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Evaluation of the Effect on Glucose Control of AC2993 in Patients With Type 2 Diabetes Mellitus Treated With a Sulfonylurea

Primary Purpose

Diabetes Mellitus, Non-Insulin-Dependent

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
AC2993
AC2993
Placebo
Placebo
Sponsored by
AstraZeneca
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetes Mellitus, Non-Insulin-Dependent focused on measuring Type 2 Diabetes Mellitis

Eligibility Criteria

16 Years - 75 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Subjects with Type 2 diabetes mellitus Treated with a sulfonylurea at defined doses for at least 3 months prior to screening BMI= 27-45 kg/m2 HbA1c value between 7.5% and 11% Exclusion Criteria: Treated with oral anti-diabetic medications other than a sulfonylurea within 3 months of screening Patients treated previously with AC2993 Patients presently treated with insulin

Sites / Locations

  • Pinnacle Research Group
  • Parkway Medical Center
  • Alabama Clinical Therapeutics
  • Eclectic Family Care
  • Winston Physician Services
  • Simon Williamson Clinic
  • Extended Arm Physicians/ Southern Drug
  • Southern Drug Research Network
  • Clinic of Physicians and Surgeons, Ltd.
  • ANA Ventures, LLC
  • Lovelace Scientific Resources-Phoenix
  • Physicians at the Peak
  • Advanced Clinical Therapeutics
  • CAVHS
  • Physicians Group Research Clinic, LLC
  • Advanced Clinical Research Institute
  • Mitchell Research Group, Inc.
  • William Zigrang, M.D.
  • International Clinical Research Network
  • Arrowhead Regional Medical Center
  • East Bay Clinical Trial Center
  • Valley Research
  • Tushar Modi, M.D.
  • Elke Jost-Vu, M.D.
  • Comprehensive Diabetes-Endocrine Medical Associates
  • nTouch
  • Radiant Research-San Diego
  • Veterans Medical Research Foundation
  • Diabetes Research Institute of Mills Peninsula
  • Advanced Clinical Research Institute
  • West Coast Clinical Trials
  • Protocare Trials at Sharp Mission Park
  • Diablo Clinical Research
  • George Washington University
  • Internal Medicine Associates
  • Clin Sci International
  • University of FL
  • Jupiter Research Institute
  • Baptist Diabetes Associates
  • Tampa Medical Group
  • Metabolic Research Institute, Inc.
  • Radiant Research
  • Clinical Research Atlanta
  • nTouch Research Corporation
  • East-West Medical Research Institute
  • St. Luke's Family Health
  • University Primary Care Center at Belvidere
  • Northwestern Memorial Physicians Group
  • Illinois Center for Clinical Trials
  • Medical Group of Fort Wayne
  • American Health Network
  • nTouch Research-South Bend
  • Kentucky Diabetes Center
  • University of Kentucky Metabolic Research Group
  • MedResearch, Inc.
  • Drug Research Services
  • New Orleans Institute of Clinical Investigation
  • Ochsner Clinic
  • St. Agnes Health Care
  • Doctors Research Associates of Maryland
  • Grunberger Diabetes Medical Center
  • Henry Ford Health System
  • Grand Rapids Associated Interns
  • University of Mississippi Medical Center
  • Diabetes and Endocrinology Specialists
  • Mid Missouri Research Specialists, Inc.
  • Radiant Research-St. Louis
  • Midwest Pharmaceutical Research
  • Mercury Street Medical
  • Lovelace Scientific Resources-Las Vegas
  • HIS Clinical Research
  • Radiant Research-Moorestown
  • Lovelace Scientific Resources
  • Medical Network Services, P.C.
  • St. Lukes Roosevelt Hospital
  • Naomi Berrie Diabetes Center at Columbia University
  • Heights Medical Care
  • DOCS at Beth Israel Medical Center
  • Metrolina Medical Research
  • Charlotte Clinical Research
  • UNC Diabetes Care Center
  • Unifour Medical Research
  • New Hanover Medical Research Associates
  • Piedmont Medical Research
  • Rapid Medical Research
  • Ohio State University-Division of Endocrinology
  • Radiant Research-Columbus
  • University Mednet
  • Comprehensive Research Services, Inc.
  • COR Clinical Research
  • nTouch Research Corporation-Oklahoma City
  • Utica Park Clinic
  • Medford Medical Clinic
  • Legacy Clinical Research
  • Radiant Research
  • Physicians for Clinical Research
  • Thomas Jefferson University Diabetes Research Center
  • Philadelphia Health Associates
  • Tipton Medical and Diagnostic Center
  • Safe Harbor Clinical Research
  • Radiant Research-Charleston
  • CNS Clinical Trials
  • Coastal Carolina Research Center
  • Integrity Clinical Research
  • Harmony Clinical Research
  • Holston Medical Group
  • Endocrine Consultants of ET
  • Central Texas Clinical Research
  • Texas Tech University Health Sciences-Internal Medicine
  • Internal Medicine Associates
  • North Texas Clinical Research
  • Dr. Humberto Bruschetta
  • South Texas Applied Research
  • University of Texas Health Sciences Center-Texas Diabetes Institute
  • Diabetes and Glandular Disease Clinic
  • SAM Clinical Research Center
  • Salt Lake Research
  • Clinical Research Center-Eastern Virginia Medical School
  • West Olympia Internal Medicine
  • Rainier Clinical Research Center
  • Northside Internal Medicine
  • Rockwood Clinic
  • Julia M. Hutchinson, M.D.
  • Wenatchee Valley Clinic
  • Hyperion Clinical Research
  • CAMC Clinical Trials Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Placebo Comparator

