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

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ClinicalTrials.gov Identifier: NCT00719108
Recruitment Status : Completed
First Posted : July 21, 2008
Last Update Posted : December 27, 2012
Information provided by (Responsible Party):

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.

Condition or disease Intervention/treatment Phase
Diabetes Biological: Wosulin R Biological: Actrapid Phase 1

Detailed Description:
The purpose of this study is the comparative evaluation of the Pharmacodynamics and Pharmacokinetics of two recombinant regular human insulin injections administered intravenously in healthy volunteers under the conditions of euglycemic clamp.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 42 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Health Services Research
Official Title: Randomized,Single Center,Double Blind,Two-period,Crossover Glucose Clamp Trial to Test Bioequivalence Between Two Recombinant Human Soluble Insulins - Wockhardt's Insulin Human Regular for Injection and Actrapid, in Healthy Subjects
Study Start Date : July 2008
Primary Completion Date : September 2008
Study Completion Date : September 2008

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: Wosulin R
Wosulin R, Regular insulin for injection (Recombinant Human Insulin) (100 IU/mL)in vials 10.0 ml
Biological: Wosulin R
Total dose per subject will be 0.3 IU/Kg given IV over 5 hrs.
Active Comparator: Actrapid
Actrapid, Regular insulin for injection (Recombinant Human Insulin) (100 IU/mL)in vials 10.0 ml
Biological: Actrapid
Total dose per subject will be 0.3 IU/Kg given IV over 5 hrs.

Primary Outcome Measures :
  1. The area under the GIR-time curve at steady state from 240 to 300 minutes (AUCGIR-SS) [ Time Frame: Visit 2 and 3 ]

Secondary Outcome Measures :
  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. [ Time Frame: Visit 2 , 3 and 4 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

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

Exclusion Criteria:

  1. Previous participation in this trial or other clinical trials within the last 3 months.
  2. Pregnant, breast-feeding or intention of becoming pregnant or not using adequate contraceptive measures.
  3. Clinically significant abnormal hematology or biochemistry screening tests, as judged by the Investigator.
  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 (below the lower limit of normal) or hemoglobinopathy will not be allowed to enter the trial.
  6. History of alcohol or drug abuse within the past 5 years and/or any positive test for drugs of abuse at screening.
  7. Positive test for hepatitis B or C or HIV positive at screening or in the past.
  8. Use of prescription drugs within 3 weeks preceding the first dosing of insulin, except for oral contraceptives/hormonal implants.
  9. Use of any insulin product in the past.
  10. 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.
  11. Blood donation of more than 500 mL (or considerable blood loss) within the last 12 weeks.
  12. History of multiple and/or severe allergies to drugs or foods or a history of severe anaphylactic reaction.
  13. Known or suspected allergy to trial products or related products.
  14. Mental incapacity, unwillingness or language barriers precluding adequate understanding or co-operation.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00719108

United States, California
Profil Institute for Clinical Research Inc.
Chula Vista, California, United States, 91911
Sponsors and Collaborators
Study Director: Marcus Hompesch, MD Profil Institute of Clinical Research

Responsible Party: Wockhardt
ClinicalTrials.gov Identifier: NCT00719108     History of Changes
Other Study ID Numbers: WosulinR/PK-PD/HV/EMEA/2008/v2
First Posted: July 21, 2008    Key Record Dates
Last Update Posted: December 27, 2012
Last Verified: December 2012

Keywords provided by Wockhardt:
Diabetes, Healthy Volunteers

Additional relevant MeSH terms:
Insulin, Globin Zinc
Hypoglycemic Agents
Physiological Effects of Drugs