Study of the Efficacy and Safety of Inhaled Technosphere Insulin in Patients With Type 2 Diabetes
Primary Purpose
Type 2 Diabetes Mellitus
Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Technosphere Insulin
Technosphere Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Type 2 Diabetes Mellitus
Eligibility Criteria
Inclusion Criteria:
- Clinical diagnosis of T2 DM of >2 years and <12 years duration
- Insulin treatment naive treated with diet/exercise or single/combination oral anti-diabetic agents, such as metformin, sulfonylurea, and/or thiazolidinediones
- Stable regimen for >3 months of oral anti-diabetes medication prior to enrollment
- HbA1c >6.6% and <10.5%
- BMI <38 kg/m2
- 18-80 years of age
- Baseline FVC and FEV1 >80% and <120% of predicted normal as measured by spirometry
- Baseline DLCO >80% and <120% of predicted normal
Exclusion Criteria:
- Clinical diagnosis of type 1 diabetes mellitus
- Subjects currently using insulin therapy or at the time of screening
- Known hypersensitivity to the study drug or to drugs of similar chemical structures
- Fasting plasma glucose >270 mg/dL without adequate explanation of a transient causality (screen could be repeated after a 2-week interim period)
- History of severe or multiple allergies
- History of tobacco or nicotine test at screening
- Severe complications of diabetes including history of blindness from or Stage III or IV diabetic retinopathy, history of renal failure requiring dialysis or transplantation, history of amputation of limbs or digits related to diabetic vasculopathy
- Treatment with another investigational drug within 3 months prior to study entry (and for the duration of the study)
- Use of medications known to modify glucose metabolism or to decrease the ability to recover from hypoglycemia such as oral, parenteral, and inhaled steroids, beta blockers, with the exception of beta blocker ophthalmic solutions for glaucoma or ocular hypertension, or hydrochlorothiazide (HCTZ) at doses >25 mg/day
- Recent loss (within the 2 months prior to screening) of >5% of body weight
- Evidence of moderate or greater ketones in urine or ketoacidosis at screening
- History of chronic obstructive pulmonary disease or history of other known chronic pulmonary disease such as reactive airway disease, chronic bronchitis, emphysema, or asthma
- Diagnosis of AIDS or ARC
- A major psychiatric disorder that would have precluded satisfactory participation in this study
- Subjects who had had a myocardial infarction or stroke within the preceding six months
- Prior diagnosis of systemic autoimmune or collagen vascular disease requiring heart disease graded as Class III or Class IV according to New York Heart Association criteria
- Prior treatment with, or participation in, a clinical study involving an inhaled insulin product
- History of malignancy within 5 years of study entry (other than basal cell carcinoma)
- Significant hepatic disease (as evidenced by ALT or AST >3 times the reference normal range or bilirubin >1.5 times the reference normal range)
- Significant renal disease (as evidenced by creatinine >1.5 mg/dL for males or >1.3 mg/dL for females), proteinuria as evidenced by greater than "small" by dipstick measurement or >2 grams in 24 hours, dialysis, or history of renal transplant
- History of previous or current treatment with systemic corticosteroids, cytotoxic drugs, or penicillamine
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Technosphere Insulin Inhalation Powder
Technosphere Inhalation Powder
Arm Description
Outcomes
Primary Outcome Measures
HbA1c change from baseline (week 2) to end of treatment (week 12)
Secondary Outcome Measures
Area under the plasma glucose concentration versus time (AUCglucose)
Timepoints: 0, 30, 60, and 120 minutes after TI administration
Maximum glucose concentration (Cmax)
Timepoints: 0, 30, 60, and 120 minutes after TI administration
Time to maximum glucose concentration (tmax)
Timepoints: 0, 30, 60, and 120 minutes after TI administration
Area under the plasma glucose concentration versus time (AUCglucose)
Timepoints: 0, 30, 60, and 120 minutes after Technosphere Placebo administration
Maximum glucose concentration (Cmax)
Timepoints: 0, 30, 60, and 120 minutes after Technosphere Placebo administration
Time to maximum glucose concentration (tmax)
Timepoints: 0, 30, 60, and 120 minutes after Technosphere Placebo administration
Safety variables included adverse events (AEs), clinical laboratory tests, vital signs and physical examinations
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00511602
Brief Title
Study of the Efficacy and Safety of Inhaled Technosphere Insulin in Patients With Type 2 Diabetes
Official Title
Efficacy and Safety of Inhaled Technosphere Insulin Compared to Technosphere Placebo in Patients With Type 2 Diabetes Mellitus Following Diabetes Education
Study Type
Interventional
2. Study Status
Record Verification Date
April 2012
Overall Recruitment Status
Completed
Study Start Date
December 2003 (undefined)
Primary Completion Date
November 2004 (Actual)
Study Completion Date
December 2005 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Mannkind Corporation
4. Oversight
5. Study Description
Brief Summary
Primary objective to evaluate the effect of a 12-week treatment period with prandial administration of Technosphere Insulin on glucose control in subjects with T2 DM. Secondary objective is to Evaluate the safety and tolerability of a 12-week treatment period of Technosphere Insulin and Technosphere Placebo.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes Mellitus
