A Clinical Trial Comparing The Efficacy And Safety Of 2 Different Initial Dose Prescriptions For Exubera.

Back to results

Primary Purpose

Status

Terminated

Phase

Phase 4

Locations

International

Study Type

Interventional

Intervention

Inhaled Human Insulin (Exubera)

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:

Diabetes mellitus Type 2
Currently treated with at least 2 oral anti-diabetic agents

Exclusion Criteria:

Severe Asthma, severe COPD
Smoking

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Control

Experimental

Arm Description

Outcomes

Primary Outcome Measures

Change in HbA1c From Baseline

Mean change of hemoglobin A1c (HbA1c %) from baseline to week 16

Secondary Outcome Measures

Fasting Plasma Glucose, and Overall Absolute, Pre-meal, and Post-meal Blood Glucose Change From Baseline to Week 16 (LOCF)

Mean change of fasting plasma glucose, and overall absolute (based on the mean of 7-point home blood glucose monitoring (HGM) values), pre- and post-meal blood glucose (based on the mean of pre- or post-meal HGM values). Change from pre- to post-meal blood glucose based on the mean of difference of pre-meal HGM values from post-meal HGM values.

Number of Subjects Who Experienced Hypoglycemia and Nocturnal Hypoglycemia

Cumulative Number Subjects Who Experienced Hypoglycemia & Nocturnal Hypoglycemia. Hypoglycemia:1)Clinical picture includes prompt resolution with food intake, subcutaneous glucagon, or intravenous glucose, 2)blood glucose check showing glucose <3.27 mmol/L (59 mg/dl), 3)glucose measurement of 2.7 mmol/L (49 mg/dl) or less, with or without symptoms.

Hypoglycemia Event Rate Per Month

Monthly event rate was calculated as the daily event rate multiplied by 30, and the daily event rate was calculated as the total number of events divided by the days in study up to the specified timepoint (ie, Week 4 or Week 16).

Full Information

NCT ID

NCT00437489

First Posted

February 20, 2007

Last Updated

April 13, 2009

Sponsor

Pfizer

1. Study Identification

Unique Protocol Identification Number

NCT00437489

Brief Title

A Clinical Trial Comparing The Efficacy And Safety Of 2 Different Initial Dose Prescriptions For Exubera.

Official Title

A 16 Week Open-Label Outpatient, Randomized, Parallel Study Assessing The Impact Of Two Different Initial Dose Prescriptions For Dry Powder Inhaled Insulin (Exubera®) On Glycemic Control In Patients With Type 2 Diabetes Mellitus Who Are Poorly Controlled On A Combination Of Two Or More Oral Agents.

Study Type

Interventional

2. Study Status

Record Verification Date

February 2009

Overall Recruitment Status

Terminated

Why Stopped

This protocol was terminated not for safety reasons, but because Pfizer decided to return the worldwide rights for Exubera to Nektar, on 18 October 2007.

Study Start Date

June 2007 (undefined)

Primary Completion Date

December 2007 (Actual)

Study Completion Date

December 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Pfizer

4. Oversight

Data Monitoring Committee

No

5. Study Description

Brief Summary

The primary objective of this study is to assess whether a simple initial dose prescription of inhaled insulin (Exubera) achieves glycemic control (HbA1c) after 16 weeks that is non-inferior compared to the standard weight-based formula.

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 4

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

49 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Control

Arm Type

Active Comparator

Arm Title

Experimental

Arm Type

Experimental

Intervention Type

Drug

Intervention Name(s)

Inhaled Human Insulin (Exubera)

Intervention Description

Initial dose (mg) as per weight based formula = 0.05 x body weight (kg) TID

Intervention Type

Drug

Intervention Name(s)

Inhaled Human Insulin (Exubera)

Intervention Description

Initial dose of 1mg TID of inhaled human insulin

Primary Outcome Measure Information:

Title

Change in HbA1c From Baseline

Description

Mean change of hemoglobin A1c (HbA1c %) from baseline to week 16

Time Frame

From baseline to week 16

Secondary Outcome Measure Information:

Title

Fasting Plasma Glucose, and Overall Absolute, Pre-meal, and Post-meal Blood Glucose Change From Baseline to Week 16 (LOCF)

Description

Mean change of fasting plasma glucose, and overall absolute (based on the mean of 7-point home blood glucose monitoring (HGM) values), pre- and post-meal blood glucose (based on the mean of pre- or post-meal HGM values). Change from pre- to post-meal blood glucose based on the mean of difference of pre-meal HGM values from post-meal HGM values.

Time Frame

From baseline to week 16

Title

Number of Subjects Who Experienced Hypoglycemia and Nocturnal Hypoglycemia

Description

Cumulative Number Subjects Who Experienced Hypoglycemia & Nocturnal Hypoglycemia. Hypoglycemia:1)Clinical picture includes prompt resolution with food intake, subcutaneous glucagon, or intravenous glucose, 2)blood glucose check showing glucose <3.27 mmol/L (59 mg/dl), 3)glucose measurement of 2.7 mmol/L (49 mg/dl) or less, with or without symptoms.

Time Frame

week 16

Title

Hypoglycemia Event Rate Per Month

Description

Monthly event rate was calculated as the daily event rate multiplied by 30, and the daily event rate was calculated as the total number of events divided by the days in study up to the specified timepoint (ie, Week 4 or Week 16).

Time Frame

up to week 4 or 16

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

No

Eligibility Criteria

Inclusion Criteria: Diabetes mellitus Type 2 Currently treated with at least 2 oral anti-diabetic agents Exclusion Criteria: Severe Asthma, severe COPD Smoking

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Pfizer CT.gov Call Center

Organizational Affiliation

Pfizer

Official's Role

Study Director

Facility Information:

Facility Name

Pfizer Investigational Site

City

Hong Kong

Country

Hong Kong

Facility Name

Pfizer Investigational Site

City

Karachi

State/Province

Sindh

ZIP/Postal Code

74600

Country

Pakistan

Facility Name

Pfizer Investigational Site

City

Makati

ZIP/Postal Code

1218

Country

Philippines

Facility Name

Pfizer Investigational Site

City

Marikina City

ZIP/Postal Code

1810

Country

Philippines

Facility Name

Pfizer Investigational Site

City

Pasay City

ZIP/Postal Code

1300

Country

Philippines

Facility Name

Pfizer Investigational Site

City

Pasig City

ZIP/Postal Code

1605

Country

Philippines

Facility Name

Pfizer Investigational Site

City

Quezon City

ZIP/Postal Code

1102

Country

Philippines

Facility Name

Pfizer Investigational Site

City

Singapore

ZIP/Postal Code

119074

Country

Singapore

Facility Name

Pfizer Investigational Site

City

Singapore

ZIP/Postal Code

159964

Country

Singapore

12. IPD Sharing Statement

Links:

URL

https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A2171086&StudyName=A%20Clinical%20Trial%20Comparing%20The%20Efficacy%20And%20Safety%20Of%202%20Different%20Initial%20Dose%20Prescriptions%20For%20Exubera.

Description

To obtain contact information for a study center near you, click here.

Diabetes Mellitus, Type 2

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial