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CompletedPhase 2Results posted

Effects of LY2189265 on Glycemic Control in Participants With Type 2 Diabetes

Assessment of Dose-Dependent Effects of LY2189265 on Glycemic Control in Patients With Type 2 Diabetes Treated Only With Lifestyle Interventions

Asset

Dulaglutide

Subcutaneous · GLP-1 agonist

Listed sites

46

Recruiting sites

Enrollment

167

actual

Study population

Type 2 diabetes

Key I/E criterion

BMI 23-40

Primary endpoint

HbA1c, change

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT00791479
Org study ID12565
Secondary IDCTRI/2009/091/000105India
Secondary IDH9X-MC-GBCKEli Lilly and Company

Timeline

Milestones

Study first posted2008-11-14estimated
Last update posted2014-12-10estimated
Results first posted2014-12-10estimated
Study start2008-12 (month precision)
Primary completion2010-01actual (month precision)
Study completion2010-01actual (month precision)

Assets

Investigational agents

Study populations

Who this study enrolls

Type 2 diabetes

Eligibility

Who can enroll

Minimum age18 Years
Maximum age75 Years
SexAll
Healthy volunteersNot accepted

Inclusion criteria

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

Exclusion criteria

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)
Significant active, uncontrolled endocrine or autoimmune abnormality
History of a transplanted organ (corneal transplants are allowed)
Active or untreated malignancy (other than basal or squamous cell skin cancer, in situ carcinomas of the cervix, or in situ prostate cancer) for less than 5 years
Have any other condition, in the opinion of the investigator, that may preclude the participant from following or completing the protocol
Investigator site personnel directly affiliated with this study and/or their immediate families (spouse, parent, child, or sibling, whether biological or legally adopted)
Sponsor employees
Received treatment within the last 30 days with a drug that has not received regulatory approval for any indication at the time of study entry
Participated in an interventional medical, surgical, or pharmaceutical study within 30 days prior to entry into the study
Have previously completed or withdrawn from this study after providing informed consent

Endpoints (34)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Glycemic / diabetes
14
Safety / tolerability / PK
12
Cardiometabolic biomarkers
6
Weight & body composition
2

Weight & body composition

2 endpoints
Secondary/registry result

Change From Baseline in Body Weight

Time frame:Baseline, 12 weeks

Body weight, absolute change (kg)

change from baseline, improvement

Posted result

GroupValue (least_squares_mean), kilogram (kg)95% CI
0.1 Milligrams (mg) LY2189265-0.19
0.5 Milligrams (mg) LY2189265-0.34
1.0 Milligrams (mg) LY2189265-1.11
1.5 Milligrams (mg) LY2189265-1.49
Placebo-1.38
p0.969Mixed Models Analysis

Test of log linear dose response with placebo.

p0.009Mixed Models Analysis

Test of log linear dose response without placebo.

Mean Difference (Final Values)1.19p0.140Mixed Models Analysis
Mean Difference (Final Values)1.04p0.247Mixed Models Analysis
Mean Difference (Final Values)0.27p0.975Mixed Models Analysis
Mean Difference (Final Values)-0.11p1.00Mixed Models Analysis
Secondary/protocol endpoint

Change From Baseline in Body Weight

Time frame:Baseline, 12 weeks

Body weight, absolute change (kg)

change from baseline, improvement

Glycemic / diabetes

14 endpoints
Primary/registry result

Change From Baseline in Glycosylated Hemoglobin (HbA1c)

Time frame:Baseline, 12 weeks

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Posted result

GroupValue (least_squares_mean), percentage of glycosylated hemoglobin95% CI
0.1 Milligrams (mg) LY2189265-0.37
0.5 Milligrams (mg) LY2189265-0.89
1.0 Milligrams (mg) LY2189265-1.03
1.5 Milligrams (mg) LY2189265-1.04
Placebo0.01
p<0.001Mixed Models Analysis

Test of log linear dose response with placebo.

p<0.001Mixed Models Analysis

Test of log linear dose response without placebo.

