Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Comparative Glucose Clamp Study of Wockhardt's Recombinant Insulin Analog Glargine(Glaritus) With Lantus in T1DM

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Wockhardt
ClinicalTrials.gov Identifier:
NCT01357603
First received: May 12, 2011
Last updated: January 24, 2013
Last verified: January 2013
  Purpose

The aim of this trial is to demonstrate bioequivalence of Glaritus® to Lantus® with regard to its total and to its maximum serum insulin concentrations.


Condition Intervention Phase
Type1 Diabetes
Biological: Glargine
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: A Randomized, Double-blind, Two Period, Cross Over Glucose Clamp Study to Test for Bioeqivalence Between Two Long Acting Insulin Analogs-Wockhardt's Glaritus™ (Insulin Glargine) and Lantus (Insulin Glargine) in Subjects With Type 1 Diabetes

Resource links provided by NLM:


Further study details as provided by Wockhardt:

Primary Outcome Measures:
  • Bioequivalence based on Pharmacokinetic parameter:AUC INS-GLR 0-24h. [ Time Frame: over 24hrs post dose ] [ Designated as safety issue: No ]
  • Bioequivalence based on Pharmacodynamic parameter: AUC GIR 0-24hrs [ Time Frame: over 24hrs post dose ] [ Designated as safety issue: No ]
  • Pharmacokinetic Parameters: Maximum concentration (Cmax) [ Time Frame: over 24hrs post dose ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Safety parameters [ Time Frame: till 24 hrs post-dose ] [ Designated as safety issue: Yes ]
    Number of AE's, SAE's, Hypoglycemic events and local tolerability

  • Pharmacodynamic parameters: Area under curve glucose infusion rate from 0-24hrs [ Time Frame: over 24hrs post dose ] [ Designated as safety issue: No ]
    AUC GIR 0-12h,AUC GIR 12-24h,AUC GIR 0-24h

  • Pharmacokinetic parameter: Area under curve from 0-24hrs [ Time Frame: over 24hrs post dose ] [ Designated as safety issue: No ]
    AUC INS-GLR 0-12hrs, AUC INS-GLR 12-24hrs,AUC INS-GLR 0-24hrs

  • Pharmacokinetic Parameters: tmax and t1/2 [ Time Frame: over 24hrs post dose ] [ Designated as safety issue: No ]
  • Pharmacodynamic parameter: GIR max and tGIR max [ Time Frame: over 24hrs post dose ] [ Designated as safety issue: No ]

Enrollment: 111
Study Start Date: June 2011
Study Completion Date: August 2012
Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Glaritus arm
Insulin glargine (Glaritus: 100 U/ml), Penfill® cartridges 3.0ml
Biological: Glargine
dosage form: Subcutaneous injection
Active Comparator: Lantus arm
Insulin glargine (Lantus: 100 U/ml), Penfill® cartridges 3.0ml
Biological: Glargine
dosage form: Subcutaneous injection

Detailed Description:

The purpose of this study is to test for bioequivalence based on the pharmacokinetic parameter AUC INS-GLR 0-24h and on pharmacodynamic parameter AUC GIR 0-24h between the two long-acting insulin glargine formulations, Lantus® and Wockhardt's Glaritus® in subjects with type1 diabetes as well as assessing safety and local tolerability of the two insulin preparations.

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Male or female subjects with type 1 diabetes ≥12 months.
  2. HbA1c ≤9% by local laboratory analysis (one retest within a week is permitted with the result of the last test being conclusive).
  3. Age ≥18 and ≤60 years.
  4. Considered generally healthy upon completion of medical history, physical examination and biochemical investigations as judged by the Investigator.
  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 participation in other clinical trials within the last 30 days.
  2. Pregnant, breast-feeding or the intention of becoming pregnant or not using adequate contraceptive measures (e.g. 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 or double barrier method including male condoms used plus spermicide, diaphragm with spermicide plus male condom, cap with spermicide plus male condom).
  3. 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 (hemoglobin below the lower limit of normal) or hemoglobinopathy will not be allowed to enter the trial.
  4. Cardiac problems defined as decompensated heart failure (New York Heart Association (NYHA) class III and IV) at any time and/or angina pectoris within the last 12 months and/or acute myocardial infarction at any time.
  5. Clinically significant abnormal ECG at screening, as judged by the Investigator.
  6. History of alcohol or drug abuse in the past five years.
  7. Any positive reaction of drug abuse.
  8. Hepatitis B or C or HIV positive.
  9. Mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation.
  10. History of multiple and/or severe allergies to drugs or foods or a history of severe anaphylactic reaction.
  11. Regular cigarette smoker, defined as smoking >1 pack/day and unable to refrain from smoking during the in house period.
  12. Known or suspected allergy to trial product or related products.
  13. Any disease or condition that, in the opinion of the Investigator, would represent an unacceptable risk for the subject's safety.
  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: NCT01357603

Locations
United States, California
Profil Institute for clinical Research
Chula Vista, California, United States, 91911
Sponsors and Collaborators
Wockhardt
Investigators
Principal Investigator: Dr. Elaine Watkins Profil Institute of Clinical Research
  More Information

No publications provided

Responsible Party: Wockhardt
ClinicalTrials.gov Identifier: NCT01357603     History of Changes
Other Study ID Numbers: Glaritus/PK-PD/FDA/2011
Study First Received: May 12, 2011
Last Updated: January 24, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Autoimmune Diseases
Endocrine System Diseases
Glucose Metabolism Disorders
Immune System Diseases
Metabolic Diseases
Glargine
Insulin
Hypoglycemic Agents
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on November 24, 2014