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Completed

NCT Number: NCT01000922

A Study Comparing the Pharmacodynamic Properties of Insulin VIAJECT™, Regular Human Insulin, and Insulin Lispro

Evaluation of post-prandial blood glucose excursions after a standardized meal and pre meal injections of individual doses of the study insulins.

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Key information

Age range

19 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Profil Institute for Clinical Research, Inc. (PICR)

Chula Vista, California, 91911, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Established diagnosis of type 1 diabetes for not less than 5 years
  • HbA1c values of not more than 9%
  • Age: 19 to 70 years
  • Sex: Male or Female
  • Body Mass Index: 18 - 28 kg/m2
  • Informed consent must be obtained in writing for all volunteers.

Exclusion criteria

  • Type 2 Diabetes mellitus.
  • History of hypersensitivity to any of the components in the study medication.
  • History of severe or multiple allergies.
  • Treatment with any other investigational drug in the last 1 month before study entry.
  • Treatment with any concomitant medication that in the judgment of the investigator. would interfere with the study results.
  • Progressive disease likely to prove fatal (e.g. malignancies).
  • Current drug or alcohol abuse, or a history which in the opinion of the Investigator will impair subject safety or protocol compliance.
  • Having a significant cardiovascular, respiratory, gastrointestinal, hepatic, renal, neurological, psychiatric and/or hematological disease as evaluated by the investigator.
  • Blood donation within the last 30 days.
  • A women who is lactating.
  • Pregnant women or women intending to become pregnant during the study.
  • A sexually active woman of childbearing age not actively practicing birth control by using a medically accepted device or therapy.
  • Positive Serology for HIV, Hepatitis B or Hepatitis C.
  • Abnormal ECG, safety lab or physical examination results that are deemed clinically significant by the investigator.
  • A lack of compliance or other reasons which, in the opinion of the investigator, prevent the participation of the subject in the study.

Treatment and study plan

regular human insulin

Drug

Individual dose of RHI administered subcutaneously

Lispro

Drug

Individual dose of lispro administered subcutaneously

VIAject

Drug

Individual dose of VIAject administered subcutaneously

VIAject 50%

Drug

Individual dose of VIAject 50% administered subcutaneously

VIAject/Insulin Glargine

Drug

VIAject mixed wiht insulin glargine and administered subcutaneously

Insulin Glargine/VIAject

Drug

Individual dose of VIAject and Insulin Glargine administered seperately and subcutaneously

Primary outcomes

  1. To compare the maximal post prandial blood glucose concentration and the time to maximal post prandial glucose concentration between the different treatments

    Time frame: 8 hours

Secondary outcomes

  1. To compare the ppGlucmax for all treatments, the ppTGluc-max, the AUCGluc 0-180 and the AUCGluc 0-360, CGluc-baseline for all treatments.

    Time frame: 8 hours

Sponsors and collaborators

Lead sponsor

Biodel

Industry

Registry information

Official study title

A Single Center, Randomized, Open-Label, Crossover Study, Comparing the Pharmacodynamic Properties of Insulin VIAJECT™, Regular Human Insulin, and Insulin Lispro Either in Combination With a Basal Insulin Infusion or With Insulin Glargine Relative to a Standardized Meal in Patients With Type 1 Diabetes

Important dates

Study start
2006
Primary completion
2008
Study completion
2008
First posted
Oct 23, 2009
Registry last updated
Jul 29, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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