Dose-Ranging Study to Evaluate the Glycemic Effects, Safety, and Tolerability of Metformin Delayed Release in Subjects With T2DM



Status:Completed
Conditions:Diabetes, Diabetes
Therapuetic Areas:Endocrinology
Healthy:No
Age Range:25 - Any
Updated:4/29/2018
Start Date:September 2015
End Date:September 2016

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Randomized, Double-Blind, Parallel-Group, Multicenter, Placebo-Controlled, Dose-Ranging Study to Evaluate the Glycemic Effects, Safety, and Tolerability of Metformin Delayed Release In Subjects With Type 2 Diabetes Mellitus

The purpose of the study is to compare the glycemic effects of delayed-release metformin (Met
DR) to placebo in subjects with type 2 diabetes mellitus (T2DM) over 16 weeks. The study is
designed to evaluate several doses of Met DR (600 to 1500 mg once daily in the morning [qAM])
compared to placebo. A single-blind reference treatment of 2000 mg metformin
immediate-release (Met IR) per day administered as equal divided doses (1000 mg Met IR BID)
will also be included.


Inclusion Criteria:

1. Is at least 25 years old at Visit 1 (Screening).

2. Is male, or is female and meets all of the following criteria:

1. Not breastfeeding

2. Negative pregnancy test result at Visit 1 (not applicable to post-menopausal or
surgically sterile females)

3. Surgically sterile, postmenopausal, or if of childbearing potential, must
practice and be willing to continue to practice appropriate birth control during
the entire duration of the study.

3. Body mass index (BMI) 20.0 to 45.0 kg/m² (inclusive) at Visit 1 (Screening).

4. Has a physical examination with no clinically significant abnormalities as judged by
the investigator.

5. Has T2DM and an HbA1c of 7.5% to 10.5%, inclusive, at Visit 1.

6. Has an estimated glomerular filtration rate (eGFR) value of ≥60 mL/min/1.73 m² based
on the Modification of Diet in Renal Disease (MDRD) equation.

7. Either is not treated with or has been on a stable treatment regimen with any of the
following medications for a minimum of 3 months prior to Visit 1:

1. Thiazolidinedione, sulfonylurea, dipeptidyl peptidase-4 inhibitors, and
alpha-glucosidase inhibitors

2. Hormone replacement therapy (female subjects) and testosterone (male subjects)

3. Oral contraceptives (female subjects)

4. Antihypertensive agents

5. Lipid-lowering agents

6. Thyroid replacement therapy

7. Antidepressant agents

8. Ability to understand and willingness to adhere to protocol requirements.

Exclusion Criteria:

1. Has a clinically significant medical condition as judged by the investigator that
could potentially affect study participation and/or personal well-being, including but
not limited to the following conditions:

1. Hepatic disease

2. Gastrointestinal disease

3. Endocrine disorder (T2DM is allowed)

4. Cardiovascular disease

5. Central nervous system diseases

6. Psychiatric or neurological disorders

7. Organ transplantation

8. Chronic or acute infection

9. Orthostatic hypotension, fainting spells or blackouts

10. Allergy or hypersensitivity.

2. A history of diabetic ketoacidosis or hyperosmolar non-ketotic hyperglycemia within
the past year.

3. Prior major surgery of any kind within 6 months of Visit 1.

4. A history of >3% weight change within 3 months of Visit 1.

5. A clinical laboratory test (clinical chemistry, hematology, or urinalysis)
abnormality, other than that related to T2DM, judged by the investigator to be
clinically significant at Visit 1.

6. An alanine aminotransferase or aspartate aminotransferase result >2.5 × upper limit of
normal (ULN) or a bilirubin result >1.5 × ULN.

7. A physical, psychological, or historical finding that, in the investigator's opinion,
would make the subject unsuitable for the study.

8. Has been treated, is currently being treated, or is expected to require or undergo
treatment with any of the following excluded medications:

1. Metformin within 2 months of Visit 1 (Screening)

2. Insulin within 2 weeks of Visit 1 (Screening) or for more than 1 week within 3
months of Visit 1 (Screening)

3. Glucagon-like peptide-1 receptor agonists or sodium-glucose co-transporter 2
inhibitors within 3 months of Visit 1

4. Drugs known to affect body weight, including prescription medications and
over-the-counter anti obesity agents within 3 months of Visit 1.

5. Systemic corticosteroids by oral, intravenous, or intramuscular route; or potent,
inhaled, or intrapulmonary steroids known to have a high rate of systemic
absorption within 3 months of Visit 1

6. Planned use of any drug treatment that affects gastric pH (prescription or
over-the-counter), such as H2-receptor antagonists and proton pump inhibitors,
after Visit 2 (Week -2), or planned chronic use of any antacids (i.e., more than
twice per week) after Visit 2 (Week -2)

7. Cationic drugs that are eliminated by renal tubular secretion within 1 week of
Visit 1.

8. Iodinated contrast dye within 1 week prior to Visit 1.

9. Investigational drug within 2 months (or five half-lives of the investigational
drug, whichever is greater) of the date of the first dose of randomized study
medication.

10. Met DR or double-blind matching placebo for Met DR at any time prior to Visit 1
(Screening)

9. Currently abuses drugs or alcohol or has a history of abuse that in the investigator's
opinion would cause the individual to be noncompliant with study procedures.

