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Diabetes, Type 1Phase 3NCT00700622

Safety and Efficacy of Technosphere® Insulin Inhalation Powder and Lantus® Compared to Humalog® and Lantus® Over 16-Weeks

A Phase 3 study testing Technosphere Insulin, Insulin glargine and Insulin lispro in people with Diabetes, Type 1, run by Mannkind Corporation at 22 sites in 2 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

The objective of this study is to demonstrate that TI® Inhalation Powder combined with Lantus® is as effective as Humalog® combined with Lantus® on HbA1c. Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Diabetes, Type 1
What is being tested?
Technosphere Insulin, Insulin glargine and Insulin lispro
Could I receive a placebo?
No, everyone receives an active treatment
How many people
130 participants
Where
22 sitesin 2 countries
Study dates
May 2008to Mar 2010
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 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Men or women ≥ 18 and ≤ 80 years old
  • Clinical diagnosis of type 1 diabetes mellitus for more than 12 months
  • Body mass index (BMI) ≤ 30 kg/m2
  • Stable antidiabetic regimen of sc insulin therapy at a total daily dose ≤ 1.5 IU/kg/day
  • HbA1c > 7.0% and ≤ 9.0%
  • C-peptide level ≤ 0.30 pmol/mL
Show all 15Show fewer
  • Nonsmokers (includes cigarettes, cigars, pipes, and chewing tobacco) for at least the preceding 6 months
  • Negative urine cotinine defined as ≤ 100 ng/mL
  • Pulmonary function tests (PFTs):
  • Forced expiratory volume in 1 second (FEV1) ≥ 70% Third National Health and Nutrition Examination Survey (NHANES III) predicted
  • FEV1 as a percentage of FEV1/forced vital capacity (FVC) ≥ 70% (NHANES III) predicted
  • Total lung capacity (TLC) ≥ 80% predicted (Intermountain Thoracic Society [ITS])
  • Single breath carbon monoxide diffusing capacity of the lung, hemoglobin-corrected (DLco-Hb) (uncorrected) ≥ 70% predicted
  • For the subset of subjects having Doppler echocardiograms: right ventricular systolic pressure (RVSP) ≤ 40 mm Hg at Visit 1
  • Written informed consent

