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Type 1 Diabetes MellitusPhase 3NCT01445951

Clinical Trial Evaluating Technosphere® Insulin Versus Insulin Aspart in Subjects With Type 1 Diabetes Mellitus Over a 24-week Treatment Period

A Phase 3 study testing Technosphere® Insulin with MedTone C Inhaler, Technosphere ®Insulin with Gen2 Inhaler and Insulin Aspart in combination with a basal insulin in people with Type 1 Diabetes Mellitus, run by Mannkind Corporation at 90 sites in 4 countries.

Completed

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

Official record
Search all trials

Trial summary

Open-label, randomized, forced-titration clinical trial evaluating the efficacy and safety of TI Inhalation Power in combination with a basal insulin versus insulin aspart in combination with a basal insulin Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Type 1 Diabetes Mellitus
What is being tested?
Technosphere® Insulin with MedTone C Inhaler, Technosphere ®Insulin with Gen2 Inhaler and Insulin Aspart in combination with a basal insulin
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
518 participants
Where
90 sitesin 4 countries
Study dates
Sep 2011to Jun 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

  • Men and women = 18 years of age
  • Clinical diagnosis of type 1 diabetes mellitus for at least 12 months
  • Body mass index (BMI) = 38 kg/m2
  • Stable dose of basal/bolus insulin therapy for at least 3 months with an FPG consistently < 220 mg/dL:
  • HbA1c = 7.5% and = 10.0%
  • Fasting C-peptide = 0.30 pmol/mL
Show all 11Show fewer
  • Subject willingness to not use CGM during the entire course of the trial
  • Nonsmoking (includes cigarettes, cigars, pipes, and chewing tobacco) for the preceding 6 months
  • Negative urine cotinine test, defined as = 100 ng/mL
  • Lung function tests: • Forced expiratory volume in 1 second (FEV1) = 70% Third National Health and Nutrition Examination Survey (NHANES III) predicted
  • Written informed consent

Who cannot join

  • Total daily insulin dose = 2 IU/kg/day. History of insulin pump use within 3 months of Screening or use of continuous glucose monitoring within 6 weeks of Screening
  • History of inhaled insulin use in the previous 6 months
  • Two or more unexplained severe hypoglycemic episodes within 3 months of Screening or an episode of severe hypoglycemia between Visit 1 and Visit 2. Unexplained refers to episodes of severe hypoglycemia that are not related to a dosing error, lack of or a change in meal size, or related to additional/unanticipated exercise
  • Any hospitalization or emergency room visit due to poor diabetic control within 6 months of Screening, or hospitalization or emergency room visit due to poor diabetic control between Visit 1 and Visit 2
  • Allergy or known hypersensitivity to insulin or to any of the drugs to be used in the study, or a history of hypersensitivity to TI Inhalation Powder or to drugs with a similar chemical structure
  • History of recent blood transfusions (within previous 3 months), hemoglobinopathies, or any other conditions that affect HbA1c measurements.
Show all 17Show fewer
  • History of COPD, asthma, or any other clinically important pulmonary disease (eg, pulmonary fibrosis), or use of any medications for these conditions
  • Any clinically significant radiological findings on screening chest x-ray
  • Active respiratory infection within 30 days before Screening (subject may return after 30 days from resolution for rescreening)
  • Major organ system diseases, including: ? Seizure disorder; systemic autoimmune or collagen vascular disease requiring previous or current treatment with systemic corticosteroids, cytotoxic drugs, or penicillamine; cancer (other than excised cutaneous basal cell carcinoma) or any history of lung neoplasms
  • Current or previous chemotherapy or radiation therapy that may result in pulmonary toxicity; use of medications for weight loss (eg, sibutramine, orlistat) within 12 weeks of Screening; treatment with amiodarone within 12 weeks of Screening
  • Clinically significant abnormalities on screening laboratory evaluation or chest x-ray
  • Severe complications of diabetes, in the opinion of the PI, including symptomatic autonomic neuropathy; disabling peripheral neuropathy; active proliferative retinopathy; nephropathy with renal failure, renal transplant, or dialysis; nontraumatic amputations due to gangrene; or vascular claudication
  • Women who are pregnant, lactating, or planning to become pregnant during the clinical study period; women of childbearing potential (defined as premenopausal and not surgically sterilized or postmenopausal for fewer than 2 years) not practicing adequate birth control. Adequate birth control is defined as using oral, percutaneous, or transdermal contraceptives; condoms and diaphragms (double barrier) with a spermicide; or intrauterine devices. Postmenopausal for this study includes amenorrhea f
  • Current drug or alcohol abuse or a history of drug or alcohol abuse that, in the opinion of the PI, would make the subject an unsuitable candidate for participation in the study
  • Exposure to any investigational medications or devices within the previous 30 days before study entry
  • Unable to read or write, or unlikely to comprehend and follow the study protocol procedures; lack of compliance with medication or procedures that, in the PI's opinion, may affect the study data or subject safety and that precludes the subject from participation in the study; or any other concurrent medical or major psychiatric condition that, in the opinion of the PI, makes the subject unsuitable for the clinical study or could limit the validity of the informed consent or impair the subject'

Trial locations and contacts

90 sites in 4 countries.

90 sites in 4 countries

United States58 sites

  • Study site

    Albuquerque, New Mexico, 87131

  • Study site

    Arlington, Texas, 76014

  • Study site

    Asheville, North Carolina, 28803

  • Study site

    Atlanta, Georgia, 30308

  • Study site

    Atlanta, Georgia, 30318

  • Study site

    Aurora, Colorado, 80045

  • Study site

    Bartlett, Tennessee, 38133

  • Study site

    Baton Rouge, Louisiana, 70808

  • Study site

    Billings, Montana, 59101

  • Study site

    Burlingame, California, 94010

  • Study site

    Chicago, Illinois, 60602

  • Study site

    City of Saint Peters, Missouri, 63376

  • Study site

    Dallas, Texas, 75230

  • Study site

    Dallas, Texas, 75246

  • Study site

    Des Moines, Iowa, 50314

  • Study site

    Dunwoody, Georgia, 30338

  • Study site

    Edina, Minnesota, 55435

  • Study site

    Escondido, California, 92026

  • Study site

    Federal Way, Washington, 98003

  • Study site

    Flushing, New York, 11365

  • Study site

    Greenville, North Carolina, 27834

  • Study site

    Greer, South Carolina, 29651

  • 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

    La Jolla, California, 92037

  • Study site

    La Mesa, California, 91942

  • Study site

    Lawrenceville, Georgia, 30045

  • Study site

    Long Beach, California, 90806

  • Study site

    Los Angeles, California, 90017

  • Study site

    Los Angeles, California, 90036

  • Study site

    Los Gatos, California, 95032

  • Study site

    Metairie, Louisiana, 70006

  • Study site

    Miami, Florida, 33156

  • Study site

    Miami, Florida, 33173

  • Study site

    Morehead City, North Carolina, 28557

  • Study site

    Murray, Utah, 84123

  • Study site

    New Hyde Park, New York, 11042

  • Study site

    New Orleans, Louisiana, 70112

  • Study site

    New Port Richey, Florida, 34652

  • Study site

    New York, New York, 10016

  • Study site

    Omaha, Nebraska, 68114

  • Study site

    Omaha, Nebraska, 68131

  • Study site

    Palm Harbor, Florida, 34652

  • Study site

    Paramus, New Jersey, 07652

  • Study site

    Portland, Oregon, 97239

  • Study site

    Renton, Washington, 98057

  • Study site

    Roswell, Georgia, 30076

  • Study site

    San Antonio, Texas, 78229

  • Study site

    San Mateo, California, 94401

  • Study site

    Santa Barbara, California, 93105

  • Study site

    St Louis, Missouri, 63110

  • Study site

    Tustin, California, 92780

  • Study site

    Vincennes, Indiana, 47591

  • Study site

    Wenatchee, Washington, 98801

  • Study site

    West Palm Beach, Florida, 33401

Other trials in United States

Russia21 sites

  • Study site

    Kemerovo, RUS, 650066

  • Study site

    Moscow, RUS, 105120

  • Study site

    Moscow, RUS, 109240

  • Study site

    Moscow, RUS, 117036

  • Study site

    Moscow, RUS, 117593

  • Study site

    Moscow, RUS, 119048

  • Study site

    Moscow, RUS, 119435

  • Study site

    Moscow, RUS, 125299

  • Study site

    Moscow, RUS, 125315

  • Study site

    Petrozavodsk, RUS, 185019

  • Study site

    Saint Petersburg, Russia, 191186

  • Study site

    Saint Petersburg, Russia, 193312

  • Study site

    Saint Petersburg, RUS, 192148

  • Study site

    Saint Petersburg, RUS, 194044

  • Study site

    Saint Petersburg, RUS, 194291

  • Study site

    Saint Petersburg, RUS, 194354

  • Study site

    Saint Petersburg, RUS, 195257

  • Study site

    Saint Petersburg, RUS, 198013

  • Study site

    Smolensk, RUS, 214018

  • Study site

    Yaroslavl, RUS, 150003

  • Study site

    Yaroslavl, RUS, 150062

Other trials in Russia

Ukraine9 sites

  • Study site

    Dnipropetrovsk, UKR, 49023

  • Study site

    Donetsk, UKR, 83114

  • Study site

    Kharkiv, UKR, 61070

  • Study site

    Kiev, UKR, 04053

  • Study site

    Kiev, UKR, 04114

  • Study site

    Kyiv, UKR, 02175

  • Study site

    Odesa, UKR, 65039

  • Study site

    Odesa, UKR, 65114

  • Study site

    Vinnytsia, UKR, 21010

Other trials in Ukraine

Brazil2 sites

  • Study site

    Porto Alegre, Rio Grande do Sul, 90035-170

  • Study site

    São Paulo, São Paulo, 01244-030

Other trials in Brazil

About this study

Official title: A Phase 3, Multicenter, Open-label, Randomized, Forced-titration Clinical Trial Evaluating the Efficacy and Safety of Technosphere® Insulin Inhalation Powder in Combination With a Basal Insulin Versus Insulin Aspart in Combination With a Basal Insulin in Subjects With Type 1 Diabetes Mellitus Over a 24-week Treatment Period

