Type 2 DiabetesPhase 2CPEX-011NCT00850096

Effects of Nasulin Versus Placebo on Blood Glucose Control in Patient Volunteers With Type 2 Diabetes Mellitus

A Phase 2 study testing Nasulin in people with Type 2 Diabetes, run by CPEX Pharmaceuticals Inc. at 21 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The purpose of this study is: To assess the efficacy of Nasulin vs. placebo as indicated by time spent in euglycemia, assessed by continuous glucose monitoring data and serum fructosamine levels in patient volunteers with Type 2 Diabetes. Read more about this study

Who is it for?: Ages 18 to 90 years
Conditions the study is for: Type 2 Diabetes
What is being tested?: Nasulin
Type of treatment: Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 94 participants
Where: 21 sitesUnited States
Study dates: Jan 2009to Mar 2010
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 90 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Adults with Type 2 diabetes (18 years of age or older)
Currently treated with basal insulin and OAD(s)
HbA1c range of 6.5 - 10.
BMI less than 41

Who cannot join

Multiple daily injections of mealtime insulin
Regular use of nasal sprays
Significant nasal pathology
Employed in a job which required irregular shift or night work

Trial locations and contacts

21 sites in 1 country.

City, postcode or hospital

21 sites in 1 country

United States21 sites

Mountain Diabetes and Endocrine Center
Asheville, North Carolina, 28803
Atlanta Diabetes Associates
Atlanta, Georgia, 30309
Maine Research Associates
Auburn, Maine, 04210
Barbara Davis Center
Aurora, Colorado, 80045
Texas Diabetes and Endocrinology
Austin, Texas, 78731
Radiant Research
Chandler, Arizona, 85225
Clinical Research of West Florida
Clearwater, Florida, 33765
University of Texas; Southwestern Medical Center
Dallas, Texas, 75390
AMCR Institute, Inc
Escondido, California, 92026
ECU Diabetes Research Center
Greenville, North Carolina, 27834
Physician's East PA
Greenville, North Carolina, 27834
East-West Medical Research Institute
Honolulu, Hawaii, 96814
Rocky Mountain Clinical Research
Idaho Falls, Idaho, 83404-7596
Scripps Whittier Diabetes Clinic
La Jolla, California, 92037
University of Miami Diabetes Research Institute
Miami, Florida, 33136
Rainier Clinical Research
Renton, Washington, 98057
University of Rochester
Rochester, New York, 14642
Mills-Penninsula Health Services; Dorothy & Frank Diabetes Inst.
San Mateo, California, 94401
Washington University
St Louis, Missouri, 63110
Diablo Clinical Research
Walnut Creek, California, 94598
Metabolic Research Institute
West Palm Beach, Florida, 33401

Other trials in United States

About this study

Official title: Effects of Nasulin v.Placebo on Blood Glucose Control in Patients With Type 2 DM Treated With Basal Insulin & Oral Antidiabetic Meds, Excluding Secretagogues in Phase 2A, Randomized, Parallel, Double-Blind, Placebo-Controlled, Multi-Center Study

The purpose of this study is:

To assess the efficacy of Nasulin vs. placebo as indicated by time spent in euglycemia, assessed by continuous glucose monitoring data and serum fructosamine levels in patient volunteers with Type 2 Diabetes.
To asses the safety and tolerability of Nauslin at 50 IU and 100IU doses in patient volunteers with Type 2 Diabetes

Read the detailed description

This proof of concept trial has a randomized, parallel, double-blind, placebo-controlled design with a 4-week single-blind placebo and diet run-in period. Given a ratio of 1:1, patient volunteers will be randomized into one of two parallel treatment arms, Nasulin in a combination with insulin glargine or placebo in combination with insulin glargine. The randomization period will be 6 weeks in length. The total length of individual patient volunteer participation, including screening and follow-up will be approximately 13-14 weeks.

Conditions: Type 2 Diabetes
Being tested: Placebo for Nasulin, Nasulin
Keywords: Phase 2 Study for novel insulin delivery of type 2 diabetes
Medical subject headings: Diabetes Mellitus, Type 2

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Placebo for NasulinOther
Basal insulin (glargine) administered as a 1x daily injection in the morning and two placebo sprays administered three times daily just prior to meals for 6 weeks.
NasulinDrug
Also called Intranasal insulin spray 1%
Basal insulin (glargine) administered as a 1x daily injection in the morning and two (50 IU) or four (100 IU) sprays of Nasulin (intranasal insulin spray 1%) administered three times daily just prior to meals for 6 weeks.

Study groups in NCT00850096
Study group	Role	What they receive
Placebo for Nasulin	Placebo comparator	Placebo for Nasulin Spray Receives: Other: Placebo for Nasulin
Nasulin	Active comparator	Nasulin (intranasal insulin spray 1%) Receives: Drug: Nasulin

What is being measured

The primary outcome is the main question the study is designed to answer.

