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Comparison Between Technosphe...

Comparison Between Technosphere/Insulin Inhalation Powder Versus Rapid Acting Insulin in Subjects With Type 2 Diabetes Mellitus

Last Updated: 2009-10-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Study Classification

INTERVENTIONAL

Study Start Date

2005-11-30

Study Completion Date

2006-07-31

Brief Summary

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To compare the efficacy of prandial TI plus basal insulin versus prandial rapid acting, subcutaneous insulin plus basal insulin in subjects with type 2 diabetes who had an HbA1c \>7.0% and \<11.5%.

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Detailed Description

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Conditions

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Diabetes Type 2

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Technosphere Insulin

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* At least 2 years since diagnosis of type 2 diabetes mellitus
* Received subcutaneous (sc) insulin for at least 3 months
* Body Mass Index \<44 kg/m2
* HbA1c\>7.0% and \<11.5%
* Serum creatinine \<2.0 mg/dL for males and \<1.8 mg/dL for females
* Baseline FVC and FEV1\>70% and \< 125% of predicted normal

Exclusion Criteria

* Significant hepatic disease (AST/ALT3 x ULN)
* Diagnosis of Type 1 diabetes
* Severe complications of diabetes
* History of moderate to severe ketoacidosis within the past 3 months
* Upper respiratory infection in the last 15 days or a lower respiratory infection in the past 30 days
* Diagnosis of HIV
* Positive serology for hepatitis B or C
* COPD, emphysema, or asthma
* Current smokers or smoking history within the past 6 months
* Major psychiatric disorder precluding satisfactory completion of protocol
* Clinically significant heart disease disease, stroke or heart attack within the past 6 months
* Treatment with an investigational drug within 30 days
* Previous treatment with Technosphere/Insulin
* History of malignancy in the past 5 years except basal cell carcinoma
* Anemia (hemoglobin \<10.5 g/dL for females and \<11.5 g/dL (for males)
* Women who were pregnant of lactating
* History of hypersensitivity to drugs resembling FDKP carrier products
* Treatment with another inhaled insulin product during the duration of the study

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers