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Efficacy and Safety of Exenatide Once Weekly Suspension in Subjects With Type 2 Diabetes (DURATION-NEO-1)

Primary Purpose

Diabetes Mellitus, Type 2

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Exenatide once weekly suspension
Exenatide twice daily
Sponsored by
AstraZeneca
About
Eligibility
Locations
Arms
Outcomes
Full info

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:

  • At least 18 years old
  • Diagnosed with type 2 diabetes mellitus
  • HbA1c 7.1 to 11%, inclusive, at screening
  • Fasting plasma glucose <280 mg/dL (15.5 mmol/L)
  • Body mass index (BMI) <=45 kg/m2, inclusive, at screening
  • Treated with diet and exercise or a stable regimen of metformin, sulfonylurea, pioglitazone or any 2 of these agents

Exclusion Criteria:

  • History of pancreatitis or triglycerides >=500 mg/dL
  • Medullary carcinoma or multiple endocrine neoplasia (MEN2) or a family history of either
  • Active cardiovascular disease
  • Presence of congestive heart failure
  • Liver disease
  • History of severe gastrointestinal diseases
  • Repeated severe hypoglycemia within the last 6 months
  • Any previous use of exenatide or other glucagon-like peptide-1 (GLP-1 ) analog
  • Dipeptidyl peptidase-4 (DPP-4) inhibitor use in the last 3 months

Sites / Locations

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Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Exenatide once weekly suspension

Exenatide twice daily (BID)

Arm Description

Exenatide suspension 2 mg weekly subcutaneous injection

Exenatide 5 mcg BID for 4 weeks followed by 10 mcg BID for 24 weeks

Outcomes

Primary Outcome Measures

Change in HbA1c (Glycosylated Hemoglobin) From Baseline to Week 28
The primary objective of this study was to compare the effect on glycemic control (HbA1c) of exenatide suspension administered once weekly to that achieved by exenatide administered twice daily for 28 weeks in subjects with type 2 diabetes mellitus.

Secondary Outcome Measures

Percentage of Subjects Achieving HbA1c <7% at Week 28
Percentage of subjects achieving HbA1c <7% at Week 28/Study Termination
Change in Fasting Plasma Glucose Concentrations From Baseline to Week 28
Change in fasting plasma glucose concentrations from baseline to Week 28/Study Termination
Change in Body Weight (kg) From Baseline to Week 28
Change in body weight (kg) from baseline to Week 28/Study Termination.
Change in 2-hour Postprandial Glucose Concentrations From Baseline to Week 16
Change in 2-hour postprandial glucose concentrations from baseline to Week 16.

Full Information

First Posted
July 26, 2012
Last Updated
June 4, 2018
Sponsor
AstraZeneca
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1. Study Identification

Unique Protocol Identification Number
NCT01652716
Brief Title
Efficacy and Safety of Exenatide Once Weekly Suspension in Subjects With Type 2 Diabetes
Acronym
DURATION-NEO-1
Official Title
A Randomized, Open-Label, Long-Term, Parallel-Group, Comparator-Controlled, Multicenter Study to Compare the Glycemic Effects, Safety, and Tolerability of Exenatide Once Weekly Suspension to Exenatide Twice Daily in Subjects With Type 2 Diabetes Mellitus
Study Type
Interventional

2. Study Status

Record Verification Date
May 2018
Overall Recruitment Status
Completed
Study Start Date
January 2013 (undefined)
Primary Completion Date
August 2014 (Actual)
Study Completion Date
August 2014 (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
To compare the effect on glycemic control (HbA1c) of exenatide suspension administered once weekly to that achieved by exenatide administered twice daily for 28 weeks in subjects with type 2 diabetes mellitus. To examine the long-term (52 weeks of treatment) safety and effect on glucose control of exenatide suspension administered once weekly in subjects with type 2 diabetes mellitus.

