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A Study for Patients With Type 2 Diabetes Mellitus | Clinical Trials | Clareo Health

COMPLETEDPHASE2

A Study for Patients With Type 2 Diabetes Mellitus

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

NCT00804986•Eli Lilly and Company

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.

Eligibility

Age

18 - 70 years

Sex

ALL

Healthy Volunteers

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

Locations (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, United States

Chula Vista, California, United States

Huntington Beach, California, United States

Long Beach, California, United States

Pomona, California, United States

Sacramento, California, United States

Melbourne, Florida, United States

Chicago, Illinois, United States

Baltimore, Maryland, United States

Waltham, Massachusetts, United States

Key Dates

Start Date

December 1, 2008

Primary Completion Date

January 1, 2010

Completion Date

January 1, 2010

Last Updated

July 14, 2011

Enrollment

247

ACTUAL participants

Conditions

Diabetes Mellitus, Type 2

Interventions

LY2428757

DRUG

Placebo

DRUG

PATHS-UP Health Behavior Self-monitoring Mobile App for Adolescents

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Obesity and Diabetes Mellitus, Type 2Diabetes Prevention

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RECRUITINGNA

Michigan Men's Diabetes Project III(MenDIII): Mind and Motion

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: July 14, 2011Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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A Study for Patients With Type 2 Diabetes Mellitus

Inclusion Criteria

Exclusion Criteria

PATHS-UP Health Behavior Self-monitoring Mobile App for Adolescents

Michigan Men's Diabetes Project III(MenDIII): Mind and Motion

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Continuous Glucose Monitoring in Non-Insulin Treated Type 2 Diabetes: Continuous vs. Periodic Use

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