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A Study for Patients With Type 2 Diabetes Mellitus

Primary Purpose

Diabetes Mellitus, Type 2

Status

Completed

Phase

Phase 2

Locations

International

Study Type

Interventional

Intervention

LY2428757

Placebo

About this trial

This is an interventional treatment trial for Diabetes Mellitus, Type 2

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Experimental

Placebo Comparator

Arm Label

0.5 mg LY2428757

2.0 mg LY2428757

6.2 mg LY2428757

12.0 mg LY2428757

17.6 mg LY2428757

Placebo

Arm Description

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.

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.

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.

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.

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.

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

Outcomes

Primary Outcome Measures

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

LSMean adjusted for baseline HbA1c, metformin use, treatment, visit, treatment-by-visit interaction.

Secondary Outcome Measures

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.

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.

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).

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.

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.

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.

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.

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.

Change in Fasting Weight From Baseline to Week 12 Endpoint

LSMean adjusted for baseline, treatment, visit, treatment-by-visit interaction.

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.

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.

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.

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.

Full Information

NCT ID

NCT00804986

First Posted

December 8, 2008

Last Updated

July 12, 2011

Sponsor

Eli Lilly and Company

1. Study Identification

Unique Protocol Identification Number

NCT00804986

Brief Title

A Study for Patients With Type 2 Diabetes Mellitus

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

July 2011

Overall Recruitment Status

Completed

Study Start Date

December 2008 (undefined)

Primary Completion Date

January 2010 (Actual)

Study Completion Date

January 2010 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Eli Lilly and Company

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Diabetes Mellitus, Type 2

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

247 (Actual)

8. Arms, Groups, and Interventions

Arm Title

0.5 mg LY2428757

Arm Type

Experimental

Arm Description

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.

Arm Title

2.0 mg LY2428757

Arm Type

Experimental

Arm Description

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.

Arm Title

6.2 mg LY2428757

Arm Type

Experimental

Arm Description

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.

Arm Title

12.0 mg LY2428757

Arm Type

Experimental

Arm Description

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.

Arm Title

17.6 mg LY2428757

Arm Type

Experimental

Arm Description

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.

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

LY2428757

Intervention Description

Once weekly for 12 weeks as a subcutaneous injection.

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

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

Primary Outcome Measure Information:

Title

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

Description

LSMean adjusted for baseline HbA1c, metformin use, treatment, visit, treatment-by-visit interaction.

Time Frame

baseline, 12 weeks

Secondary Outcome Measure Information:

Title

Change in Visual Analogue Scales (VAS) For Appetite and Satiety From Baseline to Week 12 Endpoint

Description

Time Frame

baseline, 12 weeks

Title

Number of Participants With Detectable Antibodies To LY2428757 At Any Time During The Study

Description

Time Frame

baseline through 16 weeks

Title

Total Average Concentration (Cavg) of LY2428757

Description

Time Frame

4 weeks, 6 weeks, 8 weeks, 10 weeks

Title

Change in 7-Point Self-Monitored Glucose From Baseline to Week 12 Endpoint

Description

Time Frame

baseline, 12 weeks

Title

Change in Total Glucose Area Under the Curve (AUC) From Baseline to Week 12 Endpoint

Description

Time Frame

baseline, 12 weeks

Title

Change in Insulin Total Area Under the Curve (AUC) From Baseline to Week 12 Endpoint

Description

Time Frame

baseline, 12 weeks

Title

Change in C-peptide Area Under the Curve (AUC) From Baseline to Week 12 Endpoint

Description

Time Frame

baseline, 12 weeks

Title

Change in Fasting Lipids From Baseline to Week 12 Endpoint

Description

Time Frame

baseline, 12 weeks

Title

Change in Fasting Weight From Baseline to Week 12 Endpoint

Description

LSMean adjusted for baseline, treatment, visit, treatment-by-visit interaction.

Time Frame

baseline, 12 weeks

Title

Change in Impact of Weight on Quality of Life - Lite (IWQoL-Lite) Average Score From Baseline to Week 12 Endpoint

Description

Time Frame

baseline, 12 weeks

Title

Change in Diabetes Symptom Checklist-Revised (DSC-R) Average Score From Baseline to Week 12 Endpoint

Description

Time Frame

baseline, 12 weeks

Title

Change in European Quality of Life (EuroQol)- Visual Analog Scale From Baseline to Week 12 Endpoint

Description

Time Frame

baseline, 12 weeks

Title

Percent of Participants Domain Scores Indicating No Problems on European Quality of Life (EuroQol) at Baseline and Week 12 Endpoint

Description

Time Frame

Baseline, 12 Weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

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)

Organizational Affiliation

Eli Lilly and Company

Official's Role

Study Director

Facility Information:

Facility Name

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.

