Diabetes Mellitus Type 2Phase 2EGONCT00630825

A Study of Dose Titration of LY2189265 in Overweight Participants With Type 2 Diabetes Mellitus

A Phase 2 study testing LY2189265 in people with Diabetes Mellitus Type 2, run by Eli Lilly and Company at 34 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

To study once weekly injections of LY2189265 compared to placebo on blood glucose by measuring glycosylated hemoglobin (HbA1c) change from baseline after 16 weeks in overweight Type 2 Diabetes Mellitus participants. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Diabetes Mellitus Type 2
What is being tested?: LY2189265
Type of treatment: Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 262 participants
Where: 34 sitesin 2 countries
Study dates: Apr 2008to Jan 2009
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Type 2 Diabetes Mellitus >3 months by history prior to entering the trial, based on disease diagnostic criteria from the American Diabetes Association (ADA 2007).
Men or women 18 years of age or older. Women must have a negative pregnancy test and be willing to use birth control during study duration and one month post.
Have glycosylated hemoglobin (HbA1c) of >7.0% to ≤10.5% as determined by central laboratory at screening.
Have a body mass index (BMI) between 27 and 40 kilograms/meter squared (kg/m^2), inclusive.
Have been on the same doses for 3 months of any approved combination of 2 oral antihyperglycemic medications in any combination of the following: sulfonylureas (e.g. Chlorpropamide or Diabinese, Glimepiride or Amaryl, Tolbutamide or Orinase, Tolazamide or Tolinase, Glipizide or Glucotrol, Glyburide also known as Micronase, Diabeta, or Glynase), biguanides (e.g. Glucophage or metformin), thiazolidinediones (e.g. Rosiglitazone or Avandia, or Pioglitazone or Actos), or dipeptidyl peptidase 4 (DPP-IV) inhibitors (e.g. Sitagliptin or Januvia). A combination pill of any 2 of these drugs is allowed (1 only), (e.g. Metformin and Glipizide or Metaglip), (e.g. Metformin and Glyburide or Glucovance), (e.g. Pioglitazone and Glimepiride or Duetact), or (e.g. Sitagliptin and Metformin or Janumet).

Who cannot join

Have known Type 1 Diabetes Mellitus
Have taken glucagon-like peptide-1 (GLP-1) or any GLP-1 analog drug (Byetta)
Have a history of unstable angina, heart attack (myocardial infarction), heart arrhythmia (ventricular), congestive heart failure, or other coronary intervention (percutaneous transluminal coronary angioplasty [PTCA], open heart surgery, or coronary artery bypass graft [CABG]), a transient ischemic attack (TIA) or stroke (cerebrovascular accident) in the last 6 months prior to screening.
Have acute or chronic hepatitis or elevated liver function tests (alanine transaminase), a history of chronic or recurrent pancreatitis. Have renal disease or a serum creatinine (blood test) >2 milligrams per deciliter (mg/dL). If taking biguanides (e.g. metformin or Glucophage), or DPP-IV inhibitors (e.g. Sitagliptin or Januvia or Janumet), creatinine must be ≤1.5 mg/dL.
Currently taking prescription or over the counter medications to prevent weight loss.

Trial locations and contacts

34 sites in 2 countries.

Country

City, postcode or hospital

34 sites in 2 countries

United States31 sites

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.
Anaheim, California, 92805
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Ann Arbor, Michigan, 48108
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Athens, Georgia, 30606
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Atlanta, Georgia, 30303
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Austin, Texas, 78731
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Biddeford, Maine, 04005
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Billings, Montana, 59101
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Bloomfield Hills, Michigan, 48302
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Dallas, Texas, 75230
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Flemington, New Jersey, 08822
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Greensboro, North Carolina, 27401
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Greenville, North Carolina, 27834
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Indianapolis, Indiana, 46250
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Lancaster, California, 93534
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Memphis, Tennessee, 38119
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Menomonee Falls, Wisconsin, 53051
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Morehead City, North Carolina, 28557
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Norfolk, Virginia, 23510
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Northridge, California, 91326
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Palm Springs, California, 92262
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Peoria, Arizona, 85381
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Renton, Washington, 98057
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San Antonio, Texas, 78237
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South Miami, Florida, 33143
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Spokane, Washington, 99216
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Springfield, Illinois, 62704
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St Louis, Missouri, 63141
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Syracuse, New York, 13210
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Tacoma, Washington, 98405
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Wenatchee, Washington, 98801
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West Palm Beach, Florida, 33401

