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Completed

NCT Number: NCT00849576

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.

The purpose of this study is to compare the effects of insulin VIAject with Regular Human Insulin and Insulin Lispro on measures of mealtime blood vessel stress and blood flow.

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Key information

Conditions

Type 2 Diabetes Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

40 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

IKFE

Parcusstrasse 8, Mainz, 55116, Germany

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Type 2 diabetes mellitus according to the ADA criteria
  • HbA1c between 6.5 % and 9.9 %
  • Treatment with sulfonylurea and/or metformin in a stable dosage within the last 3 months
  • Age between 40 and 75 years
  • BMI < 40

Exclusion criteria

  • Type 1 diabetes mellitus
  • Pre-treatment with insulin within the last 6 months prior to screening
  • Pre-treatment with PPARy-agonists or glucosidase inhibitors within the last 4 weeks prior to screening
  • Untreated hypertension stage II-III according to WHO criteria
  • Planned or anticipated change in antidiabetic and/or concomitant medication during study participation
  • Total cholesterol > 300 mg/dl (anamnestically)
  • Major micro- or macrovascular complications as judged by the investigator
  • Tobacco use within the last 6 months prior to screening
  • Drugs with major impact on endothelial function like nitrates etc.
  • History of drug or alcohol abuse which in the opinion of the investigator will impair subject safety or protocol compliance
  • History of hypersensitivity to the study drugs or to drugs with similar chemical structures
  • History of severe or multiple allergies
  • Treatment with any other investigational drug within 3 months prior to screening
  • Progressive fatal disease
  • 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
  • Pregnancy or breast feeding
  • 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
  • Lack of compliance or other similar reason that at the discretion of the investigator precludes satisfactory participation in the study
  • Hypopotassemia (K<3.5 mmol /l)

Treatment and study plan

regular human insulin

Drug

0.10 U/Kg- 15 minutes before ingestion of a standardized liquid meal.

Insulin Lispro

Drug

90% of Regular Human Insulin dose administer immediately before ingestion of a standardized liquid meal.

Insulin VIAject™ (75%)

Drug

75 % of Regular Human Insulin dose administer immediately before ingestion of a standardized liquid meal

Insulin VIAject™ (90%)

Drug

90 % of Regular Human Insulin dose administer immediately before ingestion of a standardized liquid meal

Primary outcomes

  1. Postprandial time course of Asymmetric dimethyl arginine (ADMA) after injection of insulin VIAjectTM compared with regular human insulin and insulin lispro.

    Time frame: 0 - 240 minutes

Secondary outcomes

  1. The secondary objectives are to evaluate the postprandial time course of arterial elasticity (pulse wave analysis; PWA), blood glucose, insulin, intact proinsulin, nitrotyrosine, glucagon, ICAM-1, VCAM, E-selectin.

    Time frame: 0 - 240 minutes

Sponsors and collaborators

Lead sponsor

Biodel

Industry

Registry information

Important dates

Study start
2008
Primary completion
2008
Study completion
2008
First posted
Feb 24, 2009
Registry last updated
Aug 3, 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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