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

NCT01451398 | Completed Phase 3 Results DMC

• 2 other identifiers: MKC-TI-175Affinity2
• Study Type: interventional
• Target: 353
• Locations: 4 countries
• Sites: 76

Brief 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 oral antidiabetic drugs.

Conditions

Type 2 Diabetes

Outcome Measures

Primary Outcomes (1)

• Change From Baseline to Week 24 in HbA1c

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

  Baseline to Week 24

Secondary Outcomes (13)

• Proportion of Responders Achieving HbA1c <= 7.0%

  Week 24

• Proportion of Responders Achieving HbA1c <= 6.5%

  Week 24

• FPG Change From Baseline to Week 24

  Baseline to Week 24

• Proportion of Subjects Requiring Rescue Therapy

  Baseline to Week 24

• Time to Rescue

  Baseline to Week 24

Study Arms (2)

TI inhalation powder

EXPERIMENTAL

Technosphere® Insulin powder administered via the Gen2 inhaler added to 2 or more stable OADs

Drug: Technosphere® Insulin

Technosphere powder

PLACEBO COMPARATOR

Technosphere powder (with no insulin) administered via the Gen2 inhaler added to 2 or more stable OADs

Drug: Technosphere Powder

Interventions

Technosphere® Insulin DRUG

Technosphere® Insulin Inhalation Powder

TI inhalation powder

Technosphere Powder DRUG

Placebo Comparator

Technosphere powder

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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)

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Mannkind Corporation: lead

Study Sites (76)

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Anaheim, California, 92807, United States

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Huntington Beach, California, 92648, United States

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Laguna Hills, California, 92653, United States

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Long Beach, California, 90806, United States

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Los Angeles, California, 90036, United States

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Los Gatos, California, 95032, United States

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Tustin, California, 92780, United States

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West Hills, California, 91307, United States

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Hialeah, Florida, 33012, United States

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Hollywood, Florida, 33021, United States

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Miami, Florida, 33156, United States

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Miami, Florida, 33173, United States

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New Port Richey, Florida, 34652, United States

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North Miami Beach, Florida, 33179, United States

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Pembroke Pines, Florida, 33026, United States

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Pinellas Park, Florida, 33781, United States

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West Palm Beach, Florida, 33401, United States

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Atlanta, Georgia, 30308, United States

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Atlanta, Georgia, 30318, United States

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Dunwoody, Georgia, 30338, United States

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Lawrenceville, Georgia, 30045, United States

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Roswell, Georgia, 30076, United States

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Chicago, Illinois, 60607, United States

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Baton Rouge, Louisiana, 70808, United States

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Edina, Minnesota, 55435, United States

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City of Saint Peters, Missouri, 63376, United States

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Jefferson City, Missouri, 65109, United States

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St Louis, Missouri, 63110, United States

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St Louis, Missouri, 63117, United States

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Omaha, Nebraska, 68114, United States

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Omaha, Nebraska, 68131, United States

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Clifton, New Jersey, 07012, United States

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Hackensack, New Jersey, 07601, United States

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Paramus, New Jersey, 07652, United States

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Flushing, New York, 11365, United States

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New Hyde, New York, 11042, United States

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Greenville, North Carolina, 27834, United States

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Perrysburg, Ohio, 43551, United States

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Portland, Oregon, 97239, United States

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Greer, South Carolina, 29651, United States

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Memphis, Tennessee, 38119, United States

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Arlington, Texas, 76014, United States

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Dallas, Texas, 75230, United States

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Dallas, Texas, 75246, United States

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Houston, Texas, 77095, United States

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San Antonio, Texas, 78229, United States

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San Antonio, Texas, 78249, United States

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Magna, Utah, 84044, United States

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Renton, Washington, 98057, United States

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Wenatchee, Washington, 98801, United States

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Porto Alegre, 90035, Brazil

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São Paulo, 01244, Brazil

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Kemerovo, 650066, Russia

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Leningrad Region, Russia

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Moscow, 105120, Russia

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Moscow, 117036, Russia

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Moscow, 119435, Russia

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Moscow, 119991, Russia

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Moscow, 121374, Russia

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Moscow, 129128, Russia

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Moscow, 143420, Russia

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Petrozavodsk, 185019, Russia

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Saint Petersburg, 194044, Russia

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Saint Petersburg, 194354, Russia

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Saint Petersburg, 195257, Russia

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Saint Petersburg, 196601, Russia

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Saint Petersburg, 198013, Russia

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Smolensk, 214018, Russia

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Yaroslavl, 150003, Russia

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Yaroslavl, 150023, Russia

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Kharkiv, UKR, 61070, Ukraine

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Kiev, UKR, 04053, Ukraine

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Kyiv, UKR, 02175, Ukraine

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Odesa, UKR, 65039, Ukraine

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Vinnytsia, UKR, 21010, Ukraine

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Kiev, 04114, Ukraine

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Related Publications (1)

• 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.

  PMID: 26253730 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Results Point of Contact

• Title: Chief Medical Officer
• Organization: MannKind Corporation

aboss@mannkindcorp.com

201-983-5000

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 7, 2011
• First Posted: October 13, 2011
• Study Start: November 1, 2011
• Primary Completion: June 1, 2013
• Study Completion: July 1, 2013
• Last Updated: October 17, 2014
• Results First Posted: October 17, 2014

Record last verified: 2014-10

Locations

US (50); UA (6); BR (2); RU (18)