Efficacy and Safety in Subjects With Type 2 Diabetes Receiving Subcutaneous Basal Insulin and Prandial Inhalation of Technosphere/Insulin Versus Subcutaneous Premixed Insulin Therapy Over a 52-Week Treatment Period and a 4-Week Follow-up

This study has been completed.
Sponsor:
Information provided by:
Mannkind Corporation
ClinicalTrials.gov Identifier:
NCT00309244
First received: March 27, 2006
Last updated: October 1, 2009
Last verified: October 2009

March 27, 2006
October 1, 2009
February 2006
August 2008   (final data collection date for primary outcome measure)
To compare the mean change from baseline to Week 52 of percentage of glycosylated hemoglobin (HbA1c) [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Change in HbA1c
Complete list of historical versions of study NCT00309244 on ClinicalTrials.gov Archive Site
Not Provided
  • Evaluate safety of T/I treatment by assessing clinical laboratory parameters, hypoglycemia, hyperglycemia, and other adverse events and pulmonary function tests.
  • Compare the AUC postprandial venous plasma glucose values following a standardized liquid meal from 0 - 360 minutes.
  • Evaluate the proportion of subjects with HbA1c ≤ 7.0% and ≤ 8.0%.
  • Evaluate changes in the SF-36 Quality of Life (QoL) between treatment groups.
  • Evaluate changes from the Insulin Treatment Questionnaire (ITQ) between treatment groups.
Not Provided
Not Provided
 
Efficacy and Safety in Subjects With Type 2 Diabetes Receiving Subcutaneous Basal Insulin and Prandial Inhalation of Technosphere/Insulin Versus Subcutaneous Premixed Insulin Therapy Over a 52-Week Treatment Period and a 4-Week Follow-up
A Prospective, Multi-Center, Open-Label, Randomized, Controlled Clinical Trial Comparing the Efficacy and Safety in Subjects With Ty0pe 2 Diabetes Receiving Subcutaneous Basal Insulin and Prandial Inhalation of Technosphere /Insulin Versus Subcutaneous Premixed Insulin Therapy Over a 52-Week Treatment Period and a 4-Week Follow-up

The purpose of this 13 month study (12 month treatment period and 1 month follow-up period) is to determine whether inhaled insulin is safe and effective in the treatment of type 2 diabetes.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Diabetes Type 2
  • Drug: Technosphere/Insulin
    Inhalation, 15U/30U
  • Drug: Comparator Treatment
    BPR 70/30, which is a premix of intermediate acting and rapid acting insulin given sc
  • Experimental: 1
    Technosphere Insulin
    Intervention: Drug: Technosphere/Insulin
  • Active Comparator: 2
    Comparator Treatment
    Intervention: Drug: Comparator Treatment

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
676
September 2008
August 2008   (final data collection date for primary outcome measure)

Inclusion Criteria:

Type 2 diabetes currently receiving pre-/self mixed insulin therapy 2 to 3 times daily where fast acting component is either regular or rapid acting insulin non-smoking Body mass index 40 kg/m2 HbA1c > 7.0% < 11.0% FEV1 > or = 70% predicted (NHANES III); DLco > or = 70% predicted (Miller) Total Lung Capacity > or = 80% predicted (ITS)

Exclusion Criteria:

Concomitant sulphonylureas, meglitinide, or other non-sulfonylurea secretagogues, pramlintide acetate (Symlin®), and/or any incretin (eg, Byetta®) within the preceding 6 weeks History of viral and/or cirrhotic hepatic disease and/or abnormal liver enzymes history of chronic obstructive pulmonary disease, asthma (any history of bronchospasm or asthma after the age of 14), and/or any other clinically important pulmonary disease Evidence of severe complications of diabetes

Both
18 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
United States,   Argentina,   Brazil,   Canada,   Chile,   Mexico,   Poland,   Russian Federation,   Spain,   United Kingdom
 
NCT00309244
MKC-TI-102
Not Provided
Anders Boss, MD, MFPM, Chief Medical Officer, MannKind Corporation
Mannkind Corporation
Not Provided
Not Provided
Mannkind Corporation
October 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP