Comparative Bioequivalence Study of Wockhardt's Insulin Analogue Lispro (Listro™) With Humalog® in Healthy Subjects

NCT01399255 | Withdrawn Phase 1

• 1 other identifier: Listro/PK-PD/FDA/2011
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study is to assess the bioequivalence of two rapid-acting insulin Lispro formulations: Humalog® and Listro™ in healthy subjects based on the pharmacokinetic parameter (PK) and the pharmacodynamic parameter (PD).

Conditions

Bioequivalence in Healthy Subjects

Outcome Measures

Primary Outcomes (2)

• Bioequivalence based on Pharmacokinetic parameter AUC (INS-LIS 0-8h)

  Glucose clamp will be terminated 10 hours post dose and the primary pharmacokinetic bioequivalance will be calculated based on the Area under the curve (AUC) between 0 - 8 hours postdose of the study medication.

  8 hrs post dose

• Bioequivalence based on Pharmacodynamic parameter: AUC (GIR 0-8h)

  Glucose clamp will be terminated 10 hours post dose and the primary pharmacodymanic bioequivalance will be calculated based on the Area under the curve (AUC) for the glucose infusion rate (GIR) between 0 - 8 hours postdose of the study medication

  8 hrs post dose

Secondary Outcomes (6)

• Pharmacokinetic parameters:Maximum concentration (Cmax)

  over 10 hrs post dose

• Pharmacodynamic parameters: Area under curve glucose infusion rate from 0-10hrs

  over 10 hrs post dose

• Safety endpoints

  over 10 hrs post dose

• Pharmacokinetic parameter: Area under curve from 0-10hrs

  over 10 hours postdose

• Pharmacokinetic Parameters: tmax and t1/2

  Over 10 hours postdose

Study Arms (2)

Listro™ Arm

EXPERIMENTAL

Insulin Lispro (Listro™); 100 U/mL, DispoPen 3.0 mL.

Biological: Insulin lispro

Humalog® Arm

ACTIVE COMPARATOR

Insulin Lispro (Humalog®; 100 U/mL), Humalog® Kwik Pen™ 3.0 mL.

Biological: Insulin lispro

Interventions

Insulin lispro BIOLOGICAL

Dosage form- Subcutaneous Injection

Also known as: Listro™ and Humalog®

Humalog® Arm; Listro™ Arm

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy male or female subjects.
• Age ≥18 and ≤50 years.
• Considered generally healthy upon completion of medical history, physical examination and biochemical investigations as judged by the Investigator.
• Body Mass Index (BMI) between 18.0 and 27.0 kg/m2, inclusive.
• Non-smoker, defined as no nicotine consumption for at least one year.
• 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 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 are acceptable options).
• Clinically significant abnormal hematology or biochemistry screening tests, as judged by the Investigator. In particular, subjects with an elevated fasting blood glucose, elevated liver enzymes (AST or ALT \>2 times the upper limit of normal) or impaired renal function (elevated serum creatinine values above the upper limit will not be allowed to enter the trial. Subjects with abnormal TSH may be required to have additional testing of thyroid hormones for further clarification. Subjects with abnormal TSH judged by the Investigator as clinically significant will be excluded from the study.
• Any serious systemic infectious disease during the four weeks prior to the first dose of test drug, as judged by the Investigator.
• 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 screen for drugs of abuse.
• Hepatitis B or C or HIV positive.
• Use of prescription drugs within 3 weeks preceding the first dosing of insulin, except for oral contraceptives/hormonal implants.
• Use of non-prescription drugs, except routine vitamins or herbal products, within 3 weeks prior to the first dose of the test drug.
• Occasional use of acetaminophen is permitted. Acetaminophen is not allowed on the dosing day until 4 hours postdosing.
• Use of systemic corticosteroids, monoamine oxidase (MAO) inhibitors, prostaglandin blockers, systemic non-selective beta-blockers, growth hormones
• Thyroid hormones are not allowed unless stable during the past 3 months.

Sponsors & Collaborators

• Wockhardt: lead

Study Sites (1)

Profil Institute for Clinical Research, Inc.

Chula Vista, California, 91911, United States

Location

MeSH Terms

Interventions

Insulin Lispro

Intervention Hierarchy (Ancestors)

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

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

Study Record Dates

• First Submitted: July 19, 2011
• First Posted: July 21, 2011
• Study Start: November 1, 2011
• Primary Completion: May 1, 2012
• Study Completion: June 1, 2012
• Last Updated: January 25, 2013

Record last verified: 2013-01

Locations

US (1)