Clinical Trials/NCT01241448

NCT01241448

Completed

Phase 2

A Randomized, Double-Blind, Placebo-Controlled Phase 2b Study of LY2409021 in Patients With Type 2 Diabetes Mellitus

Eli Lilly and Company1 site in 1 country263 target enrollmentJanuary 2011

ConditionsDiabetes Mellitus, Type 2

InterventionsPlacebo LY2409021

DrugsLY2409021 Placebo

Overview

Phase: Phase 2
Intervention: Placebo
Conditions: Diabetes Mellitus, Type 2
Sponsor: Eli Lilly and Company
Enrollment: 263
Locations: 1
Primary Endpoint: Change From Baseline to 24 Week Endpoint in Hemoglobin A1c (HbA1c)
Status: Completed
Last Updated: 8 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

LY2409021 is being evaluated for possible treatment in type 2 diabetes. This study is designed to compare LY2409021 given alone or given in combination with metformin against placebo the change in hemoglobin A1c after a 24-week treatment period.

Registry

clinicaltrials.gov

Start Date

January 2011

End Date

March 2012

Last Updated

8 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Eli Lilly and Company

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Have a diagnosis of Type 2 diabetes mellitus according to the World Health Organization (WHO) diagnostic criteria
•Are women not of child-bearing potential due to surgical sterilization (hysterectomy or bilateral oophorectomy or tubal ligation) or menopause.
•Are male patients using a reliable method of birth control during the study and until 3 months after the last dose of study medication.
•Are being treated with either diet and exercise alone, or with diet and exercise in combination with metformin. Metformin therapy must have been stable and unchanged for at least 3 months prior to screening and at a dose of at least 1000 milligram per day (mg/day).
•Have a hemoglobin A1c (HbA1c) value of 7.0% to 10.5%, inclusive.
•Have a body mass index (BMI) between 25 to 45 kilogram per meter squared (kg/m\^2), inclusive.
•In the opinion of the investigator, are capable and willing to:
•Perform self-monitoring of blood glucose
•Complete a study diary as required for this protocol
•Maintain consistent dietary, physical activity, and sleeping patterns throughout the duration of the study

Exclusion Criteria

•Have more than 1 episode of severe hypoglycemia (defined as an event during which the patient requires the assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions) within 6 months prior to screening, or have a current diagnosis of hypoglycemia unawareness.
•Have had two or more emergency room visits or hospitalizations due to poor glucose control in the 6 months prior to screening.
•Have gastrointestinal disease that may significantly impact gastric emptying or motility or have undergone gastric bypass or gastric banding surgery.
•Have had a previous diagnosis of pancreatitis.
•Have New York Heart Association (NYHA) class II, III, or IV symptoms of heart failure
•Have a history of myocardial infarction, unstable angina, or a coronary revascularization procedure within 6 months of screening.
•Have a history of supraventricular tachycardia, ventricular tachycardia, or other cardiac arrhythmia.
•Have a history of transient ischemic attack (TIA) or stroke within 6 months of screening.
•Have poorly controlled hypertension (systolic blood pressure greater than or equal to 150 mm Hg or diastolic blood pressure greater than or equal to 90 mm Hg) as determined by the mean of three separate measurements.
•Show evidence of labile blood pressure, including symptomatic postural hypotension.

Arms & Interventions

Placebo

Taken orally once daily for 24 weeks. Participants who entered the study on stable metformin therapy were to continue at the dose prescribed by their physician.

Intervention: Placebo

2.5 mg LY2409021

Taken orally once daily for 24 weeks. Participants who entered the study on stable metformin therapy were to continue at the dose prescribed by their physician.

Intervention: LY2409021

10 mg LY2409021

Taken orally once daily for 24 weeks. Participants who entered the study on stable metformin therapy were to continue at the dose prescribed by their physician.

Intervention: LY2409021

20 mg LY2409021

Taken orally once daily for 24 weeks. Participants who entered the study on stable metformin therapy were to continue at the dose prescribed by their physician.

Intervention: LY2409021

Outcomes

Primary Outcomes

Change From Baseline to 24 Week Endpoint in Hemoglobin A1c (HbA1c)

Time Frame: Baseline, 24 weeks

Least squares means of the change from baseline is from a mixed-model repeated measures analysis (MMRM). The model included terms for treatment group, baseline HbA1c, metformin use, visit, and visit-by-treatment interaction.

Secondary Outcomes

Change From Baseline to 24 Week Endpoint in 7-point Self Monitored Glucose (SMBG) Profile(Baseline, 24 weeks)
Change From Baseline to 24 Week Endpoint in Fasting Insulin(Baseline, 24 weeks)
Change From Baseline to 24 Week Endpoint Indices in Beta-cell Function Using HOMA-B(Baseline, 24 week)
Change From Baseline to 24 Week Endpoint in Plasma Glucose(Baseline, 24 weeks)
Change From Baseline to 24 Week Endpoint in Fasting Glucagon-like Peptide 1 (GLP-1) Active and Total(Baseline, 24 weeks)
Change From Baseline to 24 Week Endpoint Indices in Insulin Sensitivity Using Homeostasis Model Assessment of Insulin Resistance (HOMA-IR)(Baseline, 24 weeks)
Change From Baseline to 24 Week Endpoint in Weight(Baseline, 24 weeks)
Population Pharmacokinetics: Apparent Clearance (CL/F) of LY2409021(Baseline up to 26 weeks)
Change From Baseline to 24 Week Endpoint in Fasting Lipid Profile(Baseline, 24 weeks)
Change From Baseline to 24 Week Endpoint in Free Fatty Acids(Baseline, 24 weeks)
Population Pharmacokinetics: Apparent Volume of Distribution of LY2409021(Baseline up to 26 weeks)
Change From Baseline to 24 Week Endpoint in Fasting Blood Glucose (FBG)(Baseline, 24 weeks)
Change From Baseline to 24 Week Endpoint in Lipoprotein Subfractions-Particles (Total)(Baseline, 24 weeks)
The Percentage of Participants Experiencing a Hypoglycemic Episode(Baseline through 24 weeks)
The 30-Day Adjusted Rate of Hypoglycemic Episodes(Baseline through 24 weeks)