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

NCT01357603 | Completed Phase 1

• 1 other identifier: Glaritus/PK-PD/FDA/2011
• Study Type: interventional
• Target: 111
• Locations: 1 country
• Sites: 1

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.

Conditions

Type1 Diabetes

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (5)

• Safety parameters

  till 24 hrs post-dose

• Pharmacodynamic parameters: Area under curve glucose infusion rate from 0-24hrs

  over 24hrs post dose

• Pharmacokinetic parameter: Area under curve from 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

Study Arms (2)

Glaritus arm

EXPERIMENTAL

Insulin glargine (Glaritus: 100 U/ml), Penfill® cartridges 3.0ml

Biological: Glargine

Lantus arm

ACTIVE COMPARATOR

Insulin glargine (Lantus: 100 U/ml), Penfill® cartridges 3.0ml

Biological: Glargine

Interventions

Glargine BIOLOGICAL

dosage form: Subcutaneous injection

Glaritus arm; Lantus arm

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Wockhardt: lead

Study Sites (1)

Profil Institute for clinical Research

Chula Vista, California, 91911, United States

Location

MeSH Terms

Interventions

Insulin Glargine

Intervention Hierarchy (Ancestors)

Insulin, Long-Acting; Insulins; Pancreatic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Study Officials

• Dr. Elaine Watkins

  Profil Institute of Clinical Research

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 12, 2011
• First Posted: May 20, 2011
• Study Start: June 1, 2011
• Primary Completion: May 1, 2012
• Study Completion: August 1, 2012
• Last Updated: January 25, 2013

Record last verified: 2013-01

Locations

US (1)