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The purpose of this study is:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo for Nasulin | Placebo Comparator | Placebo for Nasulin Spray |
|
| Nasulin | Active Comparator | Nasulin (intranasal insulin spray 1%) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo for Nasulin | Other | 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. |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Lance Berman, MD | CPEX Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Radiant Research | Chandler | Arizona | 85225 | United States | ||
| AMCR Institute, Inc |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | Nasulin |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Nasulin | Drug | 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. |
|
|
| Escondido |
| California |
| 92026 |
| United States |
| Scripps Whittier Diabetes Clinic | La Jolla | California | 92037 | United States |
| Mills-Penninsula Health Services; Dorothy & Frank Diabetes Inst. | San Mateo | California | 94401 | United States |
| Diablo Clinical Research | Walnut Creek | California | 94598 | United States |
| Barbara Davis Center | Aurora | Colorado | 80045 | United States |
| Clinical Research of West Florida | Clearwater | Florida | 33765 | United States |
| University of Miami Diabetes Research Institute | Miami | Florida | 33136 | United States |
| Metabolic Research Institute | West Palm Beach | Florida | 33401 | United States |
| Atlanta Diabetes Associates | Atlanta | Georgia | 30309 | United States |
| East-West Medical Research Institute | Honolulu | Hawaii | 96814 | United States |
| Rocky Mountain Clinical Research | Idaho Falls | Idaho | 83404-7596 | United States |
| Maine Research Associates | Auburn | Maine | 04210 | United States |
| Washington University | St Louis | Missouri | 63110 | United States |
| University of Rochester | Rochester | New York | 14642 | United States |
| Mountain Diabetes and Endocrine Center | Asheville | North Carolina | 28803 | United States |
| ECU Diabetes Research Center | Greenville | North Carolina | 27834 | United States |
| Physician's East PA | Greenville | North Carolina | 27834 | United States |
| Texas Diabetes and Endocrinology | Austin | Texas | 78731 | United States |
| University of Texas; Southwestern Medical Center | Dallas | Texas | 75390 | United States |
| Rainier Clinical Research | Renton | Washington | 98057 | United States |
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.
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | 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. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Number | participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | 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. | Posted | Mean | Standard Error | Percentage of day (24h) in euglycemia | Baseline and 5-6 weeks |
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| ||||||||||||||||||||||||||||
| 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. | 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. | Posted | Mean | Standard Error | mg/dl | 5-6 weeks |
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. | 3 | 47 | 35 | 47 | ||
| EG001 | 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. | 2 | 47 | 28 | 47 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abscess intra abdominal | Infections and infestations |
| |||
| Abdominal wall seroma | Injury, poisoning and procedural complications |
| |||
| Nasal irritation | General disorders |
| |||
| Elevated blood cell count | Investigations |
| |||
| Arthralgia | Musculoskeletal and connective tissue disorders |
| |||
| Abdominal distension | Gastrointestinal disorders |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Ventricular tachychardia | Cardiac disorders |
| |||
| Ear congestion | Ear and labyrinth disorders |
| |||
| Vertigo | Ear and labyrinth disorders |
| |||
| Eye irritation | Eye disorders |
| |||
| Lacrimation increased | Eye disorders |
| |||
| Ocular hyeraemia | Eye disorders |
| |||
| Photophobia | Eye disorders |
| |||
| Abdominal discomfort | Gastrointestinal disorders |
| |||
| Abdominal pain lower | Gastrointestinal disorders |
| |||
| Constipation | Gastrointestinal disorders |
| |||
| Diarrhoea | Gastrointestinal disorders |
| |||
| Gastroesophageal reflux disease | Gastrointestinal disorders |
| |||
| Nausea | Gastrointestinal disorders |
| |||
| Oral discomfort | Gastrointestinal disorders |
| |||
| Tongue disorder | Gastrointestinal disorders |
| |||
| Toothache | Gastrointestinal disorders |
| |||
| Vomiting | Gastrointestinal disorders |
| |||
| Application site irritation | General disorders |
| |||
| Chest pain | General disorders |
| |||
| Drug effect decreased | General disorders |
| |||
| Fatigue | General disorders |
| |||
| Injection site haematoma | General disorders |
| |||
| Injection site pain | General disorders |
| |||
| Oedema peripheral | General disorders |
| |||
| Pain | General disorders |
| |||
| Pyrexia | General disorders |
| |||
| Hypersensitivity | Immune system disorders |
| |||
| Cellulitis | Infections and infestations |
| |||
| Diverticulitis | Infections and infestations |
| |||
| Fungal infection | Infections and infestations |
| |||
| Gastroenteritis | Infections and infestations |
| |||
| Influenza | Infections and infestations |
| |||
| Localized infection | Infections and infestations |
| |||
| Nasopharyngitis | Infections and infestations |
| |||
| Rhinitis | Infections and infestations |
| |||
| Upper respiratory tract infection | Infections and infestations |
| |||
| Urinary tract infection | Infections and infestations |
| |||
| Viral infection | Infections and infestations |
| |||
| Viral upper respiratory tract infection | Infections and infestations |
| |||
| Vulvovaginal candidiasis | Infections and infestations |
| |||
| Confusion | Injury, poisoning and procedural complications |
| |||
| Foot fracture | Injury, poisoning and procedural complications |
| |||
| Joint injury | Injury, poisoning and procedural complications |
| |||
| Mucle strain | Injury, poisoning and procedural complications |
| |||
| Road traffic accident | Injury, poisoning and procedural complications |
| |||
| Carotid bruit | Investigations |
| |||
| Electrocadiogram abnormal | Investigations |
| |||
| Prostatic specific antigen increased | Investigations |
| |||
| Decreased appetite | Metabolism and nutrition disorders |
| |||
| Vitamin D deficiency | Metabolism and nutrition disorders |
| |||
| Muscle spasm | Musculoskeletal and connective tissue disorders |
| |||
| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders |
| |||
| Pain in extremety | Musculoskeletal and connective tissue disorders |
| |||
| Disturbance in attention | Nervous system disorders |
| |||
| Dizziness | Nervous system disorders |
| |||
| Headache | Nervous system disorders |
| |||
| Presyncope | Nervous system disorders |
| |||
| Sinus headache | Nervous system disorders |
| |||
| Nephrolithiasis | Renal and urinary disorders |
| |||
| Cough | Respiratory, thoracic and mediastinal disorders |
| |||
| Dyspnoea | Respiratory, thoracic and mediastinal disorders |
| |||
| Epistaxis | Respiratory, thoracic and mediastinal disorders |
| |||
| Nasal congestion | Nervous system disorders |
| |||
| Nasal discomfort | Respiratory, thoracic and mediastinal disorders |
| |||
| Nasal mucosal disorder | Respiratory, thoracic and mediastinal disorders |
| |||
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders |
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| Postnasal drip | Respiratory, thoracic and mediastinal disorders |
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| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders |
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| Sinus congestion | Respiratory, thoracic and mediastinal disorders |
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| Sneezing | Respiratory, thoracic and mediastinal disorders |
| |||
| Throat irritation | Respiratory, thoracic and mediastinal disorders |
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| Wheezing | Reproductive system and breast disorders |
| |||
| Dermatitis contact | Skin and subcutaneous tissue disorders |
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| Pruritus | Skin and subcutaneous tissue disorders |
| |||
| Seborrhoea | Skin and subcutaneous tissue disorders |
| |||
| Hypertension | Vascular disorders |
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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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Chief Medical Officer | CPEX Pharmaceuticals, Inc. | 603-658-6100 | 503 |
| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| Male |
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