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Type 2 DiabetesPhase 3NCT01451398

Comparison of Technosphere® Insulin Versus Technosphere Powder (Placebo) in Insulin-Naive Subjects With Type 2 Diabetes Mellitus

A Phase 3 study testing Technosphere® Insulin and Technosphere Powder in people with Type 2 Diabetes, run by Mannkind Corporation at 76 sites in 4 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Insulin-naive subjects with Type 2 Diabetes Mellitus who are sub-optimally controlled on either maximum tolerated dose of metformin or maximum tolerated dose of metformin plus one or two other oral anti-diabetic medications will have either Prandial Technosphere® Insulin or Technosphere Powder (placebo) added to their… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Type 2 Diabetes
What is being tested?
Technosphere® Insulin and Technosphere Powder
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
353 participants
Where
76 sitesin 4 countries
Study dates
Nov 2011to Jul 2013
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • HbA1c > or = to 7.5% and < or = to 10.0%
  • Body mass index (BMI) < or = to 45 kg/m2
  • Non smoker for at least 6 months before Screening
  • Clinical diagnosis of type 2 diabetes mellitus for more than 12 months
  • Currently receiving as diabetes treatment only metformin or 2 or more OADs and on stable doses for at least 3 months before enrollment
  • Subjects receiving metformin must be on at least 1.5gm daily, or up to the maximum tolerated dose
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  • Subjects treated with a sulfonylurea must be on at least 50% of the total maximum approved dose for a given agent
  • Subjects receiving a DPP-4 inhibitor must receive the maximum approved dose specific for that agent
  • Metiglinide and alpha-glucoside inhibitors must be taken at the highest tolerated dose within the approved dose range
  • No previous or current treatment with insulin, except during an acute illness, gestational diabetes, or at time of initial diagnosis of diabetes
  • Forced expiratory volume in one second (FEV1) > or = to 70% Third National Health and Nutrition Examination Survey (NHANES III) predicted
  • Forced vital capacity (FVC) > or = to 70% NHANES III predicted
  • Forced expiratory volume in one second as a percentage of forced vital capacity (FEV1/FVC) > or = to NHANES III lower limit of normal (LLN)

Who cannot join

  • History of chronic obstructive pulmonary disease (COPD), clinically proven asthma, or any other clinically important pulmonary disease (eg, pulmonary fibrosis)
  • Any clinically significant radiological findings on screening chest x-ray
  • Use of medications for asthma, COPD, or any other chronic respiratory conditions
  • Evidence of serious complications of diabetes (proliferative retinopathy, autonomic neuropathy with symptoms of gastroparesis or cardiac arrhythmia; sensory neuropathy that makes manipulation of the Gen2C inhaler difficult)
  • Renal disease or renal dysfunction
  • Significant cardiovascular dysfunction or history thereof within 12 months of screening; serious arrhythmia, treatment with medications to control/treat arrhythmias; myocardial infarction; cardiac surgery; history of valvular heart disease
Show all 10Show fewer
  • Previous or current use of amiodarone
  • Treatment with glucagon-like peptide-1 (GLP-1) analogs, thiazolidinediones (TZD), or weight loss drugs (eg, sibutramine, orlistat) within 3 months of screening
  • History of pulmonary embolism or deep venous thrombosis in the 12 months before Screening
  • History of recent blood transfusion (within previous 3 months) or diagnosis of hemoglobinopathies that may affect HbA1c measurements

Trial locations and contacts

76 sites in 4 countries.

76 sites in 4 countries

United States50 sites

  • Study site

    Anaheim, California, 92807

  • Study site

    Arlington, Texas, 76014

  • Study site

    Atlanta, Georgia, 30308

  • Study site

    Atlanta, Georgia, 30318

  • Study site

    Baton Rouge, Louisiana, 70808

  • Study site

    Chicago, Illinois, 60607

  • Study site

    City of Saint Peters, Missouri, 63376

  • Study site

    Clifton, New Jersey, 07012

  • Study site

    Dallas, Texas, 75230

  • Study site

    Dallas, Texas, 75246

  • Study site

    Dunwoody, Georgia, 30338

  • Study site

    Edina, Minnesota, 55435

  • Study site

    Flushing, New York, 11365

  • Study site

    Greenville, North Carolina, 27834

  • Study site

    Greer, South Carolina, 29651

  • Study site

    Hackensack, New Jersey, 07601

  • Study site

    Hialeah, Florida, 33012

  • Study site

    Hollywood, Florida, 33021

  • Study site

    Houston, Texas, 77095

  • Study site

    Huntington Beach, California, 92648

  • Study site

    Jefferson City, Missouri, 65109

  • Study site

    Laguna Hills, California, 92653

  • Study site

    Lawrenceville, Georgia, 30045

  • Study site

    Long Beach, California, 90806

  • Study site

    Los Angeles, California, 90036

  • Study site

    Los Gatos, California, 95032

  • Study site

    Magna, Utah, 84044

  • Study site

    Memphis, Tennessee, 38119

  • Study site

    Miami, Florida, 33156

  • Study site

    Miami, Florida, 33173

  • Study site

    New Hyde, New York, 11042

  • Study site

    New Port Richey, Florida, 34652

  • Study site

    North Miami Beach, Florida, 33179

  • Study site

    Omaha, Nebraska, 68114

  • Study site

    Omaha, Nebraska, 68131

  • Study site

    Paramus, New Jersey, 07652

  • Study site

    Pembroke Pines, Florida, 33026

  • Study site

    Perrysburg, Ohio, 43551

  • Study site

    Pinellas Park, Florida, 33781

  • Study site

    Portland, Oregon, 97239

  • Study site

    Renton, Washington, 98057

  • Study site

    Roswell, Georgia, 30076

  • Study site

    San Antonio, Texas, 78229

  • Study site

    San Antonio, Texas, 78249

  • Study site

    St Louis, Missouri, 63110

  • Study site

    St Louis, Missouri, 63117

  • Study site

    Tustin, California, 92780

  • Study site

    Wenatchee, Washington, 98801

  • Study site

    West Hills, California, 91307

  • Study site

    West Palm Beach, Florida, 33401

Other trials in United States

Russia18 sites

  • Study site

    Kemerovo, 650066

  • Study site

    Leningrad Region

  • Study site

    Moscow, 105120

  • Study site

    Moscow, 117036

  • Study site

    Moscow, 119435

  • Study site

    Moscow, 119991

  • Study site

    Moscow, 121374

  • Study site

    Moscow, 129128

  • Study site

    Moscow, 143420

  • Study site

    Petrozavodsk, 185019

  • Study site

    Saint Petersburg, 194044

  • Study site

    Saint Petersburg, 194354

  • Study site

    Saint Petersburg, 195257

  • Study site

    Saint Petersburg, 196601

  • Study site

    Saint Petersburg, 198013

  • Study site

    Smolensk, 214018

  • Study site

    Yaroslavl, 150003

  • Study site

    Yaroslavl, 150023

Other trials in Russia

Ukraine6 sites

  • Study site

    Kharkiv, UKR, 61070

  • Study site

    Kiev, UKR, 04053

  • Study site

    Kiev, 04114

  • Study site

    Kyiv, UKR, 02175

  • Study site

    Odesa, UKR, 65039

  • Study site

    Vinnytsia, UKR, 21010

Other trials in Ukraine

Brazil2 sites

  • Study site

    Porto Alegre, 90035

  • Study site

    São Paulo, 01244

Other trials in Brazil

About this study

Official title: A Phase 3, Multicenter, Double-blind, Placebo-controlled, Randomized, Clinical Trial Evaluating the Efficacy and Safety of Prandial Technosphere® Insulin Inhalation Powder Versus Technosphere Inhalation Powder in Insulin Naïve Subjects With Type 2 Diabetes Mellitus Poorly Controlled With Oral Antidiabetic Agents Over a 24 Week Treatment Period

Insulin-naive subjects with Type 2 Diabetes Mellitus who are sub-optimally controlled on either maximum tolerated dose of metformin or maximum tolerated dose of metformin plus one or two other oral anti-diabetic medications will have either Prandial Technosphere® Insulin or Technosphere Powder (placebo) added to their oral antidiabetic drugs.