Placebo Comparator

Arm Label

AC2993 5 mcg (0.02 mL)

AC2993 10mcg (0.04 mL)

Placebo 0.02 mL

Placebo 0.04 mL

Arm Description

Placebo, then AC2993 5 mcg, then AC2993 5 mcg

Placebo, then AC2993 5 mcg, then AC2993 10 mcg

Placebo 0.02 mL, then Placebo 0.02 mL, then Placebo 0.02 mL

Placebo 0.02 mL / Placebo 0.02 mL / Placebo 0.04 mL

Outcomes

Primary Outcome Measures

Change in HbA1c from Baseline to Week 30
Change in HbA1c from Baseline (Day 1) to study termination (Week 30)

Secondary Outcome Measures

Change in HbA1c from baseline (Day 1) to each of the intermediate visits
Change in HbA1c from baseline, measured from Visit 3 (Day 1) to each of the intermediate visits (Baseline (Day 1), Week 2, Week 4, Week 6, Week 12, Week 18, and Week 24
The number of subjects achieving HbA1c target values of < 7% and < 8% by Week 30
The number of subjects achieving HbA1c target values of < 7% and < 8% by study termination (Week 30)
The number of subjects achieving HbA1c reductions of > 0.5% and > 1.0% by Week 30
The number of subjects achieving HbA1c reductions of > 0.5% and > 1.0% by study termination (Week 30)
The time to achieve HbA1c reductions of 0.5% or more and >1.0% or more
The time it takes subjects to achieve HbA1c reductions of 0.5% or more and >1.0% or more
The time to achieve specific HbA1c target values of < 7% and < 8%
The time it takes subjects to achieve HbA1c target values of < 7% and < 8%
Change in body weight from Baseline to each intermediate visit and Week 30
Change in body weight (kg) from Baseline to each intermediate visit and Week 30

Full Information

First Posted
June 6, 2002
Last Updated
February 23, 2015
Sponsor
AstraZeneca
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1. Study Identification

Unique Protocol Identification Number
NCT00039026
Brief Title
Evaluation of the Effect on Glucose Control of AC2993 in Patients With Type 2 Diabetes Mellitus Treated With a Sulfonylurea
Official Title
A Phase 3, Randomized, Triple-Blind, Parallel-Group, Long-Term, Placebo-Controlled, Multicenter Study to Examine the Effect on Glucose Control (HbA1c) of AC2993 Given Two Times a Day in Subjects With Type 2 Diabetes Mellitus Treated With a Sulfonylurea Alone
Study Type
Interventional

2. Study Status

Record Verification Date
January 2015
Overall Recruitment Status
Completed
Study Start Date
February 2002 (undefined)
Primary Completion Date
August 2003 (Actual)
Study Completion Date
August 2003 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AstraZeneca

