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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Type1 Diabetes

Intervention / Treatment
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* Biological: Glargine


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Glaritus arm<br>Insulin glargine (Glaritus: 100 U/ml), Penfill® cartridges 3.0ml | Biological: Glargine<br>* dosage form: Subcutaneous injection<br>|
| Active Comparator: Lantus arm<br>Insulin glargine (Lantus: 100 U/ml), Penfill® cartridges 3.0ml | Biological: Glargine<br>* dosage form: Subcutaneous injection<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 |