Diabetes MellitusPhase 2NCT00624767
A Study to Evaluate the Effect of Nasal Insulin on Postprandial Glycemic Control in Type 2 Diabetic Patients
A Phase 2 study testing Insulin (recombinant human insulin) and NovoLog in people with Diabetes Mellitus, run by Nastech Pharmaceutical Company, Inc. at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Diabetes Mellitus
- What is being tested?
- Insulin (recombinant human insulin) and NovoLog
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2008to May 2008
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Type 2 diabetes for at least 3 months
- Type 2 diabetics on oral antidiabetic medicines and/or insulin therapies
Who cannot join
- Patients taking intermediate acting insulin such as NPH
- Recurrent severe hypoglycemia
- Patients with late diabetic complications
Trial locations and contacts
1 site in 1 country.
United States1 site
Diabetes and Glandular Disease Research Associates
San Antonio, Texas, 78258
About this study
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
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.
Read the 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.
- Conditions
- Diabetes Mellitus
- Being tested
- Insulin (recombinant human insulin), NovoLog
- Keywords
- insulin, insulin aspart, Type 2 Diabetes, diabetes mellitus
- Medical subject headings
- Diabetes Mellitus, Insulin Resistance, Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Insulin (recombinant human insulin)Drug
Also called recombinant human insulin
Insulin Nasal Spray at doses up to 200 IU.
NovoLogDrug
Also called insulin aspart
NovoLog at doses up to 30 IU
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Insulin Nasal Spray Receives: Drug: Insulin (recombinant human insulin) |
| 2 | Active comparator | NovoLog Receives: Drug: NovoLog |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the effect on postprandial glycemic control of intranasal insulin compared to NovoLog
Measured: 4 hour Profile
Secondary outcomes (1)
To evaluate the pharmacokinetics of intranasal insulin compared to NovoLog
Measured: 4 hour Profile
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2008 (estimated)
- Study startMar 2008
- Primary completionApr 2008
- Study completionMay 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes MellitusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nastech Pharmaceutical Company, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Sherwyn Schwartz, MD, Principal investigator, Diabetes and Glandular Disease Research Associates
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00624767
- Sponsor's protocol ID
- C08-002
- Status last verified
- May 2008
- First submitted
- 7 Feb 2008
- Last updated
- 20 May 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00624767
- Acronym / sponsor ID
- C08-002
- Conditions
- Diabetes Mellitus
- Keywords
- insulin, insulin aspart, Type 2 Diabetes, diabetes mellitus
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Nastech Pharmaceutical Company, Inc.Industry (pharma, biotech, devices)
- Study start
- Mar 2008
- Primary completion
- Apr 2008 (actual)
- Study completion
- May 2008 (actual)
- First posted
- 27 Feb 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Insulin (recombinant human insulin)Insulin Nasal Spray |
| 2 | Active comparator | Drug: NovoLogNovoLog |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Type 2 diabetes for at least 3 months
- Type 2 diabetics on oral antidiabetic medicines and/or insulin therapies
Key exclusion criteria (3 listed)
- Patients taking intermediate acting insulin such as NPH
- Recurrent severe hypoglycemia
- Patients with late diabetic complications
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Insulin (recombinant human insulin)Also: recombinant human insulinInsulin Nasal Spray at doses up to 200 IU. | Drug | 1 |
| NovoLogAlso: insulin aspartNovoLog at doses up to 30 IU | Drug | 2 |
Primary outcome
To evaluate the effect on postprandial glycemic control of intranasal insulin compared to NovoLog
Time frame: 4 hour Profile
1 secondary outcome
To evaluate the pharmacokinetics of intranasal insulin compared to NovoLog
Time frame: 4 hour Profile
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2008.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sherwyn Schwartz, MD principal investigator
Diabetes and Glandular Disease Research Associates
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Insulin (recombinant human insulin) and NovoLog in people with Diabetes Mellitus, run by Nastech Pharmaceutical Company, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 May 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To evaluate the effect on postprandial glycemic control of intranasal insulin compared to NovoLog (time frame: 4 hour Profile). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 May 2008.