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Effects of Nasulin Versus Placebo on Blood Glucose Control in Patient Volunteers With Type 2 Diabetes Mellitus (CPEX-011)

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ClinicalTrials.gov Identifier: NCT00850096
Recruitment Status : Completed
First Posted : February 24, 2009
Results First Posted : May 15, 2012
Last Update Posted : December 13, 2013
Sponsor:
Information provided by (Responsible Party):
CPEX Pharmaceuticals Inc.

Brief 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.
  • To asses the safety and tolerability of Nauslin at 50 IU and 100IU doses in patient volunteers with Type 2 Diabetes

Condition or disease Intervention/treatment Phase
Type 2 Diabetes Other: Placebo for Nasulin Drug: Nasulin Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 94 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
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
Study Start Date : January 2009
Actual Primary Completion Date : March 2010
Actual Study Completion Date : March 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Blood Sugar

Arm Intervention/treatment
Placebo Comparator: Placebo for Nasulin
Placebo for Nasulin Spray
Other: Placebo for Nasulin
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.

Active Comparator: Nasulin
Nasulin (intranasal insulin spray 1%)
Drug: Nasulin
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.
Other Name: Intranasal insulin spray 1%




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Overall Glycemic Control [ Time Frame: 5-6 weeks ]
    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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00850096


Locations
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Sponsors and Collaborators
CPEX Pharmaceuticals Inc.
Investigators
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Study Director: Lance Berman, MD CPEX Pharmaceuticals
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Responsible Party: CPEX Pharmaceuticals Inc.
ClinicalTrials.gov Identifier: NCT00850096    
Other Study ID Numbers: US-0100-CPEX011
First Posted: February 24, 2009    Key Record Dates
Results First Posted: May 15, 2012
Last Update Posted: December 13, 2013
Last Verified: November 2013
Keywords provided by CPEX Pharmaceuticals Inc.:
Phase 2 Study for novel insulin delivery of type 2 diabetes
Additional relevant MeSH terms:
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Diabetes Mellitus, Type 2
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Insulin
Hypoglycemic Agents
Physiological Effects of Drugs