Who cannot join

  • Treatment with any type of antidiabetic drugs, other than sc insulin, within the preceding 12 weeks
  • Two or more severe hypoglycemic episodes within 6 months of screening or episode of severe hypoglycemia between Visit 1 and Visit 5
  • Any hospitalization or emergency room visit due to poor diabetic control within 6 months of Visit 1, or hospitalization or emergency room visit due to poor diabetic control between Visit 1 and Visit 5
  • 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; history of foot ulcers; nontraumatic amputations due to gangrene; or vascular claudication
  • Previous exposure to an inhaled insulin product within 3 months of Visit 1
  • History of insulin pump use within 6 weeks of Visit 1
Show all 42Show fewer
  • Allergy or known hypersensitivity to insulin or to any of the drugs to be used in the trial, or a history of hypersensitivity to TI Inhalation Powder or to drugs with a similar chemical structure
  • Significant improvement in pre- to postbronchodilator spirometry at Visit 1 (defined as an increase of 12% and 200 mL in either FEV1 or FVC)
  • History of chronic obstructive pulmonary disease (COPD), clinically proven asthma, or any other clinically important pulmonary disease (eg, obstructive sleep apnea) confirmed by pulmonary function testing or radiologic findings
  • Inability to perform spirometry maneuvers meeting recommended American Thoracic Society (ATS) standards of acceptability and repeatability criteria
  • Active respiratory infection (subject could return after 30 days from resolution for rescreening); if respiratory infection manifested after Visit 1 but before Visit 1 PFTs, subject was to be scheduled for PFTs after 30 days from resolution of respiratory infection. An additional hemoglobin was to be required
  • Major organ system diseases, including:
  • Seizure disorder
  • Significant cardiovascular dysfunction or history within 3 months of Visit 1, eg, congestive heart failure (New York Heart Association [NYHA] Class III or IV), or serious arrhythmia, myocardial infarction, cardiac surgery, recurrent syncope, transient ischemic attacks, or cerebrovascular accident
  • Uncontrolled hypertension with a systolic blood pressure > 180 mm Hg or diastolic blood pressure > 110 mm Hg at Visit 1 despite pharmacologic treatment
  • Nephrotic syndrome; renal dysfunction or disease; serum creatinine > 2.0 mg/dL (0.11 mmol/L) in men and > 1.8 mg/dL (0.1 mmol/L) in women; or blood urea nitrogen (BUN) > 50 mg/dL (2.8 mmol/L)
  • Cancer (other than excised cutaneous basal cell carcinoma) within the past 5 years or any history of lung neoplasms
  • History of active viral or cirrhotic hepatic disease or abnormal liver enzymes as evidenced by serum aspartate aminotransferase (AST) or alanine aminotransferase (ALT) ≥ 3 times the upper limit of normal (ULN)
  • Active infection (eg, human immunodeficiency virus [HIV], hepatitis) or history of severe infection within 30 days of Visit 1
  • Anemia (hemoglobin ≤ 10.5 g/dL for women or ≤ 11.5 g/dL for men)
  • Diagnosis of systemic autoimmune or collagen vascular disease requiring previous or current treatment with systemic corticosteroids, cytotoxic drugs, or penicillamine
  • Any concurrent illness, other than diabetes mellitus, not controlled by a stable therapeutic regimen
  • Current or previous chemotherapy or radiation therapy that might result in pulmonary toxicity
  • Use of medications prescribed for weight loss (eg, sibutramine, orlistat) within 12 weeks of Visit 1
  • Any history of or current use of amiodarone
  • Clinically significant abnormalities on screening laboratory evaluation (unless discussed with and approved by the medical monitor)
  • Women who were pregnant, lactating, or planning to become pregnant during the trial
  • 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 was defined as using oral, percutaneous, or transdermal contraceptives; condoms and diaphragms (double barrier) with a spermicide; or intrauterine devices. Postmenopausal for this trial included amenorrhea for 2 or more years or surgically sterile
  • 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 trial
  • Exposure to any investigational medications or devices within 30 days before trial entry, or participation in another clinical trial while participating in this trial
  • Unable or unlikely to comprehend and follow the trial protocol (including SBGM and diabetes education)
  • Unable or unlikely to comprehend how to use the MedTone Inhaler or inability to use the device
  • Unable or unlikely to follow a meal plan that included at least 2 meals/day (with or without a third meal or additional snacks)
  • Noncompliance with medication or procedures that, in the PI's opinion, might affect the trial data or subject safety and that precluded the subject from further participation in the trial
  • Any other concurrent medical or major psychiatric condition that, in the opinion of the PI, made the subject unsuitable for the clinical trial or could limit the validity of the informed consent or impair the subject's ability to participate in the trial
  • For the subset of subjects having Doppler echocardiograms:
  • Subjects with left ventricular ejection fraction (LVEF) ≤ 35% at Visit 1
  • Subjects with known history of sickle cell disease
  • Previous use of Redux® (dexfenfluramine) or Pondimin® (fenfluramine)
  • History of valvular heart disease, including mild or greater aortic insufficiency or moderate or greater mitral insufficiency
  • Significant cardiovascular dysfunction or history within 12 months of Visit 1 (eg, congestive heart failure [NYHA Class III or IV]) or serious arrhythmia, treatment with medications to control or treat arrhythmias, myocardial infarction, cardiac surgery, recurrent syncope, transient ischemic attacks, or cerebrovascular accident
  • History of pulmonary embolism or deep venous thrombosis in the 12 months before Screening

Trial locations and contacts

22 sites in 2 countries.

