Diabetes Mellitus, Type 2Phase 2NCT02119819

A Study to Compare a New Drug for Type 2 Diabetes to Placebo and to a Treatment Already Available for Type 2 Diabetes

A Phase 2 study testing LY2944876, Exenatide extended-release and Metformin in people with Diabetes Mellitus, Type 2, run by OPKO Health, Inc. at 51 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

Who is it for?: Ages 18 to 80 years
Conditions the study is for: Diabetes Mellitus, Type 2
What is being tested?: LY2944876, Exenatide extended-release and Metformin
Type of treatment: Pill or oral medicine, Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 420 participants
Where: 51 sitesin 6 countries
Study dates: Apr 2014to Oct 2015
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 to 80 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Men or women with diabetes mellitus Type 2
Have screening HbA1c ≥7.0% and ≤10.5% either on diet and exercise alone or on a stable dose of metformin (≥1000 mg/day) for 3 months prior to screening
Have body mass index (BMI) ≥23 and ≤45 kilograms per meter squared at screening

Who cannot join

Women of child bearing potential
Participants who have used thiazolidinediones within 3 months prior to screening, or any other drugs for treatment of hyperglycemia (except metformin) within the prior 2 months
Participants who have used insulin for diabetic control for more than 6 consecutive days within the prior year
Participants with impaired renal function (serum creatinine >124 micromole per liter (µmol/L) [1.4 milligrams per deciliter (mg/dL)] in women, >133 µmol/L [1.5 mg/dL] in men)

Trial locations and contacts

51 sites in 6 countries.

Country

City, postcode or hospital

51 sites in 6 countries

United States31 sites

Blair Medical Associates, Inc.
Altoona, Pennsylvania, 16602
Texas Diabetes and Endocrinology
Austin, Texas, 78731
Wade Family Medicine
Bountiful, Utah, 84010
Meridien Research
Bradenton, Florida, 34208
John Muir Physician Network Clinical Research Center
Concord, California, 94520
The Corvallis Clinic P.C.
Corvallis, Oregon, 97330
Dallas Diabetes Endocrine Center
Dallas, Texas, 75230
Iderc, P.L.C.
Des Moines, Iowa, 50314
Lillestol Research LLC
Fargo, North Dakota, 58103
M & O Clinical Research, LLC
Fort Lauderdale, Florida, 33316
Valley Endocrine, Fresno
Fresno, California, 93720
San Gabriel Clinical Research
Georgetown, Texas, 78626
High Point Clinical Trials Center
High Point, North Carolina, 27265
University of Hawaii
Honolulu, Hawaii, 96813
East West Medical Institute
Honolulu, Hawaii, 96814
Rocky Mountain Diabetes and Osteoporosis Center
Idaho Falls, Idaho, 83404
National Research Institute
Los Angeles, California, 90057
Suncoast Research Group, LLC
Miami, Florida, 33135
Southern New Hampshire Diabetes and Endocrinology
Nashua, New Hampshire, 03063
Suncoast Clinical Research
New Port Richey, Florida, 34652
Compass Research
Oviedo, Florida, 32765
Desert Medical Group Inc
Palm Springs, California, 92262
Oakwell Clinical Research
San Antonio, Texas, 78218
Artemis Institute for Clinical Research
San Diego, California, 92103
Encompass Clinical Research
Spring Valley, California, 91978
Mercy Medical Research Institute
Springfield, Missouri, 65807
St John's Mercy Medical Center
St Louis, Missouri, 63141
Southwest Health Associates, P.A.
Sugar Land, Texas, 77478
Cotton O'Neil Diabetes and Endocrinology Center
Topeka, Kansas, 66606
Mercy Health Research
Washington, Missouri, 63090
Clinical Research of Central Florida
Winter Haven, Florida, 33880

Other trials in United States

Poland7 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, 15-351
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Gdansk, 80-546
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Gdynia, 81-553
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Lodz, 90-242
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Poznan, 61-853
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Szczecin, 70-506
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Warsaw, 01-518

Other trials in Poland

Romania5 sites

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Cluj-Napoca, 400349
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Iași, 700547
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Ploieşti, 100342
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Târgu Mureş, 540098
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Timișoara, 300456

Other trials in Romania

Greece3 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.
Ampelokipoi, 11527
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Athens, 11527
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Thessaloniki, 57010

Other trials in Greece

Mexico3 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.
Chihuahua City, 31238
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Guadalajara, 44690
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Tampico, 89000

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Puerto Rico2 sites

Manati Medical Center
Manati, 00674
American Telemedicine Center
San Juan, 00917-3104

Other trials in Puerto Rico

About this study

Official title: Comparison of the Oxyntomodulin Analog, LY2944876, to Once-Weekly Exenatide and to Placebo in Patients With Type 2 Diabetes

The main purpose of this study is to compare the safety and effectiveness of the study drug known as LY2944876 to exenatide extended-release and placebo in participants with type 2 diabetes mellitus. All drugs will be given by an injection under the skin. Participants remain on stable doses of metformin, as prescribed by their personal investigator if they were on metformin at study entry. Participants' involvement in the study is expected to last about 30 weeks.

