Study of the Efficacy and Safety of Inhaled Technosphere Insulin in Patients With Type 2 Diabetes

NCT00511602 | Completed Phase 2

• 1 other identifier: PDC-INS-0008
• Study Type: interventional
• Target: 123
• Locations: 0 countries
• Sites: N/A

Brief Summary

Primary objective to evaluate the effect of a 12-week treatment period with prandial administration of Technosphere Insulin on glucose control in subjects with T2 DM. Secondary objective is to Evaluate the safety and tolerability of a 12-week treatment period of Technosphere Insulin and Technosphere Placebo.

Conditions

Type 2 Diabetes Mellitus

Outcome Measures

Primary Outcomes (1)

• HbA1c change from baseline (week 2) to end of treatment (week 12)

  12 weeks

Secondary Outcomes (7)

• Area under the plasma glucose concentration versus time (AUCglucose)

  every 4 weeks

• Maximum glucose concentration (Cmax)

  every 4 weeks

• Time to maximum glucose concentration (tmax)

  every 4 weeks

• Area under the plasma glucose concentration versus time (AUCglucose)

  every 4 weeks

• Maximum glucose concentration (Cmax)

  every 4 weeks

Study Arms (2)

Technosphere Insulin Inhalation Powder

EXPERIMENTAL

Drug: Technosphere Insulin

Technosphere Inhalation Powder

PLACEBO COMPARATOR

Drug: Technosphere Placebo

Interventions

Technosphere Insulin DRUG

Technosphere Insulin Inhalation Powder

Technosphere Insulin Inhalation Powder

Technosphere Placebo DRUG

Technosphere Inhalation Powder

Technosphere Inhalation Powder

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Clinical diagnosis of T2 DM of \>2 years and \<12 years duration
• Insulin treatment naive treated with diet/exercise or single/combination oral anti-diabetic agents, such as metformin, sulfonylurea, and/or thiazolidinediones
• Stable regimen for \>3 months of oral anti-diabetes medication prior to enrollment
• HbA1c \>6.6% and \<10.5%
• BMI \<38 kg/m2
• years of age
• Baseline FVC and FEV1 \>80% and \<120% of predicted normal as measured by spirometry
• Baseline DLCO \>80% and \<120% of predicted normal

You may not qualify if:

• Clinical diagnosis of type 1 diabetes mellitus
• Subjects currently using insulin therapy or at the time of screening
• Known hypersensitivity to the study drug or to drugs of similar chemical structures
• Fasting plasma glucose \>270 mg/dL without adequate explanation of a transient causality (screen could be repeated after a 2-week interim period)
• History of severe or multiple allergies
• History of tobacco or nicotine test at screening
• Severe complications of diabetes including history of blindness from or Stage III or IV diabetic retinopathy, history of renal failure requiring dialysis or transplantation, history of amputation of limbs or digits related to diabetic vasculopathy
• Treatment with another investigational drug within 3 months prior to study entry (and for the duration of the study)
• Use of medications known to modify glucose metabolism or to decrease the ability to recover from hypoglycemia such as oral, parenteral, and inhaled steroids, beta blockers, with the exception of beta blocker ophthalmic solutions for glaucoma or ocular hypertension, or hydrochlorothiazide (HCTZ) at doses \>25 mg/day
• Recent loss (within the 2 months prior to screening) of \>5% of body weight
• Evidence of moderate or greater ketones in urine or ketoacidosis at screening
• History of chronic obstructive pulmonary disease or history of other known chronic pulmonary disease such as reactive airway disease, chronic bronchitis, emphysema, or asthma
• Diagnosis of AIDS or ARC
• A major psychiatric disorder that would have precluded satisfactory participation in this study
• Subjects who had had a myocardial infarction or stroke within the preceding six months

Sponsors & Collaborators

• Mannkind Corporation: lead

Related Publications (1)

• Rosenstock J, Bergenstal R, Defronzo RA, Hirsch IB, Klonoff D, Boss AH, Kramer D, Petrucci R, Yu W, Levy B; 0008 Study Group. Efficacy and safety of Technosphere inhaled insulin compared with Technosphere powder placebo in insulin-naive type 2 diabetes suboptimally controlled with oral agents. Diabetes Care. 2008 Nov;31(11):2177-82. doi: 10.2337/dc08-0315. Epub 2008 Aug 4.

  PMID: 18678610 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 3, 2007
• First Posted: August 6, 2007
• Study Start: December 1, 2003
• Primary Completion: November 1, 2004
• Study Completion: December 1, 2005
• Last Updated: April 30, 2012

Record last verified: 2012-04