22 sites in 2 countries

United States20 sites

  • Mountain Diabetes & Endocrine Center

    Asheville, North Carolina, 28803

  • Atlanta Diabetes Associates

    Atlanta, Georgia, 30309

  • Barbara Davis Center for Diabetes Young Adult Clinic

    Aurora, Colorado, 80045

  • AM Diabetes and Endocrinology Center

    Barrtlett, Tennessee, 38133

  • Deaconess Billings Clinic Research Center

    Billings, Montana, 59101

  • Dallas Diabetes & Endocrine Center

    Dallas, Texas, 75230

  • Baylor Endocrine Center

    Dallas, Texas, 75246

  • University of Texas Southwestern Medical Center

    Dallas, Texas, 75390

  • Endocrine Research Physicians East PA

    Greenville, North Carolina, 27834

  • Diabetes/Lipid Management and Research Center

    Huntington Beach, California, 92648

  • The Whittier Institute for Diabetes Clinical Trials

    La Jolla, California, 92037

  • Your Diabetes Endocrine Nutrition Group, Inc.

    Mentor, Ohio, 44060

  • University of Miami Diabetes Research Institute

    Miami, Florida, 33136

  • University of Miami School of Medicine

    Miami, Florida, 33136

  • Tulane University Health Sciences Center

    New Orleans, Louisiana, 70112-2699

  • OHSU Diabetes Center Research Oregon Health & Science University

    Portland, Oregon, 97239

  • Dorothy L & James E Frank Diabetes Research Institute

    San Mateo, California, 94401

  • Diabetes Care Center

    Seattle, Washington, 98105

  • Diabetes Research Center -Fletcher Allen Health Care

    South Burlington, Vermont, 05403

  • Washington University School of Medicine

    St Louis, Missouri, 63110

Other trials in United States

Brazil2 sites

  • Centro de Pesquisas em Diabetes Ltda

    Porto Alegre, Rio Grande do Sul, -90035-170

  • CPClin-Centro de Pesquisas Clinicas

    São Paulo, São Paulo, 01244-030

Other trials in Brazil

About this study

Official title: A Phase3, Multi-Center, Open-Label, Randomized, Clinical Trial Evaluating the Efficacy and Safety of Technosphere® Insulin Inhalation Powder in Combination With Lantus® Versus Humalog® in Combination With Lantus® in Subjects With Type 1 Diabetes Mellitus Over a 16-Week Treatment Period

The objective of this study is to demonstrate that TI® Inhalation Powder combined with Lantus® is as effective as Humalog® combined with Lantus® on HbA1c.

Being tested
Technosphere Insulin, Insulin glargine, Insulin lispro
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 InsulinDrug

    Technosphere Insulin Inhalation Powder 15U or 30U

  • Insulin glargineDrug

    Lantus-injectible supplied as 3mL (300 units) pens

  • Insulin lisproDrug

    Humalog autopen cartridges pre-filled with 3mL (300 units)

Study groups in NCT00700622
Study groupRoleWhat they receive
TI + Insulin glargineExperimentalTechnosphere Insulin Inhalation Powder in combination with Lantus (insulin glargine)
Receives: Drug: Technosphere Insulin
Insulin lispro + Insulin glargineExperimentalHumalog (insulin lispro) in combination with Lantus (insulin glargine)
Receives: Drug: Insulin glargine; Drug: Insulin lispro

What is being measured

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

  1. Change From Baseline in HbA1c to Week 16

    Change from Baseline in glycosylated hemoglobin at Week 16

    Measured: Baseline to Week 16

Timeline

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

  1. First posted18 Jun 2008 (estimated)
  2. Study startMay 2008
  3. Primary completionNov 2009
  4. Study completionMar 2010

Why it stopped: Sponsor stopped development of the MedTone inhaler in favor of an improved device (Gen2 inhaler)

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
130 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00700622
Sponsor's protocol ID
MKC-TI-117
Status last verified
Oct 2014
First submitted
16 Jun 2008
Last updated
16 Oct 2014
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Technosphere Insulin, Insulin glargine and Insulin lispro in people with Diabetes, Type 1, run by Mannkind Corporation at 22 sites in 2 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 15 inclusion and 42 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: stopped early, as of the sponsor's last update on 16 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 22 sites in United States, 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 16 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 in HbA1c to Week 16 (time frame: Baseline to Week 16). 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 NCT00700622.

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 16 Oct 2014.

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