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

Sponsor
Nastech Pharmaceutical Company, Inc. (Industry)
Overall Status
Completed
CT.gov ID
NCT00624767
Collaborator
(none)
18
Enrollment
1
Location
2
Arms
2
Duration (Months)
9
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Phase 2

Detailed Description

This study is being conducted to evaluate the effect on postprandial glucose levels and safety of Nastech's insulin nasal spray compared with a rapid acting insulin (i.e., insulin aspart) in Type 2 diabetics. Insulin aspart is marketed as NovoLog® in the United States and NovoRapid® in Europe.

The target for the patient titration scheme is that the 60 minute glucose reading does not increase more than 3.3 mmol/L (60 mg/dL) above the fasting glucose level AND does not result in hypoglycemia at any time within four hours post meal.

NovoLog doses will be chosen based on a patient's current prandial insulin dose, or a dose of 25% of their basal insulin dose or 8 IU if on oral antidiabetic therapy only. Then patients will be titrated up or down for up to three additional consecutive treatments from the initial dose (potential of 4 doses of NovoLog). Once a patient reaches their target titrated dose with NovoLog they are then titrated with nasal insulin.

The nasal doses will correspond to the injectable dose based on bioavailability. For example, the nasal formulation being tested in this study has a 17%-28% bioavailability compared to NovoLog. Therefore a 25 IU nasal dose corresponds to a 4-7 IU NovoLog injectable dose. The patients will be titrated up or down per dose with nasal insulin for up to three additional consecutive treatments from the initial dose (potential of 4 doses of nasal insulin). Once a patient has been successfully titrated with NovoLog and then nasal insulin, they will be randomized to a two-way crossover where they will be given NovoLog and Nasal insulin. There will be at least a 20 hour washout period between titration and randomization stages. Patients will be monitored for symptoms consistent with hypoglycemia. If needed, treatment with oral carbohydrates such as glucose tablets, fruit juices, non-diet soda will be provided. In the event a patient is unable to take oral glucose, intravenous 20% glucose solution (D20) will be available.

Study Design

Study Type:
Interventional
Actual Enrollment :
18 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Phase 2, Randomized, Crossover Study to Evaluate the Effect of Intranasal Insulin and NovoLog on Postprandial Glycemic Control in Type 2 Diabetic Patients
Study Start Date :
Mar 1, 2008
Actual Primary Completion Date :
Apr 1, 2008
Actual Study Completion Date :
May 1, 2008

Arms and Interventions

Arm Intervention/Treatment
Experimental: 1

Insulin Nasal Spray

Drug: Insulin (recombinant human insulin)
Insulin Nasal Spray at doses up to 200 IU.
Other Names:
  • recombinant human insulin

    		•
    Active Comparator: 2

    NovoLog

    Drug: NovoLog
    NovoLog at doses up to 30 IU
    Other Names:
  • insulin aspart

    		•

    Outcome Measures

    Primary Outcome Measures

    1. To evaluate the effect on postprandial glycemic control of intranasal insulin compared to NovoLog [4 hour Profile]

    Secondary Outcome Measures

    1. To evaluate the pharmacokinetics of intranasal insulin compared to NovoLog [4 hour Profile]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 65 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Type 2 diabetes for at least 3 months

    • Type 2 diabetics on oral antidiabetic medicines and/or insulin therapies

    Exclusion Criteria:

    • Patients taking intermediate acting insulin such as NPH

    • Recurrent severe hypoglycemia

    • Patients with late diabetic complications

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Diabetes and Glandular Disease Research Associates San Antonio Texas United States 78258

    Sponsors and Collaborators

    • Nastech Pharmaceutical Company, Inc.

    Investigators

    • Principal Investigator: Sherwyn Schwartz, MD, Diabetes and Glandular Disease Research Associates

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00624767
    Other Study ID Numbers:
    • C08-002
    First Posted:
    Feb 27, 2008
    Last Update Posted:
    May 20, 2008
    Last Verified:
    May 1, 2008
    Keywords provided by , ,
    insulin
    insulin aspart
    Type 2 Diabetes
    diabetes mellitus
    Additional relevant MeSH terms:
    Diabetes Mellitus
    Insulin
    Insulin, Globin Zinc
    Insulin Aspart

    Study Results

    No Results Posted as of May 20, 2008