Trial Outcomes & Findings for Effects of Nasulin Versus Placebo on Blood Glucose Control in Patient Volunteers With Type 2 Diabetes Mellitus (NCT NCT00850096)
NCT ID: NCT00850096
Last Updated: 2013-12-13
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
94 participants
Primary outcome timeframe
Baseline and 5-6 weeks
Results posted on
2013-12-13
Participant Flow
Participant milestones
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
47
|
47
|
|
Overall Study
COMPLETED
|
44
|
45
|
|
Overall Study
NOT COMPLETED
|
3
|
2
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Effects of Nasulin Versus Placebo on Blood Glucose Control in Patient Volunteers With Type 2 Diabetes Mellitus
Baseline characteristics by cohort
| Measure |
Placebo for Nasulin
n=47 Participants
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.
|
Nasulin
n=47 Participants
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.
|
Total
n=94 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
55.3 years
STANDARD_DEVIATION 10.2 • n=5 Participants
|
57.4 years
STANDARD_DEVIATION 8.85 • n=7 Participants
|
56.3 years
STANDARD_DEVIATION 9.50 • n=5 Participants
|
|
Sex: Female, Male
Female
|
27 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
45 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
20 Participants
n=5 Participants
|
29 Participants
n=7 Participants
|
49 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
47 participants
n=5 Participants
|
47 participants
n=7 Participants
|
94 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline and 5-6 weeksPopulation: 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.
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.
Outcome measures
| Measure |
Placebo for Nasulin
n=44 Participants
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.
|
Nasulin
n=45 Participants
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.
|
|---|---|---|
|
Continuous Glucose Monitoring (CGM)
|
-6.23 Percentage of day (24h) in euglycemia
Standard Error 3.295
|
-0.72 Percentage of day (24h) in euglycemia
Standard Error 3.361
|
SECONDARY outcome
Timeframe: 5-6 weeksPopulation: 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.
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.
Outcome measures
| Measure |
Placebo for Nasulin
n=44 Participants
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.
|
Nasulin
n=45 Participants
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.
|
|---|---|---|
|
Overall Glycemic Control
|
174.64 mg/dl
Standard Error 3.962
|
163.34 mg/dl
Standard Error 4.134
|
Adverse Events
Placebo for Nasulin
Serious events: 3 serious events
Other events: 35 other events
Deaths: 0 deaths
Nasulin
Serious events: 2 serious events
Other events: 28 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo for Nasulin
n=47 participants at risk
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.
|
Nasulin
n=47 participants at risk
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.
|
|---|---|---|
|
Infections and infestations
Abscess intra abdominal
|
2.1%
1/47 • Number of events 1 • 10 weeks
|
0.00%
0/47 • 10 weeks
|
|
Injury, poisoning and procedural complications
Abdominal wall seroma
|
2.1%
1/47 • Number of events 1 • 10 weeks
|
0.00%
0/47 • 10 weeks
|
|
General disorders
Nasal irritation
|
0.00%
0/47 • 10 weeks
|
2.1%
1/47 • Number of events 1 • 10 weeks
|
|
Investigations
Elevated blood cell count
|
2.1%
1/47 • Number of events 1 • 10 weeks
|
0.00%
0/47 • 10 weeks
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/47 • 10 weeks
|
2.1%
1/47 • Number of events 1 • 10 weeks
|
|
Gastrointestinal disorders
Abdominal distension
|
2.1%
1/47 • Number of events 1 • 10 weeks
|
0.00%
0/47 • 10 weeks
|
Other adverse events
| Measure |
Placebo for Nasulin
n=47 participants at risk
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.
|
Nasulin
n=47 participants at risk
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.