Mean Difference (Final Values)-0.37p0.069Mixed Models Analysis
Mean Difference (Final Values)-0.89p<0.001Mixed Models Analysis
Mean Difference (Final Values)-1.04p<0.001Mixed Models Analysis
Mean Difference (Final Values)-1.04p<0.001Mixed Models Analysis
Primary/protocol endpoint

Change From Baseline in Glycosylated Hemoglobin (HbA1c)

Time frame:Baseline, 12 weeks

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Secondary/registry result

Change From Baseline in Glycosylated Hemoglobin (HbA1c)

Time frame:Baseline, 4 weeks, 8 weeks

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Posted result

GroupValue (least_squares_mean), percentage of glycosylated hemoglobin95% CI
0.1 Milligrams (mg) LY2189265Week 4 (n=35, n=34, n=34, n=25, n=29)-0.28
Week 8 (n=35, n=30, n=33, n=24, n=28)-0.33
0.5 Milligrams (mg) LY2189265Week 4 (n=35, n=34, n=34, n=25, n=29)-0.51
Week 8 (n=35, n=30, n=33, n=24, n=28)-0.74
1.0 Milligrams (mg) LY2189265Week 4 (n=35, n=34, n=34, n=25, n=29)-0.46
Week 8 (n=35, n=30, n=33, n=24, n=28)-0.78
1.5 Milligrams (mg) LY2189265Week 4 (n=35, n=34, n=34, n=25, n=29)-0.53
Week 8 (n=35, n=30, n=33, n=24, n=28)-0.90
PlaceboWeek 4 (n=35, n=34, n=34, n=25, n=29)-0.01
Week 8 (n=35, n=30, n=33, n=24, n=28)-0.00
p<0.001Mixed Models Analysis

Test of log linear dose response with placebo.

p0.023Mixed Models Analysis

Test of log linear dose response without placebo.

p<0.001Mixed Models Analysis

Test of log linear dose response with placebo.

p<0.001Mixed Models Analysis

Test of log linear dose response without placebo.

Secondary/registry result

Change From Baseline in Fasting Blood Glucose

Time frame:Baseline, 12 weeks

Fasting glucose, change

change from baseline, improvement

LOINC 1558-6

Posted result

GroupValue (least_squares_mean), milligrams per deciliter (mg/dL)95% CI
0.1 Milligrams (mg) LY2189265-11.59
0.5 Milligrams (mg) LY2189265-30.31
1.0 Milligrams (mg) LY2189265-33.73
1.5 Milligrams (mg) LY2189265-37.49
Placebo-3.78
p<0.001Mixed Models Analysis

Test of log linear dose response with placebo.

p<0.001Mixed Models Analysis

Test of log linear dose response without placebo.

Mean Difference (Final Values)-7.81p0.456Mixed Models Analysis
Mean Difference (Final Values)-26.53p<0.001Mixed Models Analysis
Mean Difference (Final Values)-29.96p<0.001Mixed Models Analysis
Mean Difference (Final Values)-33.71p<0.001Mixed Models Analysis
Secondary/registry result

Percentage of Participants Who Achieve Glycosylated Hemoglobin (HbA1c) <7% or ≤6.5%

Time frame:12 weeks

HbA1c <7.0% achievement

threshold achievement, improvement

componentsHbA1c <7.0% achievement, HbA1c <6.5% achievement

LOINC 4548-4

Posted result

GroupValue (number), percentage of participants95% CI
0.1 Milligrams (mg) LY2189265HbA1c levels <7.0% (n=34, n=30, n=32, n=21, n=28)47.1
HbA1c levels ≤6.5% (n=34, n=30, n=32, n=21, n=28)14.7
0.5 Milligrams (mg) LY2189265HbA1c levels <7.0% (n=34, n=30, n=32, n=21, n=28)73.3
HbA1c levels ≤6.5% (n=34, n=30, n=32, n=21, n=28)53.3
1.0 Milligrams (mg) LY2189265HbA1c levels <7.0% (n=34, n=30, n=32, n=21, n=28)75.0
HbA1c levels ≤6.5% (n=34, n=30, n=32, n=21, n=28)50.0
1.5 Milligrams (mg) LY2189265HbA1c levels <7.0% (n=34, n=30, n=32, n=21, n=28)71.4
HbA1c levels ≤6.5% (n=34, n=30, n=32, n=21, n=28)52.4
PlaceboHbA1c levels <7.0% (n=34, n=30, n=32, n=21, n=28)21.4
HbA1c levels ≤6.5% (n=34, n=30, n=32, n=21, n=28)7.1
p<0.001Cochran-Armitage trend test
p<0.001Cochran-Armitage trend test
Secondary/registry result

