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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Wockhardt
ClinicalTrials.gov Identifier:
NCT00719108
First received: July 18, 2008
Last updated: December 26, 2012
Last verified: December 2012
  Purpose

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 Intervention Phase
Diabetes
Biological: Wosulin R
Biological: Actrapid
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


Further study details as provided by Wockhardt:

Primary Outcome Measures:
  • The area under the GIR-time curve at steady state from 240 to 300 minutes (AUCGIR-SS) [ Time Frame: Visit 2 and 3 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Enrollment: 42
Study Start Date: July 2008
Study Completion Date: September 2008
Primary Completion Date: September 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  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 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.
  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: NCT00719108

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

No publications provided

Responsible Party: Wockhardt
ClinicalTrials.gov Identifier: NCT00719108     History of Changes
Other Study ID Numbers: WosulinR/PK-PD/HV/EMEA/2008/v2
Study First Received: July 18, 2008
Last Updated: December 26, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Wockhardt:
Diabetes, Healthy Volunteers

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

ClinicalTrials.gov processed this record on September 16, 2014