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
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
377 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Exenatide once weekly suspension
Arm Type
Experimental
Arm Description
Exenatide suspension 2 mg weekly subcutaneous injection
Arm Title
Exenatide twice daily (BID)
Arm Type
Active Comparator
Arm Description
Exenatide 5 mcg BID for 4 weeks followed by 10 mcg BID for 24 weeks
Intervention Type
Drug
Intervention Name(s)
Exenatide once weekly suspension
Intervention Description
Exenatide suspension 2 mg weekly subcutaneous injection
Intervention Type
Drug
Intervention Name(s)
Exenatide twice daily
Other Intervention Name(s)
Byetta
Intervention Description
5 mcg twice daily for 4 weeks followed by 10 mcg twice daily for 24 weeks
Primary Outcome Measure Information:
Title
Change in HbA1c (Glycosylated Hemoglobin) From Baseline to Week 28
Description
The primary objective of this study was to compare the effect on glycemic control (HbA1c) of exenatide suspension administered once weekly to that achieved by exenatide administered twice daily for 28 weeks in subjects with type 2 diabetes mellitus.
Time Frame
Baseline to Week 28
Secondary Outcome Measure Information:
Title
Percentage of Subjects Achieving HbA1c <7% at Week 28
Description
Percentage of subjects achieving HbA1c <7% at Week 28/Study Termination
Time Frame
Baseline to Week 28
Title
Change in Fasting Plasma Glucose Concentrations From Baseline to Week 28
Description
Change in fasting plasma glucose concentrations from baseline to Week 28/Study Termination
Time Frame
Baseline to Week 28
Title
Change in Body Weight (kg) From Baseline to Week 28
Description
Change in body weight (kg) from baseline to Week 28/Study Termination.
Time Frame
Baseline to Week 28
Title
Change in 2-hour Postprandial Glucose Concentrations From Baseline to Week 16
Description
Change in 2-hour postprandial glucose concentrations from baseline to Week 16.
Time Frame
Baseline to Week 16

