Diabetes Mellitus, Type 2Phase 2NCT00804986

A Study for Patients With Type 2 Diabetes Mellitus

A Phase 2 study testing LY2428757 in people with Diabetes Mellitus, Type 2, run by Eli Lilly and Company at 60 sites in 11 countries.

Completed

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

Official record

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Trial summary

Who is it for?: Ages 18 to 70 years
Conditions the study is for: Diabetes Mellitus, Type 2
What is being tested?: LY2428757
Type of treatment: Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 247 participants
Where: 60 sitesin 11 countries
Study dates: Dec 2008to Jan 2010
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 70 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Have type 2 diabetes mellitus for at least 6 months prior to entering the trial.
Treated with diet and exercise alone or in combination with at least 1000 milligrams (mg)/day of metformin for at least 2 months prior to screening.
Have a glycosylated fraction of hemoglobin A (HbA1c) value of 7.0% - 10.0% at screening
Women of child-bearing potential must test negative for pregnancy at screening and agree to abstain from heterosexual intercourse for the duration of the study, or use 2 effective forms of birth control during the study.
Have a body mass index (BMI) between 25 and 40 kilograms per square meters kg/m^2) at screening
Stable weight during the 3 months prior to screening.

Who cannot join

Use any antidiabetic agent other than metformin during the 2 months prior to screening.
Have a gastrointestinal disease that significantly impacts gastric emptying or motility or have undergone bariatric surgery.
Are currently taking prescription or over-the counter medications to promote weight loss.
Have been previously diagnosed with pancreatitis
Women who are breastfeeding.
Have a history of myocardial infarction, unstable angina, coronary artery bypass graft (CABG), percutaneous coronary intervention, transient ischemic attack, stroke or decompensated congestive heart failure in the past 6 months.
Have poorly controlled hypertension

Trial locations and contacts

60 sites in 11 countries.

Country

City, postcode or hospital

60 sites in 11 countries

United States15 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.
Baltimore, Maryland, 21204
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Bermuda Dunes, California, 92203
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Chicago, Illinois, 60607
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Chula Vista, California, 91911
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Huntington Beach, California, 92648
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Las Vegas, Nevada, 89101
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Long Beach, California, 90806
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Melbourne, Florida, 32901
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Mentor, Ohio, 44060
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Pomona, California, 91767
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Sacramento, California, 95825
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Spokane, Washington, 99220
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St Louis, Missouri, 63141
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Vancouver, Washington, 98664
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Waltham, Massachusetts, 02453

Other trials in United States

Ukraine8 sites

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Dnipro, 49027
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Dnipropetrovsk, 49023
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Donetsk, 83037
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Kharkiv, 61048
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Kirovograd, 25001
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Kyiv, 02175
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Odesa, 65114
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Vinnytsia, 21010

Other trials in Ukraine

Romania7 sites

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Brasov, 500365
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Bucharest, 010507
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Cluj-Napoca, 400006
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Ploieşti, 100163
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Satu Mare, 440055
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Sf Gheorghe
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Târgu Mureş, 540142

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Germany6 sites

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Berlin, 12627
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Cologne, 50931
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Hamburg, 20253
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Lübeck, 23562
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Magdeburg, 39104
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Mainz, D-55116

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Spain5 sites

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Granada, 18012
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Lleida, 25198
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Madrid, 28046
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Santiago de Compostela, 15706
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Valencia, 46017

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India4 sites

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Bangalore, 580043
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Chennai, 60004
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Cooperage, 400021
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Shivājīnagar, 411005

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Mexico4 sites

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Garza García, 66260
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Guadalajara, 44340
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Mexico City, 10700
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Monterrey, 64461

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South Africa4 sites

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Bellville, 7531
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Benoni, 1500
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Kempton Park, 1619
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Somerset West, 7129

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United Kingdom4 sites

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Barnsley, S75 2EP
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Bath, Banes, BA1 3NG
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Birmingham, BS 5SS
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Liverpool, L9 7AL

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Austria2 sites

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Vienna, 1090
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Vorarlberg, 6800

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Puerto Rico1 site

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Rio Piedras, 00921

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About this study

Official title: A 12-Week,Double-Blind, Placebo-Controlled Trial of LY2428757 in Patients With Type 2 Diabetes Mellitus

A multicenter, multinational, randomized,double-blind, placebo-controlled study in patients with Type 2 Diabetes Mellitus (T2DM). Patients with inadequate glycemic control using diet and exercise alone, or in combination with metformin, will be enrolled. The primary objective of this study is to test the hypothesis that LY2428757 given to patients with T2DM inadequately controlled with diet and exercise alone, or metformin monotherapy, produces a significant decrease in the mean hemoglobin A1c (HbA1c) from baseline to endpoint at 12 weeks as compared to placebo. Trial consists of 12 weeks of double-blind treatment and 4-week safety follow-up.

