Type 2 Diabetes
Conditions
Keywords
Phase 2 Study for novel insulin delivery of type 2 diabetes
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
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.
Interventions
OTHERPlacebo 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.
DRUGNasulin
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.
Sponsors
CPEX Pharmaceuticals Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Continuous Glucose Monitoring (CGM) | 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
| Measure | Time frame | Description |
|---|---|---|
| Overall Glycemic Control | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 47 |
| 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. | 47 |
| Total | 94 |
Baseline characteristics
| Characteristic | Placebo for Nasulin | Nasulin | Total |
|---|---|---|---|
| Age, Continuous | 55.3 years STANDARD_DEVIATION 10.2 | 57.4 years STANDARD_DEVIATION 8.85 | 56.3 years STANDARD_DEVIATION 9.5 |
| Region of Enrollment United States | 47 participants | 47 participants | 94 participants |
| Sex: Female, Male Female | 27 Participants | 18 Participants | 45 Participants |
| Sex: Female, Male Male | 20 Participants | 29 Participants | 49 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 35 / 47 | 28 / 47 |
| serious Total, serious adverse events | 3 / 47 | 2 / 47 |
Outcome results
Primary
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.
Time frame: Baseline and 5-6 weeks
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo for Nasulin | Continuous Glucose Monitoring (CGM) | -6.23 Percentage of day (24h) in euglycemia | Standard Error 3.295 |
| Nasulin | Continuous Glucose Monitoring (CGM) | -0.72 Percentage of day (24h) in euglycemia | Standard Error 3.361 |
Secondary
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.
Time frame: 5-6 weeks
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo for Nasulin | Overall Glycemic Control | 174.64 mg/dl | Standard Error 3.962 |
| Nasulin | Overall Glycemic Control | 163.34 mg/dl | Standard Error 4.134 |