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

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

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.

Study Overview

• Status: Completed
• Conditions: Diabetes
• Intervention / Treatment: Biological: Wosulin R; Biological: Actrapid

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
• Enrollment (Actual): 42
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • California
    • Chula Vista, California, United States, 91911
      • Profil Institute for Clinical Research Inc.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
The area under the GIR-time curve at steady state from 240 to 300 minutes (AUCGIR-SS)	Visit 2 and 3

Secondary Outcome Measures

Outcome Measure	Time Frame
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.	Visit 2 , 3 and 4

Collaborators and Investigators

• Sponsor: Wockhardt
• Investigators: Study Director: Marcus Hompesch, MD, Profil Institute of Clinical Research

Study record dates

Study Major Dates

• Study Start: July 1, 2008
• Primary Completion (Actual): September 1, 2008
• Study Completion (Actual): September 1, 2008

Study Registration Dates

• First Submitted: July 18, 2008
• First Submitted That Met QC Criteria: July 18, 2008
• First Posted (Estimate): July 21, 2008

Study Record Updates

• Last Update Posted (Estimate): December 27, 2012
• Last Update Submitted That Met QC Criteria: December 26, 2012
• Last Verified: December 1, 2012

More Information

Terms related to this study

• Keywords: Diabetes, Healthy Volunteers
• Additional Relevant MeSH Terms: Hypoglycemic Agents; Physiological Effects of Drugs; Insulin; Insulin, Globin Zinc
• Other Study ID Numbers: WosulinR/PK-PD/HV/EMEA/2008/v2