Open-label, randomized, forced-titration clinical trial evaluating the efficacy and safety of TI Inhalation Power in combination with a basal insulin versus insulin aspart in combination with a basal insulin

Read the detailed description

Phase 3 clinical trial designed to examine the efficacy and safety of inhaled prandial TI Inhalation Power in combination with basal insulin versus insulin aspart in combination with basal insulin in subjects with type 1 diabetes who are suboptimally controlled with their current insulin regimens. This trial will employ a variety of methods to intensively manage these subjects.

Being tested
Technosphere® Insulin with MedTone C Inhaler, Technosphere ®Insulin with Gen2 Inhaler, Insulin Aspart in combination with a basal insulin
Medical subject headings
Diabetes Mellitus, Type 1

What participants receive

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

  • Technosphere® Insulin with MedTone C InhalerDrug

    Inhalation Powder and injectable insulin

  • Technosphere ®Insulin with Gen2 InhalerDrug

    Inhalation Powder and injectable insulin

  • Insulin Aspart in combination with a basal insulinDrug

    Injectable insulin

Study groups in NCT01445951
Study groupRoleWhat they receive
Technosphere® Insulin with MedTone C InhalerExperimentalSubjects will receive TI with the MedToneC inhaler and remain on the basal insulin they were taking prior to study entry
Receives: Drug: Technosphere® Insulin with MedTone C Inhaler
Aspart GroupActive comparatorSubjects will receive insulin aspart and remain on the basal insulin they were taking prior to study entry
Receives: Drug: Insulin Aspart in combination with a basal insulin
Technosphere ® Insulin-Gen2 GroupExperimentalSubject will receive Technosphere Insulin with Gen2 Inhaler and remain on the basal insulin they were taking prior to study entry
Receives: Drug: Technosphere ®Insulin with Gen2 Inhaler

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

    Effect of treatment as measured by change from baseline in glycated hemoglobin (HbA1c). Primary treatment difference is TI-Gen2 vs. Insulin Aspart at Week 24

    Measured: Baseline to Week 24

Secondary outcomes (6)

  1. FEV1 Change From Baseline to Week 24

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

    Measured: Baseline to Week 24

  2. FPG Change From Baseline to Week 24

    Comparison of mean change from Baseline to Week 24 visit in fasting plasma glucose (FPG) levels (central laboratory results)

    Measured: Baseline to Week 24

  3. Mean 7-point Glucose Baseline Values

    Mean 7-point glucose at baseline

    Measured: Baseline

  4. Mean 7-point Glucose Week 24 Values

    Measured: Week 24

  5. Change in Body Weight From Baseline to Week 24

    Change in body weight from Baseline to Week 24

    Measured: Baseline to Week 24

  6. Proportion of Responders Achieving HbA1c <= 7.0%

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

    Measured: 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 posted4 Oct 2011 (estimated)
  2. Study startSep 2011
  3. Primary completionMay 2013
  4. Study completionJun 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
None (open label)
Enrolment
518 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01445951
Sponsor's protocol ID
MKC-TI-171
Status last verified
Oct 2014
First submitted
30 Sep 2011
Last updated
22 Oct 2014
Data monitoring committee
Yes

Publications

  • Seaquist ER, Blonde L, McGill JB, Heller SR, Kendall DM, Bumpass JB, Pompilio FM, Grant ML. Hypoglycaemia is reduced with use of inhaled Technosphere(R) Insulin relative to insulin aspart in type 1 diabetes mellitus. Diabet Med. 2020 May;37(5):752-759. doi: 10.1111/dme.14202. Epub 2019 Dec 19.

    PubMed 31811662

  • Bode BW, McGill JB, Lorber DL, Gross JL, Chang PC, Bregman DB; Affinity 1 Study Group. Inhaled Technosphere Insulin Compared With Injected Prandial Insulin in Type 1 Diabetes: A Randomized 24-Week Trial. Diabetes Care. 2015 Dec;38(12):2266-73. doi: 10.2337/dc15-0075. Epub 2015 Jul 15.

    PubMed 26180109

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Technosphere® Insulin with MedTone C Inhaler, Technosphere ®Insulin with Gen2 Inhaler and Insulin Aspart in combination with a basal insulin in people with Type 1 Diabetes Mellitus, run by Mannkind Corporation at 90 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 11 inclusion and 17 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 22 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 90 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. 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 22 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 NCT01445951, which also lists 2 linked publications.

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 22 Oct 2014.

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