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

October 12, 2009 updated by: Mannkind Corporation

A Phase 3 Randomized, Open Label, Multi-Center Comparative Study of Technosphere /Insulin Versus Rapid Acting Insulin in Subjects With Type-2 Diabetes Mellitus Receiving Lantus as Basal Insulin

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%.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Russian Federation
    • RUS
      • Chelyabinsk, RUS, Russian Federation, 454021
        • Ural State Medical Academy of Post-Graduate Education Municipal Clinical Hospital # 3
      • Kemerovo, RUS, Russian Federation, 650061
        • NHI Kemerovo Regional Clinical Hospital
      • Moscow, RUS, Russian Federation, 105229
        • NI Principal Military Clinical Hospital n a academician N.N. Burdenko of the Ministry of Defense
      • Moscow, RUS, Russian Federation, 111399
        • NEI HPE Moscow State University of Medicine and Dentistry of FAHSD City Clinical Hospital #70
      • Moscow, RUS, Russian Federation, 109240
        • Moscow State Medico-Stomatological University City Hospital # 23
      • Moscow, RUS, Russian Federation, 113093
        • Russian State Medical University City Hospital # 4
      • Moscow, RUS, Russian Federation, 117593
        • Russian State Medical University Central Clinical Hospital Russian Science Academy
      • Moscow, RUS, Russian Federation, 127644
        • SIH of Moscow City Clinical Hopsital #81 Endocrinology and Diabetology
      • Moscow, RUS, Russian Federation, 125315
      • Moscow, RUS, Russian Federation, 117036
        • Russian Academy of Medical Sciences National Research Ctr for Endocrinology Institute of Diabetes
      • Moscow, RUS, Russian Federation, 150062
        • Municipal Clinical Hospital #13
      • Moscow, RUS, Russian Federation, 109263
        • Russian State Medical University
      • Moscow, RUS, Russian Federation, 111020
        • Clinical Research Institute of Physic-Chemical Medicine Hospital # 29
      • Moscow, RUS, Russian Federation, 117192
        • Moscow Hospital of Glavmosstroy State Unitary Enterprise Medical Centre Medical Sanitary Unit #47
      • Moscow, RUS, Russian Federation, 119881
        • Sechenov Moscow Medical Academy
      • Moscow, RUS, Russian Federation, 123478
        • Moscow Medical Academy
      • Moscow, RUS, Russian Federation, 129090
        • Moscow State Medical Stomatology University Municipal Hospital # 63 Endocrinology Diabetology
      • Moscow, RUS, Russian Federation, 129327
        • Moscow City Clinical Hospital # 20
      • N Novgorod, RUS, Russian Federation, 603126
        • Nizhni Novgorod regional hospital na Semashko
      • Samara, RUS, Russian Federation, 443067
        • Center Diabetes LLC
      • Saratov, RUS, Russian Federation, 410038
        • Saratov City Outpatient Clinic # 20
      • Saratov, RUS, Russian Federation, 410054
        • Saratov Medical University Faculty Therapy Chair Clinical Hospital # 3
      • Smolensk, RUS, Russian Federation, 214018
        • NEI HPE Smolensk State Medical Academy of FAHSD RNHI Smolensk Regional Clinical Hospital
      • St Petersburg, RUS, Russian Federation, 193012
        • St Petersburg NHI City Polytclinic #77 City Diabetological Center #4
      • St Petersburg, RUS, Russian Federation, 194291
        • Central Medical Sanitary Unit #122
      • St Petersburg, RUS, Russian Federation, 197022
        • Pavlov State Medical Univ of St Petersburg
      • St Petersburg, RUS, Russian Federation, 195257
        • St Petersburg Medical Academy St Elizabeth Hospital
      • St Petersburg, RUS, Russian Federation, 198013
        • TUV Medico-Military Academy
      • St Petersburg, RUS, Russian Federation, 194354
        • SPb Diabetological Center
      • St Petersburg, RUS, Russian Federation, 197198
        • City Outpatient Clinic # 34
      • St. Petersburg, RUS, Russian Federation, 194354
        • St Petersburg NHI Municipal Multi-Speciality Hospital # 2
      • Yaroslavl, RUS, Russian Federation, 150003
        • MHI Clinical Hospital for Emergency Care na NV Soloviev
      • Yaroslavl, RUS, Russian Federation, 150062
        • Yaroslavl Regional Clinical Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Mean change in HbA1c from baseline to treatment week 24
Time Frame: 24 weeks
24 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Mannkind Corporation

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Robert Baughman, PhD, Mannkind Corporation

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 1, 2005

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 1, 2006

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 3, 2007

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 3, 2007

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 5, 2007

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 14, 2009

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 12, 2009

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2009

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • MKC-TI-014

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.

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