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Comparison Study of the Glycemic Effects, Safety, and Tolerability of Exenatide Once Weekly Suspension to Sitagliptin and Placebo in Subjects With Type 2 Diabetes Mellitus (DURATION-NEO-2)

Primary Purpose

Diabetes Type 2

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

About this trial

This is an interventional treatment trial for Diabetes Type 2 focused on measuring Diabetes, Type 2, exenatide, Sitagliptin

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 of 7.1% to 11.0%, inclusive, at screening
  • Has stable body weight, i.e., not varying by >3% for at least 3 months prior to screening
  • Fasting plasma glucose concentration <280 mg/dL (15.5 mmol/L) at screening
  • Body mass index of <45 kg/m2 at screening
  • Has been treated with a stable regimen of ≥1500 mg/day metformin for a minimum of 2 months prior to Visit 1 (Screening)

Exclusion Criteria:

  • History of pancreatitis or triglycerides >=500 mg/dL
  • Medullary carcinoma or multiple endocrine neoplasia (MEN2) or a family history of either
  • History of renal transplantation, or is currently receiving renal dialysis, or has an estimated creatinine clearance <50 mL/min
  • Active cardiovascular disease
  • Presence or history of severe congestive heart failure
  • Central nervous system disease, including epilepsy
  • Liver disease
  • History of severe gastrointestinal diseases
  • Clinically significant malignant disease
  • Repeated severe hypoglycemia within the last 6 months
  • Any exposure to exenatide (BYETTA® or BYDUREON™) or any GLP-1 analog
  • Any DPP-4 inhibitor within 3 months prior screening

Sites / Locations

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Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Placebo Comparator

Arm Label

Exenatide once weekly suspension

Sitagliptin 100mg

Placebo

Arm Description

Exenatide once weekly suspension 2mg subcutaneous injection

Overencapsulated Sitagliptin 100mg oral tablet once daily

Placebo oral capsule once daily

Outcomes

Primary Outcome Measures

Change in HbA1c (Glycosylated Hemoglobin) From Baseline to Week 28
Absolute change in HbA1c from baseline (Day 1, Visit 3) to Week 28/Study Termination (Visit 11). Hypothesis testing on the primary endpoint followed a serial gated procedure with all tests carried out at a 2-sided significance level of 0.05 to protect the family-wise error rate. These tests were conducted sequentially, and are presented in the statistical analysis section below in the order in which they were performed; each test was the gatekeeper of later tests.

Secondary Outcome Measures

Percentage of Subjects Achieving HbA1c <7% at Week 28
Percentage of subjects achieving HbA1c target values of < 7.0% at Week 28/Study Termination.
Change in Fasting Plasma Glucose Concentrations From Baseline to Week 28
The change in fasting plasma glucose concentrations from baseline (Day 1) to Week 28/Study Termination.
Change in Body Weight (kg) From Baseline to Week 28
The change in body weight (kg) from baseline (Day 1) to Week 28/Study Termination.
Change in 2-hour Postprandial Glucose Concentrations From Baseline to Week 16 (Visit 8)
The change in 2-hour postprandial plasma glucose from baseline (Day 1) to Visit 8 (Week 16) was analyzed using a general linear model including treatment, and baseline HbA1c stratum (< 9% or ≥ 9%) as fixed factors, and the baseline 2-hour postprandial plasma glucose concentrations as a covariate.

Full Information

First Posted
July 26, 2012
Last Updated
July 31, 2015
Sponsor
AstraZeneca
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1. Study Identification

Unique Protocol Identification Number
NCT01652729
Brief Title
Comparison Study of the Glycemic Effects, Safety, and Tolerability of Exenatide Once Weekly Suspension to Sitagliptin and Placebo in Subjects With Type 2 Diabetes Mellitus
Acronym
DURATION-NEO-2
Official Title
A Randomized, Long-Term, Open-Label, 3-Arm, Multicenter Study to Compare the Glycemic Effects, Safety, and Tolerability of Exenatide Once Weekly Suspension to Sitagliptin and Placebo in Subjects With Type 2 Diabetes Mellitus
Study Type
Interventional

2. Study Status

Record Verification Date
July 2015
Overall Recruitment Status
Completed
Study Start Date
February 2013 (undefined)
Primary Completion Date
April 2014 (Actual)
Study Completion Date
April 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 sitagliptin or placebo administered once daily for 28 weeks 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 Type 2
Keywords
Diabetes, Type 2, exenatide, Sitagliptin

