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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
Lead sponsor
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
Timeline
Milestones
Assets
Investigational agents
Study populations
Who this study enrolls
Eligibility
Who can enroll
Inclusion criteria
Exclusion criteria
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
Weight & body composition
2 endpointsChange From Baseline in Body Weight
Time frame:Baseline, 12 weeks
Body weight, absolute change (kg)
change from baseline, improvement
Posted result
| Group | Value (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 | — |
Test of log linear dose response with placebo.
Test of log linear dose response without placebo.
Change From Baseline in Body Weight
Time frame:Baseline, 12 weeks
Body weight, absolute change (kg)
change from baseline, improvement
Glycemic / diabetes
14 endpointsChange From Baseline in Glycosylated Hemoglobin (HbA1c)
Time frame:Baseline, 12 weeks
HbA1c, change
change from baseline, improvement
LOINC 4548-4
Posted result
| Group | Value (least_squares_mean), percentage of glycosylated hemoglobin | 95% 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 | — |
| Placebo | 0.01 | — |
Test of log linear dose response with placebo.
Test of log linear dose response without placebo.
Change From Baseline in Glycosylated Hemoglobin (HbA1c)
Time frame:Baseline, 12 weeks
HbA1c, change
change from baseline, improvement
LOINC 4548-4
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
| Group | Value (least_squares_mean), percentage of glycosylated hemoglobin | 95% 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 | — |
Test of log linear dose response with placebo.
Test of log linear dose response without placebo.
Test of log linear dose response with placebo.
Test of log linear dose response without placebo.
Change From Baseline in Fasting Blood Glucose
Time frame:Baseline, 12 weeks
Fasting glucose, change
change from baseline, improvement
LOINC 1558-6
Posted result
| Group | Value (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 | — |
Test of log linear dose response with placebo.
Test of log linear dose response without placebo.
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
| Group | Value (number), percentage of participants | 95% 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 | — |
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
| Group | Value (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 | — |
Test of log linear dose response with placebo.
Test of log linear dose response without placebo.
Change From Baseline in Beta-cell Function (HOMA2-%B)
Time frame:Baseline, 12 weeks
change from baseline, improvement
Posted result
| Group | Value (least_squares_mean), percentage of HOMA2-%B | 95% CI |
|---|---|---|
| 0.1 Milligrams (mg) LY2189265 | 13.18 | — |
| 0.5 Milligrams (mg) LY2189265 | 31.66 | — |
| 1.0 Milligrams (mg) LY2189265 | 39.04 | — |
| 1.5 Milligrams (mg) LY2189265 | 29.29 | — |
| Placebo | -2.06 | — |
Test of log linear dose response with placebo.
Test of log linear dose response without placebo.
Change From Baseline in Insulin Sensitivity (HOMA2-%S)
Time frame:Baseline, 12 weeks
HOMA-IR (insulin sensitivity)
change from baseline, improvement
Posted result
| Group | Value (least_squares_mean), percentage of HOMA2-%S | 95% CI |
|---|---|---|
| 0.1 Milligrams (mg) LY2189265 | -2.41 | — |
| 0.5 Milligrams (mg) LY2189265 | 6.10 | — |
| 1.0 Milligrams (mg) LY2189265 | -4.80 | — |
| 1.5 Milligrams (mg) LY2189265 | 12.98 | — |
| Placebo | 0.58 | — |
Test of log linear dose response with placebo.
Test of log linear dose response without placebo.
Change From Baseline in Glycosylated Hemoglobin (HbA1c)
Time frame:Baseline, 4 weeks, 8 weeks
HbA1c, change
change from baseline, improvement
LOINC 4548-4
Change From Baseline in Fasting Blood Glucose
Time frame:Baseline, 12 weeks
Fasting glucose, change
change from baseline, improvement
LOINC 1558-6
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
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
Change From Baseline in Beta-cell Function (HOMA2-%B)
Time frame:Baseline, 12 weeks
change from baseline, improvement
Change From Baseline in Insulin Sensitivity (HOMA2-%S)
Time frame:Baseline, 12 weeks
HOMA-IR (insulin sensitivity)
change from baseline, improvement
