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

This study has been completed.
Sponsor:
Information provided by:
Nastech Pharmaceutical Company, Inc.
ClinicalTrials.gov Identifier:
NCT00624767
First received: February 7, 2008
Last updated: May 16, 2008
Last verified: May 2008
  Purpose

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 Intervention Phase
Diabetes Mellitus
Drug: Insulin (recombinant human insulin)
Drug: NovoLog
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Nastech Pharmaceutical Company, Inc.:

Primary Outcome Measures:
  • To evaluate the effect on postprandial glycemic control of intranasal insulin compared to NovoLog [ Time Frame: 4 hour Profile ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • To evaluate the pharmacokinetics of intranasal insulin compared to NovoLog [ Time Frame: 4 hour Profile ] [ Designated as safety issue: No ]

Enrollment: 18
Study Start Date: March 2008
Study Completion Date: May 2008
Primary Completion Date: April 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Insulin Nasal Spray
Drug: Insulin (recombinant human insulin)
Insulin Nasal Spray at doses up to 200 IU.
Other Name: recombinant human insulin
Active Comparator: 2
NovoLog
Drug: NovoLog
NovoLog at doses up to 30 IU
Other Name: insulin aspart

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

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00624767

Locations
United States, Texas
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
  More Information

No publications provided

Responsible Party: Sherwyn Schwartz, MD, Diabetes and Glandular Disease Research Associates
ClinicalTrials.gov Identifier: NCT00624767     History of Changes
Other Study ID Numbers: C08-002
Study First Received: February 7, 2008
Last Updated: May 16, 2008
Health Authority: United States: Food and Drug Administration

Keywords provided by Nastech Pharmaceutical Company, Inc.:
insulin
insulin aspart
Type 2 Diabetes
diabetes mellitus

Additional relevant MeSH terms:
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Insulin, Globin Zinc
Insulin
Insulin Aspart
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on October 19, 2014