- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00570687
A Study Comparing Subcutaneous Rapid Acting Insulin and One Formulation of Inhaled Insulin in Subjects With Type 2 Diabetes
The original protocol was a randomized, open-label, 3-way cross-over study with 9 scheduled visits. The visits comprised an initial screening visit, 3 treatment visits for the meal challenge followed by a 2-6-week blood-loss recovery period, an interim safety visit, 3 sequential visits for the glucose clamp, and a final close-out visit.
Protocol Amendment 1 was a randomized, open-label, 2-way cross-over study with 7 visits for each completed subject. The visits comprise an initial screening visit, 2 treatment visits for the meal challenge followed by a 2-6-week blood-loss recovery period, an interim safety visit, 2 sequential visits for the glucose clamp, and a final close-out visit.
For both the original protocol and Protocol Amendment 1, subjects were hospitalized in the clinical unit for all procedures.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The original protocol was a randomized, open-label, 3-way cross-over study with 9 scheduled visits. The visits comprised an initial screening visit, 3 treatment visits for the meal challenge followed by a 2-6-week blood-loss recovery period, an interim safety visit, 3 sequential visits for the glucose clamp, and a final close-out visit.
After review of the meal challenge data from the Original Protocol design, it became apparent that the TI Inhalation Powder, insulin lispro, and Exubera doses were not well matched, and resulted in significantly higher insulin exposure following insulin lispro than the two inhaled treatments. All meal challenge visits were completed for the 18 subjects enrolled. However, the glucose clamp visits were discontinued since it was discovered that a direct comparison between the treatments was not possible.
The protocol was amended (Amendment 1) to ensure that the insulin exposures between TI Inhalation Powder and insulin lispro were more suited (increased the TI Inhalation Powder doses and decreased the insulin lispro dose). An Exubera arm was not included in Amendment 1 due to the market removal of this product.
Protocol Amendment 1 was a randomized, open-label, 2-way cross-over study with 7 visits for each completed subject. The visits comprise an initial screening visit, 2 treatment visits for the meal challenge followed by a 2-6-week blood-loss recovery period, an interim safety visit, 2 sequential visits for the glucose clamp, and a final close-out visit.
For both the original protocol and Protocol Amendment 1, subjects were hospitalized in the clinical unit for all procedures.
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
GER
-
Neuss, GER, Germany
- Profil Institute for Metabolic Research
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Receiving diabetes treatment with insulin for a minimum of 3 months
- Body Mass Index (BMI) of ≤ 34 kg/m2 and ≥ 25 kg/m2
- HbA1c ≤ 8.5% based upon results from a central laboratory
- Non-smoking Males and females ≥ 18 and ≤ 70 years of age
- A clinical diagnosis of type 2 diabetes mellitus for ≥ 12 months
Exclusion Criteria:
- Total daily insulin requirement of ≥ 1.2 U/kg body weight
- Use of Symlin® (pramlintide acetate) and/or Byetta® (exenatide) within the preceding 8 weeks
- Two or more severe hypoglycemic episodes within 6 months of screening
- Any hospitalization or emergency room visit due to poor diabetic control within 6 months of Screening
- Severe complications of diabetes
- Previous exposure to any inhaled insulin product
- Currently using an insulin delivery pump
- Allergy or known hypersensitivity to insulin or to any of the drugs to be used in the trial
- Any clinically important pulmonary disease, confirmed by documented history, pulmonary function testing, or radiologic findings
- Chronic use of systemic steroids
- Inability to perform PFT maneuvers to meet the recommended American Thoracic Society (ATS) standards of acceptability and repeatability
- Significant improvement in spirometry following bronchodilation
- Active respiratory infection
- Seizure disorder
- Significant cardiovascular dysfunction and/or history within 3 months of Screening
- Uncontrolled hypertension with a systolic blood pressure of >160 mm Hg and/or diastolic blood pressure > 95 mm Hg at screening, despite pharmacologic treatment
- Clinical nephrotic syndrome or renal dysfunction or disease
- Cancer (other than an excised cutaneous basal cell carcinoma) within the past 5 years or any history of lung neoplasms
- History of active viral and/or cirrhotic hepatic disease and/or abnormal liver enzymes
- Active infection eg, Human Immunodeficiency Virus (HIV), Hepatitis, or history of severe infection within 30 days of Screening
- Anemia
- A previous diagnosis of systemic autoimmune or collagen vascular disease requiring prior or current treatment with systemic corticosteroids, cytotoxic drugs or penicillamine
- Any concurrent illness, other than diabetes mellitus not controlled by a stable therapeutic regime
- Current or previous chemotherapy or radiation therapy that may result in pulmonary toxicity
- Clinically significant abnormalities on screening laboratory evaluation
- Female subjects who are pregnant, lactating or planning to become pregnant during the clinical trial period
- Female subjects of childbearing potential (defined as pre-menopausal and not surgically sterilized or post-menopausal for less than 2 years) not practicing adequate birth control.
