Comparative Glucose Clamp Study of Wockhardt's Recombinant Insulin Analog Glargine(Glaritus) With Lantus in T1DM
Primary Purpose
Type1 Diabetes
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Glargine
Sponsored by
About this trial
This is an interventional health services research trial for Type1 Diabetes
Eligibility Criteria
Inclusion Criteria:
- Male or female subjects with type 1 diabetes ≥12 months.
- HbA1c ≤9% by local laboratory analysis (one retest within a week is permitted with the result of the last test being conclusive).
- Age ≥18 and ≤60 years.
- Considered generally healthy upon completion of medical history, physical examination and biochemical investigations as judged by the Investigator.
- 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:
- Previous participation in this trial, or participation in other clinical trials within the last 30 days.
- 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).
- 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.
- 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.
- Clinically significant abnormal ECG at screening, as judged by the Investigator.
- History of alcohol or drug abuse in the past five years.
- Any positive reaction of drug abuse.
- Hepatitis B or C or HIV positive.
- Mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation.
- History of multiple and/or severe allergies to drugs or foods or a history of severe anaphylactic reaction.
- Regular cigarette smoker, defined as smoking >1 pack/day and unable to refrain from smoking during the in house period.
- Known or suspected allergy to trial product or related products.
- Any disease or condition that, in the opinion of the Investigator, would represent an unacceptable risk for the subject's safety.
Sites / Locations
- Profil Institute for clinical Research
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Glaritus arm
Lantus arm
Arm Description
Insulin glargine (Glaritus: 100 U/ml), Penfill® cartridges 3.0ml
Insulin glargine (Lantus: 100 U/ml), Penfill® cartridges 3.0ml
Outcomes
Primary Outcome Measures
Bioequivalence based on Pharmacokinetic parameter:AUC INS-GLR 0-24h.
Bioequivalence based on Pharmacodynamic parameter: AUC GIR 0-24hrs
Pharmacokinetic Parameters: Maximum concentration (Cmax)
Secondary Outcome Measures
Safety parameters
Number of AE's, SAE's, Hypoglycemic events and local tolerability
Pharmacodynamic parameters: Area under curve glucose infusion rate from 0-24hrs
AUC GIR 0-12h,AUC GIR 12-24h,AUC GIR 0-24h
Pharmacokinetic parameter: Area under curve from 0-24hrs
AUC INS-GLR 0-12hrs, AUC INS-GLR 12-24hrs,AUC INS-GLR 0-24hrs
Pharmacokinetic Parameters: tmax and t1/2
Pharmacodynamic parameter: GIR max and tGIR max
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01357603
Brief Title
Comparative Glucose Clamp Study of Wockhardt's Recombinant Insulin Analog Glargine(Glaritus) With Lantus in T1DM
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 Type
Interventional
2. Study Status
Record Verification Date
January 2013
Overall Recruitment Status
Completed
Study Start Date
June 2011 (undefined)
Primary Completion Date
May 2012 (Actual)
Study Completion Date
August 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Wockhardt
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type1 Diabetes
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
111 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Glaritus arm
Arm Type
Experimental
Arm Description
Insulin glargine (Glaritus: 100 U/ml), Penfill® cartridges 3.0ml
Arm Title
Lantus arm
Arm Type
Active Comparator
Arm Description
Insulin glargine (Lantus: 100 U/ml), Penfill® cartridges 3.0ml
Intervention Type
Biological
Intervention Name(s)
Glargine
Intervention Description
dosage form: Subcutaneous injection
Primary Outcome Measure Information:
Title
Bioequivalence based on Pharmacokinetic parameter:AUC INS-GLR 0-24h.
Time Frame
over 24hrs post dose
Title
Bioequivalence based on Pharmacodynamic parameter: AUC GIR 0-24hrs
Time Frame
over 24hrs post dose
Title
Pharmacokinetic Parameters: Maximum concentration (Cmax)
Time Frame
over 24hrs post dose
Secondary Outcome Measure Information:
Title
Safety parameters
Description
Number of AE's, SAE's, Hypoglycemic events and local tolerability
Time Frame
till 24 hrs post-dose
Title
Pharmacodynamic parameters: Area under curve glucose infusion rate from 0-24hrs
Description
AUC GIR 0-12h,AUC GIR 12-24h,AUC GIR 0-24h
Time Frame
over 24hrs post dose
Title
Pharmacokinetic parameter: Area under curve from 0-24hrs
Description
AUC INS-GLR 0-12hrs, AUC INS-GLR 12-24hrs,AUC INS-GLR 0-24hrs
Time Frame
over 24hrs post dose
Title
Pharmacokinetic Parameters: tmax and t1/2
Time Frame
over 24hrs post dose
Title
Pharmacodynamic parameter: GIR max and tGIR max
Time Frame
over 24hrs post dose
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Male or female subjects with type 1 diabetes ≥12 months.
HbA1c ≤9% by local laboratory analysis (one retest within a week is permitted with the result of the last test being conclusive).
Age ≥18 and ≤60 years.
Considered generally healthy upon completion of medical history, physical examination and biochemical investigations as judged by the Investigator.
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:
Previous participation in this trial, or participation in other clinical trials within the last 30 days.
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).
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.
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.
Clinically significant abnormal ECG at screening, as judged by the Investigator.
History of alcohol or drug abuse in the past five years.
Any positive reaction of drug abuse.
Hepatitis B or C or HIV positive.
Mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation.
History of multiple and/or severe allergies to drugs or foods or a history of severe anaphylactic reaction.
Regular cigarette smoker, defined as smoking >1 pack/day and unable to refrain from smoking during the in house period.
Known or suspected allergy to trial product or related products.
Any disease or condition that, in the opinion of the Investigator, would represent an unacceptable risk for the subject's safety.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dr. Elaine Watkins
Organizational Affiliation
Profil Institute of Clinical Research
Official's Role
Principal Investigator
Facility Information:
Facility Name
Profil Institute for clinical Research
City
Chula Vista
State/Province
California
ZIP/Postal Code
91911
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Comparative Glucose Clamp Study of Wockhardt's Recombinant Insulin Analog Glargine(Glaritus) With Lantus in T1DM
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