Read the detailed description

The study will include a 12 week blinded treatment period, where neither the participant nor the investigator will know to which treatment each individual is assigned. Thereafter follows a 12 week period where participants and the investigator will know which treatment they are assigned to. Participants' on LY2944876 and on exenatide extended-release continue treatment in this period, those who received placebo will be followed without treatment.

Conditions: Diabetes Mellitus, Type 2
Being tested: LY2944876, Exenatide extended-release, Placebo, Metformin
Keywords: Weight loss
Medical subject headings: Diabetes Mellitus, Type 2, Weight Loss

What participants receive

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

LY2944876Drug
Administered SC
Exenatide extended-releaseDrug
Administered SC
PlaceboDrug
Administered SC
MetforminDrug
Oral

Study groups in NCT02119819
Study group	Role	What they receive
10 mg LY2944876	Experimental	10 milligrams (mg) LY2944876 given subcutaneously (SC) once weekly for 24 weeks. Participants remain on stable doses of metformin, as prescribed by their personal investigator if they were on metformin at study entry. Receives: Drug: LY2944876; Drug: Metformin
15 mg LY2944876	Experimental	15 mg LY2944876 given SC once weekly for 24 weeks. Participants remain on stable doses of metformin, as prescribed by their personal investigator if they were on metformin at study entry. Receives: Drug: LY2944876; Drug: Metformin
30 mg LY2944876	Experimental	30 mg LY2944876 given SC once weekly for 24 weeks. Participants remain on stable doses of metformin, as prescribed by their personal investigator if they were on metformin at study entry. Receives: Drug: LY2944876; Drug: Metformin
50 mg LY2944876	Experimental	50 mg LY2944876 given SC once weekly for 24 weeks. Participants remain on stable doses of metformin, as prescribed by their personal investigator if they were on metformin at study entry. Receives: Drug: LY2944876; Drug: Metformin
Exenatide extended-release	Experimental	2 mg exenatide extended-release given SC once weekly for 24 weeks. Participants remain on stable doses of metformin, as prescribed by their personal investigator if they were on metformin at study entry. Receives: Drug: Exenatide extended-release; Drug: Metformin
Placebo	Placebo comparator	Placebo for LY2944876 and Exenatide given SC once weekly for 12 weeks. Participants assigned to placebo will have no injections during the second 12 weeks of the study. Participants remain on stable doses of metformin, as prescribed by their personal investigator if they were on metformin at study entry. Receives: Drug: Placebo; Drug: Metformin

What is being measured

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

Change From Baseline in Hemoglobin A1c (HbA1c) at Week 12
HbA1c is the glycosylated fraction of hemoglobin A. HbA1c is measured to identify average plasma glucose concentration over prolonged periods of time.
Measured: Baseline, Week 12

Secondary outcomes (14)

