A Study to Evaluate the Effect of Nasal Insulin on Postprandial Glycemic Control in Type 2 Diabetic Patients
Condition: Diabetes Mellitus
MeSH terms: Diabetes Mellitus
Study type: Interventional
Phase: Phase 2

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.
    

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.
    

Intervention name(s): Insulin (recombinant human insulin); NovoLog
Intervention type(s): Drug; Drug
Intervention description(s): Insulin Nasal Spray at doses up to 200 IU.; NovoLog at doses up to 30 IU
Other intervention name(s): recombinant human insulin; insulin aspart
Intervention MeSH terms: Insulin; Insulin, Globin Zinc; Insulin Aspart
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: insulin; insulin aspart; Type 2 Diabetes; diabetes mellitus