Comparative Wockhardt's Glucose Clamp Study-Human Isophane Susp 30IU/ml/70IU/ml With Novolin70/30, in Healthy Subjects

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Wockhardt
ClinicalTrials.gov Identifier:
NCT01358435
First received: May 20, 2011
Last updated: December 26, 2012
Last verified: December 2012
  Purpose

The aim of this trial is to demonstrate bioequivalence of Wosulin 70/30 to Novolin® 70/30 with regard to its total and to its maximum serum insulin concentrations.


Condition Intervention Phase
Diabetes Mellitus
Biological: 30% Regular Insulin Human Neutral and 70%Isophane Insulin
Biological: Novolin 70/30
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: Randomized,Single Center,Double Blind,Two-period,Crossover Glucose Clamp Trial Study to Test Bioequivalence Between Two Recombinant Human Mixed Insulins-Wockhardt's Human/Isophane Susp 30IU/ml/70IU/ml With Novolin70/30, 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: 53
Study Start Date: January 2011
Study Completion Date: May 2011
Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Wosulin 70/30
Wosulin 70N /30R is a recombinant Human Insulin with 30 % Regular Insulin Human Neutral and 70% Isophane Insulin, 600 nmol/ml, 100 IU/ml.
Biological: 30% Regular Insulin Human Neutral and 70%Isophane Insulin
Total Dose per subject is 0.4 IU/Kg given subcutaneously.
Active Comparator: Novolin 70/30
Novolin 70/30 is a Recombinant Human Insulin with 70% NPH, Human Insulin Isophane Suspension and 30% Regular, Human Insulin Injection
Biological: Novolin 70/30
Total Dose per subject is 0.4IU/Kg given Subcutaneously.

Detailed Description:

The purpose of this study is is to test for bioequivalence based on AUC0-24h and Cmax between Wosulin 70N/30R and Novolin 70/30.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:

  1. Healthy male or female subject.
  2. Age ≥ 18 and ≤ 45 years.
  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 27.0 kg/m2, 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. (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 30 days.
  2. 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).
  3. 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) or fasting glucose at screening outside the range of 70-99 mg/dl 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 in the past five years.
  7. Any positive test for drugs of abuse and /or alcohol at screening.
  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. Treatment with any insulin product in the past.
  11. Use of non-prescription drugs, except routine vitamins, within 2 weeks prior to the first dose of the test drug. Occasional use of acetaminophen 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: NCT01358435

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

No publications provided

Responsible Party: Wockhardt
ClinicalTrials.gov Identifier: NCT01358435     History of Changes
Other Study ID Numbers: Wosulin 7030/PK-PD/HV/FDA/10/3
Study First Received: May 20, 2011
Last Updated: December 26, 2012
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on July 23, 2014