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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2006-002245-36-CZ

Enrollment

525

Registered

2006-10-13

Start date

2006-12-01

Completion date

Unknown

Last updated

2012-03-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes mellitus type II MedDRA version: 8.1 Level: LLT Classification code 10012601 Term: Diabetes mellitus

Interventions

Product Name: Technosphere®/Insulin Pharmaceutical Form: Inhalation powder, pre-dispensed INN or Proposed INN: Insulin Human rDNA CAS Number: 11061-68-0 Concentration unit: IU/mg international unit(s

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Key inclusion criteria include: Non-smoking male and female subjects = 18 and = 80 years of age with clinical diagnosis of type 2 diabetes mellitus for = 6 months. Stable regimen of metformin = 1000 mg/day (or maximum tolerated dose) and a secretagogue (sulfonylurea or meglitinide) = ½ the maximum manufacturer-recommended daily dose (or maximum tolerated dose) without any dose adjustments within the preceding 6 weeks. Fixed dose combination products of metformin and sulfonylurea are acceptable as long as each individual dose meets inclusion criteria. HbA1c = 7.5% and = 11.0%. Body Mass Index (BMI) = 40 kg/m2. The following PFTs: FEV1 = 70 % National Health and Nutrition Examination Survey (NHANES) III Predicted, Total Lung Capacity (TLC) = 80% of Predicted (ITS) and single breath carbon monoxide diffusing capacity (DLco (unc)) = 80% of Predicted (Miller). Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: Key exclusion criteria include: Treatment with any type of anti-diabetic therapy, other than metformin and secretagogues (sulfonylureas or meglitinides), within the preceding 12 weeks. Serum creatinine > 1.4 mg/dL in female subjects and > 1.5 mg/dL in male subjects. History of chronic obstructive pulmonary disease (COPD), clinically proven asthma and/or any other clinically important pulmonary disease confirmed by pulmonary function testing and/or radiologic findings. Evidence of serious complications of diabetes (eg, autonomic neuropathy).

Design outcomes

Primary

Measure	Time frame
Main Objective: The primary objective of this trial is to demonstrate the efficacy of inhaled prandial Technosphere®/Insulin (T/I) in combination with metformin versus combination metformin and a secretagogue (sulfonylurea or meglitinide) in subjects with sub-optimally controlled type 2 diabetes mellitus.;Secondary Objective: The secondary objectives are to evaluate the: • Efficacy of inhaled prandial T/I alone versus combination metformin and a secretagogue (sulfonylurea or meglitinide). • Effect of inhaled prandial T/I on post-prandial glucose (PPG) excursions following the ingestion of a standardized liquid meal (Meal Challenge). • Effect of inhaled prandial T/I on the proportion of subjects achieving predefined targets of glycemic control. • Effect of inhaled prandial T/I on Quality of Life (QoL) and treatment satisfaction. • Safety of inhaled prandial T/I, expressed as the incidence of hypoglycemia, pulmonary and other adverse events (AEs) and changes in pulmonary function. ;Primary end point(s): Primary Efficacy Endpoint: The primary efficacy endpoint is the change from Baseline to Week 12 in glycated hemoglobin (HbA1c) for prandial T/I in combination with metformin versus combination metformin and a secretagogue (sulfonylurea or meglitinide).	—

Measure

Time frame

Main Objective: The primary objective of this trial is to demonstrate the efficacy of inhaled prandial Technosphere®/Insulin (T/I) in combination with metformin versus combination metformin and a secretagogue (sulfonylurea or meglitinide) in subjects with sub-optimally controlled type 2 diabetes mellitus.;Secondary Objective: The secondary objectives are to evaluate the: • Efficacy of inhaled prandial T/I alone versus combination metformin and a secretagogue (sulfonylurea or meglitinide). • Effect of inhaled prandial T/I on post-prandial glucose (PPG) excursions following the ingestion of a standardized liquid meal (Meal Challenge). • Effect of inhaled prandial T/I on the proportion of subjects achieving predefined targets of glycemic control. • Effect of inhaled prandial T/I on Quality of Life (QoL) and treatment satisfaction. • Safety of inhaled prandial T/I, expressed as the incidence of hypoglycemia, pulmonary and other adverse events (AEs) and changes in pulmonary function. ;Primary end point(s): Primary Efficacy Endpoint: The primary efficacy endpoint is the change from Baseline to Week 12 in glycated hemoglobin (HbA1c) for prandial T/I in combination with metformin versus combination metformin and a secretagogue (sulfonylurea or meglitinide).

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Countries

Czech Republic, Spain

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026