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
365 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Exenatide once weekly suspension
Arm Type
Experimental
Arm Description
Exenatide once weekly suspension 2mg subcutaneous injection
Arm Title
Sitagliptin 100mg
Arm Type
Active Comparator
Arm Description
Overencapsulated Sitagliptin 100mg oral tablet once daily
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo oral capsule once daily
Intervention Type
Drug
Intervention Name(s)
Exenatide once weekly suspension
Intervention Type
Drug
Intervention Name(s)
Sitagliptin
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo oral capsule once daily
Primary Outcome Measure Information:
Title
Change in HbA1c (Glycosylated Hemoglobin) From Baseline to Week 28
Description
Absolute change in HbA1c from baseline (Day 1, Visit 3) to Week 28/Study Termination (Visit 11). Hypothesis testing on the primary endpoint followed a serial gated procedure with all tests carried out at a 2-sided significance level of 0.05 to protect the family-wise error rate. These tests were conducted sequentially, and are presented in the statistical analysis section below in the order in which they were performed; each test was the gatekeeper of later tests.
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 target values of < 7.0% at Week 28/Study Termination.
Time Frame
Baseline to Week 28
Title
Change in Fasting Plasma Glucose Concentrations From Baseline to Week 28
Description
The change in fasting plasma glucose concentrations from baseline (Day 1) to Week 28/Study Termination.
Time Frame
Baseline to Week 28
Title
Change in Body Weight (kg) From Baseline to Week 28
Description
The change in body weight (kg) from baseline (Day 1) to Week 28/Study Termination.
Time Frame
Baseline to Week 28
Title
Change in 2-hour Postprandial Glucose Concentrations From Baseline to Week 16 (Visit 8)
Description
The change in 2-hour postprandial plasma glucose from baseline (Day 1) to Visit 8 (Week 16) was analyzed using a general linear model including treatment, and baseline HbA1c stratum (< 9% or ≥ 9%) as fixed factors, and the baseline 2-hour postprandial plasma glucose concentrations as a covariate.
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 of 7.1% to 11.0%, inclusive, at screening Has stable body weight, i.e., not varying by >3% for at least 3 months prior to screening Fasting plasma glucose concentration <280 mg/dL (15.5 mmol/L) at screening Body mass index of <45 kg/m2 at screening Has been treated with a stable regimen of ≥1500 mg/day metformin for a minimum of 2 months prior to Visit 1 (Screening) Exclusion Criteria: History of pancreatitis or triglycerides >=500 mg/dL Medullary carcinoma or multiple endocrine neoplasia (MEN2) or a family history of either History of renal transplantation, or is currently receiving renal dialysis, or has an estimated creatinine clearance <50 mL/min Active cardiovascular disease Presence or history of severe congestive heart failure Central nervous system disease, including epilepsy Liver disease History of severe gastrointestinal diseases Clinically significant malignant disease Repeated severe hypoglycemia within the last 6 months Any exposure to exenatide (BYETTA® or BYDUREON™) or any GLP-1 analog Any DPP-4 inhibitor within 3 months prior screening
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Peter Ohman
Organizational Affiliation
AstraZeneca
Official's Role
Study Chair
Facility Information:
Facility Name
Research Site
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35216
Country
United States
Facility Name
Research Site
City
Huntsville
State/Province
Alabama
ZIP/Postal Code
35801
Country
United States
Facility Name
Research Site
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85018
Country
United States
Facility Name
Research Site
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85020
Country
United States
Facility Name
Research Site
City
Beverly Hills
State/Province
California
ZIP/Postal Code
90036
Country
United States
Facility Name
Research Site
City
Buena Park
State/Province
California
ZIP/Postal Code
90620
Country
United States
Facility Name
Research Site
City
Chino
State/Province
California
ZIP/Postal Code
91710
Country
United States
Facility Name
Research Site
City
Chula Vista
State/Province
California
ZIP/Postal Code
91910
Country
United States
Facility Name
Research Site
City
Encinitas
State/Province
California
ZIP/Postal Code
92024
Country
United States
Facility Name
Research Site
City
Greenbrae
State/Province
California
ZIP/Postal Code
94904
Country
United States
Facility Name
Research Site
City
Los Angeles
State/Province
California
ZIP/Postal Code
90057
Country
United States
Facility Name
Research Site
City
Los Angeles
State/Province
California
ZIP/Postal Code
90059
Country
United States
Facility Name
Research Site
City
North Hollywood
State/Province
California
ZIP/Postal Code
91606
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
West Hills
State/Province
California
ZIP/Postal Code
91307
Country
United States
Facility Name
Research Site
City
Boca Raton
State/Province
Florida
ZIP/Postal Code
33432
Country
United States
Facility Name
Research Site
City
Hialeah
State/Province
Florida
ZIP/Postal Code
33012
Country
United States
Facility Name
Research Site
City
Miami
State/Province
Florida
ZIP/Postal Code
33143
Country
United States
Facility Name
Research Site
City
Miami
State/Province
Florida
ZIP/Postal Code
33169