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: At least 18 years old Diagnosed with type 2 diabetes mellitus HbA1c 7.1 to 11%, inclusive, at screening Fasting plasma glucose <280 mg/dL (15.5 mmol/L) Body mass index (BMI) <=45 kg/m2, inclusive, at screening Treated with diet and exercise or a stable regimen of metformin, sulfonylurea, pioglitazone or any 2 of these agents Exclusion Criteria: History of pancreatitis or triglycerides >=500 mg/dL Medullary carcinoma or multiple endocrine neoplasia (MEN2) or a family history of either Active cardiovascular disease Presence of congestive heart failure Liver disease History of severe gastrointestinal diseases Repeated severe hypoglycemia within the last 6 months Any previous use of exenatide or other glucagon-like peptide-1 (GLP-1 ) analog Dipeptidyl peptidase-4 (DPP-4) inhibitor use in the last 3 months
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Vice President Medical Research & Development, M.D.
Organizational Affiliation
Amylin Pharmaceuticals, LLC.
Official's Role
Study Director
Facility Information:
Facility Name
Research Site
City
Muscle Shoals
State/Province
Alabama
ZIP/Postal Code
35662
Country
United States
Facility Name
Research Site
City
Mesa
State/Province
Arizona
ZIP/Postal Code
85206
Country
United States
Facility Name
Research Site
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85020
Country
United States
Facility Name
Research Site
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72205
Country
United States
Facility Name
Research Site
City
Escondido
State/Province
California
ZIP/Postal Code
92026
Country
United States
Facility Name
Research Site
City
Garden Grove
State/Province
California
ZIP/Postal Code
92844
Country
United States
Facility Name
Research Site
City
Lomita
State/Province
California
ZIP/Postal Code
90717
Country
United States
Facility Name
Research Site
City
Los Angeles
State/Province
California
ZIP/Postal Code
90015
Country
United States
Facility Name
Research Site
City
Santa Ana
State/Province
California
ZIP/Postal Code
92705
Country
United States
Facility Name
Research Site
City
Spring Valley
State/Province
California
ZIP/Postal Code
91978
Country
United States
Facility Name
Research Site
City
Walnut Creek
State/Province
California
ZIP/Postal Code
94598
Country
United States
Facility Name
Research Site
City
Denver
State/Province
Colorado
ZIP/Postal Code
80220
Country
United States
Facility Name
Research Site
City
Coral Gables
State/Province
Florida
ZIP/Postal Code
33134
Country
United States
Facility Name
Research Site
City
DeLand
State/Province
Florida
ZIP/Postal Code
32720
Country
United States
Facility Name
Research Site
City
Kissimmee
State/Province
Florida
ZIP/Postal Code
34741
Country
United States
Facility Name
Research Site
City
Miami
State/Province
Florida
ZIP/Postal Code
33156
Country
United States
Facility Name
Research Site
City
Orlando
State/Province
Florida
ZIP/Postal Code
32806
Country
United States
Facility Name
Research Site
City
Oviedo
State/Province
Florida
ZIP/Postal Code
32765
Country
United States
Facility Name
Research Site
City
Palm Harbor
State/Province
Florida
ZIP/Postal Code
34684
Country
United States
Facility Name
Research Site
City
Ponte Vedra
State/Province
Florida
ZIP/Postal Code
32081
Country
United States
Facility Name
Research Site
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60607
Country
United States
Facility Name
Research Site
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60616
Country
United States
Facility Name
Research Site
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40503
Country
United States
Facility Name
Research Site
City
Paducah
State/Province
Kentucky
ZIP/Postal Code
42003
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United States
Facility Name
Research Site
City
Lake Charles
State/Province
Louisiana
ZIP/Postal Code
70601
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United States
Facility Name
Research Site
City
Columbia
State/Province
Maryland
ZIP/Postal Code
21045
Country
United States
Facility Name
Research Site
City
Elkridge
State/Province
Maryland
ZIP/Postal Code
21075
Country
United States
Facility Name
Research Site
City
Hyattsville
State/Province
Maryland
ZIP/Postal Code
20782
Country
United States
Facility Name
Research Site
City
New Bedford
State/Province
Massachusetts
ZIP/Postal Code
02740
Country
United States
Facility Name
Research Site
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States
Facility Name
Research Site
City
Troy
State/Province
Michigan
ZIP/Postal Code
48098
Country
United States
Facility Name
Research Site
City
Edina
State/Province
Minnesota
ZIP/Postal Code
55435
Country
United States
Facility Name
Research Site
City
Port Gibson
State/Province
Mississippi
ZIP/Postal Code
39150
Country
United States
Facility Name
Research Site
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63128
Country
United States
Facility Name
Research Site
City
Butte
State/Province
Montana
ZIP/Postal Code
59701
Country
United States
Facility Name
Research Site
City
Henderson
State/Province
Nevada
ZIP/Postal Code
89052
Country
United States
Facility Name
Research Site
City
Endwell
State/Province
New York
ZIP/Postal Code
13760
Country
United States
Facility Name
Research Site
City
New Windsor
State/Province
New York
ZIP/Postal Code
12553
Country
United States
Facility Name
Research Site
City
Greensboro
State/Province
North Carolina
ZIP/Postal Code
27408
Country
United States
Facility Name
Research Site
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45219
Country
United States
Facility Name
Research Site
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45227
Country
United States
Facility Name
Research Site
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43213
Country
United States
Facility Name
Research Site
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73103
Country
United States
Facility Name
Research Site
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73112
Country
United States
Facility Name
Research Site
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
Facility Name
Research Site
City
Harleysville
State/Province
Pennsylvania
ZIP/Postal Code
19438
Country
United States
Facility Name
Research Site
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29407
Country
United States
Facility Name
Research Site
City
Mount Pleasant
State/Province
South Carolina
ZIP/Postal Code
29464
Country
United States
Facility Name
Research Site
City
Dallas
State/Province
Texas
ZIP/Postal Code
75230
Country
United States
Facility Name
Research Site
City
Houston
State/Province
Texas
ZIP/Postal Code
77062
Country
United States
Facility Name
Research Site
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78205
Country
United States
Facility Name
Research Site
City
Murray
State/Province
Utah
ZIP/Postal Code
84123
Country
United States
Facility Name
Research Site
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84107
Country
United States
Facility Name
Research Site
City
Manassas
State/Province
Virginia
ZIP/Postal Code
20110
Country
United States
Facility Name
Research Site
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23502
Country
United States
Facility Name
Research Site
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23294
Country
United States
Facility Name
Research Site
City
Olympia
State/Province
Washington
ZIP/Postal Code
98502
Country
United States
Facility Name
Research Site
City
Spokane
State/Province
Washington
ZIP/Postal Code
99202
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
33037036
Citation
Wysham CH, Rosenstock J, Vetter ML, Wang H, Hardy E, Iqbal N. Further improvement in glycemic control after switching from exenatide two times per day to exenatide once-weekly autoinjected suspension in patients with type 2 diabetes: 52-week results from the DURATION-NEO-1 study. BMJ Open Diabetes Res Care. 2020 Oct;8(1):e000773. doi: 10.1136/bmjdrc-2019-000773.
Results Reference
derived
PubMed Identifier
28685973
Citation
Wysham CH, Rosenstock J, Vetter ML, Dong F, Ohman P, Iqbal N. Efficacy and tolerability of the new autoinjected suspension of exenatide once weekly versus exenatide twice daily in patients with type 2 diabetes. Diabetes Obes Metab. 2018 Jan;20(1):165-172. doi: 10.1111/dom.13056. Epub 2017 Aug 22.
Results Reference
derived

Learn more about this trial

Efficacy and Safety of Exenatide Once Weekly Suspension in Subjects With Type 2 Diabetes

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