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Efficacy and Safety of Prandi...

Efficacy and Safety of Prandial Inhalation of Technosphere/Insulin in Combination With Metformin or Technosphere/Insulin Alone Versus 2 Oral Anti-Diabetic Agents in Subjects With Type 2 Diabetes

Last Updated: 2014-10-16

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

547 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-12-31

Brief Summary

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to demonstrate the efficacy of inhaled Technosphere/Insulin in combination with metformin versus combination metformin and a secretagogue

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Detailed Description

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Conditions

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Diabetes Mellitus, Type 2

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

Technosphere Insulin

Group Type EXPERIMENTAL

Technosphere Insulin

Intervention Type DRUG

Inhalation, 15U/30U, prandial

2

Metformin \& Secretagogues

Group Type ACTIVE_COMPARATOR

Metformin & Secretagogues

Intervention Type DRUG

Metformin tablets,Secretagogues supplied as any of the currently marketed brands and formulations.

3

Technosphere \& Metformin

Group Type EXPERIMENTAL

Technosphere Insulin & Metformin

Intervention Type DRUG

Technosphere Insulin Inhalation Powder 15U/30U, Metformin tablets

Interventions

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Technosphere Insulin

Inhalation, 15U/30U, prandial

Intervention Type DRUG

Metformin & Secretagogues

Metformin tablets,Secretagogues supplied as any of the currently marketed brands and formulations.

Intervention Type DRUG

Technosphere Insulin & Metformin

Technosphere Insulin Inhalation Powder 15U/30U, Metformin tablets

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Non-smokers with clinical diagnosis of Type 2 diabetes mellitus for \>or= to 6 months
* Stable regimen of metformin for \> or = to 1000mg/day or maximum tolerated dose) and a secretagogue \< or = 1/2 the maximum manufacturer-recommended daily dose without any dose adjustments within the preceding 6 wks.
* HbA1c \>or= to 7.5% and \< or= to 11.0%
* BMI \< or = to 40kg/m2.
* FEV1\> or = to 70%, Total Lung capacity and \> or =80% DLco \> or= to 70%

Exclusion Criteria

* Treatment with any type of anti-diabetic therapy, other than metformin \& secretagogues within the preceding 12 weeks
* Serum creatinine \> 1.4mg/dL in female subjects and \>1.5mg/dL in male subjects
* History of chronic obstructive pulmonary disease, clinically proven asthma and/or any other clinically important pulmonary function testing and/or radiologic findings
* Evidence of serious complications of diabetes (e.g. autonomic neuropathy)

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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For MannKind sponsored trials, the Overall Study Official is the Chief Scientific Officer

Role: STUDY_DIRECTOR

Mannkind Corporation

Locations

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Radiant Research-Birmingham

Birmingham, Alabama, United States

Site Status

Parkway Medical Center

Birmingham, Alabama, United States

Site Status

Redpoint Research

Phoenix, Arizona, United States

Site Status

Arizona Center for Clinical Research

Phoenix, Arizona, United States

Site Status

International Clinical Research Network

Chula Vista, California, United States

Site Status

National Jewish Medical & Research Center

Denver, Colorado, United States

Site Status

Creekside Endocrine Associates

Denver, Colorado, United States

Site Status

Jennifer Hone MD

Denver, Colorado, United States

Site Status

Chase Medical Research, LLC

Waterbury, Connecticut, United States

Site Status

Center for Diabetes & Endocrine Care

Hollywood, Florida, United States

Site Status

International Research Associates LLC

Miami, Florida, United States

Site Status

Cedar-Crosse Research Center

Chicago, Illinois, United States

Site Status

John H Stoger Jr Hospital of Cook County

Chicago, Illinois, United States

Site Status

Clintell Inc

Skokie, Illinois, United States

Site Status

James A Dicke MDPA

Towson, Maryland, United States

Site Status

East Coast Clinical Research Inc

Haverhill, Massachusetts, United States

Site Status

Wayne State University

Detroit, Michigan, United States

Site Status

Michigan Institute of Medicine

Livonia, Michigan, United States

Site Status

Washington University School of Medicine

St Louis, Missouri, United States

Site Status

Clayton Medical Research

St Louis, Missouri, United States

Site Status

Raidant Research-St Louis

St Louis, Missouri, United States

Site Status

Creighton Diabetes Center

Omaha, Nebraska, United States

Site Status

Lovelace Scientific Resources (Albuquerque)

Albuquerque, New Mexico, United States

Site Status

Winthrop University Hospital

Mineola, New York, United States

Site Status

North Shore Diabetes and Endocrine Associates

New Hyde Park, New York, United States

Site Status

Metrolina Internal Medicine

Charlotte, North Carolina, United States

Site Status

Charlotte Clinical Research Inc

Charlotte, North Carolina, United States

Site Status

Sensenbrenner Primary Care

Charlotte, North Carolina, United States

Site Status

Duke Medical Center

Durham, North Carolina, United States

Site Status

Dayton Clinical Research

Dayton, Ohio, United States

Site Status

Providence Health Partners - Center of Clinical Research

Dayton, Ohio, United States

Site Status

Radiant Research

Portland, Oregon, United States

Site Status

Upstate Pharmaceutical Research

Greenville, South Carolina, United States

Site Status

Collierville Medical Specialists

Collierville, Tennessee, United States

Site Status

Memphis Internal Medicine (Kathawala)

Memphis, Tennessee, United States

Site Status

GoodLife Medical Center PLLC

Memphis, Tennessee, United States

Site Status