Change From Baseline in HbA1c at Week 24
HbA1c is the glycosylated fraction of hemoglobin A. HbA1c is measured to identify average plasma glucose concentration over prolonged periods of time.
Measured: Baseline, Week 24
Percent Change From Baseline in Body Weight
Measured: Baseline, Week 12; Baseline, Week 24
Change From Baseline in Fasting Blood Glucose
Least square means (LSM) was calculated from mixed-effects model with repeated measures (MMRM) analysis using restricted maximum likelihood (REML) with metformin use, baseline body mass index (BMI) category, baseline HbA1c category, country, treatment, visit, and treatment-by-visit interaction as fixed effects, baseline fasting blood glucose as a covariate, and participant as a random effect.
Measured: Baseline, Week 12; Baseline, Week 24
Change From Baseline in 7-point Self-Monitored Blood Glucose (SMBG) Values
SMBG 7-point profiles were measured at morning pre-meal, morning 2 hours post-meal, mid-day pre-meal, mid-day 2 hours post-meal, evening pre-meal, evening 2 hours post-meal, and at bedtime. LSM were calculated from MMRM analysis using REML with metformin use, baseline BMI category, baseline HbA1c category, country, treatment, visit, and treatment-by-visit interaction as fixed effects, baseline fasting blood glucose as a covariate, and participant as a random effect.
Measured: Baseline, Week (Wk) 12; Baseline, Week 24
Change From Baseline in Lipids
Change from baseline in high-density lipoprotein cholesterol (HDL-C), total cholesterol, triglycerides, and low-density lipoprotein cholesterol (LDL-C). LSM was calculated from MMRM analysis using REML with metformin use, baseline BMI category, baseline HbA1c category, country, treatment, visit, and treatment-by-visit interaction as fixed effects, baseline parameter result as a covariate, and participant an a random effect.
Measured: Baseline, Week 24
Change From Baseline in Fasting Fibroblast Growth Factor 21
LSM was calculated from MMRM analysis using REML with metformin use, baseline BMI category, baseline HbA1c category, country, treatment, visit, and treatment-by-visit interaction as fixed effects, baseline parameter result as a covariate, and participant as a random effect.
Measured: Baseline, Week 12; Baseline, Week 24
Percentage of Participants Requiring Rescue Therapy
Participants who received rescue medication with non-study antihyperglycemic medications or change their stable dose of metformin.
Measured: Baseline through Therapy Completion (Week 24)
Percentage of Participants Developing Anti-Drug Antibodies to LY2944876
Percentage of participants developing anti-drug antibodies to LY2944876.
Measured: Week 12 and Week 24
Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY2944876
Evaluable pharmacokinetic concentrations from the specified timepoints were combined and utilized in a population approach to determine the population mean estimate and standard deviation at steady-state.
Measured: Baseline, Week 8, Week 12, Week 16, Week 20, Week 24
Pharmacokinetics: Area Under the Concentration Curve (AUC) of LY2944876
Evaluable pharmacokinetic concentrations from the specified timepoints were combined and utilized in a population approach to determine the population mean estimate and standard deviation at steady-state.
Measured: Baseline, Week 8, Week 12, Week 16, Week 20, Week 24
Change From Baseline in Adiponectin Levels
LSM are calculated from MMRM analysis using REML with metformin use, baseline BMI category, baseline HbA1c category, country, treatment, visit, and treatment-by-visit interaction as fixed effects, baseline parameter result as a covariate, and participant as a random effect.
Measured: Baseline, Week 12; Baseline, Week 24
Change From Baseline in Beta-Hydroxy Butyrate Levels
LSM are calculated from MMRM analysis using REML with metformin use, baseline BMI category, baseline HbA1c category, country, treatment, visit, and treatment-by-visit interaction as fixed effects, baseline parameter result as a covariate, and participant as a random effect.
Measured: Baseline, Week 12; Baseline, Week 24
Change From Baseline in Glucagon Levels
LSM are calculated from MMRM analysis using REML with metformin use, baseline BMI category, baseline HbA1c category, country, treatment, visit, and treatment-by-visit interaction as fixed effects, baseline parameter result as a covariate, and participant as a random effect.
Measured: Baseline, Week 12; Baseline, Week 24
Change From Baseline in Insulin Levels
LSM are calculated from MMRM analysis using REML with metformin use, baseline BMI category, baseline HbA1c category, country, treatment, visit, and treatment-by-visit interaction as fixed effects, baseline parameter result as a covariate, and participant as a random effect.
Measured: Baseline, Week 12; Baseline, Week 24

Timeline

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

Apr 2014Oct 2015

First posted22 Apr 2014 (estimated)
Study startApr 2014
Primary completionAug 2015
Study completionOct 2015

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.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
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: 420 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02119819
Sponsor's protocol ID: 15062
Other IDs: 2013-003552-21, I7I-MC-XNAA
Status last verified: May 2021
First submitted: 17 Apr 2014
Last updated: 27 May 2021
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: Yes: Lilly provides access to the individual patient data from studies on approved medicines and indications as defined by the sponsor specific information on ClinicalStudyDataRequest.com. This access is provided in a timely fashion after the primary publication is accepted. Researchers need to have an approved research proposal submitted through ClinicalStudyDataRequest.com. Access to the data will be provided in a secure data sharing environment after signing a data sharing agreement.

Publications

Park EJ, Choi J, Lee KC, Na DH. Emerging PEGylated non-biologic drugs. Expert Opin Emerg Drugs. 2019 Jun;24(2):107-119. doi: 10.1080/14728214.2019.1604684. Epub 2019 Apr 19.
PubMed 30957581

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?

