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

Primary Purpose

Diabetes Mellitus, Type 2

Status

Completed

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

Human Insulin Inhalation Powder

Insulin Glargine

About this trial

This is an interventional treatment trial for Diabetes Mellitus, Type 2

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Mean change in HbA1c from baseline to various timepoints

Insulin dose requirements

Patient-reported outcomes of W-BQ12

Hypoglycemia rate

Changes in body weight

Adverse events

Safety as assessed by total pulmonary function testing and fasting lipid profile

Assess inhaler reliability.

Patient Reported outcomes of DSC-R

Patient reported outcomes of DTSQS

Patient reported outcome of IDSQ

Patient reported outcome of preference questionnaire

Patient reported outcome of Expectations About Insulin Therapy Questionnaire

Patient reported outcome of Experience with Insulin Therapy Questionnaire

Full Information

NCT ID

NCT00437112

First Posted

February 16, 2007

Last Updated

March 7, 2018

Sponsor

Eli Lilly and Company

Collaborators

Alkermes, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT00437112

Brief Title

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

Official Title

A Phase 3, Open-Label, Crossover Study to Evaluate the Efficacy and Safety of Human Insulin Inhalation Powder (HIIP) Compared With Once-Daily Insulin Glargine in Insulin-Naive Patients With Type 2 Diabetes Mellitus on Oral Agents

Study Type

Interventional

2. Study Status

Record Verification Date

March 2018

Overall Recruitment Status

Completed

Study Start Date

February 2007 (undefined)

Primary Completion Date

May 2008 (Actual)

Study Completion Date

May 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Eli Lilly and Company

Collaborators

Alkermes, Inc.

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Diabetes Mellitus, Type 2

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Crossover Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

142 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Experimental

Arm Description

Arm Title

Arm Type

Experimental

Arm Description

Intervention Type

Drug

Intervention Name(s)

Human Insulin Inhalation Powder

Other Intervention Name(s)

LY041001

Intervention Description

patient specific dose, inhaled, before meals, 24 weeks

Intervention Type

Drug

Intervention Name(s)

Insulin Glargine

Intervention Description

patient specific dose, injectable, before meals, 24 weeks

Primary Outcome Measure Information:

Title

Time Frame

56 weeks

Secondary Outcome Measure Information:

Title

Mean change in HbA1c from baseline to various timepoints

Time Frame

56 weeks

Title

Insulin dose requirements

Time Frame

56 weeks

Title

Patient-reported outcomes of W-BQ12

Time Frame

screening,baseline, week 12,24, and 48

Title

Hypoglycemia rate

Time Frame

throughout the study

Title

Changes in body weight

Time Frame

every visit

Title

Adverse events

Time Frame

throughout the study

Title

Safety as assessed by total pulmonary function testing and fasting lipid profile

Time Frame

throughout the study

Title

Assess inhaler reliability.

Time Frame

throughout the study

Title

Patient Reported outcomes of DSC-R

Time Frame

screening,baseline, week 12,24, and 48

Title

Patient reported outcomes of DTSQS

Time Frame

screening,baseline, week 12, 24 and 48

Title

Patient reported outcome of IDSQ

Time Frame

week 12, 24, and 48

Title

Patient reported outcome of preference questionnaire

Time Frame

week 48

Title

Patient reported outcome of Expectations About Insulin Therapy Questionnaire

Time Frame

screening,baseline

Title

Patient reported outcome of Experience with Insulin Therapy Questionnaire

Time Frame

week 12, 24 and 48

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

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)

Organizational Affiliation

Eli Lilly and Company

Official's Role

Study Director

Facility Information:

Facility Name

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.

City

Greenbrae

State/Province

California

ZIP/Postal Code

94904

Country

United States

Facility Name

City

Topeka

State/Province

Kansas

ZIP/Postal Code

66606

Country

United States

Facility Name

City

Toms River

State/Province

New Jersey

ZIP/Postal Code

08753

Country

United States

Facility Name

City

Albuquerque

State/Province

New Mexico

ZIP/Postal Code

87108

Country

United States

Facility Name

City

New Braunfels

State/Province

Texas

ZIP/Postal Code

78130

Country

United States

Facility Name

City

San Antonio

State/Province

Texas

ZIP/Postal Code

78229

Country

United States

Facility Name

City

Porto Alegre

ZIP/Postal Code

90035-003

Country

Brazil

Facility Name

City

Sao Paulo

ZIP/Postal Code

04025-011

Country

Brazil

Facility Name

City

Cochin

ZIP/Postal Code

682026

Country

India

Facility Name

City

Indore

ZIP/Postal Code

452 003

Country

India

Facility Name

City

Pune

ZIP/Postal Code

411005

Country

India

Facility Name

City

Vellore

ZIP/Postal Code

632 004

Country

India

Facility Name

City

Manatí

ZIP/Postal Code

00674

Country

Puerto Rico

Facility Name

City

San Juan

ZIP/Postal Code

00907

Country

Puerto Rico

Facility Name

City

Barakaldo

ZIP/Postal Code

48903

Country

Spain

Facility Name

City

Dos Hermanas

ZIP/Postal Code

41014

Country

Spain

Facility Name

City

Madrid

ZIP/Postal Code

28006

Country

Spain

Facility Name

City

Requena

ZIP/Postal Code

46340

Country

Spain

Facility Name

City

Sabadell

ZIP/Postal Code

08208

Country

Spain

12. IPD Sharing Statement

Links:

URL

https://www.lilly.com/clinical-study-report-csr-synopses

Description

Lilly CSR Synopsis

Learn more about this trial

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

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