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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Wockhardt
ClinicalTrials.gov Identifier:
NCT00596063
First received: January 7, 2008
Last updated: December 26, 2012
Last verified: December 2012
  Purpose

The purpose of this study is the comparative evaluation of the pharmacokinetics and pharmacodynamics of two recombinant regular human insulin injections administered subcutaneously in healthy volunteers under the conditions of euglycemic clamp.


Condition Intervention Phase
Diabetes Mellitus
Biological: Wosulin R
Biological: Novolin R
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized, Single Center, Double Blind, Two Period, Crossover Glucose Clamp Study to Test for Bioequivalence Between Two Recombinant Human Soluble Insulins- Wockhardts Insulin Human Regular for Injection and Novolin R in Healthy Subjects

Resource links provided by NLM:


Further study details as provided by Wockhardt:

Primary Outcome Measures:
  • The primary objective is to test for bioequivalence based on AUC0-12h and Cmax between Wockhardt's Insulin Human Regular for injection and Novolin® R [ Time Frame: Visit 2 & 3 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • PK endpoints: AUC, tmax and t½ PD endpoints: AUC-GIR, GIRmax and tGIRmax Safety endpoints: AEs, haematology, biochemistry, urinalyses, physical examination, vital signs, ECGs, blood glucose and local tolerability. [ Time Frame: Visit 2, 3 and 4 ] [ Designated as safety issue: Yes ]

Enrollment: 25
Study Start Date: January 2008
Study Completion Date: February 2008
Primary Completion Date: February 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Wosulin R
Regular insulin for subcutaneous injection (recombinant human insulin), 600nmol, 100 IU
Biological: Wosulin R
Penfill cartridges; Single Dose, 0.2 IU/ kg;
Active Comparator: Novolin R
Regular insulin for injection (recombinant human insulin)
Biological: Novolin R
Penfill cartridges; Single Dose, 0.2 IU/ kg;

Detailed Description:

A comparative evaluation of the pharmacokinetics and pharmacodynamics of two recombinant regular human insulin injections administered subcutaneously in healthy volunteers. It is a crossover study. The subjects shall be administered single doses of each insulin during two separate visits under the conditions of euglycemic clamp.

  Eligibility

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

Inclusion Criteria:

  1. Healthy male or female subject.
  2. Age ≥ 18 and ≤ 45 years.
  3. Body Mass Index (BMI) between 18.0 and 27.0 kg/m2, inclusive.
  4. Non-smoker, defined as no nicotine consumption for at least one year.
  5. 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:

  1. Previous participation in this trial or other clinical trials within the last 3 months.
  2. Pregnant, breast-feeding or the intention of becoming pregnant or not using adequate contraceptive measures (intrauterine device (IUD) that has been in place for at least 3 months, or sterilization, or the oral contraceptive pill, which should have been taken without difficulty for at least 3 months, an approved hormonal implant).
  3. Clinically significant abnormal hematology 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.
  4. Any serious systemic infectious disease during the four weeks prior to the first dose of test drug, as judged by the Investigator.
  5. 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.
  6. History of alcohol or drug abuse.
  7. Any positive reaction of drugs of abuse.
  8. Hepatitis B or C or HIV positive.
  9. Use of prescription drugs within 3 weeks preceding the first dosing of insulin, except for oral contraceptives/hormonal implants.
  10. Use of any insulin product for therapeutic purposes in the past.
  11. Use of non-prescription drugs, except routine vitamins, within 3 weeks prior to the first dose of the test drug. Occasional use of paracetamol is permitted.
  12. Mental incapacity, unwillingness or language barriers precluding adequate understanding or co-operation.
  13. Blood donation of more than 500 ml within the last 12 weeks.
  14. History of multiple and/or severe allergies to drugs or foods or a history of severe anaphylactic reaction.
  15. 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: NCT00596063

Locations
United States, California
Profil Institute for Clinical Research Inc.
Chula Vista, California, United States, 91911
Profil Institute for Clinical Research, Inc.
Chula Vista, California, United States, 91911
Sponsors and Collaborators
Wockhardt
Investigators
Principal Investigator: Linda Morrow, M.D Profil Institute for Clinical Research, Inc.
  More Information

No publications provided

Responsible Party: Wockhardt
ClinicalTrials.gov Identifier: NCT00596063     History of Changes
Other Study ID Numbers: Wosulin R/PK-PD/HV/FDA/07/v1, Not yet created
Study First Received: January 7, 2008
Last Updated: December 26, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Wockhardt:
pharmacokinetics
pharmacodynamics
recombinant human insulin
healthy volunteers

Additional relevant MeSH terms:
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Insulin, Globin Zinc
Insulin
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 18, 2014