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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Type 2 Diabetes

Intervention / Treatment
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* Other: Placebo for Nasulin
* Drug: Nasulin


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo for Nasulin<br>Placebo for Nasulin Spray | Other: Placebo for Nasulin<br>* 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.<br>|
| Active Comparator: Nasulin<br>Nasulin (intranasal insulin spray 1%) | Drug: Nasulin<br>* 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.<br>* Other names: Intranasal insulin spray 1%;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Baseline and 5-6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 5-6 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Phase 2 Study for novel insulin delivery of type 2 diabetes