A Study to Evaluate the Effect of Nasal Insulin on Postprandial Glycemic Control in Type 2 Diabetic Patients
Information source: Nastech Pharmaceutical Company, Inc.
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Diabetes Mellitus
Intervention: Insulin (recombinant human insulin) (Drug); NovoLog (Drug)
Phase: Phase 2
Status: Completed
Sponsored by: Nastech Pharmaceutical Company, Inc. Official(s) and/or principal investigator(s):
Sherwyn Schwartz, MD, Principal Investigator, Affiliation: Diabetes and Glandular Disease Research Associates
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.
Clinical Details
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 design: Treatment, Randomized, Open Label, Active Control, Crossover Assignment, Safety/Efficacy Study
Primary outcome: To evaluate the effect on postprandial glycemic control of intranasal insulin compared to NovoLog
Secondary outcome: To evaluate the pharmacokinetics of intranasal insulin compared to NovoLog
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.
Eligibility
Minimum age: 18 Years.
Maximum age: 65 Years.
Gender(s): Both.
Criteria:
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
Locations and Contacts
Diabetes and Glandular Disease Research Associates, San Antonio, Texas 78258, United States
Additional Information
Starting date: March 2008
Ending date: May 2008
Last updated: May 16, 2008
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