Type 2 DiabetesPhase 2NCT02973100

A Study of Investigational Dulaglutide Doses in Participants With Type 2 Diabetes on Metformin Monotherapy

A Phase 2 study testing Dulaglutide in people with Type 2 Diabetes, run by Eli Lilly and Company at 66 sites in 6 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

The purpose of this study is to evaluate the efficacy and safety of investigational doses of dulaglutide in participants with type 2 diabetes on metformin monotherapy. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Type 2 Diabetes
What is being tested?: Dulaglutide
Type of treatment: Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 318 participants
Where: 66 sitesin 6 countries
Study dates: Dec 2016to 14 Aug 2017
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Have had type 2 diabetes (T2D) for ≥6 months according to the World Health Organization (WHO) classification
Have HbA1c of 7.0% to 10.0%, inclusive, as assessed by the central laboratory
Have been treated with stable doses of metformin for at least 3 months
Have a body mass index (BMI) ≥25 kilograms per square meter

Who cannot join

Have type 1 diabetes (T1D)
Have used any glucose-lowering medication other than metformin 3 months prior to study entry or during screening/lead-in period or have used any glucagon-like peptide-1 receptor agonists (GLP-1 RAs) at any time in the past
Have had any of the following cardiovascular conditions: acute myocardial infarction (MI), New York Heart Association Class III or Class IV heart failure, or cerebrovascular accident (stroke)
Have acute or chronic hepatitis, signs and symptoms of any other liver disease other than nonalcoholic fatty liver disease (NAFLD), or alanine aminotransferase (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
Have had chronic or acute pancreatitis any time prior to study entry
Have an estimated glomerular filtration rate (eGFR) <45 milliliters/minute/1.73 square meter, calculated by the Chronic Kidney Disease-Epidemiology (CKD-EPI) equation
Have serum calcitonin ≥20 picograms per milliliter, as determined by the central laboratory at study entry

Trial locations and contacts

66 sites in 6 countries.

Country

City, postcode or hospital

66 sites in 6 countries

United States38 sites

Heritage Valley Medical Group, Inc.
Beaver, Pennsylvania, 15009
Elite Cilnical Trials LLLP
Blackfoot, Idaho, 83221
StudyMetrix Research, LLC
City of Saint Peters, Missouri, 63303
Aventiv Research
Columbus, Ohio, 43213
Axes Medical Research, LLC
Cooper City, Florida, 33024
Clinical Research of South Florida
Coral Gables, Florida, 33134
The Corvallis Clinic P.C.
Corvallis, Oregon, 97330
Dallas Diabetes Endocrine Center
Dallas, Texas, 75230
Iderc, P.L.C.
Des Moines, Iowa, 50314
Parexel Early Phase Unit at Glendale
Glendale, California, 91206-4140
Marin Endocrine Associates
Greenbrae, California, 94904
High Point Clinical Trials Center
High Point, North Carolina, 27265
East West Medical Institute
Honolulu, Hawaii, 96814
National Research Institute
Huntington Park, California, 90255
American Health Network
Indianapolis, Indiana, 46254
East Coast Institute For Research
Jacksonville, Florida, 32204
New Phase Research & Development
Knoxville, Tennessee, 37909
National Research Institute
Los Angeles, California, 90057
Solaris Clinical Research
Meridian, Idaho, 83646
ActivMed Practices & Research, Inc
Methuen, Massachusetts, 01844
New Horizon Research Center
Miami, Florida, 33175
Suncoast Research Group, LLC
Miami Lakes, Florida, 33135
Catalina Research Institute, LLC
Montclair, California, 91763
Manhattan Medical Research
New York Mills, New York, 10016
In-Quest Medical Research, LLC - Norcross
Norcross, Georgia, 30071
Palm Harbor Medical Associates
Palm Harbor, Florida, 34684
Rainier Clinical Research Center
Renton, Washington, 98057
Consano Clinical Research
San Antonio, Texas, 78231
Artemis Institute for Clinical Research
San Diego, California, 92103
Encompass Clinical Research
Spring Valley Lake, California, 91978
HSHS Medical Group Diabetes Research
Springfield, Illinois, 62711
Chrysalis Clinical Research
St. George, Utah, 84790
Cotton O'Neil Diabetes and Endocrinology Center
Topeka, Kansas, 66606
University Clinical Investigators, Inc.
Tustin, California, 92780
Infosphere
Van Nuys, California, 91405
Diablo Clinical Research
Walnut Creek, California, 94598
Chase Medical Research, LLC
Waterbury, Connecticut, 06708
Clinpoint Trial, LLC
Waxahachie, Texas, 75165

