Comparative Glucose Clamp Study of Wockhardt's Insulin Human Regular for Injection and Actrapid, in Type 1 Diabetics

NCT00752180 | Completed Phase 1

• 1 other identifier: WosulinR/PK-PD/type1/EMEA/2008
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this trial is to demonstrate bioequivalence of Wosulin R to Actrapid with regard to its total and to its maximum serum insulin concentrations.

Conditions

Diabetes

Keywords

pharmacokinetics; pharmacodynamics; type 1 diabetics; recombinant human insulin

Outcome Measures

Primary Outcomes (1)

• Mean AUCins.0-12h and Cins.max

  Visit 2 and 3

Secondary Outcomes (1)

• PK endpoints: AUC0-4h, AUC0-6h, AUC6-12h,tmax, t½ and elimination rate constant.PD endpoints: AUCGIR0-4h, AUCGIR0-6h, AUCGIR6-12h, AUCGIR0-12h, GIRmax and tGIRmax .Safety endpoints: AEs, hematology, biochemistry, urinalyses, physical exam

  Visit 2, 3 and 4

Study Arms (2)

Wosulin R

EXPERIMENTAL

Wosulin R,Regular insulin for injection(Recombinant Human Insulin)(600 nmol/ml, 100IU/ml)in vials 10.0 ml given subcutaneously.

Biological: Wosulin R

Actrapid

ACTIVE COMPARATOR

Actrapid, Regular insulin for injection (Recombinant Human Insulin) (600nmol/ml,100IU/ml)in vials 10.0 ml given subcutaneously.

Biological: Actrapid

Interventions

Wosulin R BIOLOGICAL

Total dose per subject will be 0.3 IU/Kg given Subcutaneously.

Wosulin R

Actrapid BIOLOGICAL

Total dose per subject will be 0.3 IU/kg given Subcutaneously.

Actrapid

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Male or female subjects with type 1 diabetes mellitus
• Age between 18 and 45 years (both inclusive)
• Insulin treatment for at least 12 months before the screening visit
• Daily basal insulin requirement between 0.2 and 0.6 IU/kg/day (both inclusive) and current total daily insulin dose less than 1.2 IU/kg/day.
• Body Mass Index (BMI) between 18.0 and 35.0 kg/m2
• HbA1c less than or equal to 10.0%
• Fasting C-peptide \< 0.4 nmol/L
• Non-smoker, no nicotine consumption for at least one year.
• Subjects considered generally healthy, except for the underlying diabetes mellitus and related morbidity (such as well controlled hypertension and dyslipidemia)
• Signed and dated informed consent obtained before any trial-related activities

You may not qualify if:

• Previous participation in this trial or other clinical trials within 30 days of dosing or 5 half-lives of any investigational drug, whichever is longer. If half life of the investigational drug is unknown, previous participation in other clinical trials within 3 months of dosing.
• Pregnant, breast-feeding or intention of becoming pregnant or not using adequate contraceptive measures (defined as intrauterine device that has been in place for at least 3 months, double barrier contraception, sterilization or abstinence, or oral contraceptive pill, which should have been taken without difficulty for at least 3 months, or an approved hormonal implant).
• Clinically significant abnormal hematology or biochemistry screening tests, as judged by the Investigator. In particular, subjects with elevated liver enzymes (AST or ALT \> 2 times the upper limit of normal) or impaired renal function will not be allowed to enter the trial.
• Any serious systemic infectious disease during the four weeks prior to first dose of test drug,
• 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 or hemoglobinopathy will not be allowed to enter the trial.
• Cardiac problems defined as: decompensated heart failure (NYHA class III and IV) at any time and/or angina pectoris and/or myocardial infarction within the last 12 months.
• Uncontrolled hypertension
• Subjects who have at screening, after 5 minutes rest, a supine blood pressure outside the range of 90-140 mmHg systolic or 50-90 mmHg diastolic, or pulse rate outside the range 40 to 90 beats per minute, or who are requiring more than two anti-hypertensive medications.
• Severe neuropathy (in particular autonomic neuropathy), retinopathy or maculopathy
• Clinically significant abnormal ECG at screening
• Recurrent major hypoglycemia or hypoglycemic unawareness as judged by the investigator or hospitalization for diabetic ketoacidosis during the 6 months preceding the screening visit.
• History of alcohol or drug abuse in the past five years and/or any positive test for drugs of abuse at screening.
• Positive test for hepatitis B or C or HIV
• Any systemic treatment with drugs known to interfere with glucose metabolism such as systemic corticoids, non-selective beta-blockers, thyroid hormone and monoamine oxidase inhibitors within 3 months prior to the first dosing visit.
• Use of drugs which may interfere with the interpretation of trial results or are known to cause clinically relevant interference with insulin action, glucose utilization or recovery from hypoglycemia

Sponsors & Collaborators

• Wockhardt: lead

Study Sites (1)

Profil Institute for Clinical Research

Chula Vista, California, 91911, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus

Interventions

Insulin

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Proinsulin; Insulins; Pancreatic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Study Officials

• Till Schroer

  Profil Institute for Clinical Research, Inc.

  STUDY DIRECTOR

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: September 12, 2008
• First Posted: September 15, 2008
• Study Start: August 1, 2008
• Primary Completion: March 1, 2009
• Study Completion: April 1, 2009
• Last Updated: December 27, 2012

Record last verified: 2012-12

Locations

US (1)