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

Sponsored by:	Mannkind Corporation
Information provided by:	Mannkind Corporation
ClinicalTrials.gov Identifier:	NCT00700622

Purpose

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.

Condition	Intervention	Phase
Diabetes, Type I	Drug: Technosphere Insulin Drug: Humalog Drug: Lantus	Phase III

MedlinePlus related topics: Diabetes

Drug Information available for: Insulin Insulin glargine Insulin lispro

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy 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

Further study details as provided by Mannkind Corporation:

Primary Outcome Measures:

The primary efficacy endpoint is the change from Visit 5 to Visit 14 in A1c. [ Time Frame: 16 Weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Proportion of subjects who achieve an A1c of less than or equal to 6.5% [ Time Frame: 16 Weeks ] [ Designated as safety issue: No ]
Proportion of subjects who achieve an A1c of less than or equal to 7.0 % [ Time Frame: 16 Weeks ] [ Designated as safety issue: No ]
Proportion of subjects who achieve an A1c of less than or equal to 7.0%, AND do not have any episodes of severe hypoglycemia [ Time Frame: 16 Weeks ] [ Designated as safety issue: No ]
Area under the glucose concentration curve (AUC0-240 min), based on plasma glucose concentrations measured at -30, 0, 30, 60, 90, 105, 120, 180, and 240 min following the Meal Challenge(s) [ Time Frame: 240 Minutes ] [ Designated as safety issue: No ]
Responder rate as measured by the number of subjects who attain 2-hour PPG levels of < 180 mg/dL (10.0 mmol/L), and < 140 mg/dL (7.8 mmol/L) following Meal Challenges [ Time Frame: 2 Hours ] [ Designated as safety issue: No ]
7-point blood glucose (BG) profiles at regular intervals [ Time Frame: 16 Weeks ] [ Designated as safety issue: No ]
CGM parameters [ Time Frame: 16 Weeks ] [ Designated as safety issue: No ]
Body weight [ Time Frame: 16 Weeks ] [ Designated as safety issue: No ]
Subject treatment satisfaction [ Time Frame: 16 Weeks ] [ Designated as safety issue: No ]

Estimated Enrollment:	230
Study Start Date:	May 2008
Estimated Study Completion Date:	May 2009
Estimated Primary Completion Date:	December 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Technosphere Insulin Inhalation Powder in combination with Lantus	Drug: Technosphere Insulin Technosphere Insulin Inhalation Powder 15U or 30U Drug: Humalog Humalog autopen cartridges pre-filled with 3mL (300 units)
2: Experimental Humalog in combination with Lantus	Drug: Technosphere Insulin Technosphere Insulin Inhalation Powder 15U or 30U Drug: Lantus Lantus-injectible supplied as 3mL (300 units)pens.

Eligibility

Ages Eligible for Study:	18 Years to 80 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Key Inclusion Criteria:

Non-smoking
Clinical diagnoses of type 1 diabetes mellitus
Currently receiving subcutaneous (sc) insulin therapy at a total daily dose (TDD) < 1.5 IU/kg/day.
Body mass index (BMI) of less than or equal to 30 kg/m2. A1c greater than 7.0% and less than or equal to 9.0%.
Subjects must have a C-peptide level of less than or equal to 0.30 pmol/mL.

Key Exclusion Criteria:

History of insulin pump within 6 weeks of Screening/Visit 1 (Week -5).
Treatment with any type of anti-diabetic drugs, other than sc insulin, within the preceding 12 weeks.
History of chronic obstructive pulmonary disease (COPD), clinically proven asthma, and/or any other clinically important pulmonary disease (eg, obstructive sleep apnea) confirmed by pulmonary function testing, and/or radiologic findings.
Significant improvement in pre- to post- bronchodilator spirometry (defined as an increase of 12% and 200 mL in FEV1 or FVC at Visit 1).
Evidence of serious complications of diabetes.
Use of medications prescribed for weight loss within 12 weeks of Visit 1.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00700622