Other trials in United States

Puerto Rico3 sites

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.
Manati, 00674
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.
San Juan, 00907
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.
Toa Baja, 00949

Other trials in Puerto Rico

About this study

Official title: The Effect of Dose Titration of LY2189265 in Overweight and Obese Patients With Type 2 Diabetes Mellitus

Conditions: Diabetes Mellitus Type 2
Being tested: LY2189265, Placebo
Medical subject headings: Diabetes Mellitus, Type 2

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

LY2189265Drug
Also called Dulaglutide
PlaceboDrug

Study groups in NCT00630825
Study group	Role	What they receive
1.0/2.0 milligram (mg) LY2189265	Experimental	LY2189265: 1.0 milligram (mg), subcutaneous (SC) injection, once weekly (QW) for 4 weeks; followed by 2.0 mg, SC injection, QW for 12 weeks Receives: Drug: LY2189265
1.0/1.0 milligram (mg) LY2189265	Experimental	LY2189265: 1.0 mg, subcutaneous (SC) injection, once weekly (QW) for 16 weeks Receives: Drug: LY2189265
0.5/1.0 milligram (mg) LY2189265	Experimental	LY2189265: 0.5 milligram (mg), subcutaneous (SC) injection, once weekly (QW) for 4 weeks; followed by 1.0 mg, SC injection, QW for 12 weeks Receives: Drug: LY2189265
Placebo	Placebo comparator	Placebo: subcutaneous (SC) injection, once weekly (QW) for 16 weeks Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Change From Baseline in Glycosylated Hemoglobin (HbA1c) in Overweight and Obese Participants With Type 2 Diabetes Mellitus
Once weekly injections of LY2189265 (titrated and non-titrated doses) compared to placebo on blood glucose were evaluated. Least Squares (LS) means of change from baseline were calculated using analysis of covariance (ANCOVA) adjusting for treatment, combination of oral medications, and baseline glycosylated hemoglobin (HbA1c).
Measured: Baseline, 16 weeks

Secondary outcomes (15)

