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

MannKind

Status and phase: Completed; Phase 3

Conditions: Diabetes Mellitus, Type 2

Treatments: Drug: Technosphere Insulin & Metformin; Drug: Metformin & Secretagogues; Drug: Technosphere Insulin

Study type: Interventional

Funder types: Industry

Identifiers

NCT00332488

MKC-TI-103

Details and patient eligibility

About

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

Enrollment: 547 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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547 participants in 3 patient groups

1

Experimental group

Description:

Technosphere Insulin

Treatment:

Drug: Technosphere Insulin

2

Active Comparator group

Description:

Metformin \& Secretagogues

Treatment:

Drug: Metformin & Secretagogues

3

Experimental group

Description:

Technosphere \& Metformin

Treatment:

Drug: Technosphere Insulin & Metformin