Conditions
Type 2 Diabetes
Being tested
Technosphere® Insulin, Technosphere Powder
Medical subject headings
Diabetes Mellitus, Type 2

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Technosphere® InsulinDrug

    Technosphere® Insulin Inhalation Powder

  • Technosphere PowderDrug

    Placebo Comparator

Study groups in NCT01451398
Study groupRoleWhat they receive
TI inhalation powderExperimentalTechnosphere® Insulin powder administered via the Gen2 inhaler added to 2 or more stable OADs
Receives: Drug: Technosphere® Insulin
Technosphere powderPlacebo comparatorTechnosphere powder (with no insulin) administered via the Gen2 inhaler added to 2 or more stable OADs
Receives: Drug: Technosphere Powder

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change From Baseline to Week 24 in HbA1c

    Efficacy as measured by change in glycated hemoglobin (HbA1c) at Week 24

    Measured: Baseline to Week 24

Secondary outcomes (13)

  1. Proportion of Responders Achieving HbA1c <= 7.0%

    Efficacy as measured in proportion of subjects achieving HbA1c < or = to 7.0%

    Measured: Week 24

  2. Proportion of Responders Achieving HbA1c <= 6.5%

    Efficacy as measured in proportion of subjects achieving HbA1c < or = to 6.5% at Week 24

    Measured: Week 24

  3. FPG Change From Baseline to Week 24

    Efficacy as measured by mean change in fasting plasma glucose (FPG)

    Measured: Baseline to Week 24

  4. Proportion of Subjects Requiring Rescue Therapy

    Measured: Baseline to Week 24

  5. Time to Rescue

    Time from Week 0 (baseline) to initiation of rescue therapy (up to a maximum of 24 weeks/end of treatment) for subjects not responding to treatment

    Measured: Baseline to Week 24

  6. FEV1 Change From Baseline to Week 24

    Forced Expiratory Volume in 1 second - change from baseline to week 24

    Measured: Baseline to Week 24

  7. Incidence of Total Hypoglycemia

    Hypoglycemia, defined as blood glucose <= 70 mg/dL or in absence of blood glucose, symptoms that are resolved by the administration of carbohydrates.

    Measured: Baseline to Week 24

  8. Incidence of Severe Hypoglycemia

    Severe Hypoglycemia defined as: Requiring 3rd party assistance.

    Measured: Baseline to Week 24

  9. Total Hypoglycemia Event Rate

    Number of Hypoglycemic Events/Total Subject Exposure Time (in months)

    Measured: Baseline to Week 24

  10. Severe Hypoglycemia Event Rate

    Number of Severe Hypoglycemic Events/Total Subject Exposure Time (in months)

    Measured: Baseline to Week 24

  11. Mean 7-point Glucose Baseline Values

    Mean 7-point self-monitored glucose at baseline

    Measured: Baseline

  12. Mean 7-point Glucose Week 24 Values

    Mean 7-point self-monitored blood glucose at Week 24

    Measured: Week 24

  13. Change in Body Weight From Baseline to Week 24

    Change in body weight from Baseline to Week 24

    Measured: Baseline to Week 24

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Oct 2011 (estimated)
  2. Study startNov 2011
  3. Primary completionJun 2013
  4. Study completionJul 2013

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
353 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01451398
Sponsor's protocol ID
MKC-TI-175
Other IDs
Affinity2
Status last verified
Oct 2014
First submitted
7 Oct 2011
Last updated
17 Oct 2014
Data monitoring committee
Yes

Publications

  • Rosenstock J, Franco D, Korpachev V, Shumel B, Ma Y, Baughman R, Amin N, McGill JB; Affinity 2 Study Group. Inhaled Technosphere Insulin Versus Inhaled Technosphere Placebo in Insulin-Naive Subjects With Type 2 Diabetes Inadequately Controlled on Oral Antidiabetes Agents. Diabetes Care. 2015 Dec;38(12):2274-81. doi: 10.2337/dc15-0629. Epub 2015 Aug 7.

    PubMed 26253730

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Technosphere® Insulin and Technosphere Powder in people with Type 2 Diabetes, run by Mannkind Corporation at 76 sites in 4 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 13 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 17 Oct 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 76 sites in United States, Russia, Ukraine, Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 17 Oct 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change From Baseline to Week 24 in HbA1c (time frame: Baseline to Week 24). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01451398, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Oct 2014.

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