A Study to Evaluate the Effect of Nasal Insulin on Postprandial Glycemic Control in Type 2 Diabetic Patients
Information source: Nastech Pharmaceutical Company, Inc.
ClinicalTrials.gov processed this data on August 23, 2015
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: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment
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
Last updated: May 16, 2008
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