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Business reasons
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The purpose of this study is to determine if, once a favorable dose of TI Inhalation Powder is established for either a type 1 or 2 patient, based on a average diabetic meal, the patient's favorable dose can be used safely, regardless of change in meal carbohydrate content. Patients were randomly assigned to various carbohydrate loads (0%, 50%, 100%, 150% or 200%). The 100% carbohydrate load was determined based upon their standard insulin dose for their normal meal.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TI Inhalation Powder (original protocol) | Experimental | Under the original protocol, subjects with Type 1 and Type 2 diabetes will have TI Inhalation Powder administered prandially during dose optimization visits and meal challenge visits (with meals of varying carbohydrate contents). Subjects with Type 2 diabetes will also use TI Inhalation Powder daily at each meal between visits. |
|
| TI Inhalation Powder and Humalog (Amendment 1) | Other | Under Amendment 1, TI Inhalation Powder will be administered prandially to a new subset of subjects with Type 2 diabetes during TI dose optimization visits and TI meal challenge visits (with meals of varying carbohydrate contents). Subjects will be crossed over to administration of Humalog 15 minutes before meals during Humalog dose optimization visits and Humalog meal challenge visits (with meals of varying carbohydrate contents). Subjects will also use TI Inhalation Powder daily at each meal between visits. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TI Inhalation Powder and Humalog (Amendment 1) | Drug | Subcutaneous (sc) rapid acting analog to be administered at one half of the meal challenge visits 15 minutes before a meal. Only the last 5 - 10 patients (Type 2) will be undergoing this amendment to the protocol. |
| Measure | Description | Time Frame |
|---|---|---|
| Lunch Plasma Glucose Time 0 Corrected AUC (0-240) - Original Protocol (TI Treated Type 1 Subjects) | AUC (area under the plasma glucose - time curve) from time 0 (immediately before starting meal) to 240 minutes after the start of the meal when the curve is above time 0 value. AOC (area over the plasma glucose - time curve) from time 0 (immediately before starting meal) to 240 minutes after the start of the meal when the curve is below time 0 value. TIme 0 corrected AUC (0-240) = AUC - AOC | 0 to 240 minutes |
| Breakfast Plasma Glucose Time 0 Corrected AUC(0-240) - Original Protocol (TI Treated Type 1 Subjects) | AUC (area under the plasma glucose - time curve) from time 0 (immediately before starting meal) to 240 minutes after the start of the meal when the curve is above time 0 value. AOC (area over the plasma glucose - time curve) from time 0 (immediately before starting meal) to 240 minutes after the start of the meal when the curve is below time 0 value. TIme 0 corrected AUC (0-240) = AUC - AOC | 0 to 240 minutes |
| Lunch Plasma Glucose Time 0 Corrected AUC(0-240) - Amendment 1 (TI Treated Type 2 Subjects) | AUC (area under the plasma glucose - time curve) from time 0 (immediately before starting meal) to 240 minutes after the start of the meal when the curve is above time 0 value. AOC (area over the plasma glucose - time curve) from time 0 (immediately before starting meal) to 240 minutes after the start of the meal when the curve is below time 0 value. TIme 0 corrected AUC (0-240) = AUC - AOC | 0 to 240 minutes |
