A Study for Patients With Type 2 Diabetes Mellitus

NCT ID: NCT00804986

Last Updated: 2011-07-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 247 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-12-31
• Study Completion Date: 2010-01-31

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.

Conditions

Diabetes Mellitus, Type 2

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

0.5 mg LY2428757

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.

Group Type: EXPERIMENTAL

LY2428757

Intervention Type: DRUG

Once weekly for 12 weeks as a subcutaneous injection.

2.0 mg LY2428757

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.

Group Type: EXPERIMENTAL

LY2428757

Intervention Type: DRUG

Once weekly for 12 weeks as a subcutaneous injection.

6.2 mg LY2428757

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.

Group Type: EXPERIMENTAL

LY2428757

Intervention Type: DRUG

Once weekly for 12 weeks as a subcutaneous injection.

12.0 mg LY2428757

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.

Group Type: EXPERIMENTAL

LY2428757

Intervention Type: DRUG

Once weekly for 12 weeks as a subcutaneous injection.

17.6 mg LY2428757

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.

Group Type: EXPERIMENTAL

LY2428757

Intervention Type: DRUG

Once weekly for 12 weeks as a subcutaneous injection.

Placebo

Once weekly, subcutaneous injection of placebo for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

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

Interventions

LY2428757

Once weekly for 12 weeks as a subcutaneous injection.

Intervention Type: DRUG

Placebo

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

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Eli Lilly and Company

INDUSTRY

Sponsor Role: lead

Responsible Party

Eli Lilly

Principal Investigators

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)

Role: STUDY_DIRECTOR

Eli Lilly and Company

Locations

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Bermuda Dunes, California, United States

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Chula Vista, California, United States

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Huntington Beach, California, United States

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Long Beach, California, United States

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Pomona, California, United States

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Sacramento, California, United States

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Melbourne, Florida, United States

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Chicago, Illinois, United States

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Baltimore, Maryland, United States

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Waltham, Massachusetts, United States

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St Louis, Missouri, United States

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Las Vegas, Nevada, United States

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Mentor, Ohio, United States

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Spokane, Washington, United States

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Vancouver, Washington, United States

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Vienna, , Austria

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Vorarlberg, , Austria

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Berlin, , Germany

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Cologne, , Germany

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Hamburg, , Germany

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Lübeck, , Germany

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Magdeburg, , Germany

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Mainz, , Germany

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Bangalore, , India

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Chennai, , India

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Cooperage, , India

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Shivājīnagar, , India

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Garza García, , Mexico

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Guadalajara, , Mexico

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Mexico City, , Mexico

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Monterrey, , Mexico

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Rio Piedras, , Puerto Rico

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Brasov, , Romania

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Bucharest, , Romania

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Cluj-Napoca, , Romania

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Ploieşti, , Romania

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Satu Mare, , Romania

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Sf Gheorghe, , Romania

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Târgu Mureş, , Romania

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Bellville, , South Africa

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Benoni, , South Africa

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Kempton Park, , South Africa

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Somerset West, , South Africa

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Granada, , Spain

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Lleida, , Spain

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Madrid, , Spain

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Santiago de Compostela, , Spain

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Valencia, , Spain

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Dnipro, , Ukraine

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Dnipropetrovsk, , Ukraine

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Donetsk, , Ukraine

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Kharkiv, , Ukraine

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Kirovograd, , Ukraine

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Kyiv, , Ukraine

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Odesa, , Ukraine

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Vinnytsia, , Ukraine

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Bath, Banes, United Kingdom

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Barnsley, , United Kingdom

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Birmingham, , United Kingdom

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Liverpool, , United Kingdom

Countries

United States; Austria; Germany; India; Mexico; Puerto Rico; Romania; South Africa; Spain; Ukraine; United Kingdom

References

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.

Reference Type: DERIVED

PMID: 30957581 (View on PubMed)

Other Identifiers

I1I-MC-GECD

Identifier Type: OTHER

Identifier Source: secondary_id

CTRI/2009/091/000091

Identifier Type: REGISTRY

Identifier Source: secondary_id

12134

Identifier Type: -

Identifier Source: org_study_id