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.

NCT00849576 | Completed Phase 3

• 1 other identifier: VIAject™-15J
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Type 2 Diabetes

Outcome Measures

Primary Outcomes (1)

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

  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.

  0 - 240 minutes

Study Arms (4)

Regular Human Insulin

ACTIVE COMPARATOR

Single Injection

Drug: Regular Human Insulin

Inuslin Lispro (90%)

ACTIVE COMPARATOR

Single Injection

Drug: Insulin Lispro

Insulin VIAject™ (75%)

EXPERIMENTAL

Single Injection

Drug: Insulin VIAject™ (75%)

Insulin VIAject™ (90%)

EXPERIMENTAL

Single injection

Drug: Insulin VIAject™ (90%)

Interventions

Regular Human Insulin DRUG

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

Regular Human Insulin

Insulin Lispro DRUG

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

Inuslin Lispro (90%)

Insulin VIAject™ (75%) DRUG

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

Insulin VIAject™ (75%)

Insulin VIAject™ (90%) DRUG

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

Insulin VIAject™ (90%)

Eligibility Criteria

• Age: 40 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Biodel: lead

Study Sites (1)

IKFE

Parcusstrasse 8, Mainz, 55116, Germany

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Insulin; Insulin Lispro

Condition Hierarchy (Ancestors)

Diabetes Mellitus; 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; Insulin, Short-Acting

Study Officials

• Thomas Forst, MD

  IKFE Institute for Clinical Research and Development

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 20, 2009
• First Posted: February 24, 2009
• Study Start: April 1, 2008
• Primary Completion: August 1, 2008
• Study Completion: August 1, 2008
• Last Updated: August 3, 2015

Record last verified: 2015-07

Locations

DE (1)