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
This is a multicenter, randomized, blinded, placebo-controlled study to assess the effects on glucose control of AC2993 as compared to placebo in patients with type 2 diabetes. Patients will be randomized into one of two AC2993 treatment arms or to placebo treatment and will continue with their required existing diabetes medication (sulfonylurea) throughout the study.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Non-Insulin-Dependent
Keywords
Type 2 Diabetes Mellitis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
377 (Actual)

8. Arms, Groups, and Interventions

Arm Title
AC2993 5 mcg (0.02 mL)
Arm Type
Experimental
Arm Description
Placebo, then AC2993 5 mcg, then AC2993 5 mcg
Arm Title
AC2993 10mcg (0.04 mL)
Arm Type
Experimental
Arm Description
Placebo, then AC2993 5 mcg, then AC2993 10 mcg
Arm Title
Placebo 0.02 mL
Arm Type
Placebo Comparator
Arm Description
Placebo 0.02 mL, then Placebo 0.02 mL, then Placebo 0.02 mL
Arm Title
Placebo 0.04 mL
Arm Type
Placebo Comparator
Arm Description
Placebo 0.02 mL / Placebo 0.02 mL / Placebo 0.04 mL
Intervention Type
Drug
Intervention Name(s)
AC2993
Other Intervention Name(s)
synthetic exendin-4
Intervention Description
Placebo Lead In (0.02 mL) for 4 weeks / AC2993 5mcg (0.02 mL) for 4 weeks / AC2993 5mcg (0.02 mL) for 26 weeks - All are subcutaneously injected twice daily
Intervention Type
Drug
Intervention Name(s)
AC2993
Other Intervention Name(s)
synthetic exendin-4
Intervention Description
Placebo Lead In (0.02 mL) for 4 weeks / AC2993 5mcg (0.02 mL) for 4 weeks / AC2993 5mcg (0.02 mL) for 26 weeks - All are subcutaneously injected twice daily
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo Lead In (0.02 mL) for 4 weeks / Placebo (0.02 mL) for 4 weeks / Placebo (0.02 mL) for 26 weeks - All are subcutaneously injected twice daily
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo Lead In (0.02 mL) for 4 weeks / Placebo mcg (0.02 mL) for 4 weeks / Placebo (0.04 mL) for 26 weeks - All are subcutaneously injected twice daily
Primary Outcome Measure Information:
Title
Change in HbA1c from Baseline to Week 30
Description
Change in HbA1c from Baseline (Day 1) to study termination (Week 30)
Time Frame
Baseline (Day 1) to Week 30
Secondary Outcome Measure Information:
Title
Change in HbA1c from baseline (Day 1) to each of the intermediate visits
Description
Change in HbA1c from baseline, measured from Visit 3 (Day 1) to each of the intermediate visits (Baseline (Day 1), Week 2, Week 4, Week 6, Week 12, Week 18, and Week 24
Time Frame
Baseline (Day 1), Week 2, Week 4, Week 6, Week 12, Week 18, Week 24
Title
The number of subjects achieving HbA1c target values of < 7% and < 8% by Week 30
Description
The number of subjects achieving HbA1c target values of < 7% and < 8% by study termination (Week 30)
Time Frame
Baseline (Day 1) and Week 30
Title
The number of subjects achieving HbA1c reductions of > 0.5% and > 1.0% by Week 30
Description
The number of subjects achieving HbA1c reductions of > 0.5% and > 1.0% by study termination (Week 30)
Time Frame
Baseline (Day 1), and Week 30
Title
The time to achieve HbA1c reductions of 0.5% or more and >1.0% or more
Description
The time it takes subjects to achieve HbA1c reductions of 0.5% or more and >1.0% or more
Time Frame
Baseline (Day 1), Week 2, Week 4, Week 6, Week 12, Week 18, Week 24, Week 30
Title
The time to achieve specific HbA1c target values of < 7% and < 8%
Description
The time it takes subjects to achieve HbA1c target values of < 7% and < 8%
Time Frame
Baseline (Day 1), Week 2, Week 4, Week 6, Week 12, Week 18, Week 24, Week 30
Title
Change in body weight from Baseline to each intermediate visit and Week 30
Description
Change in body weight (kg) from Baseline to each intermediate visit and Week 30
Time Frame
Baseline (Day 1), Week 2, Week 4, Week 6, Week 12, Week 18, Week 24, Week 30

