Type 2 Diabetes Clinical Trial
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
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. ;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
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