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Study at a glance

From the registry record, last updated by the sponsor on 27 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Comparison of the Oxyntomodulin Analog, LY2944876, to Once-Weekly Exenatide and to Placebo in Patients With Type 2 Diabetes
ClinicalTrials.gov ID: NCT02119819
Acronym / sponsor ID: 15062
Conditions: Diabetes Mellitus, Type 2
Keywords: Weight loss
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 420 participants (actual)
Lead sponsor: OPKO Health, Inc.Industry (pharma, biotech, devices)
Study start: Apr 2014
Primary completion: Aug 2015 (actual)
Study completion: Oct 2015 (actual)
First posted: 22 Apr 2014 (estimated)
Results: Posted 14 Apr 2021

Clinical summary

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

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 6

Arm	Type	Receives
10 mg LY2944876	Experimental	Drug: LY2944876, Drug: Metformin10 milligrams (mg) LY2944876 given subcutaneously (SC) once weekly for 24 weeks. Participants remain on stable doses of metformin, as prescribed by their personal investigator if they were on metformin at study entry.
15 mg LY2944876	Experimental	Drug: LY2944876, Drug: Metformin15 mg LY2944876 given SC once weekly for 24 weeks. Participants remain on stable doses of metformin, as prescribed by their personal investigator if they were on metformin at study entry.
30 mg LY2944876	Experimental	Drug: LY2944876, Drug: Metformin30 mg LY2944876 given SC once weekly for 24 weeks. Participants remain on stable doses of metformin, as prescribed by their personal investigator if they were on metformin at study entry.
50 mg LY2944876	Experimental	Drug: LY2944876, Drug: Metformin50 mg LY2944876 given SC once weekly for 24 weeks. Participants remain on stable doses of metformin, as prescribed by their personal investigator if they were on metformin at study entry.
Exenatide extended-release	Experimental	Drug: Exenatide extended-release, Drug: Metformin2 mg exenatide extended-release given SC once weekly for 24 weeks. Participants remain on stable doses of metformin, as prescribed by their personal investigator if they were on metformin at study entry.
Placebo	Placebo comparator	Drug: Placebo, Drug: MetforminPlacebo for LY2944876 and Exenatide given SC once weekly for 12 weeks. Participants assigned to placebo will have no injections during the second 12 weeks of the study. Participants remain on stable doses of metformin, as prescribed by their personal investigator if they were on metformin at study entry.

Who may qualify

Ages: 18 to 80 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

Men or women with diabetes mellitus Type 2
Have screening HbA1c ≥7.0% and ≤10.5% either on diet and exercise alone or on a stable dose of metformin (≥1000 mg/day) for 3 months prior to screening
Have body mass index (BMI) ≥23 and ≤45 kilograms per meter squared at screening

Key exclusion criteria (4 listed)

Women of child bearing potential
Participants who have used thiazolidinediones within 3 months prior to screening, or any other drugs for treatment of hyperglycemia (except metformin) within the prior 2 months
Participants who have used insulin for diabetic control for more than 6 consecutive days within the prior year
Participants with impaired renal function (serum creatinine >124 micromole per liter (µmol/L) [1.4 milligrams per deciliter (mg/dL)] in women, >133 µmol/L [1.5 mg/dL] in men)

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
LY2944876Administered SC	Drug	10 mg LY2944876, 15 mg LY2944876, 30 mg LY2944876, 50 mg LY2944876
Exenatide extended-releaseAdministered SC	Drug	Exenatide extended-release
PlaceboAdministered SC	Drug	Placebo
MetforminOral	Drug	10 mg LY2944876, 15 mg LY2944876, 30 mg LY2944876, 50 mg LY2944876, Exenatide extended-release, Placebo

Primary outcome

Change From Baseline in Hemoglobin A1c (HbA1c) at Week 12
Time frame: Baseline, Week 12
HbA1c is the glycosylated fraction of hemoglobin A. HbA1c is measured to identify average plasma glucose concentration over prolonged periods of time.