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Subjects with Type 2 diabetes mellitus Treated with a sulfonylurea at defined doses for at least 3 months prior to screening BMI= 27-45 kg/m2 HbA1c value between 7.5% and 11% Exclusion Criteria: Treated with oral anti-diabetic medications other than a sulfonylurea within 3 months of screening Patients treated previously with AC2993 Patients presently treated with insulin
Facility Information:
Facility Name
Pinnacle Research Group
City
Anniston
State/Province
Alabama
ZIP/Postal Code
36207
Country
United States
Facility Name
Parkway Medical Center
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35206
Country
United States
Facility Name
Alabama Clinical Therapeutics
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35235
Country
United States
Facility Name
Eclectic Family Care
City
Eclectic
State/Province
Alabama
ZIP/Postal Code
36024
Country
United States
Facility Name
Winston Physician Services
City
Haleyville
State/Province
Alabama
ZIP/Postal Code
35565
Country
United States
Facility Name
Simon Williamson Clinic
City
Hueytown
State/Province
Alabama
ZIP/Postal Code
35023
Country
United States
Facility Name
Extended Arm Physicians/ Southern Drug
City
Montgomery
State/Province
Alabama
ZIP/Postal Code
36106
Country
United States
Facility Name
Southern Drug Research Network
City
Tallassee
State/Province
Alabama
ZIP/Postal Code
36078
Country
United States
Facility Name
Clinic of Physicians and Surgeons, Ltd.
City
Mesa
State/Province
Arizona
ZIP/Postal Code
85201
Country
United States
Facility Name
ANA Ventures, LLC
City
Mesa
State/Province
Arizona
ZIP/Postal Code
85204
Country
United States
Facility Name
Lovelace Scientific Resources-Phoenix
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85016
Country
United States
Facility Name
Physicians at the Peak
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85020
Country
United States
Facility Name
Advanced Clinical Therapeutics
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85712
Country
United States
Facility Name
CAVHS
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72205
Country
United States
Facility Name
Physicians Group Research Clinic, LLC
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72205
Country
United States
Facility Name
Advanced Clinical Research Institute
City
Anaheim
State/Province
California
ZIP/Postal Code
92801
Country
United States
Facility Name
Mitchell Research Group, Inc.
City
Bakersfield
State/Province
California
ZIP/Postal Code
93309
Country
United States
Facility Name
William Zigrang, M.D.
City
Burlingame
State/Province
California
ZIP/Postal Code
94010
Country
United States
Facility Name
International Clinical Research Network
City
Chula Vista
State/Province
California
ZIP/Postal Code
91910
Country
United States
Facility Name
Arrowhead Regional Medical Center
City
Colton
State/Province
California
ZIP/Postal Code
92324
Country
United States
Facility Name
East Bay Clinical Trial Center
City
Concord
State/Province
California
Country
United States
Facility Name
Valley Research
City
Fresno
State/Province
California
ZIP/Postal Code
93720
Country
United States
Facility Name
Tushar Modi, M.D.
City
Modesto
State/Province
California
ZIP/Postal Code
95350
Country
United States
Facility Name
Elke Jost-Vu, M.D.
City
Rancho Mirage
State/Province
California
ZIP/Postal Code
92270
Country
United States
Facility Name
Comprehensive Diabetes-Endocrine Medical Associates
City
Redwood City
State/Province
California
ZIP/Postal Code
94062
Country
United States
Facility Name
nTouch
City
San Diego
State/Province
California
ZIP/Postal Code
92103
Country
United States
Facility Name
Radiant Research-San Diego
City
San Diego
State/Province
California
ZIP/Postal Code
92108
Country
United States
Facility Name
Veterans Medical Research Foundation
City
San Diego
State/Province
California
ZIP/Postal Code
92161
Country
United States
Facility Name
Diabetes Research Institute of Mills Peninsula
City
San Mateo
State/Province
California
ZIP/Postal Code
94401
Country
United States
Facility Name
Advanced Clinical Research Institute
City
Santa Ana
State/Province
California
ZIP/Postal Code
92701
Country
United States
Facility Name
West Coast Clinical Trials
City
Signal Hill
State/Province
California
ZIP/Postal Code
90755
Country
United States
Facility Name
Protocare Trials at Sharp Mission Park
