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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01357603
Recruitment Status : Completed
First Posted : May 20, 2011
Last Update Posted : January 25, 2013
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Brief Summary:
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 or disease Intervention/treatment Phase
Type1 Diabetes Biological: Glargine Phase 1

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 111 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, 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
Study Start Date : June 2011
Actual Primary Completion Date : May 2012
Actual Study Completion Date : August 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diabetes Type 1

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. Bioequivalence based on Pharmacokinetic parameter:AUC INS-GLR 0-24h. [ Time Frame: over 24hrs post dose ]
  2. Bioequivalence based on Pharmacodynamic parameter: AUC GIR 0-24hrs [ Time Frame: over 24hrs post dose ]
  3. Pharmacokinetic Parameters: Maximum concentration (Cmax) [ Time Frame: over 24hrs post dose ]

Secondary Outcome Measures :
  1. Safety parameters [ Time Frame: till 24 hrs post-dose ]
    Number of AE's, SAE's, Hypoglycemic events and local tolerability

  2. Pharmacodynamic parameters: Area under curve glucose infusion rate from 0-24hrs [ Time Frame: over 24hrs post dose ]
    AUC GIR 0-12h,AUC GIR 12-24h,AUC GIR 0-24h

  3. Pharmacokinetic parameter: Area under curve from 0-24hrs [ Time Frame: over 24hrs post dose ]
    AUC INS-GLR 0-12hrs, AUC INS-GLR 12-24hrs,AUC INS-GLR 0-24hrs

  4. Pharmacokinetic Parameters: tmax and t1/2 [ Time Frame: over 24hrs post dose ]
  5. Pharmacodynamic parameter: GIR max and tGIR max [ Time Frame: over 24hrs post dose ]

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

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 identifier (NCT number): NCT01357603

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

Responsible Party: Wockhardt Identifier: NCT01357603     History of Changes
Other Study ID Numbers: Glaritus/PK-PD/FDA/2011
First Posted: May 20, 2011    Key Record Dates
Last Update Posted: January 25, 2013
Last Verified: January 2013

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