NCT02597049

Brief Summary

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.

Trial Health

93
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
424

participants targeted

Target at P50-P75 for phase_3 type-2-diabetes-mellitus

Timeline
Completed

Started Nov 2015

Shorter than P25 for phase_3 type-2-diabetes-mellitus

Geographic Reach
9 countries

41 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2015

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

November 3, 2015

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 4, 2015

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2017

Completed
1.2 years until next milestone

Results Posted

Study results publicly available

April 27, 2018

Completed
Last Updated

June 17, 2020

Status Verified

June 1, 2020

Enrollment Period

1.3 years

First QC Date

November 3, 2015

Results QC Date

February 2, 2018

Last Update Submit

June 10, 2020

Conditions

Type 2 Diabetes Mellitus

Outcome Measures

Primary Outcomes (2)

  • Change From Baseline in Hemoglobin A1c (HbA1c) at 24 Weeks (Treatment-regimen Estimand)

    Least Squares mean (LS) of the HbA1c change from baseline to primary endpoint at week 24 was adjusted by treatment, country, SGLT2 inhibitor dose, metformin use, treatment-by-visit interactions as fixed effects, and baseline HbA1c as a covariate and participant as a random effect, via a MMRM analysis. The treatment-regimen estimand used all data including post-rescue data and compared the benefit of treatment regimens as they were actually taken.

    Baseline, Week 24

  • Change From Baseline in the HbA1c at 24 Weeks (Efficacy Estimand)

    LS mean of the HbA1c change from baseline to primary endpoint at week 24 was adjusted by treatment, country, SGLT2 inhibitor dose, metformin use, treatment-by-visit interactions as fixed effects, and baseline HbA1c as a covariate and participant as a random effect, via a MMRM analysis. The efficacy estimand excluded post-rescue data and compared the benefit of randomized treatments when taken as directed without rescue medication.

    Baseline, Week 24

Secondary Outcomes (9)

  • Percentage of Participants With HbA1c <7%

    24 Weeks

  • Change From Baseline in Body Weight at 24 Weeks

    Baseline, Week 24

  • Change From Baseline in Fasting Serum Glucose (Central Laboratory) at 24 Weeks

    Baseline, Week 24

  • Change From Baseline in 6-Point Self-Monitored Plasma Glucose (SMPG) Profile at 24 Weeks

    Baseline, Week 24

  • Change From Baseline in Fasting Glucagon at 24 Weeks

    Baseline, Week 24

  • +4 more secondary outcomes

Study Arms (3)

1.5 mg Dulaglutide

EXPERIMENTAL

1.5 milligrams (mg) given subcutaneously (SC) once a week for 24 weeks.

Drug: DulaglutideDrug: SGLT2 inhibitorDrug: Metformin

0.75 mg Dulaglutide

EXPERIMENTAL

0.75 mg dulaglutide given SC once a week for 24 weeks.

Drug: DulaglutideDrug: SGLT2 inhibitorDrug: Metformin

Placebo

PLACEBO COMPARATOR

Placebo given SC once a week for 24 weeks.

Drug: PlaceboDrug: SGLT2 inhibitorDrug: Metformin

Interventions

DulaglutideDRUG

Administered SC

Also known as: LY2189265
0.75 mg Dulaglutide1.5 mg Dulaglutide
PlaceboDRUG

Administered SC

Placebo
SGLT2 inhibitorDRUG

Administered orally as standard of care for type 2 diabetes

Also known as: Canagliflozin, Dapagliflozin, Empagliflozin
0.75 mg Dulaglutide1.5 mg DulaglutidePlacebo
MetforminDRUG

Administered orally as standard of care for type 2 diabetes

0.75 mg Dulaglutide1.5 mg DulaglutidePlacebo

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Have type 1 diabetes mellitus
  • 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 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (41)

Medical Group of Encino

Encino, California, 91436, United States

Location

National Research Institute

Huntington Park, California, 90255, United States

Location

National Research Institute

Los Angeles, California, 90057, United States

Location

New Horizon Research Center

Miami, Florida, 33175, United States

Location

Metabolic Research Institute Inc.