Change From Baseline in Fasting Blood Glucose
Fasting blood glucose is a test to determine how much glucose (sugar) is in a blood sample after an overnight fast. Least Squares (LS) means of change were calculated using analysis of covariance (ANCOVA) adjusting for treatment, combination of oral medications, and baseline.
Measured: Baseline, 16 weeks
Meal Test Glucose Excursion (Change in Blood Glucose to Test Meal)
Glucose excursion in response to a standardized solid mixed meal test was evaluated at baseline (randomization) and at Week 16, or at early termination. Each of the 2 standardized meal tests required participants to fast starting at 2200 hours the night prior to the test. A standardized breakfast meal was provided to the participant (approximately 550 kilocalorie [Kcal], 103 grams [g] carbohydrates, 22 g protein, and 8.5 g fat) and was to be consumed within 15 minutes. Serial venous blood samples were taken at the start of the meal (fasting [0]) and 30, 60, 90, 120, and 180 minutes after the start of the meal. Least Squares (LS) means of change in mean glucose area under the curve excursion following a test meal were calculated adjusting for treatment, combination of oral medications, and baseline.
Measured: Baseline and 16 weeks
Change From Baseline in Daily Mean Blood Glucose Values From the 8-point Self Monitored Blood Glucose (SMBG) Profiles
Change from baseline in mean daily blood glucose values were measured using self-monitored blood glucose (SMBG) data collected at the following 8 time points: pre-morning meal; 2 hours post-morning meal; pre-midday meal; 2 hours post-midday meal; pre-evening meal; 2 hours post-evening meal; bedtime; and 2:00 am. The daily mean was calculated as the average of the 8 blood glucose values collected on a particular day. Least Squares (LS) means of change from baseline of the mean of the 8 time points (Daily Mean) were calculated using analysis of covariance (ANCOVA) adjusting for treatment, combination of oral medications, and baseline.
Measured: 2 separate days in the week preceding the Baseline, Week 4, Week 8, and Week 16 visits.
Change From Baseline in Beta (β)-Cell Function and Insulin Sensitivity as Estimated by the Updated Homeostasis Model Assessment Method (HOMA2)
Homeostasis Model Assessment tool (HOMA2) of β-cell function is a technique for estimating beta-cell function (HOMA2-%B) and insulin sensitivity (HOMA2-%S) using basal serum glucose, and c-peptide concentrations. A fasting blood glucose, c-peptide, and serum insulin level were drawn for purposes of this determination just prior to the mixed meal test.
Measured: Baseline, 16 weeks
Percentage of Participants Achieving a Glycosylated Hemoglobin (HbA1c) of <7% or ≤6.5%
Percentages of participants who achieved glycosylated hemoglobin (HbA1c) levels of <7% or ≤6.5% were analyzed with a logistic regression model with baseline, combination of oral medications, and treatment as factors included in the model.
Measured: Baseline and 4 and 8 and 16 weeks
Change From Baseline in Body Weight
LS means of change from baseline were calculated using analysis of covariance (ANCOVA) adjusting for treatment, combination of oral medications, and baseline.
Measured: Baseline, 4, 8, and 16 weeks
Change From Baseline in Waist Circumference
Mean change from baseline in waist circumference (a measure of central obesity).
Measured: Baseline, 16 weeks
Nausea and Dyspepsia Measured by Visual Analog Scale
Participants were asked to score nausea and dyspepsia (abdominal pain and bloating) on a scale of 0 (none) to 100 after the largest meal of the day.
Measured: One week before and one week after each of the Baseline and Week 4 and Week 8 and Week 16 visits
Change From Baseline in Gastroparesis Cardinal Symptom Index (GCSI) Scores
Gastroparesis Cardinal Symptom Index (GCSI) is a participant-completed questionnaire designed to assess the severity of symptoms consistent with delayed gastric emptying (nausea/vomiting, abdominal bloating, and stomach fullness) at each study visit. GCSI scores ranged from 0=none, 1=very mild, 2=mild, 3=moderate, 4=severe, to 5=very severe.
Measured: Baseline and 4 and 8 and 16 weeks
Number of Participants With a Hypoglycemic Event
A documented hypoglycemic episode is defined as an event which is associated with a measured blood glucose of ≤70 milligrams per deciliter (mg/dL) (3.9 millimoles per liter [mmol/L]), even if it was not associated with symptoms, signs, or treatment. A severe hypoglycemic episode is defined as an event with a measured blood glucose of <50mg/dL. Participant reports of hypoglycemic events were collected at the beginning of each visit starting at Baseline. A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.
Measured: Baseline through 4, 8, and 16 weeks
Rate of Hypoglycemia Per 30 Days
Hypoglycemic episodes are defined as an event which is associated with reported signs and/or symptoms of hypoglycemia (for example, sweating, shakiness, tachycardia, etc.) or a documented blood glucose (BG) concentration of ≤70 milligrams per deciliter (mg/dL) (3.9 millimoles per liter [mmol/L]), even if it was not associated with symptoms, signs, or treatment. The rate is the average number of days out of 30 that a participant reported hypoglycemia. A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.
Measured: Baseline through 16 weeks
Change From Baseline in Lipids
Lipids include total cholesterol, low-density lipoprotein (LDL)-cholesterol, high-density lipoprotein (HDL)-cholesterol, and triglycerides.
Measured: Baseline, 16 weeks
Participants Perception of Medication Effectiveness Using the Perceptions About Medications - Diabetes, Short Version (PAM-D-S) Questionnaire
The Perceptions about Medications - Diabetes, Short Version (PAM-D-S) questionnaire consisted of: 2 items in which respondents were asked about their satisfaction with their diabetes medication over the past week using a 6-point scale ranging from 1 "completely dissatisfied" to 6 "completely satisfied"; 10 items in which respondents were asked about the effectiveness of their diabetes medications in the past week using a 4-point scale ranging from 1 "all of the time" to 4 "none of the time"; and 15 items asking respondents to indicate the frequency of physical side effects in the past week using a 4-point scale ranging from 1 "all of the time" to 4 "none of the time." These items were exploratory items taken from a Diabetes Medicines Survey and had not been validated as a scale. The percentage of participants that rated their general health as good or better are summarized.
Measured: Baseline and 4 and 8 and 16 weeks
Validation of the Psychometric Properties of the Perceptions About Medications - Diabetes, Short Version (PAM-D-S) Questionnaire
This purpose of this outcome measure was to validate the PAM-D-S questionnaire for future use. Please refer to Outcome Measure #14 for a description of the PAM-D-S questionnaire and results collected. A preliminary analysis indicated modifications to the questionnaire were required and further study is necessary to complete the validation. Therefore, the PAM-D-S questionnaire was not validated as a part of Study H9X-MC-GBCJ.
Measured: Baseline and 4 and 8 and 16 weeks
Pharmacokinetics (PK) of LY2189265 - Area Under the Concentration Time Curve (AUC)
The population mean estimates and standard deviations were calculated for pharmacokinetic parameters (area under the concentration time curve [AUC] at steady state from time zero to 168 hours after study drug administration).
Measured: Time zero to 168 hours after study drug administration at 4, 8, and 16 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Apr 2008Jan 2009