City
Vista
State/Province
California
ZIP/Postal Code
92083
Country
United States
Facility Name
Diablo Clinical Research
City
Walnut Creek
State/Province
California
ZIP/Postal Code
94598
Country
United States
Facility Name
George Washington University
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20037
Country
United States
Facility Name
Internal Medicine Associates
City
Ft. Myers
State/Province
Florida
ZIP/Postal Code
33901
Country
United States
Facility Name
Clin Sci International
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32605
Country
United States
Facility Name
University of FL
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32610-0226
Country
United States
Facility Name
Jupiter Research Institute
City
Jupiter
State/Province
Florida
ZIP/Postal Code
33458
Country
United States
Facility Name
Baptist Diabetes Associates
City
Miami
State/Province
Florida
ZIP/Postal Code
33176
Country
United States
Facility Name
Tampa Medical Group
City
Tampa
State/Province
Florida
ZIP/Postal Code
33614
Country
United States
Facility Name
Metabolic Research Institute, Inc.
City
West Palm Beach
State/Province
Florida
ZIP/Postal Code
33401
Country
United States
Facility Name
Radiant Research
City
West Palm Beach
State/Province
Florida
ZIP/Postal Code
33407
Country
United States
Facility Name
Clinical Research Atlanta
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30342
Country
United States
Facility Name
nTouch Research Corporation
City
Decatur
State/Province
Georgia
ZIP/Postal Code
30033
Country
United States
Facility Name
East-West Medical Research Institute
City
Honolulu
State/Province
Hawaii
ZIP/Postal Code
96813
Country
United States
Facility Name
St. Luke's Family Health
City
Meridian
State/Province
Idaho
ZIP/Postal Code
83642
Country
United States
Facility Name
University Primary Care Center at Belvidere
City
Belvidere
State/Province
Illinois
ZIP/Postal Code
61008
Country
United States
Facility Name
Northwestern Memorial Physicians Group
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60602
Country
United States
Facility Name
Illinois Center for Clinical Trials
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60610
Country
United States
Facility Name
Medical Group of Fort Wayne
City
Fort Wayne
State/Province
Indiana
ZIP/Postal Code
46804
Country
United States
Facility Name
American Health Network
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46222
Country
United States
Facility Name
nTouch Research-South Bend
City
South Bend
State/Province
Indiana
ZIP/Postal Code
46601
Country
United States
Facility Name
Kentucky Diabetes Center
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40503
Country
United States
Facility Name
University of Kentucky Metabolic Research Group
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40536-9841
Country
United States
Facility Name
MedResearch, Inc.
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40223
Country
United States
Facility Name
Drug Research Services
City
Metairie
State/Province
Louisiana
ZIP/Postal Code
70001
Country
United States
Facility Name
New Orleans Institute of Clinical Investigation
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70112
Country
United States
Facility Name
Ochsner Clinic
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70121
Country
United States
Facility Name
St. Agnes Health Care
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21229
Country
United States
Facility Name
Doctors Research Associates of Maryland
City
Lanham
State/Province
Maryland
ZIP/Postal Code
20706
Country
United States
Facility Name
Grunberger Diabetes Medical Center
City
Bloomfield Hills
State/Province
Michigan
ZIP/Postal Code
48302
Country
United States
Facility Name
Henry Ford Health System
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States
Facility Name
Grand Rapids Associated Interns
City
Grand Rapids
State/Province
Michigan
ZIP/Postal Code
49506
Country
United States
Facility Name
University of Mississippi Medical Center
City
Jackson
State/Province
Mississippi
ZIP/Postal Code
39216
Country
United States
Facility Name
Diabetes and Endocrinology Specialists
City
Chesterfield
State/Province
Missouri
ZIP/Postal Code
63017
Country
United States
Facility Name
Mid Missouri Research Specialists, Inc.
City
Rolla
State/Province
Missouri
ZIP/Postal Code
65401
Country
United States
Facility Name
