Brief Summary

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.

Trial Health

On Track

Trial Health Score

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

Enrollment

247

participants targeted

Target at P50-P75 for phase_2 diabetes-mellitus-type-2

Timeline

Completed

Started Dec 2008

Geographic Reach

11 countries

60 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

1.1 years study duration

Study Start

First participant enrolled

December 1, 2008

Completed

7 days until next milestone

First Submitted

Initial submission to the registry

December 8, 2008

Completed

1 day until next milestone

First Posted

Study publicly available on registry

December 9, 2008

Completed

1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2010

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2010

Completed

1.5 years until next milestone

Results Posted

Study results publicly available

June 15, 2011

Completed

Last Updated

July 14, 2011

Status Verified

July 1, 2011

Enrollment Period

1.1 years

First QC Date

December 8, 2008

Results QC Date

May 13, 2011

Last Update Submit

July 12, 2011

Conditions

Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (13)

Change in Visual Analogue Scales (VAS) For Appetite and Satiety From Baseline to Week 12 Endpoint
baseline, 12 weeks
Number of Participants With Detectable Antibodies To LY2428757 At Any Time During The Study
baseline through 16 weeks
Total Average Concentration (Cavg) of LY2428757
4 weeks, 6 weeks, 8 weeks, 10 weeks
Change in 7-Point Self-Monitored Glucose From Baseline to Week 12 Endpoint
baseline, 12 weeks
Change in Total Glucose Area Under the Curve (AUC) From Baseline to Week 12 Endpoint
baseline, 12 weeks
+8 more secondary outcomes

Study Arms (6)

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.

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.

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.

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.

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.

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.

Drug: Placebo

Interventions

LY2428757DRUG

Once weekly for 12 weeks as a subcutaneous injection.

0.5 mg LY242875712.0 mg LY242875717.6 mg LY24287572.0 mg LY24287576.2 mg LY2428757

PlaceboDRUG

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

Placebo

Eligibility Criteria

Age18 Years - 70 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Eli Lilly and Companylead

Study Sites (60)

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.

Bermuda Dunes, California, 92203, United States

Location

Chula Vista, California, 91911, United States

Location

Huntington Beach, California, 92648, United States

Location

Long Beach, California, 90806, United States

Location

Pomona, California, 91767, United States

Location

Sacramento, California, 95825, United States

Location

Melbourne, Florida, 32901, United States

Location

Chicago, Illinois, 60607, United States

Location

Baltimore, Maryland, 21204, United States

Location

Waltham, Massachusetts, 02453, United States

Location

St Louis, Missouri, 63141, United States

Location

Las Vegas, Nevada, 89101, United States

Location

Mentor, Ohio, 44060, United States

Location

Spokane, Washington, 99220, United States

Location

Vancouver, Washington, 98664, United States

Location

Vienna, 1090, Austria

Location

Vorarlberg, 6800, Austria

Location

Berlin, 12627, Germany

Location

Cologne, 50931, Germany

Location

Hamburg, 20253, Germany

Location

Lübeck, 23562, Germany

Location

Magdeburg, 39104, Germany

Location

Mainz, D-55116, Germany

Location

Bangalore, 580043, India

Location

Chennai, 60004, India

Location

Cooperage, 400021, India

Location

Shivājīnagar, 411005, India

Location

Garza García, 66260, Mexico

Location

Guadalajara, 44340, Mexico

Location

Mexico City, 10700, Mexico

Location

Monterrey, 64461, Mexico

Location

Rio Piedras, 00921, Puerto Rico

Location

Brasov, 500365, Romania

Location

Bucharest, 010507, Romania

Location

Cluj-Napoca, 400006, Romania

Location

Ploieşti, 100163, Romania

Location

Satu Mare, 440055, Romania

Location

Sf Gheorghe, Romania

Location

Târgu Mureş, 540142, Romania

Location

Bellville, 7531, South Africa

Location

Benoni, 1500, South Africa

Location

Kempton Park, 1619, South Africa

Location

Somerset West, 7129, South Africa

Location

Granada, 18012, Spain

Location

Lleida, 25198, Spain

Location

Madrid, 28046, Spain

Location

Santiago de Compostela, 15706, Spain

Location

Valencia, 46017, Spain

Location

Dnipro, 49027, Ukraine

Location

Dnipropetrovsk, 49023, Ukraine

Location

Donetsk, 83037, Ukraine

Location

Kharkiv, 61048, Ukraine

Location

Kirovograd, 25001, Ukraine

Location

Kyiv, 02175, Ukraine

Location

Odesa, 65114, Ukraine

Location

Vinnytsia, 21010, Ukraine

Location

Bath, Banes, BA1 3NG, United Kingdom

Location

Barnsley, S75 2EP, United Kingdom

Location

Birmingham, BS 5SS, United Kingdom

Location

Liverpool, L9 7AL, United Kingdom

Location

Related Publications (1)

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.
PMID: 30957581DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Results Point of Contact

Title: Chief Medical Officer
Organization: Eli Lilly and Company

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 2
Allocation: RANDOMIZED
Masking: QUADRUPLE
Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose: TREATMENT
Intervention Model: PARALLEL
Sponsor Type: INDUSTRY

Study Record Dates

First Submitted

December 8, 2008

First Posted

December 9, 2008

Study Start

December 1, 2008

Primary Completion

January 1, 2010

Study Completion

January 1, 2010

Last Updated

July 14, 2011

Results First Posted

June 15, 2011

Record last verified: 2011-07

Locations

RO(7)ES(5)ME(4)US(15)IN(4)GB(4)ZA(4)PR(1)UA(8)AU(2)DE(6)

Brief Summary

Trial Health

Trial Health Score

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Results Posted

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (13)

Study Arms (6)

0.5 mg LY2428757

2.0 mg LY2428757

6.2 mg LY2428757

12.0 mg LY2428757

17.6 mg LY2428757

Placebo

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (60)

Related Publications (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Results Point of Contact

Study Officials

Publication Agreements

Study Design

Study Record Dates

Locations