Locations

United States, California
Scripps CLI Research FND - Diabetes and Endocrinology	Not yet recruiting
La Jolla, California, United States, 92037
Contact: George Daily 858-554-7876 gdaily@scrippsclinic.com
Diabetes/Lipid Management and Research Center	Not yet recruiting
Huntington Beach, California, United States, 92648
Contact: Paul Rosenblit, Dr 714-375-7386 evechan@cox.net
Dorothy L & James E Frank Diabetes Research Institute	Not yet recruiting
San Mateo, California, United States, 94401
Contact: David Klonoff, Dr 650-696-4260 klonoff@sutterhealth.org
United States, Colorado
Barbara Davis Center for Childhood Diabetes University of Colorado Health Sciences Center	Not yet recruiting
Aurora, Colorado, United States, 80045
Contact: Satish Garg 303-724-6713 Satish.Garg@UCHSC.edu
United States, Florida
University of Miami School of Medicine	Not yet recruiting
Miami, Florida, United States, 33136
Contact: Jennifer Marks 305-243-6573
University of Miami Diabetes Research Institute	Not yet recruiting
Miami, Florida, United States, 33136
Contact: Luigi Meneghini 305-243-6504 lmeneghi@med.miami.edu
United States, Georgia
Atlanta Diabetes Associates	Not yet recruiting
Atlanta, Georgia, United States, 30309
Contact: Bruce Bode, Dr 404-355-4393 bbode@atlantadiabetes.com
United States, Louisiana
Tulane University Health Sciences Center	Not yet recruiting
New Orleans, Louisiana, United States, 70112
Contact: Vivian Fonseca, Dr 504-988-4026 vfonseca@tulane.edu
United States, Missouri
Washington University School of Medicine	Not yet recruiting
St. Louis, Missouri, United States, 63110
Contact: Janet McGill 314-362-8686 jmcgill@im.wustl.edu
United States, North Carolina
Endocrine Research - Physician's East PA	Recruiting
Greenville, North Carolina, United States, 27834
Contact: Mark Warren, Dr 252-413-6232 mwarren@physicianseast.com
United States, Ohio
Your Diabetes Endocrine Nutrition Group	Not yet recruiting
Mentor, Ohio, United States, 44060
Contact: Daniel Weiss, Dr 440-266-5005 drdanweiss@hotmail.com
United States, Tennessee
AM Diabetes and Endocrinology Center	Not yet recruiting
Barrtlett, Tennessee, United States, 38133
Contact: Kashif Latif, Dr 901-384-0065 klatifosr@gmail.com
United States, Texas
University of Texas Southwestern Medical Center	Not yet recruiting
Dallas, Texas, United States, 75390
Contact: Philip Raskin 214-648-4716
Baylor Endocrine Center	Not yet recruiting
Dallas, Texas, United States, 75246
Contact: Priscilla Hollander, Dr 214-820-3466 priscilh@baylorhealth.edu
Dallas Diabetes & Endocrine Center	Not yet recruiting
Dallas, Texas, United States, 75230
Contact: Julio Rosenstock, Dr 972-566-7799 crc7@dallasdiabetes.com
United States, Vermont
Diabetes Research Center - Fletcher Allen Health Care	Not yet recruiting
South Burlington, Vermont, United States, 05403
Contact: Richard Pratley 802-656-5811 Richard.Pratley@uvm.edu
United States, Washington
Diabetes Care Center	Not yet recruiting
Seattle, Washington, United States, 98105
Contact: Irl B Hirsch 206-598-4882 ihirsch@u.washington.edu

Sponsors and Collaborators

Mannkind Corporation

Investigators

Study Director:

Anders Boss, MD

Mannkind Corporation

More Information

Responsible Party:	MannKind Corporation ( Anders Boss/Chief Medical Officer & Senior Vice President )
Study ID Numbers:	MKC-TI-117
Study First Received:	June 16, 2008
Last Updated:	June 16, 2008
ClinicalTrials.gov Identifier:	NCT00700622
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Autoimmune Diseases
Metabolic Diseases
Diabetes Mellitus, Type 1
Glargine
Diabetes Mellitus
Insulin LISPRO

Endocrine System Diseases
Endocrinopathy
Metabolic disorder
Glucose Metabolism Disorders
Insulin

Additional relevant MeSH terms:

Hypoglycemic Agents
Immune System Diseases
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009