Radiant Research-St. Louis
City
St. Louis
State/Province
Missouri
ZIP/Postal Code
63141
Country
United States
Facility Name
Midwest Pharmaceutical Research
City
St. Peters
State/Province
Missouri
ZIP/Postal Code
63376
Country
United States
Facility Name
Mercury Street Medical
City
Butte
State/Province
Montana
ZIP/Postal Code
59701
Country
United States
Facility Name
Lovelace Scientific Resources-Las Vegas
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89102
Country
United States
Facility Name
HIS Clinical Research
City
Jersey City
State/Province
New Jersey
ZIP/Postal Code
07306
Country
United States
Facility Name
Radiant Research-Moorestown
City
Moorestown
State/Province
New Jersey
ZIP/Postal Code
08057
Country
United States
Facility Name
Lovelace Scientific Resources
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87108
Country
United States
Facility Name
Medical Network Services, P.C.
City
Brooklyn
State/Province
New York
ZIP/Postal Code
11230
Country
United States
Facility Name
St. Lukes Roosevelt Hospital
City
New York
State/Province
New York
ZIP/Postal Code
10025
Country
United States
Facility Name
Naomi Berrie Diabetes Center at Columbia University
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Facility Name
Heights Medical Care
City
New York
State/Province
New York
ZIP/Postal Code
10033
Country
United States
Facility Name
DOCS at Beth Israel Medical Center
City
Yonkers
State/Province
New York
ZIP/Postal Code
10710
Country
United States
Facility Name
Metrolina Medical Research
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28209
Country
United States
Facility Name
Charlotte Clinical Research
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28211
Country
United States
Facility Name
UNC Diabetes Care Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27713
Country
United States
Facility Name
Unifour Medical Research
City
Hickory
State/Province
North Carolina
ZIP/Postal Code
28601
Country
United States
Facility Name
New Hanover Medical Research Associates
City
Wilmington
State/Province
North Carolina
ZIP/Postal Code
28412
Country
United States
Facility Name
Piedmont Medical Research
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27103
Country
United States
Facility Name
Rapid Medical Research
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44124
Country
United States
Facility Name
Ohio State University-Division of Endocrinology
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Facility Name
Radiant Research-Columbus
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43212
Country
United States
Facility Name
University Mednet
City
Mentor
State/Province
Ohio
ZIP/Postal Code
44060
Country
United States
Facility Name
Comprehensive Research Services, Inc.
City
Mogadore
State/Province
Ohio
ZIP/Postal Code
44260
Country
United States
Facility Name
COR Clinical Research
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73103
Country
United States
Facility Name
nTouch Research Corporation-Oklahoma City
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73112
Country
United States
Facility Name
Utica Park Clinic
City
Tulsa
State/Province
Oklahoma
ZIP/Postal Code
74104
Country
United States
Facility Name
Medford Medical Clinic
City
Medford
State/Province
Oregon
ZIP/Postal Code
97504
Country
United States
Facility Name
Legacy Clinical Research
City
Portland
State/Province
Oregon
ZIP/Postal Code
97232
Country
United States
Facility Name
Radiant Research
City
Portland
State/Province
Oregon
Country
United States
Facility Name
Physicians for Clinical Research
City
Camp Hill
State/Province
Pennsylvania
ZIP/Postal Code
17011
Country
United States
Facility Name
Thomas Jefferson University Diabetes Research Center
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
Facility Name
Philadelphia Health Associates
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19146
Country
United States
Facility Name
Tipton Medical and Diagnostic Center
City
Tipton
State/Province
Pennsylvania
ZIP/Postal Code
16684
Country
United States
Facility Name
Safe Harbor Clinical Research
City
East Providence
State/Province
Rhode Island
ZIP/Postal Code
02914
Country
United States
Facility Name
Radiant Research-Charleston
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29407
Country
United States
Facility Name
CNS Clinical Trials
City
Chester
State/Province
South Carolina
