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

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • 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

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

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

Mannkind Corporation

Investigators

  • 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

November 1, 2005

Study Completion (Actual)

July 1, 2006

Study Registration Dates

First Submitted

October 3, 2007

First Submitted That Met QC Criteria

October 3, 2007

First Posted (Estimate)

October 5, 2007

Study Record Updates

Last Update Posted (Estimate)

October 14, 2009

Last Update Submitted That Met QC Criteria

October 12, 2009

Last Verified

October 1, 2009

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID 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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