|
|---|---|---|
|
Cardiac disorders
Ventricular tachychardia
|
0.00%
0/47 • 10 weeks
|
2.1%
1/47 • Number of events 1 • 10 weeks
|
|
Ear and labyrinth disorders
Ear congestion
|
—
0/0 • 10 weeks
|
2.1%
1/47 • Number of events 1 • 10 weeks
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/47 • 10 weeks
|
2.1%
1/47 • Number of events 1 • 10 weeks
|
|
Eye disorders
Eye irritation
|
2.1%
1/47 • Number of events 1 • 10 weeks
|
0.00%
0/47 • 10 weeks
|
|
Eye disorders
Lacrimation increased
|
0.00%
0/47 • 10 weeks
|
6.4%
3/47 • Number of events 3 • 10 weeks
|
|
Eye disorders
Ocular hyeraemia
|
0.00%
0/47 • 10 weeks
|
2.1%
1/47 • Number of events 1 • 10 weeks
|
|
Eye disorders
Photophobia
|
0.00%
0/47 • 10 weeks
|
2.1%
1/47 • Number of events 1 • 10 weeks
|
|
Gastrointestinal disorders
Abdominal discomfort
|
2.1%
1/47 • Number of events 1 • 10 weeks
|
0.00%
0/47 • 10 weeks
|
|
Gastrointestinal disorders
Abdominal pain lower
|
2.1%
1/47 • Number of events 1 • 10 weeks
|
0.00%
0/47 • 10 weeks
|
|
Gastrointestinal disorders
Constipation
|
2.1%
1/47 • Number of events 1 • 10 weeks
|
0.00%
0/47 • 10 weeks
|
|
Gastrointestinal disorders
Diarrhoea
|
4.3%
2/47 • Number of events 2 • 10 weeks
|
0.00%
0/47 • 10 weeks
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
4.3%
2/47 • Number of events 2 • 10 weeks
|
0.00%
0/47 • 10 weeks
|
|
Gastrointestinal disorders
Nausea
|
4.3%
2/47 • Number of events 2 • 10 weeks
|
2.1%
1/47 • Number of events 1 • 10 weeks
|
|
Gastrointestinal disorders
Oral discomfort
|
0.00%
0/47 • 10 weeks
|
2.1%
1/47 • Number of events 1 • 10 weeks
|
|
Gastrointestinal disorders
Tongue disorder
|
0.00%
0/47 • 10 weeks
|
2.1%
1/47 • Number of events 1 • 10 weeks
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/47 • 10 weeks
|
2.1%
1/47 • Number of events 1 • 10 weeks
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/47 • 10 weeks
|
2.1%
1/47 • Number of events 1 • 10 weeks
|
|
General disorders
Application site irritation
|
2.1%
1/47 • Number of events 1 • 10 weeks
|
8.5%
4/47 • Number of events 4 • 10 weeks
|
|
General disorders
Chest pain
|
0.00%
0/47 • 10 weeks
|
2.1%
1/47 • Number of events 2 • 10 weeks
|
|
General disorders
Drug effect decreased
|
2.1%
1/47 • Number of events 1 • 10 weeks
|
0.00%
0/47 • 10 weeks
|
|
General disorders
Fatigue
|
0.00%
0/47 • 10 weeks
|
2.1%
1/47 • Number of events 1 • 10 weeks
|
|
General disorders
Injection site haematoma
|
2.1%
1/47 • Number of events 1 • 10 weeks
|
6.4%
3/47 • Number of events 3 • 10 weeks
|
|
General disorders
Injection site pain
|
2.1%
1/47 • Number of events 1 • 10 weeks
|
0.00%
0/47 • 10 weeks
|
|
General disorders
Oedema peripheral
|
0.00%
0/47 • 10 weeks
|
2.1%
1/47 • Number of events 1 • 10 weeks
|
|
General disorders
Pain
|
0.00%
0/47 • 10 weeks
|
2.1%
1/47 • Number of events 1 • 10 weeks
|
|
General disorders
Pyrexia
|
2.1%
1/47 • Number of events 2 • 10 weeks
|
0.00%
0/47 • 10 weeks
|
|
Immune system disorders
Hypersensitivity
|
0.00%
0/47 • 10 weeks
|
2.1%
1/47 • Number of events 1 • 10 weeks
|
|
Infections and infestations
Cellulitis
|
2.1%
1/47 • Number of events 1 • 10 weeks
|
0.00%
0/47 • 10 weeks
|
|
Infections and infestations
Diverticulitis
|
2.1%
1/47 • Number of events 1 • 10 weeks
