Comparative Glucose Clamp Study of Wockhardt's Human Isophane Insulin With Novolin N,in Healthy Subjects
The aim of this trial is to demonstrate bioequivalence of Wosulin N to Novolin® N with regard to its total and to its maximum serum insulin concentrations.
The purpose of this study is is to test for bioequivalence based on AUC0-24h and Cmax between Wosulin N and Novolin® N.The study also compares the pharmacokinetic and pharmacodynamic profiles as well as assessing safety and local tolerability of the two insulin preparations in healthy subjects.
Allocation: Randomized, Control: Active Control, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Health Services Research
Isophane insulin for inj. (Recomb Human insulin) (Wosulin N), Isophane insulin for inj.(Recomb. Human Insulin) (Novolin N)
Profil Institute for clinical Research
Results (where available)
- Source: http://clinicaltrials.gov/show/NCT00772265
- Information obtained from ClinicalTrials.gov on July 15, 2010
Medical and Biotech [MESH] Definitions
A syndrome with excessively high INSULIN levels in the BLOOD. It may cause HYPOGLYCEMIA. Etiology of hyperinsulinism varies, including hypersecretion of a beta cell tumor (INSULINOMA); autoantibodies against insulin (INSULIN ANTIBODIES); defective insulin receptor (INSULIN RESISTANCE); or overuse of exogenous insulin or HYPOGLYCEMIC AGENTS.
Diminished effectiveness of INSULIN in lowering blood sugar levels: requiring the use of 200 units or more of insulin per day to prevent HYPERGLYCEMIA or KETOSIS. It can be caused by the presence of INSULIN ANTIBODIES or the abnormalities in insulin receptors (RECEPTOR, INSULIN) on target cell surfaces. It is often associated with OBESITY; DIABETIC KETOACIDOSIS; INFECTION; and certain rare conditions. (from Stedman, 25th ed)
Insulin formulation containing substance which delays or retards time period of the absorption of insulin.
A 51-amino acid pancreatic hormone that plays a major role in the regulation of glucose metabolism, directly by suppressing endogenous glucose production (GLYCOGENOLYSIS; GLUCONEOGENESIS) and indirectly by suppressing GLUCAGON secretion and LIPOLYSIS. Native insulin is a globular protein comprised of a zinc-coordinated hexamer. Each insulin monomer containing two chains, A (21 residues) and B (30 residues), linked by two disulfide bonds. Insulin is used as a drug to control insulin-dependent diabetes mellitus (DIABETES MELLITUS, TYPE 1).
Insulin Infusion Systems
Portable or implantable devices for infusion of insulin. Includes open-loop systems which may be patient-operated or controlled by a pre-set program and are designed for constant delivery of small quantities of insulin, increased during food ingestion, and closed-loop systems which deliver quantities of insulin automatically based on an electronic glucose sensor.
This trial is conducted in Europe. This is a single-centre, retrospective trial aiming at comparing the antibody levels in children and adolescents.
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