Efficacy and Safety of Prandial Inhalation of Technosphere/Insulin in Combination With Metformin or Technosphere/Insulin Alone Versus 2 Oral Anti-Diabetic Agents in Subjects With Type 2 Diabetes

This study has been completed.

First Received: May 31, 2006 Last Updated: October 1, 2009 History of Changes

Sponsor:	Mannkind Corporation
Information provided by:	Mannkind Corporation
ClinicalTrials.gov Identifier:	NCT00332488

Purpose

to demonstrate the efficacy of inhaled Technosphere/Insulin in combination with metformin versus combination metformin and a secretagogue

Condition	Intervention	Phase
Diabetes Mellitus, Type 2	Drug: Technosphere Insulin Drug: Metformin & Secretagogues Drug: Technosphere Insulin & Metformin	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Crossover Assignment, Safety/Efficacy Study
Official Title:	A Phase 3, 24-Week, Multi-Center, Open-Label, Randomized, Controlled Trial Comparing the Efficacy and Safety of Prandial Inhalation of Technosphere/Insulin in Combination With Metformin or Technosphere/Insulin Alone Versus 2 Oral Anti-Diabetic Agents (Metformin and a Secretagogue) in Subjects With Type 2 Diabetes Mellitus Sub-optimally Controlled on Combination Metformin and a Secretagogue.

Resource links provided by NLM:

MedlinePlus related topics: Diabetes

Drug Information available for: Insulin Metformin Metformin hydrochloride

Further study details as provided by Mannkind Corporation:

Primary Outcome Measures:

Change from baseline to Week 12 in glycated hemoglobin [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Change in HbA1c from baseline [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]

Enrollment:	547
Study Start Date:	December 2004
Estimated Study Completion Date:	October 2008
Primary Completion Date:	March 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Technosphere Insulin	Drug: Technosphere Insulin Inhalation, 15U/30U, prandial
2: Active Comparator Metformin & Secretagogues	Drug: Metformin & Secretagogues Metformin tablets,Secretagogues supplied as any of the currently marketed brands and formulations.
3: Experimental Technosphere & Metformin	Drug: Technosphere Insulin & Metformin Technosphere Insulin Inhalation Powder 15U/30U, Metformin tablets

Eligibility

Criteria

Inclusion Criteria:

Non-smokers with clinical diagnosis of Type 2 diabetes mellitus for >or= to 6 months
Stable regimen of metformin for > or = to 1000mg/day 9or maximum tolerated dose) and a secretagogue < or = 1/2 the maximum manufacturer-recommended daily dose without any dose adjustments within the preceding 6 wks.
Fixed dose combination products of metformin and sulfonylurea are acceptable as long as each individual dose meets inclusion criteria
HbA1c >or= to 7.5% and < or= to 11.0%
BMI < or = to 40kg/m2.
FEV1> or = to 70%, Total Lung capacity and > or =80% DLco > or= to 70%

Exclusion Criteria:

Treatment with any type of anti-diabetic therapy, other than metformin & secretagogues within the preceding 12 weeks
Serum creatinine > 1.4mg/dL in female subjects and >1.5mg/dL in male subjects
History of chronic obstructive pulmonary disease, clinically proven asthma and/or any other clinically important pulmonary function testing and/or radiologic findings
Evidence of serious complications of diabetes (e.g. autonomic neuropathy)

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00332488

Sponsors and Collaborators

Mannkind Corporation

Investigators

Study Director:

Anders Boss

Mannkind Corporation

More Information

No publications provided

Responsible Party:	MannKind Corporation ( Anders Boss, MD, MFPM, Chief Medical Officer )
Study ID Numbers:	MKC-TI-103
Study First Received:	May 31, 2006
Last Updated:	October 1, 2009
ClinicalTrials.gov Identifier:	NCT00332488 History of Changes
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Hypoglycemic Agents
Metabolic Diseases
Physiological Effects of Drugs
Metformin
Diabetes Mellitus, Type 2

Diabetes Mellitus
Endocrine System Diseases
Glucose Metabolism Disorders
Pharmacologic Actions
Insulin

ClinicalTrials.gov processed this record on November 09, 2009