Country
United States
Facility Name
Research Site
City
Miami
State/Province
Florida
ZIP/Postal Code
33183
Country
United States
Facility Name
Research Site
City
Port Orange
State/Province
Florida
ZIP/Postal Code
32127
Country
United States
Facility Name
Research Site
City
St. Petersburg
State/Province
Florida
ZIP/Postal Code
33709
Country
United States
Facility Name
Research Site
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60607
Country
United States
Facility Name
Research Site
City
Evanston
State/Province
Illinois
ZIP/Postal Code
60201
Country
United States
Facility Name
Research Site
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46254
Country
United States
Facility Name
Research Site
City
Oxon Hill
State/Province
Maryland
ZIP/Postal Code
20745
Country
United States
Facility Name
Research Site
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68130
Country
United States
Facility Name
Research Site
City
Henderson
State/Province
Nevada
ZIP/Postal Code
89052
Country
United States
Facility Name
Research Site
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89101
Country
United States
Facility Name
Research Site
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89123
Country
United States
Facility Name
Research Site
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87102
Country
United States
Facility Name
Research Site
City
Buffalo
State/Province
New York
ZIP/Postal Code
14215
Country
United States
Facility Name
Research Site
City
Hartsdale
State/Province
New York
ZIP/Postal Code
10530
Country
United States
Facility Name
Research Site
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28204
Country
United States
Facility Name
Research Site
City
Clayton
State/Province
North Carolina
ZIP/Postal Code
27520
Country
United States
Facility Name
Research Site
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Facility Name
Research Site
City
Greensboro
State/Province
North Carolina
ZIP/Postal Code
27410
Country
United States
Facility Name
Research Site
City
Mooresville
State/Province
North Carolina
ZIP/Postal Code
28117
Country
United States
Facility Name
Research Site
City
Salisbury
State/Province
North Carolina
ZIP/Postal Code
28144
Country
United States
Facility Name
Research Site
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45246
Country
United States
Facility Name
Research Site
City
Franklin
State/Province
Ohio
ZIP/Postal Code
45005
Country
United States
Facility Name
Research Site
City
Marion
State/Province
Ohio
ZIP/Postal Code
43302
Country
United States
Facility Name
Research Site
City
Yukon
State/Province
Oklahoma
ZIP/Postal Code
73099
Country
United States
Facility Name
Research Site
City
Eugene
State/Province
Oregon
ZIP/Postal Code
97404
Country
United States
Facility Name
Research Site
City
Portland
State/Province
Oregon
ZIP/Postal Code
97210
Country
United States
Facility Name
Research Site
City
Greer
State/Province
South Carolina
ZIP/Postal Code
29651
Country
United States
Facility Name
Research Site
City
Simpsonville
State/Province
South Carolina
ZIP/Postal Code
29681
Country
United States
Facility Name
Reseach Site
City
Rapid City
State/Province
South Dakota
ZIP/Postal Code
57702
Country
United States
Facility Name
Research Site
City
Chattanooga
State/Province
Tennessee
ZIP/Postal Code
37421
Country
United States
Facility Name
Research Site
City
Carrolton
State/Province
Texas
ZIP/Postal Code
75007
Country
United States
Facility Name
Research Site
City
Corpus Christi
State/Province
Texas
ZIP/Postal Code
78404
Country
United States
Facility Name
Research Site
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390
Country
United States
Facility Name
Research Site
City
Houston
State/Province
Texas
ZIP/Postal Code
77072
Country
United States
Facility Name
Research Site
City
Houston
State/Province
Texas
ZIP/Postal Code
77074
Country
United States
Facility Name
Research Site
City
Katy
State/Province
Texas
ZIP/Postal Code
77450
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
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84095
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
Burke
State/Province
Virginia
ZIP/Postal Code
22015
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
32306296
Citation
Guja C, Frias JP, Suchower L, Hardy E, Marr G, Sjostrom CD, Jabbour SA. Safety and Efficacy of Exenatide Once Weekly in Participants with Type 2 Diabetes and Stage 2/3 Chronic Kidney Disease. Diabetes Ther. 2020 Jul;11(7):1467-1480. doi: 10.1007/s13300-020-00815-z. Epub 2020 Apr 18. Erratum In: Diabetes Ther. 2020 Dec;11(12):3011-3013.
Results Reference
derived
PubMed Identifier
28205322
Citation
Gadde KM, Vetter ML, Iqbal N, Hardy E, Ohman P; DURATION-NEO-2 study investigators. Efficacy and safety of autoinjected exenatide once-weekly suspension versus sitagliptin or placebo with metformin in patients with type 2 diabetes: The DURATION-NEO-2 randomized clinical study. Diabetes Obes Metab. 2017 Jul;19(7):979-988. doi: 10.1111/dom.12908. Epub 2017 Mar 17. Erratum In: Diabetes Obes Metab. 2017 Sep;19(9):1332.
Results Reference
derived
Links:
URL
http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_7111&studyid=2733&filename=BCB120_Synopsis.pdf
Description
BCB120_Synopsis

Learn more about this trial

Comparison Study of the Glycemic Effects, Safety, and Tolerability of Exenatide Once Weekly Suspension to Sitagliptin and Placebo in Subjects With Type 2 Diabetes Mellitus

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