| Lunch Plasma Glucose Time 0 Corrected AUC(0-240) - Amendment 1 (Humalog Treated Type 2 Subjects) | AUC (area under the plasma glucose - time curve) from time 0 (immediately before starting meal) to 240 minutes after the start of the meal when the curve is above time 0 value. AOC (area over the plasma glucose - time curve) from time 0 (immediately before starting meal) to 240 minutes after the start of the meal when the curve is below time 0 value. TIme 0 corrected AUC (0-240) = AUC - AOC |
| Measure | Description | Time Frame |
|---|---|---|
| Lunch Plasma Glucose AOC (0-240) - Original Protocol (TI Treated Type 1 Subjects) | Area over the plasma glucose - time curve from time 0 (immediately before starting lunch) to 240 minutes after the start of the lunch | 0 to 240 minutes |
| Breakfast Plasma Glucose AOC(0-240) - Original Protocol (TI Treated Type 1 Subjects) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sansum Medical Research Institute | Santa Barbara | California | 93105 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Original Protocol Type 1 Diabetes | Original protocol participants with Type 1 diabetes given Technosphere Insulin (TI - doses individualized for each patient) at various carbohydrate loads [0%, 50%, 100% (reference), 200%, and if necessary, 150%)](streamdown:incomplete-link) |
| FG001 | Original Protocol Type 2 Diabetes |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| TI Inhalation Powder (original protocol) | Drug | Inhaled insulin technology to be administered immediately before a meal (prandially) for glucose control in Type 1 or Type 2 diabetics |
|
| 0 to 240 minutes |
| Lunch Plasma Glucose Excursion - Original Protocol (TI Treated Type 1 Subjects) | Excursion is the difference between plasma glucose Cmax and Cmin (Cmax - Cmin) at lunch | 0 to 240 minutes |
| Breakfast Plasma Glucose Excursion - Original Protocol (TI Treated - Type 1 Subjects) | Excursion is the difference between plasma glucose Cmax and Cmin (Cmax - Cmin) at breakfast | 0 to 240 minutes |
| Lunch Plasma Glucose Excursion - Amendment 1 ( TI Treated Type 2 Subjects) | Excursion is the difference between plasma glucose Cmax and Cmin (Cmax-Cmin) at lunch | 0 to 240 minutes |
| Lunch Plasma Glucose Excursion - Amendment 1 (Humalog Treated Type 2 Subjects) | Excursion is the difference between plasma glucose Cmax and Cmin (Cmax-Cmin) at lunch | 0 to 240 minutes |
Breakfast area over the plasma glucose - time curve from time 0 (immediately before breakfast) to 240 minutes after start of breakfast |
| 0 to 240 minutes |
| Lunch Plasma Glucose AOC(0-240) - Amendment 1 (TI Treated Type 2 Subjects) | Lunch area over the plasma glucose - time curve from time 0 (immediately before breakfast) to 240 minutes after start of lunch | 0 to 240 minutes |
| Lunch Plasma Glucose AOC(0-240) - Amendment 1 (Humalog Treated Type 2 Subjects) | Lunch area over the plasma glucose - time curve from time 0 (immediately before breakfast) to 240 minutes after start of lunch | 0 to 240 minutes |
Original protocol participants with Type 2 diabetes given Technosphere Insulin (TI - doses individualized for each patient) at various carbohydrate loads [0%, 50%, 100% (reference), 200%, and if necessary, 150%)](streamdown:incomplete-link) |
| FG002 | Amendment 1 Type 2 Diabetes | Protocol amendment 1 participants with Type 2 diabetes given humalog (doses individualized for each patient) or Technosphere Insulin (doses individualized for each patient) at various carbohydrate loads [0%, 50%, 100% (reference), 200%, and if necessary, 150%)](streamdown:incomplete-link) |
| COMPLETED |
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| NOT COMPLETED |
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Randomized Subjects. Patients were randomly assigned to various carbohydrate loads (0%, 50%, 100%, 150% or 200%). The 100% carbohydrate load was determined based upon their standard insulin dose for their normal meal.