First posted7 Mar 2008 (estimated)
Study startApr 2008
Primary completionJan 2009
Study completionJan 2009

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Diabetes Mellitus Type 2Studies of the same condition, open and under way.
More trials run by Eli Lilly and CompanyThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind
Who is masked: Participant, Care provider, Investigator
Enrolment: 262 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00630825
Sponsor's protocol ID: 12068
Other IDs: H9X-MC-GBCJ
Acronym: EGO
Status last verified: Dec 2014
First submitted: 28 Feb 2008
Last updated: 10 Dec 2014
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 10 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: The Effect of Dose Titration of LY2189265 in Overweight and Obese Patients With Type 2 Diabetes Mellitus
ClinicalTrials.gov ID: NCT00630825
Acronym / sponsor ID: EGO / 12068
Conditions: Diabetes Mellitus Type 2
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 262 participants (actual)
Lead sponsor: Eli Lilly and CompanyIndustry (pharma, biotech, devices)
Study start: Apr 2008
Primary completion: Jan 2009 (actual)
Study completion: Jan 2009 (actual)
First posted: 7 Mar 2008 (estimated)
Results: Posted 10 Dec 2014

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, care provider, investigator)
Number of arms: 4

Arm	Type	Receives
1.0/2.0 milligram (mg) LY2189265	Experimental	Drug: LY2189265LY2189265: 1.0 milligram (mg), subcutaneous (SC) injection, once weekly (QW) for 4 weeks; followed by 2.0 mg, SC injection, QW for 12 weeks
1.0/1.0 milligram (mg) LY2189265	Experimental	Drug: LY2189265LY2189265: 1.0 mg, subcutaneous (SC) injection, once weekly (QW) for 16 weeks
0.5/1.0 milligram (mg) LY2189265	Experimental	Drug: LY2189265LY2189265: 0.5 milligram (mg), subcutaneous (SC) injection, once weekly (QW) for 4 weeks; followed by 1.0 mg, SC injection, QW for 12 weeks
Placebo	Placebo comparator	Drug: PlaceboPlacebo: subcutaneous (SC) injection, once weekly (QW) for 16 weeks