Continuous Glucose Monitoring (CGM)
Continuous glucose monitoring (CGM) data from patients receiving either Nasulin or placebo were collected and compared at baseline and the last two weeks of the study, and changes (week 5-6 minus baseline) in the mean percentage of time spend in euglycemia (70 to 180 mg/dl blood glucose) (MPTEU) were assessed from baseline Week 0 to Week 5-6.
Measured: Baseline and 5-6 weeks

Secondary outcomes (1)

Overall Glycemic Control
Continuous glucose monitoring (CGM) data from patients at the last weeks of study (week 5-6) were averaged for assessment of glycemic control under the treatment of either Nasulin or placebo.
Measured: 5-6 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jan 2009Mar 2010

First posted24 Feb 2009 (estimated)
Study startJan 2009
Primary completionMar 2010
Study completionMar 2010

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Type 2 DiabetesStudies 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: Parallel groups
Masking: Triple blind
Who is masked: Participant, Care provider, Investigator
Enrolment: 94 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00850096
Sponsor's protocol ID: US-0100-CPEX011
Acronym: CPEX-011
Status last verified: Nov 2013
First submitted: 30 Jan 2009
Last updated: 13 Dec 2013
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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All Type 2 Diabetes trials

Study at a glance

From the registry record, last updated by the sponsor on 13 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Effects of Nasulin v.Placebo on Blood Glucose Control in Patients With Type 2 DM Treated With Basal Insulin & Oral Antidiabetic Meds, Excluding Secretagogues in Phase 2A, Randomized, Parallel, Double-Blind, Placebo-Controlled, Multi-Center Study
ClinicalTrials.gov ID: NCT00850096
Acronym / sponsor ID: CPEX-011 / US-0100-CPEX011
Conditions: Type 2 Diabetes
Keywords: Phase 2 Study for novel insulin delivery of type 2 diabetes
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 94 participants (actual)
Lead sponsor: CPEX Pharmaceuticals Inc.Industry (pharma, biotech, devices)
Study start: Jan 2009
Primary completion: Mar 2010 (actual)
Study completion: Mar 2010 (actual)
First posted: 24 Feb 2009 (estimated)
Results: Posted 15 May 2012

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

The purpose of this study is:

To assess the efficacy of Nasulin vs. placebo as indicated by time spent in euglycemia, assessed by continuous glucose monitoring data and serum fructosamine levels in patient volunteers with Type 2 Diabetes.
To asses the safety and tolerability of Nauslin at 50 IU and 100IU doses in patient volunteers with Type 2 Diabetes

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, care provider, investigator)
Number of arms: 2

Arm	Type	Receives
Placebo for Nasulin	Placebo comparator	Other: Placebo for NasulinPlacebo for Nasulin Spray
Nasulin	Active comparator	Drug: NasulinNasulin (intranasal insulin spray 1%)

Who may qualify

Ages: 18 to 90 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

Adults with Type 2 diabetes (18 years of age or older)
Currently treated with basal insulin and OAD(s)
HbA1c range of 6.5 - 10.
BMI less than 41

Key exclusion criteria (4 listed)

Multiple daily injections of mealtime insulin
Regular use of nasal sprays
Significant nasal pathology
Employed in a job which required irregular shift or night work

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
Placebo for NasulinBasal insulin (glargine) administered as a 1x daily injection in the morning and two placebo sprays administered three times daily just prior to meals for 6 weeks.	Other	Placebo for Nasulin
NasulinAlso: Intranasal insulin spray 1%Basal insulin (glargine) administered as a 1x daily injection in the morning and two (50 IU) or four (100 IU) sprays of Nasulin (intranasal insulin spray 1%) administered three times daily just prior to meals for 6 weeks.	Drug	Nasulin

Primary outcome

Continuous Glucose Monitoring (CGM)
Time frame: Baseline and 5-6 weeks
Continuous glucose monitoring (CGM) data from patients receiving either Nasulin or placebo were collected and compared at baseline and the last two weeks of the study, and changes (week 5-6 minus baseline) in the mean percentage of time spend in euglycemia (70 to 180 mg/dl blood glucose) (MPTEU) were assessed from baseline Week 0 to Week 5-6.

1 secondary outcome

Overall Glycemic Control
Time frame: 5-6 weeks

Results and safety

Results posted to the registry on 15 May 2012, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Placebo for Nasulin	47	44
Nasulin	47	45

Primary outcome: Continuous Glucose Monitoring (CGM)

Time frame: Baseline and 5-6 weeks. Mean (Standard Error). Unit: Percentage of day (24h) in euglycemia

Measure	Placebo for Nasulin n = 44	Nasulin n = 45
Value	-6.23 (3.295)	-0.72 (3.361)

Population analysed: 47 patients were randomized to the placebo/oral antidiabetic arm while 47 others were randomized to the Nasulin/oral antidiabetic arm of the study. Forty-four patients in the placebo + oral antidiabetic arm and 45 patients in the Nasulin + oral antidiabetic arm completed the study.

1 secondary outcome is reported in the full results.

Adverse events

Time frame: 10 weeks. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Placebo for Nasulin	3 of 47 (6.4%)	35 of 47 (74.5%)	Not reported
Nasulin	2 of 47 (4.3%)	28 of 47 (59.6%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 13 Dec 2013.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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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.

Lance Berman, MD study director

CPEX Pharmaceuticals

21 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Nasulin in people with Type 2 Diabetes, run by CPEX Pharmaceuticals Inc. at 21 sites 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 4 inclusion and 4 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 13 Dec 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 21 sites 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. Some participants in this study may receive a placebo. 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?

Yes. Results are posted in the registry (first posted 15 May 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Continuous Glucose Monitoring (CGM) (time frame: Baseline and 5-6 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00850096.

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 13 Dec 2013.