Conditions: Diabetes Mellitus, Type 2
Being tested: LY2428757, 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.

LY2428757Drug
Once weekly for 12 weeks as a subcutaneous injection.
PlaceboDrug
1 of 5 volumes of placebo given once weekly for 12 weeks as a subcutaneous injection.

Study groups in NCT00804986
Study group	Role	What they receive
0.5 mg LY2428757	Experimental	Once weekly, subcutaneous injection of 0.5 milligram (mg) LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment. Receives: Drug: LY2428757
2.0 mg LY2428757	Experimental	Once weekly, subcutaneous injection of 2.0 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment. Receives: Drug: LY2428757
6.2 mg LY2428757	Experimental	Once weekly, subcutaneous injection of 6.2 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment. Receives: Drug: LY2428757
12.0 mg LY2428757	Experimental	Once weekly, subcutaneous injection of 12.0 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment. Receives: Drug: LY2428757
17.6 mg LY2428757	Experimental	Once weekly, subcutaneous injection of 17.6 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment. Receives: Drug: LY2428757
Placebo	Placebo comparator	Once weekly, subcutaneous injection of placebo for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment. Receives: Drug: Placebo

What is being measured

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

Change in Hemoglobin A1C (HbA1c) From Baseline to Week 12 Endpoint
LSMean adjusted for baseline HbA1c, metformin use, treatment, visit, treatment-by-visit interaction.
Measured: baseline, 12 weeks

Secondary outcomes (13)