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| ID | Title | Description |
|---|---|---|
| BG000 | Original Protocol Type 1 Diabetes | Original protocol participants with Type 1 diabetes given Technosphere Insulin (TI - doses individualized for each patient) at various carbohydrate loads [0%, 50%, 100% (reference), 200%, and if necessary, 150%)](streamdown:incomplete-link) |
| BG001 | Original Protocol Type 2 Diabetes | Original protocol participants with Type 2 diabetes given Technosphere Insulin (TI - doses individualized for each patient) at various carbohydrate loads [0%, 50%, 100% (reference), 200%, and if necessary, 150%)](streamdown:incomplete-link) |
| BG002 | Amendment 1 Type 2 Diabetes | Protocol amendment 1 participants with Type 2 diabetes given humalog (doses individualized for each patient) or Technosphere Insulin (doses individualized for each patient) at various carbohydrate loads [0%, 50%, 100% (reference), 200%, and if necessary, 150%)](streamdown:incomplete-link) |
| BG003 | 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 | Full Range | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | 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 | Lunch Plasma Glucose Time 0 Corrected AUC (0-240) - Original Protocol (TI Treated Type 1 Subjects) | AUC (area under the plasma glucose - time curve) from time 0 (immediately before starting meal) to 240 minutes after the start of the meal when the curve is above time 0 value. AOC (area over the plasma glucose - time curve) from time 0 (immediately before starting meal) to 240 minutes after the start of the meal when the curve is below time 0 value. TIme 0 corrected AUC (0-240) = AUC - AOC | Original Protocol Type 1 Diabetes Mellitus Technosphere Insulin Treated; 50% carbohydrate load was administered but not completed due to all subjects having hypoglycemia, 0% carbohydrate load was deemed unsafe by PI | Posted | Mean | Full Range | min*mg/dL | 0 to 240 minutes |
|
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| |||||||||||||||||||||||||||||||||||||
| Primary | Breakfast Plasma Glucose Time 0 Corrected AUC(0-240) - Original Protocol (TI Treated Type 1 Subjects) | AUC (area under the plasma glucose - time curve) from time 0 (immediately before starting meal) to 240 minutes after the start of the meal when the curve is above time 0 value. AOC (area over the plasma glucose - time curve) from time 0 (immediately before starting meal) to 240 minutes after the start of the meal when the curve is below time 0 value. TIme 0 corrected AUC (0-240) = AUC - AOC | Original Protocol Type 1 Diabetes Mellitus Technosphere Insulin Treated; 0% carbohydrate load was deemed unsafe by PI | Posted | Mean | Full Range | min*mg/dL | 0 to 240 minutes |
| |||||||||||||||||||||||||||||||||||||||
| Primary | Lunch Plasma Glucose Time 0 Corrected AUC(0-240) - Amendment 1 (TI Treated Type 2 Subjects) | AUC (area under the plasma glucose - time curve) from time 0 (immediately before starting meal) to 240 minutes after the start of the meal when the curve is above time 0 value. AOC (area over the plasma glucose - time curve) from time 0 (immediately before starting meal) to 240 minutes after the start of the meal when the curve is below time 0 value. TIme 0 corrected AUC (0-240) = AUC - AOC | Protocol Amendment 1 Type 2 Diabetes Mellitus Technosphere Insulin Treated Subjects; 150% carbohydrate load was not done per protocol since the 200% carbohydrate load was administered | Posted | Mean | Full Range | min*mg/dL | 0 to 240 minutes |
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| Primary | Lunch Plasma Glucose Time 0 Corrected AUC(0-240) - Amendment 1 (Humalog Treated Type 2 Subjects) | AUC (area under the plasma glucose - time curve) from time 0 (immediately before starting meal) to 240 minutes after the start of the meal when the curve is above time 0 value. AOC (area over the plasma glucose - time curve) from time 0 (immediately before starting meal) to 240 minutes after the start of the meal when the curve is below time 0 value. TIme 0 corrected AUC (0-240) = AUC - AOC | Protocol Amendment 1 Type 2 Diabetes Mellitus Humalog Treated Subjects; 150% carbohydrate load was not done per protocol since the 200% carbohydrate load was administered | Posted | Mean | Full Range | min*mg/dL | 0 to 240 minutes |
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| Primary | Lunch Plasma Glucose Excursion - Original Protocol (TI Treated Type 1 Subjects) | Excursion is the difference between plasma glucose Cmax and Cmin (Cmax - Cmin) at lunch | Original Protocol Type 1 Diabetes Mellitus Technosphere Insulin Treated; 50% carbohydrate load was administered but not completed due to all subjects having hypoglycemia, 0% carbohydrate load was deemed unsafe by PI | Posted | Mean | Full Range | mg/dL | 0 to 240 minutes |
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| Primary | Breakfast Plasma Glucose Excursion - Original Protocol (TI Treated - Type 1 Subjects) | Excursion is the difference between plasma glucose Cmax and Cmin (Cmax - Cmin) at breakfast | Original Protocol Type 1 Diabetes Mellitus Technosphere Insulin Treated; 0% carbohydrate load was deemed unsafe by PI | Posted | Mean | Full Range | mg/dL | 0 to 240 minutes |