- Current drug or alcohol abuse, or a history of drug or alcohol abuse, that, in the opinion of the PI, would not make the subject a suitable candidate for participation in the clinical trial
- Exposure to any investigational medications or devices within the previous 30 days prior to trial entry or participation in another clinical trial during this trial
- Unable and/or unlikely to comprehend and/or follow the trial protocol
- Concurrent medical or major psychiatric condition which, in the opinion of the PI, makes the subject unsuitable for the clinical trial, or could limit the validity of the informed consent and/or impair the subject's ability to participate in the trial
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 1
Technosphere Insulin
|
Inhalation 15U/30U
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Time to Minimum Endogenous Glucose Production (EGP) - Meal Challenge
Time Frame: 0-480 minutes
|
Time to minimum EGP post dose
|
0-480 minutes
|
Minimum EGP - Meal Challenge
Time Frame: 0-480 minutes
|
Minimum calculated EGP per subject as change from baseline
|
0-480 minutes
|
EGP AOC0-480 - Meal Challenge
Time Frame: 0-480 minutes
|
EGP area over the curve from 0 to 480 minutes postdose
|
0-480 minutes
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Klaus Rave, MD, Profil Institute for Metabolic Research
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- MKC-TI-118
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Diabetes Mellitus, Type 2
-
SanofiCompletedType 1 Diabetes Mellitus-Type 2 Diabetes MellitusHungary, Russian Federation, Germany, Poland, Japan, United States, Finland
-
Mannkind CorporationTerminatedType 2 Diabetes Mellitus | Type 1 Diabetes MellitusUnited States
-
Scripps Whittier Diabetes InstituteSan Diego State UniversityCompletedType 2 Diabetes Mellitus (T2DM)United States
-
RWTH Aachen UniversityBoehringer IngelheimCompletedDiabetes Mellitus Type 2 (T2DM)Germany
-
US Department of Veterans AffairsAmerican Diabetes AssociationCompletedType 2 Diabetes MellitusUnited States
-
Dexa Medica GroupCompletedType-2 Diabetes MellitusIndonesia
-
Griffin HospitalCalifornia Walnut CommissionCompletedDIABETES MELLITUS TYPE 2United States
-
University Hospital Inselspital, BerneCompletedType 2 Diabetes MellitusSwitzerland
-
India Diabetes Research Foundation & Dr. A. Ramachandran...CompletedTYpe 2 Diabetes MellitusIndia
-
AstraZenecaRecruiting
Clinical Trials on Technosphere Insulin
-
Mannkind CorporationCompleted
-
Mannkind CorporationCompletedType 2 Diabetes Mellitus
-
Mannkind CorporationCompleted
-
Mannkind CorporationCompletedType 2 DiabetesUnited States, Russian Federation, Brazil, Ukraine
-
Mannkind CorporationCompletedHealthy VolunteersUnited States
-
Mannkind CorporationCompletedDiabetes Mellitus, Type 2United States, Brazil, Spain, Argentina, Canada, Chile, Mexico, Poland, Russian Federation, Ukraine, Czech Republic
-
Mannkind CorporationCompleted
-
Mannkind CorporationCompletedType 1 Diabetes MellitusUnited States, Brazil, Russian Federation, Ukraine
-
Mannkind CorporationCompletedDiabetes Type 2Russian Federation
-
Mannkind CorporationCompletedDiabetes Mellitus | Upper Respiratory InfectionUnited States, Russian Federation, Canada