Change in Visual Analogue Scales (VAS) For Appetite and Satiety From Baseline to Week 12 Endpoint
The VAS scales for appetite (hunger) and satiety (how full) were recorded on a scale with range of possible scores from 0 to 100 represented in millimeters on a 10 centimeter line. For appetite, participant chooses where they think their appetite lies on a 10 centimeter line between two anchors (0 - not at all hungry and 10 - extremely hungry). For satiety, participant chooses where they think their satiety lies on a 10 centimeter line between two anchors (0 - not at all full and 10 - extremely full). LSMean adjusted for baseline, treatment, visit, treatment-by-visit interaction.
Measured: baseline, 12 weeks
Number of Participants With Detectable Antibodies To LY2428757 At Any Time During The Study
Blood samples were collected from all randomized participants to test for the development of antibodies binding to LY2428757. If a participant developed a positive anti-LY2428757 antibody titer, appropriate medical management was to be utilized at the discretion of the sponsor and investigator, if deemed necessary.
Measured: baseline through 16 weeks
Total Average Concentration (Cavg) of LY2428757
Average concentration (Cavg) is calculated as the AUC0-168 (area under the plasma concentration vs. time curve during one dosing interval of 168 hours) divided by 168 hours. The numbers presented reflect the average LY2428757 drug concentration circulating in the body over 168 hours (one dosing interval).
Measured: 4 weeks, 6 weeks, 8 weeks, 10 weeks
Change in 7-Point Self-Monitored Glucose From Baseline to Week 12 Endpoint
Self-monitored glucose levels measured at 7 timepoints during the day. Timepoints include: fasting pre-breakfast, 2 hours post breakfast, prior to lunch, 2 hours post lunch, prior to dinner, 2 hours post dinner, and prior to bed. LSMean adjusted for baseline, treatment, visit, treatment-by-visit interaction.
Measured: baseline, 12 weeks
Change in Total Glucose Area Under the Curve (AUC) From Baseline to Week 12 Endpoint
An oral glucose tolerance test (OGTT) was used to assess changes in glucose tolerance. The area under the plasma glucose concentration versus time curve was calculated using the linear-trapezoidal method. Area under the curve (AUC) for glucose represents the area that is under the curve of glucose values when they are plotted over time. Larger AUC values represent a greater average glucose value over time. LSMean adjusted for baseline, treatment, visit, treatment-by-visit interaction.
Measured: baseline, 12 weeks
Change in Insulin Total Area Under the Curve (AUC) From Baseline to Week 12 Endpoint
An oral glucose tolerance test (OGTT) was used to assess changes in insulin secretory response. The area under the insulin concentration versus time curve was calculated using the linear-trapezoidal method. Area under the curve (AUC) for insulin represents the area that is under the curve of insulin values when they are plotted over time. Larger AUC values represent a greater average insulin value over time. LSMean adjusted for baseline, treatment, visit, treatment-by-visit interaction.
Measured: baseline, 12 weeks
Change in C-peptide Area Under the Curve (AUC) From Baseline to Week 12 Endpoint
An oral glucose tolerance test (OGTT) was used to assess changes in insulin secretory response. The area under the C-peptide concentration versus time curve was calculated using the linear-trapezoidal method. Area under the curve (AUC) for C-peptide represents the area that is under the curve of C-peptide values when they are plotted over time. Larger AUC values represent a greater average C-peptide value over time. LSMean adjusted for baseline, treatment, visit, treatment-by-visit interaction.
Measured: baseline, 12 weeks
Change in Fasting Lipids From Baseline to Week 12 Endpoint
Fasting lipids were measured after overnight fasting of at least 8 hours. Lipids analyzed include triglycerides, high-density lipoprotein cholesterol (HDL-C), low-density lipoprotein cholesterol (LDL-C), and total-cholesterol. LSMean adjusted for baseline and treatment.
Measured: baseline, 12 weeks
Change in Fasting Weight From Baseline to Week 12 Endpoint
LSMean adjusted for baseline, treatment, visit, treatment-by-visit interaction.
Measured: baseline, 12 weeks
Change in Impact of Weight on Quality of Life - Lite (IWQoL-Lite) Average Score From Baseline to Week 12 Endpoint
Impact of Weight on Quality of Life (IWQoL) - Lite Version consists of 31 items from 5 subscales: physical functioning, self-esteem, sexual life, public distress, and work as well as a total score. Individual item scoring ranges from 0 (never true) to 4 (always true) with total score range from 0 to 124. Higher scores on the subscales and total score correspond with lower levels of functioning or greater negative effect. LSMean adjusted for baseline, baseline HbA1c (less than 8.5% versus greater than or equal to 8.5%), metformin use, treatment.
Measured: baseline, 12 weeks
Change in Diabetes Symptom Checklist-Revised (DSC-R) Average Score From Baseline to Week 12 Endpoint
DSC-R assesses the presence and perceived burden of diabetes-related symptoms using the following subscales: hypoglycemic, hyperglycemic, psychological, cardiovascular, neurological, ophthalmological. Participants evaluate symptoms based on a 5-point Likert-type scale, ranging from 1=not at all troublesome to 5=extremely troublesome. Higher scores indicated greater severity of symptoms within a domain, or poorer perceived health, respectively. LSMean adjusted for baseline, baseline HbA1c (less than 8.5% versus greater than or equal to 8.5%), metformin use, treatment.
Measured: baseline, 12 weeks
Change in European Quality of Life (EuroQol)- Visual Analog Scale From Baseline to Week 12 Endpoint
Participant chooses where they think their current health state lies on a 10 centimeter line between two anchors (0 - worst imaginable health state and 10 - best imaginable health state). The possible range of scores is 0 to 100 and represents millimeters on the 10 centimeter line. A higher score is associated with better health state. LSMean adjusted for baseline, baseline HbA1c (less than 8.5% versus greater than or equal to 8.5%), metformin use, treatment.
Measured: baseline, 12 weeks
Percent of Participants Domain Scores Indicating No Problems on European Quality of Life (EuroQol) at Baseline and Week 12 Endpoint
The EuroQoL Questionnaire - 5 Dimension (EQ-5D) is a generic, multidimensional, health-related, quality-of-life instrument. The profile allows participants to rate their health state in 5 health domains: mobility, self-care, usual activities, pain/discomfort, and mood. A single score between 1 and 3 is generated for each domain. For each participant, the outcome rating on the 5 domains will be mapped to a single index through an algorithm. The index ranges between 0 and 1, with the higher score indicating a better health state perceived by the participant.
Measured: Baseline, 12 Weeks