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
123 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Technosphere Insulin Inhalation Powder
Arm Type
Experimental
Arm Title
Technosphere Inhalation Powder
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Technosphere Insulin
Intervention Description
Technosphere Insulin Inhalation Powder
Intervention Type
Drug
Intervention Name(s)
Technosphere Placebo
Intervention Description
Technosphere Inhalation Powder
Primary Outcome Measure Information:
Title
HbA1c change from baseline (week 2) to end of treatment (week 12)
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Area under the plasma glucose concentration versus time (AUCglucose)
Description
Timepoints: 0, 30, 60, and 120 minutes after TI administration
Time Frame
every 4 weeks
Title
Maximum glucose concentration (Cmax)
Description
Timepoints: 0, 30, 60, and 120 minutes after TI administration
Time Frame
every 4 weeks
Title
Time to maximum glucose concentration (tmax)
Description
Timepoints: 0, 30, 60, and 120 minutes after TI administration
Time Frame
every 4 weeks
Title
Area under the plasma glucose concentration versus time (AUCglucose)
Description
Timepoints: 0, 30, 60, and 120 minutes after Technosphere Placebo administration
Time Frame
every 4 weeks
Title
Maximum glucose concentration (Cmax)
Description
Timepoints: 0, 30, 60, and 120 minutes after Technosphere Placebo administration
Time Frame
every 4 weeks
Title
Time to maximum glucose concentration (tmax)
Description
Timepoints: 0, 30, 60, and 120 minutes after Technosphere Placebo administration
Time Frame
every 4 weeks
Title
Safety variables included adverse events (AEs), clinical laboratory tests, vital signs and physical examinations
Time Frame
every 2 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Clinical diagnosis of T2 DM of >2 years and <12 years duration
Insulin treatment naive treated with diet/exercise or single/combination oral anti-diabetic agents, such as metformin, sulfonylurea, and/or thiazolidinediones
Stable regimen for >3 months of oral anti-diabetes medication prior to enrollment
HbA1c >6.6% and <10.5%
BMI <38 kg/m2
18-80 years of age
Baseline FVC and FEV1 >80% and <120% of predicted normal as measured by spirometry
Baseline DLCO >80% and <120% of predicted normal
Exclusion Criteria:
Clinical diagnosis of type 1 diabetes mellitus
Subjects currently using insulin therapy or at the time of screening
Known hypersensitivity to the study drug or to drugs of similar chemical structures
Fasting plasma glucose >270 mg/dL without adequate explanation of a transient causality (screen could be repeated after a 2-week interim period)
History of severe or multiple allergies
History of tobacco or nicotine test at screening
Severe complications of diabetes including history of blindness from or Stage III or IV diabetic retinopathy, history of renal failure requiring dialysis or transplantation, history of amputation of limbs or digits related to diabetic vasculopathy
Treatment with another investigational drug within 3 months prior to study entry (and for the duration of the study)
Use of medications known to modify glucose metabolism or to decrease the ability to recover from hypoglycemia such as oral, parenteral, and inhaled steroids, beta blockers, with the exception of beta blocker ophthalmic solutions for glaucoma or ocular hypertension, or hydrochlorothiazide (HCTZ) at doses >25 mg/day
Recent loss (within the 2 months prior to screening) of >5% of body weight
Evidence of moderate or greater ketones in urine or ketoacidosis at screening
History of chronic obstructive pulmonary disease or history of other known chronic pulmonary disease such as reactive airway disease, chronic bronchitis, emphysema, or asthma
Diagnosis of AIDS or ARC
A major psychiatric disorder that would have precluded satisfactory participation in this study
Subjects who had had a myocardial infarction or stroke within the preceding six months
Prior diagnosis of systemic autoimmune or collagen vascular disease requiring heart disease graded as Class III or Class IV according to New York Heart Association criteria
Prior treatment with, or participation in, a clinical study involving an inhaled insulin product
History of malignancy within 5 years of study entry (other than basal cell carcinoma)
Significant hepatic disease (as evidenced by ALT or AST >3 times the reference normal range or bilirubin >1.5 times the reference normal range)
Significant renal disease (as evidenced by creatinine >1.5 mg/dL for males or >1.3 mg/dL for females), proteinuria as evidenced by greater than "small" by dipstick measurement or >2 grams in 24 hours, dialysis, or history of renal transplant
History of previous or current treatment with systemic corticosteroids, cytotoxic drugs, or penicillamine
12. IPD Sharing Statement
Citations:
PubMed Identifier
18678610
Citation
Rosenstock J, Bergenstal R, Defronzo RA, Hirsch IB, Klonoff D, Boss AH, Kramer D, Petrucci R, Yu W, Levy B; 0008 Study Group. Efficacy and safety of Technosphere inhaled insulin compared with Technosphere powder placebo in insulin-naive type 2 diabetes suboptimally controlled with oral agents. Diabetes Care. 2008 Nov;31(11):2177-82. doi: 10.2337/dc08-0315. Epub 2008 Aug 4.
Results Reference
derived
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Study of the Efficacy and Safety of Inhaled Technosphere Insulin in Patients With Type 2 Diabetes
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