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

Type 2 Diabetes Mellitus >3 months by history prior to entering the trial, based on disease diagnostic criteria from the American Diabetes Association (ADA 2007).
Men or women 18 years of age or older. Women must have a negative pregnancy test and be willing to use birth control during study duration and one month post.
Have glycosylated hemoglobin (HbA1c) of >7.0% to ≤10.5% as determined by central laboratory at screening.
Have a body mass index (BMI) between 27 and 40 kilograms/meter squared (kg/m^2), inclusive.
Have been on the same doses for 3 months of any approved combination of 2 oral antihyperglycemic medications in any combination of the following: sulfonylureas (e.g. Chlorpropamide or Diabinese, Glimepiride or Amaryl, Tolbutamide or Orinase, Tolazamide or Tolinase, Glipizide or Glucotrol, Glyburide also known as Micronase, Diabeta, or Glynase), biguanides (e.g. Glucophage or metformin), thiazolidinediones (e.g. Rosiglitazone or Avandia, or Pioglitazone or Actos), or dipeptidyl peptidase 4 (DPP-IV) inhibitors (e.g. Sitagliptin or Januvia). A combination pill of any 2 of these drugs is allowed (1 only), (e.g. Metformin and Glipizide or Metaglip), (e.g. Metformin and Glyburide or Glucovance), (e.g. Pioglitazone and Glimepiride or Duetact), or (e.g. Sitagliptin and Metformin or Janumet).

Key exclusion criteria (5 listed)

Have known Type 1 Diabetes Mellitus
Have taken glucagon-like peptide-1 (GLP-1) or any GLP-1 analog drug (Byetta)
Have a history of unstable angina, heart attack (myocardial infarction), heart arrhythmia (ventricular), congestive heart failure, or other coronary intervention (percutaneous transluminal coronary angioplasty [PTCA], open heart surgery, or coronary artery bypass graft [CABG]), a transient ischemic attack (TIA) or stroke (cerebrovascular accident) in the last 6 months prior to screening.
Have acute or chronic hepatitis or elevated liver function tests (alanine transaminase), a history of chronic or recurrent pancreatitis. Have renal disease or a serum creatinine (blood test) >2 milligrams per deciliter (mg/dL). If taking biguanides (e.g. metformin or Glucophage), or DPP-IV inhibitors (e.g. Sitagliptin or Januvia or Janumet), creatinine must be ≤1.5 mg/dL.
Currently taking prescription or over the counter medications to prevent weight loss.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
LY2189265Also: Dulaglutide	Drug	0.5/1.0 milligram (mg) LY2189265, 1.0/1.0 milligram (mg) LY2189265, 1.0/2.0 milligram (mg) LY2189265
Placebo	Drug	Placebo

Primary outcome

Change From Baseline in Glycosylated Hemoglobin (HbA1c) in Overweight and Obese Participants With Type 2 Diabetes Mellitus
Time frame: Baseline, 16 weeks
Once weekly injections of LY2189265 (titrated and non-titrated doses) compared to placebo on blood glucose were evaluated. Least Squares (LS) means of change from baseline were calculated using analysis of covariance (ANCOVA) adjusting for treatment, combination of oral medications, and baseline glycosylated hemoglobin (HbA1c).

