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Clinical Trials/EUCTR2009-013264-39-DE
EUCTR2009-013264-39-DE
Active, not recruiting
Not Applicable

A Single-Center, Double Blind, Randomized Crossover Study Evaluating Injection Site Toleration of VIAject® 7, VIAject® 25 and Insulin Lispro in Subjects with Type 1 or Type 2 Diabetes Mellitus

BIODEL inc.0 sitesJuly 21, 2009
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ConditionsType 1 or Type 2 Diabetes MellitusMedDRA version: 9.1Level: LLTClassification code 10045242Term: Type II diabetes mellitus
DrugsHumalog ®

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Type 1 or Type 2 Diabetes Mellitus
Sponsor
BIODEL inc.
Status
Active, not recruiting
Last Updated
14 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
July 21, 2009
End Date
TBD
Last Updated
14 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
All

Investigators

Eligibility Criteria

Inclusion Criteria

  • •1\. Age 18\-70 years
  • •2\. Body Mass Index 18\-37 kg/m2
  • •3\. Males or females diagnosed with type 1 or 2 diabetes mellitus for at least 1 year
  • •4\. Subject must usually self\-inject both basal and meal\-time insulin injections to
  • •control diabetes (at least 2 injections/day) and must have done so for at least 3
  • •months prior to the study.
  • •5\. The usual short\- or fast\- (rapid) acting insulin dose for the meal to be studied
  • •must be between 5 and 25 units inclusive.
  • •6\. Signed and dated informed consent obtained before any trial\-related activities.
  • •(Trial\-related activities are any procedure that would not have been performed

Exclusion Criteria

  • •1\. HbA1c value of \> 10\.0%
  • •2\. History of hypersensitivity to any of the components in the study medication
  • •3\. History of insulin allergy
  • •4\. Treatment with any other investigational drug in the last 3 months before study
  • •5\. Treatment with oral or parenteral corticosteroids at the time of screening or
  • •anticipated use during the course of the study.
  • •6\. Regular use of analgesics (Daily doses of up to 100 mg aspirin are acceptable)
  • •7\. Any chronic pain syndrome, e.g., chronic neuropathic pain, fibromyalgia, etc.
  • •8\. Progressive disease likely to prove fatal (e.g., malignancies)
  • •9\. Current drug or alcohol use, positive recreational drug screen or a history of drug

Outcomes

Primary Outcomes

Not specified

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