Effect of Treatment With Insulin VIAjectTM Compared to Regular Human Insulin and Insulin Lispro on Mealtime Blood Vessel Stress in Patients With Type 2 Diabetes Mellitus.
NCT ID: NCT00849576
Last Updated: 2015-08-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
15 participants
INTERVENTIONAL
2008-04-30
2008-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
CROSSOVER
TREATMENT
NONE
Study Groups
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Regular Human Insulin
Single Injection
Regular Human Insulin
0.10 U/Kg- 15 minutes before ingestion of a standardized liquid meal.
Inuslin Lispro (90%)
Single Injection
Insulin Lispro
90% of Regular Human Insulin dose administer immediately before ingestion of a standardized liquid meal.
Insulin VIAject™ (75%)
Single Injection
Insulin VIAject™ (75%)
75 % of Regular Human Insulin dose administer immediately before ingestion of a standardized liquid meal
Insulin VIAject™ (90%)
Single injection
Insulin VIAject™ (90%)
90 % of Regular Human Insulin dose administer immediately before ingestion of a standardized liquid meal
Interventions
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Regular Human Insulin
0.10 U/Kg- 15 minutes before ingestion of a standardized liquid meal.
Insulin Lispro
90% of Regular Human Insulin dose administer immediately before ingestion of a standardized liquid meal.
Insulin VIAject™ (75%)
75 % of Regular Human Insulin dose administer immediately before ingestion of a standardized liquid meal
Insulin VIAject™ (90%)
90 % of Regular Human Insulin dose administer immediately before ingestion of a standardized liquid meal
Eligibility Criteria
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Inclusion Criteria
2. HbA1c between 6.5 % and 9.9 %
3. Treatment with sulfonylurea and/or metformin in a stable dosage within the last 3 months
4. Age between 40 and 75 years
5. BMI \< 40
Exclusion Criteria
2. Pre-treatment with insulin within the last 6 months prior to screening
3. Pre-treatment with PPARy-agonists or glucosidase inhibitors within the last 4 weeks prior to screening
4. Untreated hypertension stage II-III according to WHO criteria
5. Planned or anticipated change in antidiabetic and/or concomitant medication during study participation
6. Total cholesterol \> 300 mg/dl (anamnestically)
7. Major micro- or macrovascular complications as judged by the investigator
8. Tobacco use within the last 6 months prior to screening
9. Drugs with major impact on endothelial function like nitrates etc.
10. History of drug or alcohol abuse which in the opinion of the investigator will impair subject safety or protocol compliance
11. History of hypersensitivity to the study drugs or to drugs with similar chemical structures
12. History of severe or multiple allergies
13. Treatment with any other investigational drug within 3 months prior to screening
14. Progressive fatal disease
15. History of significant cardiovascular, respiratory, gastrointestinal, hepatic (ALAT and/or ASAT \> 3 times the normal reference range), renal (creatinine \> 1.1 mg/dL in women and \> 1.5 mg/dL in men), neurological, psychiatric and/or haematological disease as judged by the investigator
16. Pregnancy or breast feeding
17. Sexually active women of childbearing potential not consistently and correctly practicing birth control by implants, injectables, oral contraceptives, hormonal intrauterine devices (IUDs), sexual abstinence or vasectomised partner
18. Lack of compliance or other similar reason that at the discretion of the investigator precludes satisfactory participation in the study
19. Hypopotassemia (K\<3.5 mmol /l)
40 Years
75 Years
ALL
No
Sponsors
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Biodel
INDUSTRY
Responsible Party
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Principal Investigators
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Thomas Forst, MD
Role: PRINCIPAL_INVESTIGATOR
IKFE Institute for Clinical Research and Development
Locations
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IKFE
Parcusstrasse 8, Mainz, Germany
Countries
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Other Identifiers
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VIAject™-15J
Identifier Type: -
Identifier Source: org_study_id
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