Other trials in United States

Poland10 sites

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.
Bialystok, 15-404
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Bialystok, 15-445
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Gdansk, 80-546
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Lodz, 90-242
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Lublin, 20-333
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Lublin, 20-538
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Poznan, 61-655
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Poznan, 61-853
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Ruda Śląska, 41-709
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Szczecin, 70-506

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Czechia6 sites

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Brandýs nad Labem-Stará Boleslav, 25001
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Krnov, 79401
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Prague, 11000
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Prague, 149 00
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Prague, 181 00
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Praha 4 - Krc, 140 59

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Mexico5 sites

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Chihuahua City, 31217
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Cuernavaca, 62250
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Guadalajara, 04460
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Monterrey, 64460
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Tampico, 89000

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Romania5 sites

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.
Alba Iulia, 510053
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Baia Mare, 430222
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Iași, 700547
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Oradea, 410159
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Satu Mare, 440055

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Puerto Rico2 sites

Marginal Doctor's Center
Manati, 00674
American Telemedicine Center
San Juan, 00917

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About this study

Official title: A Phase 2, Double-Blind, Placebo-Controlled, 18-Week Trial of Investigational Dulaglutide Doses Versus Placebo in Patients With Type 2 Diabetes on Metformin Monotherapy

The purpose of this study is to evaluate the efficacy and safety of investigational doses of dulaglutide in participants with type 2 diabetes on metformin monotherapy.

Conditions: Type 2 Diabetes
Being tested: Dulaglutide, Placebo
Medical subject headings: Diabetes Mellitus, Type 2

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

DulaglutideDrug
Also called LY2189265
Administered SC
PlaceboDrug
Administered SC

Study groups in NCT02973100
Study group	Role	What they receive
Dulaglutide 4.5mg	Experimental	4.5mg of Dulaglutide administered subcutaneously (SC) Receives: Drug: Dulaglutide
Dulaglutide 3.0mg	Experimental	3.0mg of Dulaglutide administered SC Receives: Drug: Dulaglutide
Dulaglutide 1.5mg	Active comparator	1.5mg of Dulaglutide administered SC Receives: Drug: Dulaglutide
Placebo	Placebo comparator	Placebo administered SC Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Change From Baseline in Hemoglobin A1c (HbA1c)
HbA1c is the glycosylated fraction of hemoglobin A. HbA1c is measured to identify average plasma glucose concentration over prolonged periods of time.
Least Squares (LS) mean was determined by mixed-model repeated measures (MMRM) model with baseline as a covariate, pooled country, treatment, time, treatment*time as fixed effects.
Measured: Baseline, Week 18

Secondary outcomes (7)

