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

Phase 3

Completed

• Conditions: Diabetes Mellitus, Type 2
• Interventions: Drug: Metformin & Secretagogues; Drug: Technosphere Insulin; Drug: Technosphere Insulin & Metformin

• Registration Number: NCT00332488
• Lead Sponsor: Mannkind Corporation

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2004-12
• Study First Submitted: 2006-05-31
• Study First Submitted QC: 2006-05-31
• Study First Posted: 2006-06-01
• Primary Completion: 2008-03
• Disposition First Submitted: 2009-06-09
• Disposition First Submitted QC: 2009-10-01
• Disposition First Posted: 2009-10-05
• Results First Submitted: 2014-07-22
• Status Verified: 2014-10
• Results First Submitted QC: 2014-10-09
• Last Update Submitted: 2014-10-09
• Results First Posted: 2014-10-16
• Last Update Posted: 2014-10-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 547

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 or 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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
2	Metformin & Secretagogues	Metformin \& Secretagogues
1	Technosphere Insulin	Technosphere Insulin
3	Technosphere Insulin & Metformin	Technosphere \& Metformin

Primary Outcome Measures

Name	Time	Method
Difference in Change From Baseline for HbA1c Between TI+ Metformin and Metformin+Secretagogue	Baseline to Week 12

Secondary Outcome Measures

Name	Time	Method
Difference in Change From Baseline for HbA1c Between TI Alone and Metformin+Secretagogue	Baseline to Week 12	(Change from baseline within TI Alone) minus (change from baseline within metformin + secretagogue)
Change in HbA1c From Baseline to Week 24 (Subjects Who Stayed on Original Treatment)	Week 24

Trial Locations

Locations (118)

Radiant Research-Birmingham; 🇺🇸 Birmingham, Alabama, United States

Parkway Medical Center; 🇺🇸 Birmingham, Alabama, United States

Redpoint Research; 🇺🇸 Phoenix, Arizona, United States

Arizona Center for Clinical Research; 🇺🇸 Phoenix, Arizona, United States

International Clinical Research Network; 🇺🇸 Chula Vista, California, United States

National Jewish Medical & Research Center; 🇺🇸 Denver, Colorado, United States

Creekside Endocrine Associates; 🇺🇸 Denver, Colorado, United States

Jennifer Hone MD; 🇺🇸 Denver, Colorado, United States

Chase Medical Research, LLC; 🇺🇸 Waterbury, Connecticut, United States

Center for Diabetes & Endocrine Care; 🇺🇸 Hollywood, Florida, United States

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