|
0.00%
0/47 • 10 weeks
|
|
Infections and infestations
Fungal infection
|
4.3%
2/47 • Number of events 2 • 10 weeks
|
0.00%
0/47 • 10 weeks
|
|
Infections and infestations
Gastroenteritis
|
2.1%
1/47 • Number of events 1 • 10 weeks
|
2.1%
1/47 • Number of events 1 • 10 weeks
|
|
Infections and infestations
Influenza
|
8.5%
4/47 • Number of events 4 • 10 weeks
|
0.00%
0/47 • 10 weeks
|
|
Infections and infestations
Localized infection
|
0.00%
0/47 • 10 weeks
|
2.1%
1/47 • Number of events 1 • 10 weeks
|
|
Infections and infestations
Nasopharyngitis
|
4.3%
2/47 • Number of events 2 • 10 weeks
|
0.00%
0/47 • 10 weeks
|
|
Infections and infestations
Rhinitis
|
0.00%
0/47 • 10 weeks
|
2.1%
1/47 • Number of events 1 • 10 weeks
|
|
Infections and infestations
Upper respiratory tract infection
|
2.1%
1/47 • Number of events 2 • 10 weeks
|
6.4%
3/47 • Number of events 3 • 10 weeks
|
|
Infections and infestations
Urinary tract infection
|
8.5%
4/47 • Number of events 4 • 10 weeks
|
0.00%
0/47 • 10 weeks
|
|
Infections and infestations
Viral infection
|
2.1%
1/47 • Number of events 1 • 10 weeks
|
0.00%
0/47 • 10 weeks
|
|
Infections and infestations
Viral upper respiratory tract infection
|
4.3%
2/47 • Number of events 2 • 10 weeks
|
0.00%
0/47 • 10 weeks
|
|
Infections and infestations
Vulvovaginal candidiasis
|
2.1%
1/47 • Number of events 1 • 10 weeks
|
0.00%
0/47 • 10 weeks
|
|
Injury, poisoning and procedural complications
Confusion
|
0.00%
0/47 • 10 weeks
|
2.1%
1/47 • Number of events 1 • 10 weeks
|
|
Injury, poisoning and procedural complications
Foot fracture
|
2.1%
1/47 • Number of events 1 • 10 weeks
|
2.1%
1/47 • Number of events 1 • 10 weeks
|
|
Injury, poisoning and procedural complications
Joint injury
|
2.1%
1/47 • Number of events 1 • 10 weeks
|
0.00%
0/47 • 10 weeks
|
|
Injury, poisoning and procedural complications
Mucle strain
|
4.3%
2/47 • Number of events 2 • 10 weeks
|
0.00%
0/47 • 10 weeks
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
2.1%
1/47 • Number of events 1 • 10 weeks
|
0.00%
0/47 • 10 weeks
|
|
Investigations
Carotid bruit
|
2.1%
1/47 • Number of events 1 • 10 weeks
|
0.00%
0/47 • 10 weeks
|
|
Investigations
Electrocadiogram abnormal
|
2.1%
1/47 • Number of events 1 • 10 weeks
|
0.00%
0/47 • 10 weeks
|
|
Investigations
Prostatic specific antigen increased
|
2.1%
1/47 • Number of events 1 • 10 weeks
|
0.00%
0/47 • 10 weeks
|
|
Metabolism and nutrition disorders
Decreased appetite
|
2.1%
1/47 • Number of events 1 • 10 weeks
|
0.00%
0/47 • 10 weeks
|
|
Metabolism and nutrition disorders
Vitamin D deficiency
|
0.00%
0/47 • 10 weeks
|
2.1%
1/47 • Number of events 1 • 10 weeks
|
|
Musculoskeletal and connective tissue disorders
Muscle spasm
|
0.00%
0/47 • 10 weeks
|
2.1%
1/47 • Number of events 1 • 10 weeks
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.00%
0/47 • 10 weeks
|
2.1%
1/47 • Number of events 1 • 10 weeks
|
|
Musculoskeletal and connective tissue disorders
Pain in extremety
|
0.00%
0/47 • 10 weeks
|
4.3%
2/47 • Number of events 2 • 10 weeks
|
|
Nervous system disorders
Disturbance in attention
|
2.1%
1/47 • Number of events 1 • 10 weeks
|
0.00%
0/47 • 10 weeks
|
|
Nervous system disorders
Dizziness
|
2.1%
1/47 • Number of events 1 • 10 weeks
|
0.00%
0/47 • 10 weeks
|
|
Nervous system disorders
Headache
|
6.4%
3/47 • Number of events 3 • 10 weeks
|
0.00%
0/47 • 10 weeks
|
|
Nervous system disorders
Presyncope
|
2.1%
1/47 • Number of events 1 • 10 weeks
|
0.00%
0/47 • 10 weeks
|
|
Nervous system disorders
Sinus headache
|
0.00%
0/47 • 10 weeks
|
2.1%
1/47 • Number of events 1 • 10 weeks
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.00%
0/47 • 10 weeks
|
2.1%
1/47 • Number of events 1 • 10 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
2.1%
1/47 • Number of events 1 • 10 weeks
|
0.00%
0/47 • 10 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/47 • 10 weeks
|
2.1%
1/47 • Number of events 1 • 10 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
8.5%
4/47 • Number of events 5 • 10 weeks
|
4.3%
2/47 • Number of events 3 • 10 weeks
|
|
Nervous system disorders
Nasal congestion
|
2.1%
1/47 • Number of events 1 • 10 weeks
|
4.3%
2/47 • Number of events 2 • 10 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Nasal discomfort
|
0.00%
0/47 • 10 weeks
|
2.1%
1/47 • Number of events 2 • 10 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Nasal mucosal disorder
|
6.4%
3/47 • Number of events 4 • 10 weeks
|
2.1%
1/47 • Number of events 1 • 10 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
2.1%
1/47 • Number of events 1 • 10 weeks
|
2.1%
1/47 • Number of events 1 • 10 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Postnasal drip
|
2.1%
1/47 • Number of events 1 • 10 weeks
|
0.00%
0/47 • 10 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
6.4%
3/47 • Number of events 3 • 10 weeks
|
4.3%
2/47 • Number of events 2 • 10 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Sinus congestion
|
0.00%
0/47 • 10 weeks
|
2.1%
1/47 • Number of events 1 • 10 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Sneezing
|
14.9%
7/47 • Number of events 7 • 10 weeks
|
14.9%
7/47 • Number of events 7 • 10 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Throat irritation
|
2.1%
1/47 • Number of events 1 • 10 weeks
|
4.3%
2/47 • Number of events 2 • 10 weeks
|
|
Reproductive system and breast disorders
Wheezing
|
2.1%
1/47 • Number of events 1 • 10 weeks
|
0.00%
0/47 • 10 weeks
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
2.1%
1/47 • Number of events 1 • 10 weeks
|
0.00%
0/47 • 10 weeks
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/47 • 10 weeks
|
2.1%
1/47 • Number of events 1 • 10 weeks
|
|
Skin and subcutaneous tissue disorders
Seborrhoea
|
0.00%
0/47 • 10 weeks
|
2.1%
1/47 • Number of events 1 • 10 weeks
|
|
Vascular disorders
Hypertension
|
2.1%
1/47 • Number of events 1 • 10 weeks
|
2.1%
1/47 • Number of events 1 • 10 weeks
|
Additional Information
Chief Medical Officer
CPEX Pharmaceuticals, Inc.
Phone: 603-658-6100
Results disclosure agreements
- Principal investigator is a sponsor employee Neither the complete nor any part of the results of the study carried out under this protocol, nor any of the information provided by the sponsor for the purposes of performing the study, will be published or passed on to any third party without the consent of the study sponsor.
- Publication restrictions are in place
Restriction type: OTHER