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| Primary | Lunch Plasma Glucose Excursion - Amendment 1 ( TI Treated Type 2 Subjects) | Excursion is the difference between plasma glucose Cmax and Cmin (Cmax-Cmin) at lunch | Protocol Amendment 1 Type 2 Diabetes Mellitus TI Treated Subjects; 150% carbohydrate load was not done per protocol since the 200% carbohydrate load was administered | Posted | Mean | Full Range | mg/dL | 0 to 240 minutes |
| |||||||||||||||||||||||||||||||||||||||
| Primary | Lunch Plasma Glucose Excursion - Amendment 1 (Humalog Treated Type 2 Subjects) | Excursion is the difference between plasma glucose Cmax and Cmin (Cmax-Cmin) at lunch | Protocol Amendment 1 Type 2 Diabetes Mellitus Humalog Treated Subjects; 150% carbohydrate load was not done per protocol since the 200% carbohydrate load was administered | Posted | Mean | Full Range | mg/dL | 0 to 240 minutes |
| |||||||||||||||||||||||||||||||||||||||
| Secondary | Lunch Plasma Glucose AOC (0-240) - Original Protocol (TI Treated Type 1 Subjects) | Area over the plasma glucose - time curve from time 0 (immediately before starting lunch) to 240 minutes after the start of the lunch | Original Protocol Type 1 Diabetes Mellitus Technosphere Insulin Treated; 50% carbohydrate load was administered but not completed due to all subjects having hypoglycemia, 0% carbohydrate load was deemed unsafe by PI | Posted | Mean | Full Range | min*mg/dL | 0 to 240 minutes |
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| Secondary | Breakfast Plasma Glucose AOC(0-240) - Original Protocol (TI Treated Type 1 Subjects) | Breakfast area over the plasma glucose - time curve from time 0 (immediately before breakfast) to 240 minutes after start of breakfast | Original Protocol Type 1 Diabetes Mellitus Technosphere Insulin Treated; 0% carbohydrate load was deemed unsafe by PI | Posted | Mean | Full Range | min*mg/dL | 0 to 240 minutes |
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| Secondary | Lunch Plasma Glucose AOC(0-240) - Amendment 1 (TI Treated Type 2 Subjects) | Lunch area over the plasma glucose - time curve from time 0 (immediately before breakfast) to 240 minutes after start of lunch | Protocol Amendment 1 Type 2 Diabetes Mellitus Technosphere Insulin Treated Subjects; 150% carbohydrate load was not done per protocol since the 200% carbohydrate load was administered | Posted | Mean | Full Range | min*mg/dL | 0 to 240 minutes |
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| Secondary | Lunch Plasma Glucose AOC(0-240) - Amendment 1 (Humalog Treated Type 2 Subjects) | Lunch area over the plasma glucose - time curve from time 0 (immediately before breakfast) to 240 minutes after start of lunch | Protocol Amendment 1 Type 2 Diabetes Mellitus Humalog Treated Subjects; 150% carbohydrate load was not done per protocol since the 200% carbohydrate load was administered | Posted | Mean | Full Range | min*mg/dL | 0 to 240 minutes |
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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 | TI Original Protocol Type 1 DM | Original protocol type 1 diabetes mellitus subjects | 0 | 7 | 7 | 7 | ||
| EG001 | TI Original Protocol Type 2 DM | Original protocol type 2 diabetes mellitus subjects | 3 | 8 | 7 | 8 | ||
| EG002 | TI Amendment 1 Type 2 DM | Technosphere Insulin treated subjects in protocol amendment 1 | 0 | 3 | 3 | 3 | ||
| EG003 | Humalog Amendment 1 Type 2 DM | Humalog treated subjects in protocol amendment 1 | 0 | 2 | 1 | 2 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Sinus bradycardia | Cardiac disorders | MedDRA 7.1 | Systematic Assessment |
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| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA 7.1 | Systematic Assessment |
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| Renal papillary necrosis | Renal and urinary disorders | MedDRA 7.1 | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nasopharyngitis | Infections and infestations | MedDRA (7.1) | Systematic Assessment |
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| Blood creatine phosphokinase increased | Investigations | MedDRA (7.1) | Systematic Assessment |
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| Forced expiratory volume decreased | Investigations | MedDRA (7.1) | Systematic Assessment |
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| Platelet count increased | Investigations | MedDRA (7.1) | Systematic Assessment |
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| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA (7.1) | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA (7.1) | Systematic Assessment |
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| Hypoaesthesia | Nervous system disorders | MedDRA (7.1) | Systematic Assessment |
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| Pharyngolaryngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA (7.1) | Systematic Assessment |
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| Abdominal pain | Gastrointestinal disorders | MedDRA (7.1) | Systematic Assessment |
