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Comparison of Efficacy, Safety, and Tolerability of ITCA 650 to Empagliflozin and Glimepiride as add-on Metformin

Primary Purpose

Diabetes Mellitus, Type 2

Status
Terminated
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
ITCA 650 20/60 mcg/day
Empagliflozin (oral)
Glimepiride (oral)
Sponsored by
Intarcia Therapeutics
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 - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Diagnosis of T2D 3 months prior to the Screening Visit.
  • Body mass index (BMI) between ≥25 to ≤45 kg/m2 at the Screening Visit.
  • Glycosylated hemoglobin A1c (HbA1c) ≥7.5 and ≤10.5%. 5. 6. On a stable (3 months prior to the Screening Visit) treatment regimen of metformin monotherapy of ≥1500 mg/day).

Exclusion Criteria:

  • History of type 1 diabetes.
  • Prior participation in a clinical study involving ITCA 650.
  • Treatment with any GLP-1 receptor agonist (eg, liraglutide, exenatide) within 6 months prior to Screening.
  • History or evidence, within the last 6 months prior to the Screening Visit, of myocardial infarction, coronary revascularization (coronary artery bypass grafting or percutaneous coronary intervention), unstable angina, or cerebrovascular accident or stroke.
  • History or evidence of acute or chronic pancreatitis.
  • History of medullary thyroid cancer or a family or personal history of multiple endocrine neoplasia type 2.
  • Treatment of medications that affect GI motility.
  • History of hypersensitivity to exenatide, empagliflozin, or glimepiride or to one of its excipients.
  • Women that are pregnant, lactating, or planning to become pregnant.
  • Chronic (>10 consecutive days) treatment with systemic corticosteroids within 8 weeks prior to screening.

Sites / Locations

  • Fountain Hills Family Practice, P.C.
  • Thomas C. Lenzmeier, M.D., P.C.
  • Family Practice Specialists
  • Central Phoenix Medical Center
  • Fiel Family and Sports Medicine
  • Arizona Community Physicians
  • Orange Grove Family Practice
  • Anaheim Clinical Trials
  • Radiant Research
  • Research Center of Fresno, Inc.
  • Marin Endocrine Care and Research, Inc.
  • National Research Institute
  • National Research Institute
  • Catalina Research Institute
  • Providence Clinical Research
  • Center for Clinical Trials of Sacramento, Inc.
  • Denver VA Medical Center
  • Radiant Research
  • Colorado Springs Health Partners - East
  • Columbine Family Practice
  • Nature Coast Clinical Reseaerch - Crystal River
  • Indago Research and Health Center, Inc.
  • Clinical Neuroscience Solutions, Inc.
  • Research Institure of South Florida
  • Clinical Neuroscience Solutions, Inc.
  • Palm Harbor Medical Associates
  • Andres Patron, D.O., P.A
  • South Broward Research
  • Primary Care Research Group
  • Atlanta Center for Medical Research
  • Solaris Clinical Research
  • Michigan Avenue Internists
  • Medical and Procedural Specialists
  • HSHS Medical Group DIabetes Research
  • Community Hospital of Anderson and Madison County, Inc.
  • Clinical Research Advantage
  • American Health Network of Indiana, LLC
  • American Health Network of Indiana, LLC
  • Heartland Research Associates, LLC
  • Overland Park Surgical Specialists, LLL dba College Park Family Care Center
  • Cotton O'Neil Clinical Research Center
  • Heartland Research Associates, LLC
  • Heartland Research Associates, LLC
  • Pennington Biomedical Research Center
  • Maine Research Associates
  • Joslin Diabetes Center
  • Radiant Research, Inc.
  • Ehrhardt Clinical Research, LLC
  • HealthCare Research Network
  • Mercury Street Medical Group
  • Skyline Medical Center
  • Nevada Family Care
  • Palm Research Center, Inc.
  • Albany Medical College
  • Scott Research Center
  • American Health Research
  • Medication Management, LLC
  • Down East Medical Associates, PA
  • PMG Research of Wilmington, LLC
  • Radiant Research
  • Sentral Clinical Research Services, LLC
  • Canyon Medical Center, LLC
  • Aventiv Research
  • Prestige Clinical Research
  • Wells Institute for Health Awareness
  • University of Toledo
  • Oklahoma City Clinic - Midwest City
  • Intend Research
  • Oklahoma City Clinic - Central
  • Lynn Health Science Institute
  • Clinical Research Institute of Southern Oregon, PC
  • Harleysville Medical Associates
  • Thomas Jefferson University Hospital
  • Preferred Primary Care Phys Inc
  • Preferred Primary Care Physicians
  • Clinical Research of Rock Hill
  • Spartanburg Medical Research
  • Holston Medical Group, P.C.
  • Clinical Neuroscience Solutions, Inc.
  • DCT-AACT, LLC dba Discovery Clinical Trials
  • Dallas Diabetes and Endocrine Center
  • Research Institute of Dallas
  • Global Medical Research
  • Juno Research
  • PCP for Life - -Tidwell
  • Sante Clinical Research
  • Health Texas Research Institute
  • Panacea Clinical Research
  • Clinical Trials of Texas, Inc.
  • Victorium Clinical Research Ltd.
  • MacGregor Medical Center
  • Crossroads Clinical Research, LLC
  • Ericksen Research and Development, LLC
  • Radiant Research
  • Advanced Clinical Research
  • Sound Healthcare
  • Bailey Clinic
  • CookMed Research
  • Milestone Research
  • Bluewater Clinical Research Group
  • Dr. Anil K. Gupta Medicine Professional Corporation

