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 - Tabular View

Tracking Information

First Received Date ^ICMJE

May 31, 2006

Last Updated Date

October 1, 2009

Start Date ^ICMJE

December 2004

Primary Completion Date

March 2008 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

Change from Baseline to Week 12 in glycated hemoglobin (HbA1c) for prandial T/I in combination with metformin versus combination metformin and a secretagogue

Change History

Complete list of historical versions of study NCT00332488 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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

Original Secondary Outcome Measures ^ICMJE

Changes from Baseline to Week 12 and/or Week 24 in: HbA1c for the evaluation of inhaled prandial T/I alone versus combination metformin and a secretagogue
Maximum PPG and Area Under the Curve (AUCglucose) 0-360 minutes, based on plasma glucose concentrations measured at –30, 0, 30, 60, 90, 105, 120, 180, 240, 300 and 360 minutes following the Meal Challenge(s)
Proportion of subjects with HbA1c levels less than 6.5%, 7.0% and 8.0%
QoL, as measured by Short Form (SF-36) questionnaire and treatment satisfaction, as measured by the Insulin Treatment Questionnaire (ITQ)
Proportion of subjects who attain 2-hour PPG levels less than or equal to 140 mg/dL and 180 mg/dL following the Meal Challenge(s)
Seven-point glucose profiles

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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.

Brief Summary

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

Detailed Description

Study Phase

Phase III

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Open Label, Active Control, Crossover Assignment, Safety/Efficacy Study

Condition ^ICMJE

Diabetes Mellitus, Type 2

Intervention ^ICMJE

Drug: Technosphere Insulin
Drug: Metformin & Secretagogues
Drug: Technosphere Insulin & Metformin

Study Arms / Comparison Groups

Experimental: Technosphere Insulin
Active Comparator: Metformin & Secretagogues
Experimental: Technosphere & Metformin

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

547

Completion Date

October 2008

Primary Completion Date

March 2008 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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)

Gender

Both

Ages

18 Years to 80 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States, Argentina, Brazil, Canada, Chile, Czech Republic, Mexico, Poland, Russian Federation, Spain, Ukraine

Administrative Information

NCT ID ^ICMJE

NCT00332488

Responsible Party

Anders Boss, MD, MFPM, Chief Medical Officer, MannKind Corporation

Study ID Numbers ^ICMJE

MKC-TI-103

Study Sponsor ^ICMJE

Mannkind Corporation

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:

Anders Boss

Mannkind Corporation

Information Provided By

Mannkind Corporation

Verification Date

October 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP