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

NCT00437112 | Completed Phase 3

• 2 other identifiers: 9631H7U-MC-IDAZ
• Study Type: interventional
• Target: 142
• Locations: 5 countries
• Sites: 19

Brief Summary

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.

Conditions

Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (1)

• Compare, in insulin-naive patients with type 2 diabetes on one or more oral antihyperglycemic medications, a regimen adding mealtime HIIP versus a regimen adding insulin glargine with respect to change in HbA1c from baseline to endpoint.

  56 weeks

Secondary Outcomes (14)

• Mean change in HbA1c from baseline to various timepoints

  56 weeks

• Insulin dose requirements

  56 weeks

• Patient-reported outcomes of W-BQ12

  screening,baseline, week 12,24, and 48

• Hypoglycemia rate

  throughout the study

• Changes in body weight

  every visit

Study Arms (2)

1

EXPERIMENTAL

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

Drug: Human Insulin Inhalation Powder; Drug: Insulin Glargine

2

EXPERIMENTAL

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

Drug: Human Insulin Inhalation Powder; Drug: Insulin Glargine

Interventions

Human Insulin Inhalation Powder DRUG

patient specific dose, inhaled, before meals, 24 weeks

Also known as: LY041001

1; 2

Insulin Glargine DRUG

patient specific dose, injectable, before meals, 24 weeks

1; 2

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Eli Lilly and Company: lead
• Alkermes, Inc.: collaborator

Study Sites (19)

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

Greenbrae, California, 94904, United States

Location

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Topeka, Kansas, 66606, United States

Location

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Toms River, New Jersey, 08753, United States

Location

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Albuquerque, New Mexico, 87108, United States

Location

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New Braunfels, Texas, 78130, United States

Location

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San Antonio, Texas, 78229, United States

Location

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Porto Alegre, 90035-003, Brazil

Location

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São Paulo, 04025-011, Brazil

Location

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Indore, 452 003, India

Location

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Kochi, 682026, India

Location

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Pune, 411005, India

Location

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Vellore, 632 004, India

Location

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Manatí, 00674, Puerto Rico

Location

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San Juan, 00907, Puerto Rico

Location

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Barakaldo, 48903, Spain

Location

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

Dos Hermanas, 41014, Spain

Location

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Madrid, 28006, Spain

Location

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

Requena, 46340, Spain

Location

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Sabadell, 08208, Spain

Location

Related Links

• Lilly CSR Synopsis

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Insulin Glargine

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Insulin, Long-Acting; Insulins; Pancreatic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Study Officials

• Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri from 9AM - 5PM Eastern time (UTC/GMT - 5 hours, EST)

  Eli Lilly and Company

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 16, 2007
• First Posted: February 19, 2007
• Study Start: February 1, 2007
• Primary Completion: May 1, 2008
• Study Completion: May 1, 2008
• Last Updated: March 9, 2018

Record last verified: 2018-03

Locations

IN (4); US (6); BR (2); PR (2); ES (5)