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

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

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.

Study Overview

• Status: Completed
• Conditions: Type1 Diabetes
• Intervention / Treatment: Biological: Glargine

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
• Enrollment (Actual): 111
• Phase: Phase 1

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: HEALTH_SERVICES_RESEARCH
• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: QUADRUPLE

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Bioequivalence based on Pharmacokinetic parameter:AUC INS-GLR 0-24h.	over 24hrs post dose
Bioequivalence based on Pharmacodynamic parameter: AUC GIR 0-24hrs	over 24hrs post dose
Pharmacokinetic Parameters: Maximum concentration (Cmax)	over 24hrs post dose

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety parameters	Number of AE's, SAE's, Hypoglycemic events and local tolerability	till 24 hrs post-dose
Pharmacodynamic parameters: Area under curve glucose infusion rate from 0-24hrs	AUC GIR 0-12h,AUC GIR 12-24h,AUC GIR 0-24h	over 24hrs post dose
Pharmacokinetic parameter: Area under curve from 0-24hrs	AUC INS-GLR 0-12hrs, AUC INS-GLR 12-24hrs,AUC INS-GLR 0-24hrs	over 24hrs post dose
Pharmacokinetic Parameters: tmax and t1/2		over 24hrs post dose
Pharmacodynamic parameter: GIR max and tGIR max		over 24hrs post dose

Collaborators and Investigators

• Sponsor: Wockhardt
• Investigators: Principal Investigator: Dr. Elaine Watkins, Profil Institute of Clinical Research

Study record dates

Study Major Dates

• Study Start: June 1, 2011
• Primary Completion (ACTUAL): May 1, 2012
• Study Completion (ACTUAL): August 1, 2012

Study Registration Dates

• First Submitted: May 12, 2011
• First Submitted That Met QC Criteria: May 18, 2011
• First Posted (ESTIMATE): May 20, 2011

Study Record Updates

• Last Update Posted (ESTIMATE): January 25, 2013
• Last Update Submitted That Met QC Criteria: January 24, 2013
• Last Verified: January 1, 2013

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Immune System Diseases; Autoimmune Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 1; Hypoglycemic Agents; Physiological Effects of Drugs; Insulin Glargine
• Other Study ID Numbers: Glaritus/PK-PD/FDA/2011