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| Venipuncture site thrombosis | General disorders | MedDRA (7.1) | Systematic Assessment |
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| Allergy to plants | Immune system disorders | MedDRA (7.1) | Systematic Assessment |
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| Influenza | Infections and infestations | MedDRA (7.1) | Systematic Assessment |
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| Sinusitis | Infections and infestations | MedDRA (7.1) | Systematic Assessment |
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| Tooth abscess | Infections and infestations | MedDRA (7.1) | Systematic Assessment |
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| Upper respiratory tract infection | Infections and infestations | MedDRA (7.1) | Systematic Assessment |
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| Urinary tract infection | Infections and infestations | MedDRA (7.1) | Systematic Assessment |
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| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (7.1) | Systematic Assessment |
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| Dizziness postural | Nervous system disorders | MedDRA (7.1) | Systematic Assessment |
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| Erectile dysfunction | Reproductive system and breast disorders | MedDRA (7.1) | Systematic Assessment |
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| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA (7.1) | Systematic Assessment |
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| Snoring | Respiratory, thoracic and mediastinal disorders | MedDRA (7.1) | Systematic Assessment |
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| Ingrowing nail | Skin and subcutaneous tissue disorders | MedDRA (7.1) | Systematic Assessment |
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| Thrombophlebitis | Vascular disorders | MedDRA (7.1) | Systematic Assessment |
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- Early termination of trial leading to small numbers of subjects analyzed.
MannKind has right to 1st joint multicenter publication. After 1st publication PI may publish data only if PI submits proposed publication to MNKD for review 60 days prior to publication date. MNKD may remove any confidential information. If a multicenter publication is not submitted 12 months after conclusion, abandonment, or termination of the Study at all sites, or if MNKD confirms there will be no multicenter Study publication, PI may publish the Study results subject to MNKD rights herein.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Chief Medical Officer | MannKind Corporation | 201-983-5000 | aboss@mannkindcorp.com |
| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| D003922 | Diabetes Mellitus, Type 1 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| D061268 | Insulin Lispro |
| ID | Term |
|---|---|
| D061266 | Insulin, Short-Acting |
| D061385 | Insulins |
| D010187 | Pancreatic Hormones |
| D036361 | Peptide Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
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| Male |
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Meal consisting of 1.5 times the carbohydrate load of the standard meal.
| OG004 | 200% Carbohydrate Load | Meal consisting of 2 times the carbohydrate load of the standard meal. |
|
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Meal consisting of 1.5 times the carbohydrate load of the standard meal. |
| OG004 | 200% Carbohydrate Load | Meal consisting of 2 times the carbohydrate load of the standard meal. |
|
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Meal consisting of 1.5 times the carbohydrate load of the standard meal. |
| OG004 | 200% Carbohydrate Load | Meal consisting of 2 times the carbohydrate load of the standard meal. |
|
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| 200% Carbohydrate Load |
Meal consisting of 2 times the carbohydrate load of the standard meal. |
|
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Meal consisting of 2 times the carbohydrate load of the standard meal.
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Meal consisting of 2 times the carbohydrate load of the standard meal. |
|
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Meal consisting of 2 times the carbohydrate load of the standard meal. |
|
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| OG004 |
| 200% Carbohydrate Load |
Meal consisting of 2 times the carbohydrate load of the standard meal. |
|
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Meal consisting of 2 times the carbohydrate load of the standard meal. |
|
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| 200% Carbohydrate Load |
Meal consisting of 2 times the carbohydrate load of the standard meal. |
|
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| 200% Carbohydrate Load |
Meal consisting of 2 times the carbohydrate load of the standard meal. |
|
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