Timeline

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

Dec 2008Jan 2010

First posted9 Dec 2008 (estimated)
Study startDec 2008
Primary completionJan 2010
Study completionJan 2010

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.
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: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 247 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00804986
Sponsor's protocol ID: 12134
Other IDs: I1I-MC-GECD, CTRI/2009/091/000091
Status last verified: Jul 2011
First submitted: 8 Dec 2008
Last updated: 14 Jul 2011
Results posted: Yes, on ClinicalTrials.gov

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.

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All Diabetes Mellitus, Type 2 trials

Study at a glance

From the registry record, last updated by the sponsor on 14 Jul 2011. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A 12-Week,Double-Blind, Placebo-Controlled Trial of LY2428757 in Patients With Type 2 Diabetes Mellitus
ClinicalTrials.gov ID: NCT00804986
Acronym / sponsor ID: 12134
Conditions: Diabetes Mellitus, Type 2
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 247 participants (actual)
Lead sponsor: Eli Lilly and CompanyIndustry (pharma, biotech, devices)
Study start: Dec 2008
Primary completion: Jan 2010 (actual)
Study completion: Jan 2010 (actual)
First posted: 9 Dec 2008 (estimated)
Results: Posted 15 Jun 2011

Clinical summary

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

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 6

Arm	Type	Receives
0.5 mg LY2428757	Experimental	Drug: LY2428757Once weekly, subcutaneous injection of 0.5 milligram (mg) LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.
2.0 mg LY2428757	Experimental	Drug: LY2428757Once weekly, subcutaneous injection of 2.0 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.
6.2 mg LY2428757	Experimental	Drug: LY2428757Once weekly, subcutaneous injection of 6.2 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.
12.0 mg LY2428757	Experimental	Drug: LY2428757Once weekly, subcutaneous injection of 12.0 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.
17.6 mg LY2428757	Experimental	Drug: LY2428757Once weekly, subcutaneous injection of 17.6 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.
Placebo	Placebo comparator	Drug: PlaceboOnce weekly, subcutaneous injection of placebo for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.

Who may qualify

Ages: 18 to 70 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

Have type 2 diabetes mellitus for at least 6 months prior to entering the trial.
Treated with diet and exercise alone or in combination with at least 1000 milligrams (mg)/day of metformin for at least 2 months prior to screening.
Have a glycosylated fraction of hemoglobin A (HbA1c) value of 7.0% - 10.0% at screening
Women of child-bearing potential must test negative for pregnancy at screening and agree to abstain from heterosexual intercourse for the duration of the study, or use 2 effective forms of birth control during the study.
Have a body mass index (BMI) between 25 and 40 kilograms per square meters kg/m^2) at screening

Key exclusion criteria (7 listed)

Use any antidiabetic agent other than metformin during the 2 months prior to screening.
Have a gastrointestinal disease that significantly impacts gastric emptying or motility or have undergone bariatric surgery.
Are currently taking prescription or over-the counter medications to promote weight loss.
Have been previously diagnosed with pancreatitis
Women who are breastfeeding.

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
LY2428757Once weekly for 12 weeks as a subcutaneous injection.	Drug	0.5 mg LY2428757, 12.0 mg LY2428757, 17.6 mg LY2428757, 2.0 mg LY2428757, 6.2 mg LY2428757
Placebo1 of 5 volumes of placebo given once weekly for 12 weeks as a subcutaneous injection.	Drug	Placebo

Primary outcome

Change in Hemoglobin A1C (HbA1c) From Baseline to Week 12 Endpoint
Time frame: baseline, 12 weeks
LSMean adjusted for baseline HbA1c, metformin use, treatment, visit, treatment-by-visit interaction.

