Evaluate the Efficacy and Safety of Insulin Compared to Glargine in Patients With Type 2 Diabetes

• Mean change in HbA1c from baseline to various timepoints [ Time Frame: 56 weeks ] [ Designated as safety issue: No ]
• Insulin dose requirements [ Time Frame: 56 weeks ] [ Designated as safety issue: No ]
• Patient-reported outcomes of W-BQ12 [ Time Frame: screening,baseline, week 12,24, and 48 ] [ Designated as safety issue: No ]
• Hypoglycemia rate [ Time Frame: throughout the study ] [ Designated as safety issue: No ]
• Changes in body weight [ Time Frame: every visit ] [ Designated as safety issue: No ]
• Adverse events [ Time Frame: throughout the study ] [ Designated as safety issue: No ]
• Safety as assessed by total pulmonary function testing and fasting lipid profile [ Time Frame: throughout the study ] [ Designated as safety issue: Yes ]
• Assess inhaler reliability. [ Time Frame: throughout the study ] [ Designated as safety issue: No ]
• Patient Reported outcomes of DSC-R [ Time Frame: screening,baseline, week 12,24, and 48 ] [ Designated as safety issue: No ]
• Patient reported outcomes of DTSQS [ Time Frame: screening,baseline, week 12, 24 and 48 ] [ Designated as safety issue: No ]
• Patient reported outcome of IDSQ [ Time Frame: week 12, 24, and 48 ] [ Designated as safety issue: No ]
• Patient reported outcome of preference questionnaire [ Time Frame: week 48 ] [ Designated as safety issue: No ]
• Patient reported outcome of Expectations About Insulin Therapy Questionnaire [ Time Frame: screening,baseline ] [ Designated as safety issue: No ]
• Patient reported outcome of Experience with Insulin Therapy Questionnaire [ Time Frame: week 12, 24 and 48 ] [ Designated as safety issue: No ]

• Mean change in HbA1c from baseline to various timepoints
• Insulin dose requirements
• Patient-reported outcomes
• Hypoglycemia rate
• Changes in body weight
• Adverse events
• Safety as assessed by total pulmonary function testing and fasting lipid profile
• Assess inhaler reliability.

A study to compare Human Inhalation Powder (also known as AIR® Inhaled Insulin) (AIR® is a registered trademark of Alkermes, Inc.)with insulin glargine injections in patients with Type 2 diabetes who are currently taking oral medications and have not previously taken insulin. Change in HbA1c levels will be reviewed to determine superiority or inferiority of the AIR Inhaled Insulin regimen.

• Drug: Human Insulin Inhalation Powder
  patient specific dose, inhaled, before meals, 24 weeks
  Other Name: LY041001
• Drug: Insulin Glargine
  patient specific dose, injectable, before meals, 24 weeks

• Experimental: 1

  4 week pretreatment phase consists of continuation of usual OAM therapy

  24 week treatment period with insulin glargine and OAM continuation followed by 24 week treatment period with HIIP and OAM continuation

  8 week follow up period

  Interventions:

  • Drug: Human Insulin Inhalation Powder
  • Drug: Insulin Glargine
• Experimental: 2

  4 week pretreatment phase consists of continuation of usual OAM therapy

  24 week treatment period with HIIP and OAM continuation followed by 24 week treatment period with insulin glargine and OAM continuation

  8 week follow up period

  Interventions:

  • Drug: Human Insulin Inhalation Powder
  • Drug: Insulin Glargine

Inclusion Criteria:

• Type 2 Diabetes Mellitus
• Insulin naive
• One or more oral antihyperglycemic medications
• HbA1c greater than or equal to 8.0% and less than or equal to 10.5%
• Non-smoker

Exclusion Criteria:

• Taking a TZD dose greater than what is indicated
• Have not taken insulin within 6 months of entry into study
• Have had more than 2 episodes of sever hypoglycemia during the 6 months prior to study entry
• Have had more than 1 hospitalization or emergency room visit due to poor diabetic control during the 6 months prior to study entry
• Have had pneumonia in the 3 months prior to study entry
• Systemic glucocorticoid therapy
• Clinical signs or symptoms of liver disease, acute or chronic hepatitis
• History of renal transplantation
• Have an active or untreated malignancy
• Have a current diagnosis or past history of clinically relevant pulmonary disease
• Taking or have taken exenatide during the 6 weeks prior to study entry