10. Had a blood transfusion or experienced significant blood loss (i.e., >500 mL),
including loss due to blood donation, within 2 months prior to Visit 1 (Screening), or
is planning to donate blood during the study.

11. Has known immune system based allergies or hypersensitivity to any component of study
treatment. A history of gastrointestinal intolerance to metformin is not exclusionary.

12. Is employed by Elcelyx Therapeutics, Inc. (that is an employee, contract worker, or
designee of the company).

13. Has a fasting plasma glucose value >270 mg/dL at Visit 1 (Screening), Visit 2 (Week
-2), and an unscheduled visit to be completed within 1 week following Visit 2. The
unscheduled visit is to be completed only for subjects with a fasting plasma glucose
value >270 mg/dL at Visit 1 and Visit 2.
We found this trial at
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Lincoln, California 95648
Principal Investigator: Jeffrey D Wayne, MD
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2017 Canyon Road, Suite 41
Birmingham, Alabama 35216
(205) 757-8208
Principal Investigator: Gary Boyd, MD
Site Overview Achieve has two clinical research sites in Birmingham, AL. Our Birmingham sites are conveniently located...
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900 East 30th Street
Austin, Texas 78705
512-480-9660
Principal Investigator: Cynthia Brinson, MD
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175 Cross Keys Rd.
Berlin, New Jersey 08009
856-753-7335
Principal Investigator: David Hassman, DO
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1720 2nd Ave S
Birmingham, Alabama 35233
(205) 934-4011 
Principal Investigator: Timothy Garvey, MD
University of Alabama at Birmingham The University of Alabama at Birmingham (UAB) traces its roots...
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924 W. Chandler Blvd.
Chandler, Arizona 85225
480-775-1115
Principal Investigator: Randall Severance, MD
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Kissimmee, Florida 34741
Principal Investigator: Michael H Link, MD
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2010 Wilshire Boulevard
Los Angeles, California 90057
213-413-2500
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77 West Granada Boulevard
Ormond Beach, Florida 32174
Principal Investigator: David W Carpenter, MD
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485 Simuel Road.
Spartanburg, South Carolina 29303
(864) 583-1556
Principal Investigator: Charles M Fogarty, MD, CPI
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823 SW Mulvane St
Topeka, Kansas 66606
785-368-0741
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Addison, Illinois 60101
Principal Investigator: Kathleen Kelley, MD
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Albuquerque, New Mexico
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Albuquerque, New Mexico 87109
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Anniston, Alabama 36207
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Augusta, Kansas 67010
Principal Investigator: Michael Rausch, MD
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Aurora, Illinois 60504
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Birmingham, Alabama 35209
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Bristol, Tennessee 37620
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2001 Oriental Boulevard
Brooklyn, New York 11235
Principal Investigator: Igor Grosman, DO
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Brooksville, Florida 34601
Principal Investigator: Kelli Maw, MD
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Burke, Virginia 22015
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Butte, Montana 59701
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Carolina, 00987
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Carrollton, Texas 75007
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Charleston, South Carolina 29407
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Chicago, Illinois 60607
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Cincinnati, Ohio 45219
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Cincinnati, Ohio 45212
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Columbia, Maryland 21045
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Columbus, Ohio 43214
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Dallas, Texas 75231
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Edina, Minnesota 55435
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Eugene, Oregon 97404
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Evanston, Illinois 60201
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Franklin, Ohio 45005
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Glendale, Arizona 85306
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Great Neck, New York 11023
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Greensboro, North Carolina 27408
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Greensboro, North Carolina 27410
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Greer, South Carolina 29651
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Hialeah, Florida 33012
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Hopewell Junction, New York 12553
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Houston, Texas 77062
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Houston, Texas 77074
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Houston, Texas 77074
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Houston, Texas 77098
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Huber Heights, Ohio 45424
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Huntington Park, California 90255
Principal Investigator: Stanley H-W Hsia, MD, FRCPC, FACE
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Hyattsville, Maryland 20782
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Jacksonville, Florida 32277
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Jupiter, Florida 33458
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Katy, Texas 77450
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Lakeland, Florida 33810
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Las Vegas, Nevada 89119
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Las Vegas, Nevada 89128
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Las Vegas, Nevada 89146
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Las Vegas, Nevada 89146
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Lexington, Kentucky 40503
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Long Beach, California 90806
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Louisville, Kentucky 40213
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Marion, Ohio 43302
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Memphis, Tennessee 38119
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Miami, Florida 33014
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Miami, Florida 33173
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Miami, Florida 33183
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Montclair, California 91763
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Mount Pleasant, South Carolina 29464
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Myrtle Beach, South Carolina 29588
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National City, California 91950
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North Hollywood, California 91606
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Oakland, California 94612
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Oklahoma City, Oklahoma 73103
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10040 Regency Cir
Omaha, Nebraska 68114
(402) 934-0044
Principal Investigator: Michael Dunn, MD
Quality Clinical Research, Inc. Welcome to Quality Clinical Research. We originated here in Omaha, NE...
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Omaha, Nebraska 68134
Principal Investigator: Alfred Felber, MD
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Orange, California 92868
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Orlando, Florida 32801
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Oxon Hill, Maryland 20745
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Paducah, Kentucky 42003
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Pembroke Pines, Florida 33026
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Peoria, Arizona 85381
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Phoenix, Arizona 85018
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Phoenix, Arizona 85037
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Port Gibson, Mississippi 39150
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