Percentage of Participants With HbA1c of <7.0%
Hemoglobin A1c (HbA1c) is the glycosylated fraction of hemoglobin A. HbA1c is measured to identify average plasma glucose concentration over prolonged periods of time.
Measured: Week 18
Change From Baseline in Fasting Serum Glucose (FSG)
Fasting serum glucose (FSG) is a test to determine how much glucose (sugar) is in a serum sample after an overnight fast. Least Squares (LS) means was determined by MMRM methodology with baseline as a covariate, pooled country, baseline HbA1c strata using >=8% as cutoff, treatment, time, treatment*time as fixed effects.
Measured: Baseline, Week 18
Change From Baseline in Body Weight
Least Squares (LS) mean was determined by mixed-model repeated measures (MMRM) model with baseline as a covariate, pooled country, baseline HbA1c strata using >=8% as cutoff, treatment, time, treatment*time as fixed effects.
Measured: Baseline, Week 18
Percentage of Participants Discontinuing Study Drug Due to Adverse Events
Adverse event (AE) defined as any unfavorable medical event, newly emerged or a deterioration of a preexisting condition, in other words any untoward medical occurrence in a patient administered a pharmaceutical product, without regard to the possibility of a causal relationship, that occurred after the visit for informed consent and up to the visit for completion of administration, or discontinuation.
Measured: Baseline through Week 18
Rate of Documented Symptomatic Hypoglycemia
Hypoglycemic events (HE) were classified as severe, documented symptomatic (defined as an HE with typical symptoms of hypoglycemia and a blood glucose level of ≤3.9 millimoles per liter [mmol/L]). Hypoglycemia rate per 30 days was summarized at each visit by treatment group. The rate of hypoglycemia was analyzed using a generalized estimation equations model with a negative binomial distribution and a Log link. LS mean was determined by MMRM methodology with baseline hypoglycemia rate, pooled country, HbA1c at Baseline, treatment, with log of exposure in days divided by 365.25 as the offset.
Measured: Week 18
Pharmacokinetics (PK): The Maximum Drug Concentration at Steady State (Cmax,ss) of Dulaglutide
Plasma samples for PK analysis were combined measure obtained from 0, 2, 4, 6, 10, 18, 22 weeks and until early termination of the visit. Cmax takes all time points post dose into account and one value was reported.
Measured: 0, 2, 4, 6, 10, 18, 22 weeks and early termination
Pharmacokinetics: Area Under the Concentration-Time Curve at Steady State From Time Zero to 168 Hours (AUC[0-168], ss) of Dulaglutide
AUC[0-168h] is a combined measure obtained from 0, 2, 4, 6, 10, 18, 22 weeks and until early termination of the visit.
Measured: 0, 2, 4, 6, 10, 18, 22 weeks and early termination

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Dec 201614 Aug 2017

First posted25 Nov 2016 (estimated)
Study startDec 2016
Primary completion15 Jul 2017
Study completion14 Aug 2017

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Type 2 DiabetesStudies of the same condition, open and under way.
More trials run by Eli Lilly and CompanyThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 318 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02973100
Sponsor's protocol ID: 16568
Other IDs: H9X-MC-GBGJ, 2016-002494-34, 2016
Status last verified: Sep 2019
First submitted: 22 Nov 2016
Last updated: 23 Sep 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
Individual data sharing: Yes: 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.

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 23 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 2, Double-Blind, Placebo-Controlled, 18-Week Trial of Investigational Dulaglutide Doses Versus Placebo in Patients With Type 2 Diabetes on Metformin Monotherapy
ClinicalTrials.gov ID: NCT02973100
Acronym / sponsor ID: 16568
Conditions: Type 2 Diabetes
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 318 participants (actual)
Lead sponsor: Eli Lilly and CompanyIndustry (pharma, biotech, devices)
Study start: Dec 2016
Primary completion: 15 Jul 2017 (actual)
Study completion: 14 Aug 2017 (actual)
First posted: 25 Nov 2016 (estimated)
Results: Posted 24 Aug 2018

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

The purpose of this study is to evaluate the efficacy and safety of investigational doses of dulaglutide in participants with type 2 diabetes on metformin monotherapy.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 4

Arm	Type	Receives
Dulaglutide 4.5mg	Experimental	Drug: Dulaglutide4.5mg of Dulaglutide administered subcutaneously (SC)
Dulaglutide 3.0mg	Experimental	Drug: Dulaglutide3.0mg of Dulaglutide administered SC
Dulaglutide 1.5mg	Active comparator	Drug: Dulaglutide1.5mg of Dulaglutide administered SC
Placebo	Placebo comparator	Drug: PlaceboPlacebo administered SC

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

Have had type 2 diabetes (T2D) for ≥6 months according to the World Health Organization (WHO) classification
Have HbA1c of 7.0% to 10.0%, inclusive, as assessed by the central laboratory
Have been treated with stable doses of metformin for at least 3 months
Have a body mass index (BMI) ≥25 kilograms per square meter

Key exclusion criteria (7 listed)

Have type 1 diabetes (T1D)
Have used any glucose-lowering medication other than metformin 3 months prior to study entry or during screening/lead-in period or have used any glucagon-like peptide-1 receptor agonists (GLP-1 RAs) at any time in the past
Have had any of the following cardiovascular conditions: acute myocardial infarction (MI), New York Heart Association Class III or Class IV heart failure, or cerebrovascular accident (stroke)
Have acute or chronic hepatitis, signs and symptoms of any other liver disease other than nonalcoholic fatty liver disease (NAFLD), or alanine aminotransferase (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
Have had chronic or acute pancreatitis any time prior to study entry

