Heidi Guthrie Profil Institute for Clinical Research, Inc.
  More Information

No publications provided

Responsible Party: Wockhardt
ClinicalTrials.gov Identifier: NCT00772265     History of Changes
Other Study ID Numbers: WosulinN/PK-PD/HV/FDA/10/v3
Study First Received: October 14, 2008
Last Updated: December 26, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Wockhardt:
Bioequivalence
pharmacokinetic
Pharmacodynamic
Isophane insulin

Additional relevant MeSH terms:
Insulin, Globin Zinc
Isophane insulin, beef
Insulin
Insulin, Isophane
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 18, 2014