Change From Baseline in Daily Mean Blood Glucose Values From the 7-point Self Monitored Blood Glucose (SMBG) Profiles

Time frame:Baseline, 12 weeks

change from baseline, improvement

Posted result

GroupValue (least_squares_mean), milligrams per deciliter (mg/dL)95% CI
0.1 Milligrams (mg) LY2189265-15.77
0.5 Milligrams (mg) LY2189265-32.21
1.0 Milligrams (mg) LY2189265-42.46
1.5 Milligrams (mg) LY2189265-44.79
Placebo-6.12
p<0.001Mixed Models Analysis

Test of log linear dose response with placebo.

p<0.001Mixed Models Analysis

Test of log linear dose response without placebo.

Mean Difference (Final Values)-9.65p0.378Mixed Models Analysis
Mean Difference (Final Values)-26.09p<0.001Mixed Models Analysis
Mean Difference (Final Values)-36.34p<0.001Mixed Models Analysis
Mean Difference (Final Values)-38.67p<0.001Mixed Models Analysis
Secondary/registry result

Change From Baseline in Beta-cell Function (HOMA2-%B)

Time frame:Baseline, 12 weeks

change from baseline, improvement

Posted result

GroupValue (least_squares_mean), percentage of HOMA2-%B95% CI
0.1 Milligrams (mg) LY218926513.18
0.5 Milligrams (mg) LY218926531.66
1.0 Milligrams (mg) LY218926539.04
1.5 Milligrams (mg) LY218926529.29
Placebo-2.06
p<0.001Mixed Models Analysis

Test of log linear dose response with placebo.

p0.036Mixed Models Analysis

Test of log linear dose response without placebo.

Secondary/registry result

Change From Baseline in Insulin Sensitivity (HOMA2-%S)

Time frame:Baseline, 12 weeks

HOMA-IR (insulin sensitivity)

change from baseline, improvement

Posted result

GroupValue (least_squares_mean), percentage of HOMA2-%S95% CI
0.1 Milligrams (mg) LY2189265-2.41
0.5 Milligrams (mg) LY21892656.10
1.0 Milligrams (mg) LY2189265-4.80
1.5 Milligrams (mg) LY218926512.98
Placebo0.58
p0.450Mixed Models Analysis

Test of log linear dose response with placebo.

p0.329Mixed Models Analysis

Test of log linear dose response without placebo.

Secondary/protocol endpoint

Change From Baseline in Glycosylated Hemoglobin (HbA1c)

Time frame:Baseline, 4 weeks, 8 weeks

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Secondary/protocol endpoint

Change From Baseline in Fasting Blood Glucose

Time frame:Baseline, 12 weeks

Fasting glucose, change

change from baseline, improvement

LOINC 1558-6

Secondary/protocol endpoint

Percentage of Participants Who Achieve Glycosylated Hemoglobin (HbA1c) <7% or ≤6.5%

Time frame:12 weeks

threshold achievement, improvement

componentsHbA1c <7.0% achievement, HbA1c <6.5% achievement

LOINC 4548-4

Secondary/protocol endpoint

Change From Baseline in Daily Mean Blood Glucose Values From the 7-point Self Monitored Blood Glucose (SMBG) Profiles

Time frame:Baseline, 12 weeks

change from baseline, improvement

Secondary/protocol endpoint

Change From Baseline in Beta-cell Function (HOMA2-%B)

Time frame:Baseline, 12 weeks

change from baseline, improvement

Secondary/protocol endpoint

Change From Baseline in Insulin Sensitivity (HOMA2-%S)

Time frame:Baseline, 12 weeks

HOMA-IR (insulin sensitivity)

change from baseline, improvement

Cardiometabolic biomarkers

6 endpoints
Secondary/registry result

Change From Baseline in Electrocardiograms (ECGs) - Heart Rate

Time frame:Baseline, 12 weeks

Heart rate, change

change from baseline, improvement

Posted result

GroupValue (least_squares_mean), beats per minute (bpm)95% CI
0.1 Milligrams (mg) LY21892651.38
0.5 Milligrams (mg) LY21892651.16
1.0 Milligrams (mg) LY21892651.88
1.5 Milligrams (mg) LY21892654.18
Placebo0.67
Secondary/registry result

Change From Baseline in Pulse Rate

Time frame:Baseline, 12 weeks

Heart rate, change

change from baseline, improvement

Posted result

GroupValue (least_squares_mean), beats per minute (bpm)95% CI
0.1 Milligrams (mg) LY21892650.19
0.5 Milligrams (mg) LY21892650.25
1.0 Milligrams (mg) LY21892651.02
1.5 Milligrams (mg) LY21892651.34
Placebo1.29
Secondary/registry result

Change From Baseline in Blood Pressure (BP)

Time frame:Baseline, 12 weeks

change from baseline, improvement

Posted result

GroupValue (least_squares_mean), millimeters of mercury (mmHg)95% CI
0.1 Milligrams (mg) LY2189265Sitting Systolic Blood Pressure-2.21
Sitting Diastolic Blood Pressure-0.24
0.5 Milligrams (mg) LY2189265Sitting Systolic Blood Pressure0.51
Sitting Diastolic Blood Pressure0.59
1.0 Milligrams (mg) LY2189265Sitting Systolic Blood Pressure-2.57
Sitting Diastolic Blood Pressure0.42
1.5 Milligrams (mg) LY2189265Sitting Systolic Blood Pressure1.88
Sitting Diastolic Blood Pressure1.56
PlaceboSitting Systolic Blood Pressure-0.68
Sitting Diastolic Blood Pressure1.07
Secondary/protocol endpoint

Change From Baseline in Electrocardiograms (ECGs) - Heart Rate

Time frame:Baseline, 12 weeks

Heart rate, change

change from baseline, improvement

Secondary/protocol endpoint

Change From Baseline in Pulse Rate

Time frame:Baseline, 12 weeks

Heart rate, change

change from baseline, improvement

Secondary/protocol endpoint

Change From Baseline in Blood Pressure (BP)

Time frame:Baseline, 12 weeks

change from baseline, improvement

Safety / tolerability / PK

12 endpoints
Secondary/registry result/low confidence

Change From Baseline in Electrocardiograms (ECGs) - Fridericia-corrected QT (QTcF) and PR Interval

Time frame:Baseline, 12 weeks

change from baseline, descriptive

componentsqtc f change, pr interval change

Posted result

GroupValue (least_squares_mean), millisecond (msec)95% CI
0.1 Milligrams (mg) LY2189265Fridericia-corrected QT (QTcF) Interval1.34
PR Interval3.22
0.5 Milligrams (mg) LY2189265Fridericia-corrected QT (QTcF) Interval-1.18
PR Interval4.57
1.0 Milligrams (mg) LY2189265Fridericia-corrected QT (QTcF) Interval4.56
PR Interval-0.55
1.5 Milligrams (mg) LY2189265Fridericia-corrected QT (QTcF) Interval-0.63
PR Interval2.83
PlaceboFridericia-corrected QT (QTcF) Interval0.70
PR Interval-0.89
Secondary/registry result

Number of Participants With Self-reported Hypoglycemic Events

Time frame:Baseline through 12 weeks

Documented hypoglycemia

event count, event

Posted result

GroupValue (number), participants95% CI
0.1 Milligrams (mg) LY2189265Documented Symptomatic0
Asymptomatic1
Severe0
Nocturnal1
0.5 Milligrams (mg) LY2189265Documented Symptomatic2
Asymptomatic0
Severe0
Nocturnal2
1.0 Milligrams (mg) LY2189265Documented Symptomatic2
Asymptomatic0
Severe0
Nocturnal1
1.5 Milligrams (mg) LY2189265Documented Symptomatic3
Asymptomatic0
Severe0
Nocturnal2
PlaceboDocumented Symptomatic0
Asymptomatic0
Severe0
Nocturnal0
Secondary/registry result