West Palm Beach, Florida, 33401, United States

Location

Cotton O'Neil Diabetes and Endocrinology Center

Topeka, Kansas, 66606, United States

Location

JCMG Clinical Research

Jefferson City, Missouri, 65109, United States

Location

Grand Street Medical PC

Brooklyn, New York, 11211, United States

Location

Diabetes & Endocrinology Consultants PC

Morehead City, North Carolina, 28557, United States

Location

PMG Research of Wilmington, LLC

Wilmington, North Carolina, 28401, United States

Location

Dallas Diabetes Endocrine Center

Dallas, Texas, 75230, United States

Location

Galenos Research

Dallas, Texas, 75251, United States

Location

Endeavor Clinical Trials

San Antonio, Texas, 78229, United States

Location

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

Saint Stefan Ob Stainz, 8511, Austria

Location

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Steyr, 4400, Austria

Location

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Vienna, 1030, Austria

Location

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Brandys Nad Labem-Stara Bolesl, 25001, Czechia

Location

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Holešov, 769 01, Czechia

Location

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Krnov, 79401, Czechia

Location

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Pardubice, 53002, Czechia

Location

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Prague, 149 00, Czechia

Location

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Prague, 181 00, Czechia

Location

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Münster, 48145, Germany

Location

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Oldenburg, 23758, Germany

Location

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Budapest, 1023, Hungary

Location

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

Budapest, 1042, Hungary

Location

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

Debrecen, 4043, Hungary

Location

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Nagykanizsa, 8800, Hungary

Location

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Haifa, 3299001, Israel

Location

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

Holon, 5822012, Israel

Location

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Jerusalem, 911200, Israel

Location

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Monterrey, 64460, Mexico

Location

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

Monterrey, 64620, Mexico

Location

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Zapopan, 45116, Mexico

Location

Centro de Endocrinologia y Nutricion

Caguas, 00725, Puerto Rico

Location

Manati Medical Center

Manatí, 00674, Puerto Rico

Location

Centro de Endocrinologia del Este

Yabucoa, 00767, Puerto Rico

Location

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

Alicante, 03004, Spain

Location

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

Málaga, 29006, Spain

Location

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

Seville, 41003, Spain

Location

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

Seville, 41010, Spain

Location

Related Publications (2)

  • Ferdinand KC, Dunn J, Nicolay C, Sam F, Blue EK, Wang H. Weight-dependent and weight-independent effects of dulaglutide on blood pressure in patients with type 2 diabetes. Cardiovasc Diabetol. 2023 Mar 9;22(1):49. doi: 10.1186/s12933-023-01775-x.

    PMID: 36894938DERIVED

  • Ludvik B, Frias JP, Tinahones FJ, Wainstein J, Jiang H, Robertson KE, Garcia-Perez LE, Woodward DB, Milicevic Z. Dulaglutide as add-on therapy to SGLT2 inhibitors in patients with inadequately controlled type 2 diabetes (AWARD-10): a 24-week, randomised, double-blind, placebo-controlled trial. Lancet Diabetes Endocrinol. 2018 May;6(5):370-381. doi: 10.1016/S2213-8587(18)30023-8. Epub 2018 Feb 23.

    PMID: 29483060DERIVED

Related Links

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

dulaglutideSodium-Glucose Transporter 2 InhibitorsCanagliflozindapagliflozinempagliflozinMetformin

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Molecular Mechanisms of Pharmacological ActionPharmacologic ActionsChemical Actions and UsesHypoglycemic AgentsPhysiological Effects of DrugsThiophenesSulfur CompoundsOrganic ChemicalsHeterocyclic Compounds, 1-RingHeterocyclic CompoundsGlucosidesGlycosidesCarbohydratesBiguanidesGuanidinesAmidines

Limitations and Caveats

One participant was randomized into the study but did not receive study drug. This participant was not included in the efficacy or safety analysis.

Results Point of Contact

Title
Chief Medical Officer
Organization
Eli Lilly and Company
ClinicalTrials.gov@lilly.com
800-545-5979

Study Officials

  • Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)

    Eli Lilly and Company

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
GT60
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 3, 2015

First Posted

November 4, 2015

Study Start

November 1, 2015

Primary Completion

February 1, 2017

Study Completion

February 1, 2017

Last Updated

June 17, 2020

Results First Posted

April 27, 2018

Record last verified: 2020-06

Data Sharing

IPD Sharing
Will share

Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.

Shared Documents
STUDY PROTOCOL, SAP, CSR
Time Frame
Data are available 6 months after the primary publication and approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting.
Access Criteria
A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
More information

Locations

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