Brief Summary

This is a study to demonstrate that different doses of once-weekly LY2189265 injected subcutaneously will have dose proportional effect on hemoglobin A1c (HbA1c) at 12 weeks in participants with type 2 diabetes mellitus.

Trial Health

On Track

Trial Health Score

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

Enrollment

167

participants targeted

Target at P50-P75 for phase_2 diabetes-mellitus-type-2

Timeline

Completed

Started Dec 2008

Geographic Reach

9 countries

46 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

1.1 years study duration

First Submitted

Initial submission to the registry

November 12, 2008

Completed

2 days until next milestone

First Posted

Study publicly available on registry

November 14, 2008

Completed

17 days until next milestone

Study Start

First participant enrolled

December 1, 2008

Completed

1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2010

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2010

Completed

4.9 years until next milestone

Results Posted

Study results publicly available

December 10, 2014

Completed

Last Updated

December 10, 2014

Status Verified

December 1, 2014

Enrollment Period

1.1 years

First QC Date

November 12, 2008

Results QC Date

October 3, 2014

Last Update Submit

December 8, 2014

Conditions

Diabetes Mellitus, Type 2

Keywords

Diabetes, type 2 diabetes

Outcome Measures

Primary Outcomes (1)

Change From Baseline in Glycosylated Hemoglobin (HbA1c)
Least Squares (LS) means of change from baseline for glycosylated hemoglobin (HbA1c) were calculated using mixed model repeated measures (MMRM) with pre-study therapy, country, dose, visit, and dose-by-visit interaction as fixed effects and baseline HbA1c as covariate.
Baseline, 12 weeks

Secondary Outcomes (16)

Change From Baseline in Glycosylated Hemoglobin (HbA1c)
Baseline, 4 weeks, 8 weeks
Change From Baseline in Fasting Blood Glucose
Baseline, 12 weeks
Percentage of Participants Who Achieve Glycosylated Hemoglobin (HbA1c) <7% or ≤6.5%
12 weeks
Change From Baseline in Daily Mean Blood Glucose Values From the 7-point Self Monitored Blood Glucose (SMBG) Profiles
Baseline, 12 weeks
Change From Baseline in Beta-cell Function (HOMA2-%B)
Baseline, 12 weeks
+11 more secondary outcomes

Study Arms (5)

0.1 milligram (mg) LY2189265

EXPERIMENTAL

LY2189265: 0.1 milligram (mg), subcutaneous (SC), once weekly (QW)

Drug: LY2189265 and Lifestyle Measures

0.5 milligram (mg) LY2189265

EXPERIMENTAL

LY2189265: 0.5 milligram (mg), subcutaneous (SC), once weekly (QW)

Drug: LY2189265 and Lifestyle Measures

1.0 milligram (mg) LY2189265

EXPERIMENTAL

LY2189265: 1.0 milligram (mg), subcutaneous (SC), once weekly (QW)

Drug: LY2189265 and Lifestyle Measures

1.5 milligram (mg) LY2189265

EXPERIMENTAL

LY2189265: 1.5 milligram (mg), subcutaneous (SC), once weekly (QW)

Drug: LY2189265 and Lifestyle Measures

Placebo

PLACEBO COMPARATOR

Placebo: subcutaneous (SC) once weekly (QW)

Drug: Placebo solution and Lifestyle Measures

Interventions

LY2189265 and Lifestyle MeasuresDRUG

Subcutaneous injection once-weekly for up to 12 weeks

Also known as: Dulaglutide

0.1 milligram (mg) LY21892650.5 milligram (mg) LY21892651.0 milligram (mg) LY21892651.5 milligram (mg) LY2189265

Placebo solution and Lifestyle MeasuresDRUG

Subcutaneous injection once-weekly for up to 12 weeks

Placebo

Eligibility Criteria

Age18 Years - 75 Years

Sexall

Healthy VolunteersNo

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

You may qualify if:

Diabetes mellitus, type 2
Treatment regimens: diet and exercise only or are taking metformin as monotherapy and are willing to discontinue this medication
Have completed at least 8 weeks of wash-out prior to randomization (if on metformin therapy at screening)
Have a qualifying glycosylated hemoglobin (HbA1c) value, as determined by the central laboratory: at screening (for diet and exercise only ≥7.0% to ≤9.5%; for metformin monotherapy \>6.5% to ≤9.0%) and at time of randomization for all participants ≥6.5% to ≤9.5%
Females of childbearing potential must test negative for pregnancy and agree to use a reliable birth control method
Have a body mass index (BMI) between 23 and 40 kilograms/meter squared (kg/m\^2), inclusive, for participants who are native to, and reside in, South and/or East Asia; all other participants must have a BMI between 25 and 40 kg/m\^2, inclusive.
Stable weight for 3 months prior to screening

You may not qualify if:

