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.

Trial Health

On Track

Trial Health Score

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

Enrollment

263

participants targeted

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

Timeline

Completed

Started Jan 2011

Typical duration for phase_2 diabetes-mellitus-type-2

Geographic Reach

7 countries

40 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

1.2 years study duration

First Submitted

Initial submission to the registry

November 12, 2010

Completed

4 days until next milestone

First Posted

Study publicly available on registry

November 16, 2010

Completed

2 months until next milestone

Study Start

First participant enrolled

January 1, 2011

Completed

1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2012

Completed

29 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2012

Completed

6.2 years until next milestone

Results Posted

Study results publicly available

April 24, 2018

Completed

Last Updated

April 24, 2018

Status Verified

March 1, 2018

Enrollment Period

1.1 years

First QC Date

November 12, 2010

Results QC Date

March 24, 2018

Last Update Submit

March 24, 2018

Conditions

Diabetes Mellitus, Type 2

Keywords

Type 2 Diabetes Mellitus

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (15)

Change From Baseline to 24 Week Endpoint in Fasting Blood Glucose (FBG)
Baseline, 24 weeks
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 Plasma Glucose
Baseline, 24 weeks
Change From Baseline to 24 Week Endpoint in Fasting Insulin
Baseline, 24 weeks
Change From Baseline to 24 Week Endpoint in Fasting Glucagon-like Peptide 1 (GLP-1) Active and Total
Baseline, 24 weeks
+10 more secondary outcomes

Study Arms (4)

Placebo

PLACEBO COMPARATOR

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.

Drug: Placebo

2.5 mg LY2409021

EXPERIMENTAL

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.

Drug: LY2409021

10 mg LY2409021

EXPERIMENTAL

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.

Drug: LY2409021

20 mg LY2409021

EXPERIMENTAL

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.

Drug: LY2409021

Interventions

LY2409021DRUG

Administered Orally

10 mg LY24090212.5 mg LY240902120 mg LY2409021

PlaceboDRUG

Administered Orally

Placebo

Eligibility Criteria

Age18 Years - 70 Years

Sexall

Healthy VolunteersNo

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

You may qualify if:

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
Comply with treatment regimens
Have given written informed consent to participate in this study in accordance with local regulations and the Ethical Review Board (ERB) governing the study site.

You may not qualify if:

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.
Have any abnormality of the ECG that would impact patient safety or data interpretation.
Show clinical signs or symptoms of liver disease, or liver function tests (LFTs; aspartate aminotransferase \[AST\] or alanine aminotransferase \[ALT\]) greater than 2.5 times upper limit of normal (ULN) as determined by the central laboratory at screening.
Have a current or previous diagnosis of Gilbert's disease.
Have previous or current diagnosis of Hepatitis B or C
Have a serum creatinine \>2 milligrams per deciliter (mg/dL) or, in patients being treated with metformin, a serum creatinine above (or creatinine clearance below) what is approved in the metformin product labeling in the respective country.
+17 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Eli Lilly and Companylead

Study Sites (40)

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.

Burbank, California, 91505, United States

Location

Concord, California, 94520, United States

Location

Fresno, California, 93720, United States

Location

Lakewood, California, 990712, United States

Location

Los Angeles, California, 90057, United States

Location

Mission Hills, California, 91345, United States

Location

Palm Springs, California, 92262, United States

Location

Roseville, California, 95661, United States

Location

San Luis Obispo, California, 93401, United States

Location

Idaho Falls, Idaho, 83404, United States

Location

Meridian, Idaho, 83646, United States

Location

Topeka, Kansas, 66606, United States

Location

St Louis, Missouri, 63141, United States

Location

Henderson, Nevada, 89052, United States

Location

Charlotte, North Carolina, 28209, United States

Location

Raleigh, North Carolina, 27609, United States

Location

Wilmington, North Carolina, 28401, United States

Location

Fargo, North Dakota, 58103, United States

Location

Damme, 49401, Germany

Location

Dresden, 01307, Germany

Location

Elsterwerda, 04910, Germany

Location

HohenmÃ¶lsen, 06679, Germany

Location

LÃ¼neburg, 21339, Germany

Location

Ludwigshafen, 67059, Germany

Location

Mainz, 55116, Germany

Location

Chieti Scalo, 66013, Italy

Location

Milan, 20162, Italy

Location

Hato Rey, 00917, Puerto Rico

Location

Manatí, 00674, Puerto Rico

Location

San Juan, 00917-3104, Puerto Rico

Location

Baia Mare, 430123, Romania

Location

Brasov, 500365, Romania

Location

Bucharest, 050538, Romania

Location

Iași, 700547, Romania

Location

Târgu Mureş, 540098, Romania

Location

Košice, 04012, Slovakia

Location

Malacky, 90101, Slovakia

Location

Alicante, 03114, Spain

Location

Alzira, 46600, Spain

Location

Seville, 41003, Spain

Location

Related Publications (1)

Kazda CM, Ding Y, Kelly RP, Garhyan P, Shi C, Lim CN, Fu H, Watson DE, Lewin AJ, Landschulz WH, Deeg MA, Moller DE, Hardy TA. Evaluation of Efficacy and Safety of the Glucagon Receptor Antagonist LY2409021 in Patients With Type 2 Diabetes: 12- and 24-Week Phase 2 Studies. Diabetes Care. 2016 Jul;39(7):1241-9. doi: 10.2337/dc15-1643. Epub 2015 Dec 17.
PMID: 26681715DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

adomeglivant

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 (1-877-4559) 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: DOUBLE
Who Masked: PARTICIPANT, INVESTIGATOR
Purpose: TREATMENT
Intervention Model: PARALLEL
Sponsor Type: INDUSTRY
Responsible Party: SPONSOR

Study Record Dates

First Submitted

November 12, 2010

First Posted

November 16, 2010

Study Start

January 1, 2011

Primary Completion

February 1, 2012

Study Completion

March 1, 2012

Last Updated

April 24, 2018

Results First Posted

April 24, 2018

Record last verified: 2018-03

Locations

US(18)RO(5)PR(3)SL(2)IT(2)ES(3)DE(7)

Brief Summary

Trial Health

Trial Health Score

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Results Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (15)

Study Arms (4)

Placebo

2.5 mg LY2409021

10 mg LY2409021

20 mg LY2409021

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (40)

Related Publications (1)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Results Point of Contact

Study Officials

Publication Agreements

Study Design

Study Record Dates

Locations