A Study to Evaluate the Effect of Nasal Insulin on Postprandial Glycemic Control in Type 2 Diabetic Patients

NCT00624767 | Completed Phase 2

• 1 other identifier: C08-002
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief Summary

Insulin is a hormone which is produced by the human pancreas for the lowering of blood sugar. In patients who don't produce enough insulin, additional insulin must be given several times per day by injections. Nastech Pharmaceutical Company Inc. has developed a new insulin nasal spray, as a possible way to improve patient compliance with intensive insulin treatment plans. This study is being conducted to see how Nastech's insulin nasal spray affects post-meal glucose levels compared with rapid acting insulin (i.e., insulin aspart) in Type 2 diabetics who are already taking oral antidiabetic medications and/or insulin therapy. Insulin aspart is marketed as NovoLog® in the United States. The safety of insulin nasal spray and how well it is tolerated as compared to NovoLog will also be evaluated.

Conditions

Diabetes Mellitus

Keywords

insulin; insulin aspart; Type 2 Diabetes; diabetes mellitus

Outcome Measures

Primary Outcomes (1)

• To evaluate the effect on postprandial glycemic control of intranasal insulin compared to NovoLog

  4 hour Profile

Secondary Outcomes (1)

• To evaluate the pharmacokinetics of intranasal insulin compared to NovoLog

  4 hour Profile

Study Arms (2)

1

EXPERIMENTAL

Insulin Nasal Spray

Drug: Insulin (recombinant human insulin)

2

ACTIVE COMPARATOR

NovoLog

Drug: NovoLog

Interventions

Insulin (recombinant human insulin) DRUG

Insulin Nasal Spray at doses up to 200 IU.

Also known as: recombinant human insulin

1

NovoLog DRUG

NovoLog at doses up to 30 IU

Also known as: insulin aspart

2

Eligibility Criteria

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

You may qualify if:

• Type 2 diabetes for at least 3 months
• Type 2 diabetics on oral antidiabetic medicines and/or insulin therapies

You may not qualify if:

• Patients taking intermediate acting insulin such as NPH
• Recurrent severe hypoglycemia
• Patients with late diabetic complications

Sponsors & Collaborators

• Nastech Pharmaceutical Company, Inc.: lead

Study Sites (1)

Diabetes and Glandular Disease Research Associates

San Antonio, Texas, 78258, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus; Insulin Resistance; Diabetes Mellitus, Type 2

Interventions

Insulin; Insulin Aspart

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Hyperinsulinism

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

• Sherwyn Schwartz, MD

  Diabetes and Glandular Disease Research Associates

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: February 7, 2008
• First Posted: February 27, 2008
• Study Start: March 1, 2008
• Primary Completion: April 1, 2008
• Study Completion: May 1, 2008
• Last Updated: May 20, 2008

Record last verified: 2008-05

Locations

US (1)