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
DulaglutideAlso: LY2189265Administered SC	Drug	Dulaglutide 1.5mg, Dulaglutide 3.0mg, Dulaglutide 4.5mg
PlaceboAdministered SC	Drug	Placebo

Primary outcome

Change From Baseline in Hemoglobin A1c (HbA1c)
Time frame: Baseline, Week 18
HbA1c is the glycosylated fraction of hemoglobin A. HbA1c is measured to identify average plasma glucose concentration over prolonged periods of time. Least Squares (LS) mean was determined by mixed-model repeated measures (MMRM) model with baseline as a covariate, pooled country, treatment, time, treatment*time as fixed effects.

7 secondary outcomes

Percentage of Participants With HbA1c of <7.0%
Time frame: Week 18
Change From Baseline in Fasting Serum Glucose (FSG)
Time frame: Baseline, Week 18
Change From Baseline in Body Weight
Time frame: Baseline, Week 18
Percentage of Participants Discontinuing Study Drug Due to Adverse Events
Time frame: Baseline through Week 18
Rate of Documented Symptomatic Hypoglycemia
Time frame: Week 18
Pharmacokinetics (PK): The Maximum Drug Concentration at Steady State (Cmax,ss) of Dulaglutide
Time frame: 0, 2, 4, 6, 10, 18, 22 weeks and early termination
Pharmacokinetics: Area Under the Concentration-Time Curve at Steady State From Time Zero to 168 Hours (AUC[0-168], ss) of Dulaglutide
Time frame: 0, 2, 4, 6, 10, 18, 22 weeks and early termination

Results and safety

Results posted to the registry on 24 Aug 2018, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Placebo	82	75
Dulaglutide 1.5 Milligrams (mg)	81	73
Dulaglutide 3.0mg	79	75
Dulaglutide 4.5mg	76	69

Primary outcome: Change From Baseline in Hemoglobin A1c (HbA1c)

Time frame: Baseline, Week 18. Least squares mean (Standard Error). Unit: Percentage of glycosylated hemoglobin

Measure	Placebo n = 70	Dulaglutide 1.5mg n = 73	Dulaglutide 3.0mg n = 73	Dulaglutide 4.5mg n = 66
Value	-0.44 (0.101)	-1.23 (0.099)	-1.31 (0.099)	-1.40 (0.103)

Placebo vs Dulaglutide 1.5mg: Mean Difference (Final Values): -0.80 (95% CI -1.07 to -0.53), p <.001, Mixed Models Analysis
Placebo vs Dulaglutide 3.0mg: Mean Difference (Final Values): -0.87 (95% CI -1.14 to -0.60), p <0.001, Mixed Models Analysis
Placebo vs Dulaglutide 4.5mg: Mean Difference (Final Values): -0.96 (95% CI -1.24 to -0.69), p <.001, Mixed Models Analysis

Population analysed: All randomized participants who received at least one dose of study drug and had postbaseline values, excluding post rescue data for Hemoglobin A1c.

7 secondary outcomes are reported in the full results.

Adverse events

Time frame: Up to 22 weeks. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Placebo	4 of 81 (4.9%)	29 of 81 (35.8%)	0 of 81
Dulaglutide 1.5mg	3 of 81 (3.7%)	36 of 81 (44.4%)	0 of 81
Dulaglutide 3.0mg	7 of 79 (8.9%)	49 of 79 (62%)	0 of 79
Dulaglutide 4.5mg	3 of 76 (3.9%)	39 of 76 (51.3%)	0 of 76

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
A Study of Investigational Dulaglutide Doses in Participants With Type 2 Diabetes on Metformin MonotherapyLink provided by the sponsor.
Individual participant dataSharing planned: Yes. 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.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

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) study director

Eli Lilly and Company

66 sites in 6 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Dulaglutide in people with Type 2 Diabetes, run by Eli Lilly and Company at 66 sites in 6 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 23 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 66 sites in United States, Poland, Czechia, Mexico, Romania and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 24 Aug 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change From Baseline in Hemoglobin A1c (HbA1c) (time frame: Baseline, Week 18). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02973100.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Sep 2019.