15 secondary outcomes

Change From Baseline in Fasting Blood Glucose
Time frame: Baseline, 16 weeks
Meal Test Glucose Excursion (Change in Blood Glucose to Test Meal)
Time frame: Baseline and 16 weeks
Change From Baseline in Daily Mean Blood Glucose Values From the 8-point Self Monitored Blood Glucose (SMBG) Profiles
Time frame: 2 separate days in the week preceding the Baseline, Week 4, Week 8, and Week 16 visits.
Change From Baseline in Beta (β)-Cell Function and Insulin Sensitivity as Estimated by the Updated Homeostasis Model Assessment Method (HOMA2)
Time frame: Baseline, 16 weeks
Percentage of Participants Achieving a Glycosylated Hemoglobin (HbA1c) of <7% or ≤6.5%
Time frame: Baseline and 4 and 8 and 16 weeks
Change From Baseline in Body Weight
Time frame: Baseline, 4, 8, and 16 weeks
Change From Baseline in Waist Circumference
Time frame: Baseline, 16 weeks
Nausea and Dyspepsia Measured by Visual Analog Scale
Time frame: One week before and one week after each of the Baseline and Week 4 and Week 8 and Week 16 visits
Change From Baseline in Gastroparesis Cardinal Symptom Index (GCSI) Scores
Time frame: Baseline and 4 and 8 and 16 weeks
Number of Participants With a Hypoglycemic Event
Time frame: Baseline through 4, 8, and 16 weeks
Rate of Hypoglycemia Per 30 Days
Time frame: Baseline through 16 weeks
Change From Baseline in Lipids
Time frame: Baseline, 16 weeks
Participants Perception of Medication Effectiveness Using the Perceptions About Medications - Diabetes, Short Version (PAM-D-S) Questionnaire
Time frame: Baseline and 4 and 8 and 16 weeks
Validation of the Psychometric Properties of the Perceptions About Medications - Diabetes, Short Version (PAM-D-S) Questionnaire
Time frame: Baseline and 4 and 8 and 16 weeks
Pharmacokinetics (PK) of LY2189265 - Area Under the Concentration Time Curve (AUC)
Time frame: Time zero to 168 hours after study drug administration at 4, 8, and 16 weeks

Results and safety

Results posted to the registry on 10 Dec 2014, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
1.0/2.0 Milligram (mg) LY2189265	65	56
1.0/1.0 Milligram (mg) LY2189265	65	58
0.5/1.0 Milligram (mg) LY2189265	66	58
Placebo	66	60

Primary outcome: Change From Baseline in Glycosylated Hemoglobin (HbA1c) in Overweight and Obese Participants With Type 2 Diabetes Mellitus

Time frame: Baseline, 16 weeks. Least squares mean (Standard Error). Unit: percentage of glycosylated hemoglobin

Measure	1.0/2.0 Milligram (mg) LY2189265 n = 62	1.0/1.0 Milligram (mg) LY2189265 n = 63	0.5/1.0 Milligram (mg) LY2189265 n = 65	Placebo n = 65
Value	-1.52 (0.12)	-1.29 (0.12)	-1.28 (0.12)	-0.27 (0.12)

1.0/2.0 Milligram (mg) LY2189265 vs Placebo: p <0.001, ANCOVA
1.0/1.0 Milligram (mg) LY2189265 vs Placebo: p <0.001, ANCOVA
0.5/1.0 Milligram (mg) LY2189265 vs Placebo: p <0.001, ANCOVA

Population analysed: Participants who received at least one dose of LY2189265 or Placebo with evaluable glycosylated hemoglobin (HbA1c) data. Last observation carried forward (LOCF) was used to impute missing postbaseline values. If there were no data after the date of randomization, the endpoint was considered missing.

15 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 4% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
1.0/2.0 Milligram (mg) LY2189265	1 of 65 (1.5%)	41 of 65 (63.1%)	Not reported
1.0/1.0 Milligram (mg) LY2189265	2 of 65 (3.1%)	35 of 65 (53.8%)	Not reported
0.5/1.0 Milligram (mg) LY2189265	3 of 66 (4.5%)	40 of 66 (60.6%)	Not reported
Placebo	1 of 66 (1.5%)	36 of 66 (54.5%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 10 Dec 2014.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Lilly Clinical Trial RegistryLink provided by the sponsor.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Call 1-877-CTLILLY (1-877-285-4559) Mon-Fri 9AM-5PM Eastern time (UTC/GMT - 5 hours, EST) study director

Eli Lilly and Company

34 sites in 2 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing LY2189265 in people with Diabetes Mellitus Type 2, run by Eli Lilly and Company at 34 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 10 Dec 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 34 sites in United States, Puerto Rico. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 10 Dec 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change From Baseline in Glycosylated Hemoglobin (HbA1c) in Overweight and Obese Participants With Type 2 Diabetes Mellitus (time frame: Baseline, 16 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00630825.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Dec 2014.