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Experimental: Group 1

Experimental: Group 2

Experimental: Group 3

Arm Description

ITCA 650 20/60 mcg/day

Empagliflozin 10 mg/day and 25 mg/day

Glimepiride 1-6 mg/day

Outcomes

Primary Outcome Measures

Reduction in glycosylated hemoglobin A1c
To determine whether ITCA 650 is non-inferior either to empagliflozin or to glimepiride in reducing glycosylated hemoglobin A1c (HbA1c) in patients with T2D following 65 weeks of treatment and 4 weeks of post treatment follow up.
Reduction in weight
To determine whether ITCA 650 is non-inferior either to empagliflozin or to glimepiride in reducing weight in patients with T2D following 65 weeks of treatment and 4 weeks of post treatment follow up.

Secondary Outcome Measures

Full Information

First Posted
February 9, 2017
Last Updated
March 4, 2019
Sponsor
Intarcia Therapeutics
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1. Study Identification

Unique Protocol Identification Number
NCT03060980
Brief Title
Comparison of Efficacy, Safety, and Tolerability of ITCA 650 to Empagliflozin and Glimepiride as add-on Metformin
Official Title
A Phase 3b, Randomized, Active Comparator, Open-label, Multicenter Study to Compare the Efficacy, Safety, and Tolerability of ITCA 650 to Empagliflozin and to Glimepiride as Add-on Therapy to Metformin in Patients With Type 2 Diabetes
Study Type
Interventional

2. Study Status

Record Verification Date
March 2019
Overall Recruitment Status
Terminated
Why Stopped
Decision by Sponsor
Study Start Date
March 3, 2017 (Actual)
Primary Completion Date
January 26, 2018 (Actual)
Study Completion Date
January 26, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Intarcia Therapeutics

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
A Phase 3b, open-label, randomized, multicenter, efficacy, safety, and tolerability study of ITCA 650 compared to Empagliflozin and to Glimepiride, as add-on therapy to Metformin in patients with Type 2 diabetes.