Diabetes mellitus, type 1
Taking any glucose-lowering oral agents other than metformin within 3 months prior to screening
Use of glucagon-like peptide-1 (GLP-1) analog (for example, exenatide) within 6 months prior to screening or being treated within insulin (with the exception of short-term management of acute conditions that occurred more than 3 months immediately prior to screening)
Use of medications (prescription or over-the counter) to promote weight loss
Chronic (\>2 weeks) use of systemic glucocorticoid therapy
Gastric emptying abnormality, history of bariatric surgery or chronic use of drugs that affect gastrointestinal motility
Use of central nervous system (CNS) stimulant (for example, Ritalin-sustained release \[SR\])
Cardiovascular event within 6 months prior to screening
Poorly controlled hypertension (determined by a mean seated systolic blood pressure (BP) ≥160 millimeters of mercury (mmHg) or mean seated diastolic BP ≥95 mmHg at screening or randomization)
Electrocardiogram (ECG) reading considered outside the normal limits by the investigator and relevant for interpretation or indicating cardiac disease
Liver disease, hepatitis, chronic hepatitis, or alanine transaminase levels \>3.0 times upper limit of normal
Clinical signs or symptoms of pancreatitis or history of chronic or acute pancreatitis at time of screening
Amylase ≥3 times the upper limit of normal and/or lipase ≥2 times upper limit of normal which are determined by central labs at the time of screening
Serum creatinine ≥1.5 milligrams per deciliter (mg/dL) for men or ≥1.4 mg/dL for women or a creatinine clearance \<60 milliliter (mL)/minute which are determined by central labs at the time of screening
Uncontrolled diabetes (defined as 2 or more episode of hyperosmolar state requiring hospitalization in the 6 months prior to screening)
+9 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Eli Lilly and Companylead

Study Sites (46)

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.

Concord, California, 94520, United States

Location

Lancaster, California, 93534, United States

Location

Mission Hills, California, 91345, United States

Location

Palm Springs, California, 92262, United States

Location

Vincennes, Indiana, 47591, United States

Location

Wichita, Kansas, 67208, United States

Location

Bloomfield Hills, Michigan, 48302, United States

Location

Calabash, North Carolina, 28467, United States

Location

Tabor City, North Carolina, 28463, United States

Location

Beaver, Pennsylvania, 15009, United States

Location

North Myrtle Beach, South Carolina, 29582, United States

Location

Menomonee Falls, Wisconsin, 53051, United States

Location

Dubrovnik, 20000, Croatia

Location

Osijek, HR-31000, Croatia

Location

Varaždin, HR-42000, Croatia

Location

Zagreb, HR-10000, Croatia

Location

Aalborg, DK-9000, Denmark

Location

Aarhus, 8000, Denmark

Location

Copenhagen, 2300, Denmark

Location

Copenhagen, 2400, Denmark

Location

Frederiksberg, 2000, Denmark

Location

Hillerød, Dk-3400, Denmark

Location

Bangalore, 560052, India

Location

Bilāspur, 495006, India

Location

Hyderabaad, 500001, India

Location

Indore, 452001, India

Location

Kochi, 682026, India

Location

Mumbai, 400 067, India

Location

New Delhi, 110 029, India

Location

Mexico City, 06700, Mexico

Location

Monterrey, 64570, Mexico

Location

Bialystok, 15-950, Poland

Location

Szczecin, 71-252, Poland

Location

Wroclaw, 503-349, Poland

Location

Carolina, 00983, Puerto Rico

Location

San Germán, 00685, Puerto Rico

Location

Arkhangelsk, 163045, Russia

Location

Moscow, 119881, Russia

Location

Rostov-on-Don, 344022, Russia

Location

Saint Petersburg, 193257, Russia

Location

Alzira, 46600, Spain

Location

Dos Hermanas, 41014, Spain

Location

Lleida, 25198, Spain

Location

Málaga, 29010, Spain

Location

Santa Cruz de Tenerife, 38320, Spain

Location

Torrevieja, 03186, Spain

Location

Related Publications (1)

Grunberger G, Chang A, Garcia Soria G, Botros FT, Bsharat R, Milicevic Z. Monotherapy with the once-weekly GLP-1 analogue dulaglutide for 12 weeks in patients with Type 2 diabetes: dose-dependent effects on glycaemic control in a randomized, double-blind, placebo-controlled study. Diabet Med. 2012 Oct;29(10):1260-7. doi: 10.1111/j.1464-5491.2012.03745.x.
PMID: 22804250BACKGROUND

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

dulaglutide

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 (1-877-285-4559) or 1-317-615-4559 Mon-Fri 9 AM - 5 PM Eastern Time (UTC/GMT - 5 hours, EST)
Eli Lilly and Company
STUDY CHAIR

Publication Agreements

PI is Sponsor Employee: No
Restriction Type: GT60
Restrictive Agreement: Yes

Study Design

Study Type: interventional
Phase: phase 2
Allocation: RANDOMIZED
Masking: TRIPLE
Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose: TREATMENT
Intervention Model: PARALLEL
Sponsor Type: INDUSTRY
Responsible Party: SPONSOR

Study Record Dates

First Submitted

November 12, 2008

First Posted

November 14, 2008

Study Start

December 1, 2008

Primary Completion

January 1, 2010

Study Completion

January 1, 2010

Last Updated

December 10, 2014

Results First Posted

December 10, 2014

Record last verified: 2014-12

Locations

PR(2)ME(2)CR(4)IN(7)PL(3)US(12)DK(6)RU(4)ES(6)

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 (16)

Study Arms (5)

0.1 milligram (mg) LY2189265

0.5 milligram (mg) LY2189265

1.0 milligram (mg) LY2189265

1.5 milligram (mg) LY2189265

Placebo

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (46)

Related Publications (1)

Related Links

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Results Point of Contact

Study Officials

Publication Agreements

Study Design

Study Record Dates

Locations