A Study of Dulaglutide (LY2189265) in Participants With Type 2 Diabetes Mellitus



Status:Completed
Conditions:Diabetes, Diabetes
Therapuetic Areas:Endocrinology
Healthy:No
Age Range:18 - Any
Updated:4/29/2018
Start Date:November 2015
End Date:February 2017

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A Randomized, Parallel-Arm, Double-Blind Study of Efficacy and Safety of Dulaglutide When Added to SGLT2 Inhibitors in Patients With Type 2 Diabetes Mellitus

The main purpose of this study is to evaluate the efficacy and safety of the study drug known
as dulaglutide when added to sodium-glucose co-transporter 2 (SGLT2) inhibitors in
participants with type 2 diabetes mellitus.


Inclusion Criteria:

- Have type 2 diabetes mellitus (based on the World Health Organization's [WHO]
diagnostic criteria)

- Have been treated with an SGLT2 inhibitor, with or without metformin, for at least 3
months prior to study entry (minimum required doses for that period for allowed SGLT2
inhibitors: empagliflozin 10 mg, dapagliflozin 5 or 10 mg [per country-specific
label], canagliflozin 100 mg); minimum required dose for metformin, if used, is ≥1500
mg/day and must be reached (or highest tolerated dose which is acceptable with
documented gastrointestinal [GI] intolerability)

- Daily doses of all allowed oral antihyperglycemia agent (OAMs) must have been stable
for at least 12 weeks (±3 days) prior to randomization (study enrollment); daily doses
of SGLT2 inhibitor and metformin, if used, will be considered stable during this
period if:

- all prescribed daily doses were in the range between the minimum required dose
and maximum-approved dose per country-specific label; and

- >90% of prescribed daily doses were equal to the dose at randomization

- Have HbA1c ≥7.0% and ≤9.5% at study entry and approximately 1 week prior to
randomization

- Have body mass index (BMI) ≤45 kilograms per meter squared (kg/m^2) and agree to not
initiate a diet and/or exercise program during the study with the intent of reducing
body weight other than the lifestyle and dietary measures for diabetes treatment

Exclusion Criteria:

- Have type 1 diabetes mellitus

- Have been treated with any other OAMs (other than SGLT2 inhibitors and metformin),
glucagon-like peptide-1 receptor agonist (GLP-1 RA), pramlintide or insulin 3 months
prior to study entry, or between study entry and randomization; or initiate metformin
between study entry and randomization; short-term use of insulin for acute care (≤14
days) during the 3-month period prior to entry is not exclusionary

- Have any condition that is a contraindication for use of the GLP-1 RA class or the
SGLT2 inhibitor class (per country-specific labels) at study entry or develop such
condition between study entry and randomization

- Have acute or chronic hepatitis, signs and symptoms of any other liver disease other
than nonalcoholic fatty liver disease (NAFLD), or alanine transaminase (ALT) level
>2.5 times the upper limit of the reference range, as determined by the central
laboratory at study entry; participants with NAFLD are eligible for participation in
this trial

- Had chronic or acute pancreatitis any time prior to study entry

- Estimated glomerular filtration rate (eGFR) <45 milliliters(mL)/minute/1.73m^2,
calculated by the Chronic Kidney Disease-Epidemiology (CKD-EPI) equation, as
determined by the central laboratory at study entry and confirmed at lead in

- Have any self or family history of type 2A or type 2B multiple endocrine neoplasia
(MEN 2A or 2B) in the absence of known C-cell hyperplasia (this exclusion includes
participants with a family history of MEN 2A or 2B, whose family history for the
syndrome is rearranged during transfect [RET]-negative; the only exception for this
exclusion will be for participants whose family members with MEN 2A or 2B have a known
RET mutation and the potential participant for the study is negative for the RET
mutation)

- Have any self or family history of medullary C-cell hyperplasia, focal hyperplasia,
carcinoma (including sporadic, familial, or part of MEN 2A or 2B syndrome)

- Have a serum calcitonin ≥20 picograms/mL as determined by the central laboratory at
study entry
We found this trial at
14
sites
2010 Wilshire Boulevard
Los Angeles, California 90057
213-413-2500
Principal Investigator: Juan Frias
Phone: 213-483-1800
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8042 Wurzbach Road
San Antonio, Texas 78229
210-949-0807
Principal Investigator: Firas Akhrass
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Brooklyn, New York 11211
Principal Investigator: Jayant Gandhi
Phone: 718-963-0555
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Dallas, Texas 75230
Principal Investigator: Julio Rosenstock
Phone: 972-566-7799
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Dallas, Texas 75251
Principal Investigator: Rafael Canadas
Phone: 972-233-5410
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Encino, California 91436
Principal Investigator: David Kayne
Phone: 818-990-1067
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Encino, CA
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Huntington Park, California 90255
Principal Investigator: Stanley Hsia
Phone: 323-588-1968
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Jefferson City, Missouri 65109
Principal Investigator: Christopher Case
Phone: 573-556-7785
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Jefferson City, MO
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Miami, Florida 33175
Principal Investigator: Francisco Miranda
Phone: 305-226-3933
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Miami, FL
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Morehead City, North Carolina 28557
Principal Investigator: Kathryn Lucas
Phone: 252-222-5700
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Morehead City, NC
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Saint Stefan Ob Stainz,
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Topeka, Kansas 66606
Principal Investigator: Alan Wynne
Phone: 785-368-0490
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Topeka, KS
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West Palm Beach, Florida
Principal Investigator: Barry Horowitz
Phone: 561-802-3060
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West Palm Beach, FL
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1907 Tradd Ct
Wilmington, North Carolina 28401
(910) 799-5500
Principal Investigator: John Parker
Phone: 910-815-6108
PMG Research of Wilmington PMG Research of Wilmington has two offices situated in a 1...
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