Rate of Self-reported Hypoglycemic Events

Time frame:Baseline through 12 weeks

Documented hypoglycemia

event count, event

Posted result

GroupValue (least_squares_mean), Events per participant per year95% CI
0.1 Milligrams (mg) LY2189265Documented Symptomatic Hypoglycemic Rate-0.08
Asymptomatic Hypoglycemic Rate0.19
Severe Hypoglycemic Rate0
Nocturnal Hypoglycemic Rate0.20
0.5 Milligrams (mg) LY2189265Documented Symptomatic Hypoglycemic Rate0.25
Asymptomatic Hypoglycemic Rate-0.01
Severe Hypoglycemic Rate0
Nocturnal Hypoglycemic Rate0.16
1.0 Milligrams (mg) LY2189265Documented Symptomatic Hypoglycemic Rate1.68
Asymptomatic Hypoglycemic Rate-0.01
Severe Hypoglycemic Rate0
Nocturnal Hypoglycemic Rate1.21
1.5 Milligrams (mg) LY2189265Documented Symptomatic Hypoglycemic Rate0.61
Asymptomatic Hypoglycemic Rate0.02
Severe Hypoglycemic Rate0
Nocturnal Hypoglycemic Rate0.21
PlaceboDocumented Symptomatic Hypoglycemic Rate-0.09
Asymptomatic Hypoglycemic Rate0.01
Severe Hypoglycemic Rate0
Nocturnal Hypoglycemic Rate-0.08
Secondary/registry result

Treatment Emergent Adverse Events

Time frame:Baseline through 12 weeks

Treatment-emergent AEs (any)

event count, event

Posted result

GroupValue (number), participants95% CI
0.1 Milligrams (mg) LY218926521
0.5 Milligrams (mg) LY218926517
1.0 Milligrams (mg) LY218926520
1.5 Milligrams (mg) LY218926518
3.0 Milligrams (mg) LY21892651
Placebo18
Secondary/registry result

Antibody Production and Effects to LY2189265

Time frame:Baseline, 4 weeks, 12 weeks, 16 weeks

Immunogenicity (ADA)

threshold achievement, event

Posted result

GroupValue (number), participants95% CI
0.1 Milligrams (mg) LY2189265Week 40
Week 120
Week 160
0.5 Milligrams (mg) LY2189265Week 40
Week 120
Week 160
1.0 Milligrams (mg) LY2189265Week 41
Week 120
Week 160
1.5 Milligrams (mg) LY2189265Week 40
Week 120
Week 160
PlaceboWeek 40
Week 120
Week 160
Secondary/registry result

Collection and Evaluation of Plasma Levels (Pharmacokinetics [PK]) of LY2189265

Time frame:4 weeks, 8 weeks, 12 weeks

AUC₀–∞

concentration, descriptive

Posted result

GroupValue (mean), nanograms*hour/milliliter (ng*h/mL)95% CI
0.1 Milligrams (mg) LY21892652294
0.5 Milligrams (mg) LY21892656650
1.0 Milligrams (mg) LY218926511671
1.5 Milligrams (mg) LY218926516649
3.0 Milligrams (mg) LY218926531538
Secondary/protocol endpoint

Change From Baseline in Electrocardiograms (ECGs) - Fridericia-corrected QT (QTcF) and PR Interval

Time frame:Baseline, 12 weeks

change from baseline, descriptive

componentsqtcF change, pr interval change

Secondary/protocol endpoint

Number of Participants With Self-reported Hypoglycemic Events

Time frame:Baseline through 12 weeks

Documented hypoglycemia

event count, event

Secondary/protocol endpoint

Rate of Self-reported Hypoglycemic Events

Time frame:Baseline through 12 weeks

Documented hypoglycemia

event count, event

Secondary/protocol endpoint

Treatment Emergent Adverse Events

Time frame:Baseline through 12 weeks

Treatment-emergent AEs (any)

event count, event

Secondary/protocol endpoint

Antibody Production and Effects to LY2189265

Time frame:Baseline, 4 weeks, 12 weeks, 16 weeks

Immunogenicity (ADA)

threshold achievement, event

Secondary/protocol endpoint

Collection and Evaluation of Plasma Levels (Pharmacokinetics [PK]) of LY2189265

Time frame:4 weeks, 8 weeks, 12 weeks

AUC₀–∞

concentration, descriptive

Publications (1)

Bibliography

Records linked to this trial through ClinicalTrials.gov references, PubMed NCT search, and curated study seeds. 'Canonical' marks design/result papers; others are registry references or candidates.

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2
Snapshot dateJuly 1, 2026
Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)
Results tableClinicalTrials.gov results section

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 1, 2026 snapshot.