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
245 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Experimental: Group 1
Arm Type
Experimental
Arm Description
ITCA 650 20/60 mcg/day
Arm Title
Experimental: Group 2
Arm Type
Experimental
Arm Description
Empagliflozin 10 mg/day and 25 mg/day
Arm Title
Experimental: Group 3
Arm Type
Experimental
Arm Description
Glimepiride 1-6 mg/day
Intervention Type
Drug
Intervention Name(s)
ITCA 650 20/60 mcg/day
Intervention Description
ITCA 650 osmotic mini-pump delivering exenatide 20/60 mcg/day
Intervention Type
Drug
Intervention Name(s)
Empagliflozin (oral)
Intervention Description
10 mg/day and 25 mg/day
Intervention Type
Drug
Intervention Name(s)
Glimepiride (oral)
Intervention Description
1-6 mg/day
Primary Outcome Measure Information:
Title
Reduction in glycosylated hemoglobin A1c
Description
To determine whether ITCA 650 is non-inferior either to empagliflozin or to glimepiride in reducing glycosylated hemoglobin A1c (HbA1c) in patients with T2D following 65 weeks of treatment and 4 weeks of post treatment follow up.
Time Frame
Randomization to 69 weeks
Title
Reduction in weight
Description
To determine whether ITCA 650 is non-inferior either to empagliflozin or to glimepiride in reducing weight in patients with T2D following 65 weeks of treatment and 4 weeks of post treatment follow up.
Time Frame
Randomization to 69 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Diagnosis of T2D 3 months prior to the Screening Visit. Body mass index (BMI) between ≥25 to ≤45 kg/m2 at the Screening Visit. Glycosylated hemoglobin A1c (HbA1c) ≥7.5 and ≤10.5%. 5. 6. On a stable (3 months prior to the Screening Visit) treatment regimen of metformin monotherapy of ≥1500 mg/day). Exclusion Criteria: History of type 1 diabetes. Prior participation in a clinical study involving ITCA 650. Treatment with any GLP-1 receptor agonist (eg, liraglutide, exenatide) within 6 months prior to Screening. History or evidence, within the last 6 months prior to the Screening Visit, of myocardial infarction, coronary revascularization (coronary artery bypass grafting or percutaneous coronary intervention), unstable angina, or cerebrovascular accident or stroke. History or evidence of acute or chronic pancreatitis. History of medullary thyroid cancer or a family or personal history of multiple endocrine neoplasia type 2. Treatment of medications that affect GI motility. History of hypersensitivity to exenatide, empagliflozin, or glimepiride or to one of its excipients. Women that are pregnant, lactating, or planning to become pregnant. Chronic (>10 consecutive days) treatment with systemic corticosteroids within 8 weeks prior to screening.
Facility Information:
Facility Name
Fountain Hills Family Practice, P.C.
City
Fountain Hills
State/Province
Arizona
ZIP/Postal Code
85268
Country
United States
Facility Name
Thomas C. Lenzmeier, M.D., P.C.
City
Glendale
State/Province
Arizona
ZIP/Postal Code
85308
Country
United States
Facility Name
Family Practice Specialists
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85018
Country
United States
Facility Name
Central Phoenix Medical Center
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85020
Country
United States
Facility Name
Fiel Family and Sports Medicine
City
Tempe
State/Province
Arizona
ZIP/Postal Code
85283
Country
United States
Facility Name
Arizona Community Physicians
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85712
Country
United States
Facility Name
Orange Grove Family Practice
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85741
Country
United States
Facility Name
Anaheim Clinical Trials
City
Anaheim
State/Province
California
ZIP/Postal Code
92801
Country
United States
Facility Name
Radiant Research
City
Carlsbad
State/Province
California
ZIP/Postal Code
92008
Country
United States
Facility Name
Research Center of Fresno, Inc.
City
Fresno
State/Province
California
ZIP/Postal Code
93726
Country
United States
Facility Name
Marin Endocrine Care and Research, Inc.
City
Greenbrae
State/Province
California
ZIP/Postal Code
94904
Country
United States
Facility Name
National Research Institute
City
Huntington Park
State/Province
California
ZIP/Postal Code
90255
Country
United States
Facility Name
National Research Institute
City
Los Angeles
State/Province
California
ZIP/Postal Code
91402
Country
United States
Facility Name
Catalina Research Institute
City
Montclair
State/Province
California
ZIP/Postal Code
91710
Country
United States
Facility Name
Providence Clinical Research
City
North Hollywood
State/Province
California
ZIP/Postal Code
91606
Country
United States
Facility Name
Center for Clinical Trials of Sacramento, Inc.
City
Sacramento
State/Province
California
ZIP/Postal Code
95816
Country
United States
Facility Name
Denver VA Medical Center
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Facility Name
Radiant Research
City
Centennial
State/Province
Colorado
ZIP/Postal Code
75115
Country
United States
Facility Name
Colorado Springs Health Partners - East
City
Colorado Springs
State/Province
Colorado
ZIP/Postal Code
80922
Country
United States
Facility Name
Columbine Family Practice
City
Littleton
State/Province
Colorado
ZIP/Postal Code
80128
Country
United States
Facility Name
Nature Coast Clinical Reseaerch - Crystal River
City
Crystal River
State/Province
Florida
ZIP/Postal Code
34429
Country
United States
Facility Name
Indago Research and Health Center, Inc.
City
Hialeah
State/Province
Florida
ZIP/Postal Code
33012
Country
United States
Facility Name
Clinical Neuroscience Solutions, Inc.
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32256
Country
United States
Facility Name
Research Institure of South Florida
City
Miami
State/Province
Florida
ZIP/Postal Code
33173
Country
United States
Facility Name
Clinical Neuroscience Solutions, Inc.
City
Orlando
State/Province
Florida
ZIP/Postal Code
32801
Country
United States
Facility Name
Palm Harbor Medical Associates
City
Palm Harbor
State/Province
Florida
ZIP/Postal Code
34684
Country
United States
Facility Name
Andres Patron, D.O., P.A
City
Pembroke Pines
State/Province
Florida
ZIP/Postal Code
33026
Country
United States
Facility Name
South Broward Research
City
Pembroke Pines
State/Province
Florida
ZIP/Postal Code
33027
Country
United States
Facility Name
Primary Care Research Group
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30312
Country
United States
Facility Name
Atlanta Center for Medical Research
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30331
Country
United States
Facility Name
Solaris Clinical Research
City
Meridian
State/Province
Idaho
ZIP/Postal Code
83646
Country
United States
Facility Name
Michigan Avenue Internists
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60604
Country
United States
Facility Name
Medical and Procedural Specialists
City
Skokie
State/Province
Illinois
ZIP/Postal Code
60077
Country
United States
Facility Name
HSHS Medical Group DIabetes Research
City
Springfield
State/Province
Illinois
ZIP/Postal Code
62711
Country
United States
Facility Name
Community Hospital of Anderson and Madison County, Inc.
City
Anderson
State/Province
Indiana
ZIP/Postal Code
46011
Country
United States
Facility Name
Clinical Research Advantage
City
Evansville
State/Province
Indiana
ZIP/Postal Code
47225
Country
United States
Facility Name
American Health Network of Indiana, LLC
City
Franklin
State/Province
Indiana
ZIP/Postal Code
46131
Country
United States
Facility Name
American Health Network of Indiana, LLC
City
New Albany
State/Province
Indiana
ZIP/Postal Code
47150
Country
United States
Facility Name
Heartland Research Associates, LLC
City
Augusta
State/Province
Kansas
ZIP/Postal Code
67010
Country
United States
Facility Name
Overland Park Surgical Specialists, LLL dba College Park Family Care Center
City
Overland Park
State/Province
Kansas
ZIP/Postal Code
66210
Country
United States
Facility Name
Cotton O'Neil Clinical Research Center
City
Topeka
State/Province
Kansas
ZIP/Postal Code
66606
Country
United States
Facility Name
Heartland Research Associates, LLC
City
Wichita
State/Province
Kansas
ZIP/Postal Code
67205
Country
United States
Facility Name
Heartland Research Associates, LLC
City
Wichita
State/Province
Kansas
ZIP/Postal Code
67207
Country
United States
Facility Name
Pennington Biomedical Research Center
City
Baton Rouge
State/Province
Louisiana
ZIP/Postal Code
70808
Country
United States
Facility Name
Maine Research Associates
City
Auburn
State/Province
Maine
ZIP/Postal Code
04210
Country
United States
Facility Name
Joslin Diabetes Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Facility Name
Radiant Research, Inc.
City
Edina
State/Province
Minnesota
ZIP/Postal Code
55435
Country
United States
Facility Name
Ehrhardt Clinical Research, LLC
City
Belton
State/Province
Missouri
ZIP/Postal Code
64012
Country
United States
Facility Name
HealthCare Research Network
City
Hazelwood
State/Province
Missouri
ZIP/Postal Code
63042
Country
United States
Facility Name
Mercury Street Medical Group
City
Butte
State/Province
Montana
ZIP/Postal Code
59701
Country
United States
Facility Name
Skyline Medical Center
City
Elkhorn
State/Province
Nebraska
ZIP/Postal Code
68022
Country
United States
Facility Name
Nevada Family Care
City
Henderson
State/Province
Nevada
ZIP/Postal Code
89047
Country
United States
Facility Name
Palm Research Center, Inc.
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89148
Country
United States
Facility Name
Albany Medical College
City
Albany
State/Province
New York
ZIP/Postal Code
12208
Country
United States
Facility Name
Scott Research Center
City
Laurelton
State/Province
New York
ZIP/Postal Code
11413
Country
United States
Facility Name
American Health Research
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28207
Country
United States
Facility Name
Medication Management, LLC
City
Greensboro
State/Province
North Carolina
ZIP/Postal Code
27408
Country
United States
Facility Name
Down East Medical Associates, PA
City
Morehead City
State/Province
North Carolina
ZIP/Postal Code
28557
Country
United States
Facility Name
PMG Research of Wilmington, LLC
City
Wilmington
State/Province
North Carolina
ZIP/Postal Code
28401
Country
United States
Facility Name
Radiant Research
City
Akron
State/Province
Ohio
ZIP/Postal Code
44311
Country
United States
Facility Name
Sentral Clinical Research Services, LLC
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45236
Country
United States
Facility Name
Canyon Medical Center, LLC
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43213
Country
United States
Facility Name
Aventiv Research
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43231
Country
United States
Facility Name
Prestige Clinical Research
City
Franklin
State/Province
Ohio
ZIP/Postal Code
45005
Country
United States
Facility Name
Wells Institute for Health Awareness
City
Kettering
State/Province
Ohio
ZIP/Postal Code
45429
Country
United States
Facility Name
University of Toledo
City
Toledo
State/Province
Ohio
ZIP/Postal Code
43614
Country
United States
Facility Name
Oklahoma City Clinic - Midwest City
City
Midwest City
State/Province
Oklahoma
ZIP/Postal Code
73110
Country
United States
Facility Name
Intend Research
City
Norman
State/Province
Oklahoma
ZIP/Postal Code
73069
Country
United States
Facility Name
Oklahoma City Clinic - Central
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73104
Country
United States
Facility Name
Lynn Health Science Institute
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73112
Country
United States
Facility Name
Clinical Research Institute of Southern Oregon, PC
City
Medford
State/Province
Oregon
ZIP/Postal Code
97504
Country
United States
Facility Name
Harleysville Medical Associates
City
Harleysville
State/Province
Pennsylvania
ZIP/Postal Code
19438
Country
United States
Facility Name
Thomas Jefferson University Hospital
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
Facility Name
Preferred Primary Care Phys Inc
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15243
Country
United States
Facility Name
Preferred Primary Care Physicians
City
Uniontown
State/Province
Pennsylvania
ZIP/Postal Code
15401
Country
United States
Facility Name
Clinical Research of Rock Hill
City
Rock Hill
State/Province
South Carolina
ZIP/Postal Code
29732
Country
United States
Facility Name
Spartanburg Medical Research
City
Spartanburg
State/Province
South Carolina
ZIP/Postal Code
29303
Country
United States
Facility Name
Holston Medical Group, P.C.
City
Kingsport
State/Province
Tennessee
ZIP/Postal Code
37660
Country
United States
Facility Name
Clinical Neuroscience Solutions, Inc.
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38119
Country
United States
Facility Name
DCT-AACT, LLC dba Discovery Clinical Trials
City
Austin
State/Province
Texas
ZIP/Postal Code
78758
Country
United States
Facility Name
Dallas Diabetes and Endocrine Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75230
Country
United States
Facility Name
Research Institute of Dallas
City
Dallas
State/Province
Texas
ZIP/Postal Code
75231
Country
United States
Facility Name
Global Medical Research
City
DeSoto
State/Province
Texas
ZIP/Postal Code
75115
Country
United States
Facility Name
Juno Research
City
Houston
State/Province
Texas
ZIP/Postal Code
77004
Country
United States
Facility Name
PCP for Life - -Tidwell
City
Houston
State/Province
Texas
ZIP/Postal Code
77093
Country
United States
Facility Name
Sante Clinical Research
City
Kerrville
State/Province
Texas
ZIP/Postal Code
78028
Country
United States
Facility Name
Health Texas Research Institute
City
San Angelo
State/Province
Texas
ZIP/Postal Code
78228
Country
United States
Facility Name
Panacea Clinical Research
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78228
Country
United States
Facility Name
Clinical Trials of Texas, Inc.
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Victorium Clinical Research Ltd.
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78230
Country
United States
Facility Name
MacGregor Medical Center
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78240
Country
United States
Facility Name
Crossroads Clinical Research, LLC
City
Victoria
State/Province
Texas
ZIP/Postal Code
77901
Country
United States
Facility Name
Ericksen Research and Development, LLC
City
Clinton
State/Province
Utah
ZIP/Postal Code
84015
Country
United States
Facility Name
Radiant Research
City
Murray
State/Province
Utah
ZIP/Postal Code
84123
Country
United States
Facility Name
Advanced Clinical Research
City
West Jordan
State/Province
Utah
ZIP/Postal Code
84088
Country
United States
Facility Name
Sound Healthcare
City
Port Orchard
State/Province
Washington
ZIP/Postal Code
98366
Country
United States
Facility Name
Bailey Clinic
City
Red Deer
State/Province
Alberta
ZIP/Postal Code
T466V7
Country
Canada
Facility Name
CookMed Research
City
Victoria
State/Province
British Columbia
ZIP/Postal Code
V8V 4A1
Country
Canada
Facility Name
Milestone Research
City
London
State/Province
Ontario
ZIP/Postal Code
N5W 6A2
Country
Canada
Facility Name
Bluewater Clinical Research Group
City
Sarnia
State/Province
Ontario
ZIP/Postal Code
N7T 4X3
Country
Canada
Facility Name
Dr. Anil K. Gupta Medicine Professional Corporation
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M9V 4B4
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Comparison of Efficacy, Safety, and Tolerability of ITCA 650 to Empagliflozin and Glimepiride as add-on Metformin

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