ZIP/Postal Code
29706
Country
United States
Facility Name
Coastal Carolina Research Center
City
Mt. Pleasant
State/Province
South Carolina
ZIP/Postal Code
29464
Country
United States
Facility Name
Integrity Clinical Research
City
Jackson
State/Province
Tennessee
ZIP/Postal Code
38305
Country
United States
Facility Name
Harmony Clinical Research
City
Johnson City
State/Province
Tennessee
ZIP/Postal Code
37601
Country
United States
Facility Name
Holston Medical Group
City
Kingsport
State/Province
Tennessee
ZIP/Postal Code
37660
Country
United States
Facility Name
Endocrine Consultants of ET
City
Knoxville
State/Province
Tennessee
ZIP/Postal Code
37909
Country
United States
Facility Name
Central Texas Clinical Research
City
Austin
State/Province
Texas
ZIP/Postal Code
78705
Country
United States
Facility Name
Texas Tech University Health Sciences-Internal Medicine
City
El Paso
State/Province
Texas
ZIP/Postal Code
79905
Country
United States
Facility Name
Internal Medicine Associates
City
El Paso
State/Province
Texas
ZIP/Postal Code
79912
Country
United States
Facility Name
North Texas Clinical Research
City
Irving
State/Province
Texas
ZIP/Postal Code
75038
Country
United States
Facility Name
Dr. Humberto Bruschetta
City
Kingsville
State/Province
Texas
ZIP/Postal Code
78363
Country
United States
Facility Name
South Texas Applied Research
City
McAllen
State/Province
Texas
ZIP/Postal Code
78503
Country
United States
Facility Name
University of Texas Health Sciences Center-Texas Diabetes Institute
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78207
Country
United States
Facility Name
Diabetes and Glandular Disease Clinic
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229-3894
Country
United States
Facility Name
SAM Clinical Research Center
City
San Antonio
State/Province
Texas
Country
United States
Facility Name
Salt Lake Research
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84124
Country
United States
Facility Name
Clinical Research Center-Eastern Virginia Medical School
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23507
Country
United States
Facility Name
West Olympia Internal Medicine
City
Olympia
State/Province
Washington
ZIP/Postal Code
98502
Country
United States
Facility Name
Rainier Clinical Research Center
City
Renton
State/Province
Washington
ZIP/Postal Code
98055
Country
United States
Facility Name
Northside Internal Medicine
City
Spokane
State/Province
Washington
ZIP/Postal Code
99201
Country
United States
Facility Name
Rockwood Clinic
City
Spokane
State/Province
Washington
ZIP/Postal Code
99202
Country
United States
Facility Name
Julia M. Hutchinson, M.D.
City
Spokane
State/Province
Washington
ZIP/Postal Code
99204
Country
United States
Facility Name
Wenatchee Valley Clinic
City
Wenatchee
State/Province
Washington
ZIP/Postal Code
98801
Country
United States
Facility Name
Hyperion Clinical Research
City
Charleston
State/Province
West Virginia
ZIP/Postal Code
25301
Country
United States
Facility Name
CAMC Clinical Trials Center
City
Charleston
State/Province
West Virginia
ZIP/Postal Code
25304
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
15504997
Citation
Buse JB, Henry RR, Han J, Kim DD, Fineman MS, Baron AD; Exenatide-113 Clinical Study Group. Effects of exenatide (exendin-4) on glycemic control over 30 weeks in sulfonylurea-treated patients with type 2 diabetes. Diabetes Care. 2004 Nov;27(11):2628-35. doi: 10.2337/diacare.27.11.2628.
Results Reference
result
PubMed Identifier
22913891
Citation
Pencek R, Blickensderfer A, Li Y, Brunell SC, Anderson PW. Exenatide twice daily: analysis of effectiveness and safety data stratified by age, sex, race, duration of diabetes, and body mass index. Postgrad Med. 2012 Jul;124(4):21-32. doi: 10.3810/pgm.2012.07.2567.
Results Reference
derived
PubMed Identifier
22236356
Citation
Fineman MS, Mace KF, Diamant M, Darsow T, Cirincione BB, Booker Porter TK, Kinninger LA, Trautmann ME. Clinical relevance of anti-exenatide antibodies: safety, efficacy and cross-reactivity with long-term treatment. Diabetes Obes Metab. 2012 Jun;14(6):546-54. doi: 10.1111/j.1463-1326.2012.01561.x. Epub 2012 Feb 10.
Results Reference
derived

Learn more about this trial

Evaluation of the Effect on Glucose Control of AC2993 in Patients With Type 2 Diabetes Mellitus Treated With a Sulfonylurea

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