13 secondary outcomes

Change in Visual Analogue Scales (VAS) For Appetite and Satiety From Baseline to Week 12 Endpoint
Time frame: baseline, 12 weeks
Number of Participants With Detectable Antibodies To LY2428757 At Any Time During The Study
Time frame: baseline through 16 weeks
Total Average Concentration (Cavg) of LY2428757
Time frame: 4 weeks, 6 weeks, 8 weeks, 10 weeks
Change in 7-Point Self-Monitored Glucose From Baseline to Week 12 Endpoint
Time frame: baseline, 12 weeks
Change in Total Glucose Area Under the Curve (AUC) From Baseline to Week 12 Endpoint
Time frame: baseline, 12 weeks
Change in Insulin Total Area Under the Curve (AUC) From Baseline to Week 12 Endpoint
Time frame: baseline, 12 weeks
Change in C-peptide Area Under the Curve (AUC) From Baseline to Week 12 Endpoint
Time frame: baseline, 12 weeks
Change in Fasting Lipids From Baseline to Week 12 Endpoint
Time frame: baseline, 12 weeks
Change in Fasting Weight From Baseline to Week 12 Endpoint
Time frame: baseline, 12 weeks
Change in Impact of Weight on Quality of Life - Lite (IWQoL-Lite) Average Score From Baseline to Week 12 Endpoint
Time frame: baseline, 12 weeks
Change in Diabetes Symptom Checklist-Revised (DSC-R) Average Score From Baseline to Week 12 Endpoint
Time frame: baseline, 12 weeks
Change in European Quality of Life (EuroQol)- Visual Analog Scale From Baseline to Week 12 Endpoint
Time frame: baseline, 12 weeks
Percent of Participants Domain Scores Indicating No Problems on European Quality of Life (EuroQol) at Baseline and Week 12 Endpoint
Time frame: Baseline, 12 Weeks

Results and safety

Results posted to the registry on 15 Jun 2011, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
0.5 mg LY2428757	36	35
2.0 mg LY2428757	43	35
6.2 mg LY2428757	42	40
12.0 mg LY2428757	42	34
17.6 mg LY2428757	43	34
Placebo	41	31

Primary outcome: Change in Hemoglobin A1C (HbA1c) From Baseline to Week 12 Endpoint

Time frame: baseline, 12 weeks. Least squares mean (95% Confidence Interval). Unit: percentage of glycosylated hemoglobin

Measure	0.5 mg LY2428757 n = 34	2.0 mg LY2428757 n = 34	6.2 mg LY2428757 n = 39	12.0 mg LY2428757 n = 32	17.6 mg LY2428757 n = 35	Placebo n = 32
Value	-0.60 (-0.87 to -0.34)	-0.80 (-1.05 to -0.55)	-1.24 (-1.49 to -1.00)	-1.41 (-1.67 to -1.15)	-1.37 (-1.62 to -1.11)	-0.13 (-0.39 to 0.13)

0.5 mg LY2428757 vs Placebo: Difference in mean change from baseline: -0.47 (95% CI -0.83 to -0.11), p = 0.0109, Mixed Models Analysis
2.0 mg LY2428757 vs Placebo: Difference in mean change from baseline: -0.67 (95% CI -1.02 to -0.31), p = 0.0003, Mixed Models Analysis
6.2 mg LY2428757 vs Placebo: Difference in mean change from baseline: -1.11 (95% CI -1.46 to -0.76), p <0.0001, Mixed Models Analysis

Population analysed: Modified intention to treat population, defined as all randomized participants with at least one post-baseline measurement.

13 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 2% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
0.5 mg LY2428757	1 of 36 (2.8%)	19 of 36 (52.8%)	Not reported
2.0 mg LY2428757	4 of 42 (9.5%)	25 of 42 (59.5%)	Not reported
6.2 mg LY2428757	1 of 42 (2.4%)	26 of 42 (61.9%)	Not reported
12.0 mg LY2428757	1 of 41 (2.4%)	24 of 41 (58.5%)	Not reported
17.6 mg LY2428757	0 of 43 (0%)	28 of 43 (65.1%)	Not reported
Placebo	0 of 40 (0%)	23 of 40 (57.5%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2011.
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.

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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

60 sites in 11 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing LY2428757 in people with Diabetes Mellitus, Type 2, run by Eli Lilly and Company at 60 sites in 11 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 6 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 14 Jul 2011. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 60 sites in United States, Ukraine, Romania, Germany, Spain and 6 more countries. 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 15 Jun 2011). 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 in Hemoglobin A1C (HbA1c) From Baseline to Week 12 Endpoint (time frame: baseline, 12 weeks). 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 NCT00804986, 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 14 Jul 2011.