City

Bermuda Dunes

State/Province

California

ZIP/Postal Code

92203

Country

United States

Facility Name

City

Chula Vista

State/Province

California

ZIP/Postal Code

91911

Country

United States

Facility Name

City

Huntington Beach

State/Province

California

ZIP/Postal Code

92648

Country

United States

Facility Name

City

Long Beach

State/Province

California

ZIP/Postal Code

90806

Country

United States

Facility Name

City

Pomona

State/Province

California

ZIP/Postal Code

91767

Country

United States

Facility Name

City

Sacramento

State/Province

California

ZIP/Postal Code

95825

Country

United States

Facility Name

City

Melbourne

State/Province

Florida

ZIP/Postal Code

32901

Country

United States

Facility Name

City

Chicago

State/Province

Illinois

ZIP/Postal Code

60607

Country

United States

Facility Name

City

Baltimore

State/Province

Maryland

ZIP/Postal Code

21204

Country

United States

Facility Name

City

Waltham

State/Province

Massachusetts

ZIP/Postal Code

02453

Country

United States

Facility Name

City

St Louis

State/Province

Missouri

ZIP/Postal Code

63141

Country

United States

Facility Name

City

Las Vegas

State/Province

Nevada

ZIP/Postal Code

89101

Country

United States

Facility Name

City

Mentor

State/Province

Ohio

ZIP/Postal Code

44060

Country

United States

Facility Name

City

Spokane

State/Province

Washington

ZIP/Postal Code

99220

Country

United States

Facility Name

City

Vancouver

State/Province

Washington

ZIP/Postal Code

98664

Country

United States

Facility Name

City

Vienna

ZIP/Postal Code

1090

Country

Austria

Facility Name

City

Vorarlberg

ZIP/Postal Code

6800

Country

Austria

Facility Name

City

Berlin

ZIP/Postal Code

12627

Country

Germany

Facility Name

City

Hamburg

ZIP/Postal Code

20253

Country

Germany

Facility Name

City

Koln

ZIP/Postal Code

50931

Country

Germany

Facility Name

City

Lubeck

ZIP/Postal Code

23562

Country

Germany

Facility Name

City

Magdeburg

ZIP/Postal Code

39104

Country

Germany

Facility Name

City

Mainz

ZIP/Postal Code

D-55116

Country

Germany

Facility Name

City

Bangalore

ZIP/Postal Code

580043

Country

India

Facility Name

City

Chennai

ZIP/Postal Code

60004

Country

India

Facility Name

City

Cooperage

ZIP/Postal Code

400021

Country

India

Facility Name

City

Shivajinagar

ZIP/Postal Code

411005

Country

India

Facility Name

City

Garza Garcia

ZIP/Postal Code

66260

Country

Mexico

Facility Name

City

Guadalajara

ZIP/Postal Code

44340

Country

Mexico

Facility Name

City

Mexico City

ZIP/Postal Code

10700

Country

Mexico

Facility Name

City

Monterrey

ZIP/Postal Code

64461

Country

Mexico

Facility Name

City

Rio Piedras

ZIP/Postal Code

00921

Country

Puerto Rico

Facility Name

City

Brasov

ZIP/Postal Code

500365

Country

Romania

Facility Name

City

Bucharest

ZIP/Postal Code

010507

Country

Romania

Facility Name

City

Cluj-Napoca

ZIP/Postal Code

400006

Country

Romania

Facility Name

City

Ploiesti

ZIP/Postal Code

100163

Country

Romania

Facility Name

City

Satu Mare

ZIP/Postal Code

440055

Country

Romania

Facility Name

City

Sf Gheorghe

Country

Romania

Facility Name

City

Targu Mures

ZIP/Postal Code

540142

Country

Romania

Facility Name

City

Bellville

ZIP/Postal Code

7531

Country

South Africa

Facility Name

City

Benoni

ZIP/Postal Code

1500

Country

South Africa

Facility Name

City

Kempton Park

ZIP/Postal Code

1619

Country

South Africa

Facility Name

City

Somerset West

ZIP/Postal Code

7129

Country

South Africa

Facility Name

City

Granada

ZIP/Postal Code

18012

Country

Spain

Facility Name

City

Lleida

ZIP/Postal Code

25198

Country

Spain

Facility Name

City

Madrid

ZIP/Postal Code

28046

Country

Spain

Facility Name

City

Santiago De Compostela

ZIP/Postal Code

15706

Country

Spain

Facility Name

City

Valencia

ZIP/Postal Code

46017

Country

Spain

Facility Name

City

Dnepropetrovsk

ZIP/Postal Code

49027

Country

Ukraine

Facility Name

City

Dnipropetrovsk

ZIP/Postal Code

49023

Country

Ukraine

Facility Name

City

Donetsk

ZIP/Postal Code

83037

Country

Ukraine

Facility Name

City

Kharkiv

ZIP/Postal Code

61048

Country

Ukraine

Facility Name

City

Kirovograd

ZIP/Postal Code

25001

Country

Ukraine

Facility Name

City

Kyiv

ZIP/Postal Code

02175

Country

Ukraine

Facility Name

City

Odessa

ZIP/Postal Code

65114

Country

Ukraine

Facility Name

City

Vinnytsia

ZIP/Postal Code

21010

Country

Ukraine

Facility Name

City

Bath

State/Province

Banes

ZIP/Postal Code

BA1 3NG

Country

United Kingdom

Facility Name

City

Barnsley

ZIP/Postal Code

S75 2EP

Country

United Kingdom

Facility Name

City

Birmingham

ZIP/Postal Code

BS 5SS

Country

United Kingdom

Facility Name

City

Liverpool

ZIP/Postal Code

L9 7AL

Country

United Kingdom

12. IPD Sharing Statement

Citations:

PubMed Identifier

30957581

Citation

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.

Results Reference

derived

Learn more about this trial

A Study for Patients With Type 2 Diabetes Mellitus

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