18-Week, Randomized, Double-blind, Placebo Controlled, Forced Titration Study of Patients With Type 2 Diabetes

NCT00511732 | Completed Phase 2

• 1 other identifier: MKC-TI-005
• Study Type: interventional
• Target: 227
• Locations: 0 countries
• Sites: N/A

Brief Summary

Designed to evaluate dose response of force-titrated prandial administration of TI as compared to placebo (TP) in subjects with Type 2 diabetes who were suboptimally controlled

Conditions

Type 2 Diabetes Mellitus

Outcome Measures

Primary Outcomes (3)

• HbA1c change from baseline (week 6) to end of treatment (week 17)

  measured from week 6 (baseline) to week 17

• Area under the plasma glucose concentration versus time (AUCglucose) compared to week 6 (baseline.

  Timepoints: 0 minutes (before meal) and at 15, 30, 60, 90, 120, 180, 240, and 300 minutes after TI administration

  at weeks 4, 6, 11 and 17

• Area under the plasma glucose concentration versus time (AUCglucose) compared to week 6 (baseline)

  Timepoints: 0 minutes (before meal) and at 15, 30, 60, 90, 120, 180, 240, and 300 minutes after Technosphere Placebo administration

  at weeks 4, 6, 11 and 17

Secondary Outcomes (2)

• Fasting blood glucose concentration compared to week 6 (baseline)

  at weeks 4, 6, 11 and 17

• Safety variables included adverse events (AEs), clinical laboratory tests, vital signs and physical examinations

  18 weeks

Study Arms (2)

Technosphere Insulin

EXPERIMENTAL

Drug: Technosphere Insulin

Technosphere Inhalation Powder

PLACEBO COMPARATOR

Drug: Technosphere Placebo

Interventions

Technosphere Insulin DRUG

Technosphere Insulin Inhalation Powder

Technosphere Insulin

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:

• Male and females patients from 18 to \<80 years of age
• Clinical diagnosis of type 2 diabetes mellitus
• Duration of diabetes of \>3 years and \<20 years
• Glycemic control at upper end of acceptable level or sub-optimal in control (HbA1c between 7.0% and 12?0%)
• Confirmation of diagnosis of diabetes such as a history of 2 hour postprandial blood glucose \>11.1 mmol/L (200 mg/dL) or following a glucose tolerance test
• A minimum of 2 months of treatment with a stable dose of one or more of the following anti-hyperglycemic agents: sulphonylureas, alpha glucosidase inhibitors, metformin, meglitinides, thiazolidinediones and/or Lantus basal insulin therapy
• FBG:\>6 mmol/L (108 mg/dL)
• C-peptide: \>0.5 nmol/L
• BMI \<38 kg/m2
• Baseline DLco, FVC, FEV1 \>75% of predicted normal
• Subjects who, in the opinion of the Investigator, will be able to complete this study
• Written informed consent

You may not qualify if:

• Severe complications of diabetes including history of: blindness from or grade III or IV diabetic retinopathy, renal failure requiring dialysis or transplantation, amputation of limbs or digits related to diabetic vasculopathy or foot ulcers
• Treatment with another investigational drug within 3 months prior to study entry and for the duration of the study
• History of drug or alcohol dependency
• Significant hepatic disease (as evidenced by ALT or AST \>3 times the normal upper reference range or bilirubin \>1.5 times the normal upper reference range)
• Significant renal disease (as evidenced by creatinine \>1.5 mg/dL for males or \>1.3 mg/dL for females) or proteinuria \>1,000 mg/24 hours
• History of chronic obstructive pulmonary disease, or history of other known chronic pulmonary diseases, such as reactive airway disease, chronic bronchitis, emphysema, or asthma
• Heart disease graded as class III or class IV according to New York Heart Association criteria
• Prior treatment with , or participation in a clinical study involving an inhaled insulin product
• Smokers
• Current use of preprandial or prandially administered fast-acting or rapid acting insulin or insulin analogs
• Previous participation in a TI or TP clinical trial
• Allergy to insulin or to any drugs to be used as part of the clinical trial
• History of malignancy within 5 years of study entry (other than basal cell carcinoma)
• Anemia (hemoglobin level less than 11 g/dL for females or 12 g/dL for males at study entry)
• Diagnosis of Acquired Immunodeficiency Syndrome (AIDS) and Aids Related Complex A major psychiatric disorder that will preclude satisfactory participation in this study

Sponsors & Collaborators

• Mannkind Corporation: lead

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 Officials

• Anders Boss

  Mannkind Corporation

  STUDY DIRECTOR

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: June 1, 2004
• Primary Completion: August 1, 2005
• Study Completion: August 1, 2007
• Last Updated: April 30, 2012

Record last verified: 2012-04