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

CPEX Pharmaceuticals

Status and phase: Completed; Phase 2

Conditions: Type 2 Diabetes

Treatments: Other: Placebo for Nasulin; Drug: Nasulin

Study type: Interventional

Funder types: Industry

Identifiers

NCT00850096

US-0100-CPEX011

Details and patient eligibility

About

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

Full 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.

Enrollment: 94 patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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94 participants in 2 patient groups, including a placebo group

Placebo for Nasulin

Placebo Comparator group

Description:

Placebo for Nasulin Spray

Treatment:

Other: Placebo for Nasulin

Nasulin

Active Comparator group

Description:

Nasulin (intranasal insulin spray 1%)

Treatment:

Drug: Nasulin