14 secondary outcomes

Change From Baseline in HbA1c at Week 24
Time frame: Baseline, Week 24
Percent Change From Baseline in Body Weight
Time frame: Baseline, Week 12; Baseline, Week 24
Change From Baseline in Fasting Blood Glucose
Time frame: Baseline, Week 12; Baseline, Week 24
Change From Baseline in 7-point Self-Monitored Blood Glucose (SMBG) Values
Time frame: Baseline, Week (Wk) 12; Baseline, Week 24
Change From Baseline in Lipids
Time frame: Baseline, Week 24
Change From Baseline in Fasting Fibroblast Growth Factor 21
Time frame: Baseline, Week 12; Baseline, Week 24
Percentage of Participants Requiring Rescue Therapy
Time frame: Baseline through Therapy Completion (Week 24)
Percentage of Participants Developing Anti-Drug Antibodies to LY2944876
Time frame: Week 12 and Week 24
Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY2944876
Time frame: Baseline, Week 8, Week 12, Week 16, Week 20, Week 24
Pharmacokinetics: Area Under the Concentration Curve (AUC) of LY2944876
Time frame: Baseline, Week 8, Week 12, Week 16, Week 20, Week 24
Change From Baseline in Adiponectin Levels
Time frame: Baseline, Week 12; Baseline, Week 24
Change From Baseline in Beta-Hydroxy Butyrate Levels
Time frame: Baseline, Week 12; Baseline, Week 24
Change From Baseline in Glucagon Levels
Time frame: Baseline, Week 12; Baseline, Week 24
Change From Baseline in Insulin Levels
Time frame: Baseline, Week 12; Baseline, Week 24

Results and safety

Results posted to the registry on 14 Apr 2021, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
10 mg LY2944876	66	57
15 mg LY2944876	71	66
30 mg LY2944876	73	69
50 mg LY2944876	70	63
Exenatide Extended-release	69	62
Placebo	71	56

Primary outcome: Change From Baseline in Hemoglobin A1c (HbA1c) at Week 12

Time frame: Baseline, Week 12. Mean (Standard Error). Unit: percentage of HbA1c

Measure	10 mg LY2944876 n = 57	15 mg LY2944876 n = 68	30 mg LY2944876 n = 68	50 mg LY2944876 n = 65	Exenatide Extended-release n = 63	Placebo n = 62
Value	-1.07 (0.12)	-1.09 (0.11)	-1.44 (0.11)	-1.33 (0.11)	-1.42 (0.11)	-0.29 (0.11)

10 mg LY2944876 vs Placebo: Posterior Mean Difference: -0.78 (90% CI -1.05 to -0.52), p = 0.459, Bayesian
15 mg LY2944876 vs Placebo: Posterior Mean Difference: -0.80 (90% CI -1.07 to -0.54), p = 0.511, Bayesian
30 mg LY2944876 vs Placebo: Posterior Mean Difference: -1.15 (90% CI -1.41 to -0.89), p = 0.988, Bayesian

Population analysed: All randomized participants with baseline and at least one post-baseline HbA1c data at Week 12. Missing observations are imputed using the Bayesian simple linear regression longitudinal model.

14 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
10 mg LY2944876	0 of 66 (0%)	34 of 66 (51.5%)	Not reported
15 mg LY2944876	2 of 71 (2.8%)	47 of 71 (66.2%)	Not reported
30 mg LY2944876	2 of 73 (2.7%)	39 of 73 (53.4%)	Not reported
50 mg LY2944876	3 of 70 (4.3%)	46 of 70 (65.7%)	Not reported
Exenatide Extended-release	3 of 69 (4.3%)	38 of 69 (55.1%)	Not reported
Placebo	2 of 71 (2.8%)	16 of 71 (22.5%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 27 May 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 30957581Park EJ, Choi J, Lee KC, Na DH. Emerging PEGylated non-biologic drugs. Expert Opin Emerg Drugs. 2019 Jun;24(2):107-119. doi: 10.1080/14728214.2019.1604684. Epub 2019 Apr 19.
Individual participant dataSharing planned: Yes. Lilly provides access to the individual patient data from studies on approved medicines and indications as defined by the sponsor specific information on ClinicalStudyDataRequest.com. This access is provided in a timely fashion after the primary publication is accepted. Researchers need to have an approved research proposal submitted through ClinicalStudyDataRequest.com. Access to the data will be provided in a secure data sharing environment after signing a 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

51 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 LY2944876, Exenatide extended-release and Metformin in people with Diabetes Mellitus, Type 2, run by OPKO Health, Inc. at 51 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 3 inclusion and 4 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 27 May 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 51 sites in United States, Poland, Romania, Greece, Mexico 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 14 Apr 2021). 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) at Week 12 (time frame: Baseline, Week 12). 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 NCT02119819, which also lists 1 linked publication.

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 27 May 2021.