Cardiometabolic biomarkers
6 endpointsChange From Baseline in Electrocardiograms (ECGs) - Heart Rate
Time frame:Baseline, 12 weeks
Heart rate, change
change from baseline, improvement
Posted result
| Group | Value (least_squares_mean), beats per minute (bpm) | 95% CI |
|---|---|---|
| 0.1 Milligrams (mg) LY2189265 | 1.38 | — |
| 0.5 Milligrams (mg) LY2189265 | 1.16 | — |
| 1.0 Milligrams (mg) LY2189265 | 1.88 | — |
| 1.5 Milligrams (mg) LY2189265 | 4.18 | — |
| Placebo | 0.67 | — |
Change From Baseline in Pulse Rate
Time frame:Baseline, 12 weeks
Heart rate, change
change from baseline, improvement
Posted result
| Group | Value (least_squares_mean), beats per minute (bpm) | 95% CI |
|---|---|---|
| 0.1 Milligrams (mg) LY2189265 | 0.19 | — |
| 0.5 Milligrams (mg) LY2189265 | 0.25 | — |
| 1.0 Milligrams (mg) LY2189265 | 1.02 | — |
| 1.5 Milligrams (mg) LY2189265 | 1.34 | — |
| Placebo | 1.29 | — |
Change From Baseline in Blood Pressure (BP)
Time frame:Baseline, 12 weeks
change from baseline, improvement
Posted result
| Group | Value (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 Pressure | 0.51 | — |
| Sitting Diastolic Blood Pressure | 0.59 | — |
| 1.0 Milligrams (mg) LY2189265Sitting Systolic Blood Pressure | -2.57 | — |
| Sitting Diastolic Blood Pressure | 0.42 | — |
| 1.5 Milligrams (mg) LY2189265Sitting Systolic Blood Pressure | 1.88 | — |
| Sitting Diastolic Blood Pressure | 1.56 | — |
| PlaceboSitting Systolic Blood Pressure | -0.68 | — |
| Sitting Diastolic Blood Pressure | 1.07 | — |
Change From Baseline in Electrocardiograms (ECGs) - Heart Rate
Time frame:Baseline, 12 weeks
Heart rate, change
change from baseline, improvement
Change From Baseline in Pulse Rate
Time frame:Baseline, 12 weeks
Heart rate, change
change from baseline, improvement
Change From Baseline in Blood Pressure (BP)
Time frame:Baseline, 12 weeks
change from baseline, improvement
Safety / tolerability / PK
12 endpointsChange 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
| Group | Value (least_squares_mean), millisecond (msec) | 95% CI |
|---|---|---|
| 0.1 Milligrams (mg) LY2189265Fridericia-corrected QT (QTcF) Interval | 1.34 | — |
| PR Interval | 3.22 | — |
| 0.5 Milligrams (mg) LY2189265Fridericia-corrected QT (QTcF) Interval | -1.18 | — |
| PR Interval | 4.57 | — |
| 1.0 Milligrams (mg) LY2189265Fridericia-corrected QT (QTcF) Interval | 4.56 | — |
| PR Interval | -0.55 | — |
| 1.5 Milligrams (mg) LY2189265Fridericia-corrected QT (QTcF) Interval | -0.63 | — |
| PR Interval | 2.83 | — |
| PlaceboFridericia-corrected QT (QTcF) Interval | 0.70 | — |
| PR Interval | -0.89 | — |
Number of Participants With Self-reported Hypoglycemic Events
Time frame:Baseline through 12 weeks
Documented hypoglycemia
event count, event
Posted result
| Group | Value (number), participants | 95% CI |
|---|---|---|
| 0.1 Milligrams (mg) LY2189265Documented Symptomatic | 0 | — |
| Asymptomatic | 1 | — |
| Severe | 0 | — |
| Nocturnal | 1 | — |
| 0.5 Milligrams (mg) LY2189265Documented Symptomatic | 2 | — |
| Asymptomatic | 0 | — |
| Severe | 0 | — |
| Nocturnal | 2 | — |
| 1.0 Milligrams (mg) LY2189265Documented Symptomatic | 2 | — |
| Asymptomatic | 0 | — |
| Severe | 0 | — |
| Nocturnal | 1 | — |
| 1.5 Milligrams (mg) LY2189265Documented Symptomatic | 3 | — |
| Asymptomatic | 0 | — |
| Severe | 0 | — |
| Nocturnal | 2 | — |
| PlaceboDocumented Symptomatic | 0 | — |
| Asymptomatic | 0 | — |
| Severe | 0 | — |
| Nocturnal | 0 | — |
Rate of Self-reported Hypoglycemic Events
Time frame:Baseline through 12 weeks
Documented hypoglycemia
event count, event
Posted result
| Group | Value (least_squares_mean), Events per participant per year | 95% CI |
|---|---|---|
| 0.1 Milligrams (mg) LY2189265Documented Symptomatic Hypoglycemic Rate | -0.08 | — |
| Asymptomatic Hypoglycemic Rate | 0.19 | — |
| Severe Hypoglycemic Rate | 0 | — |
| Nocturnal Hypoglycemic Rate | 0.20 | — |
| 0.5 Milligrams (mg) LY2189265Documented Symptomatic Hypoglycemic Rate | 0.25 | — |
| Asymptomatic Hypoglycemic Rate | -0.01 | — |
| Severe Hypoglycemic Rate | 0 | — |
| Nocturnal Hypoglycemic Rate | 0.16 | — |
| 1.0 Milligrams (mg) LY2189265Documented Symptomatic Hypoglycemic Rate | 1.68 | — |
| Asymptomatic Hypoglycemic Rate | -0.01 | — |
| Severe Hypoglycemic Rate | 0 | — |
| Nocturnal Hypoglycemic Rate | 1.21 | — |
| 1.5 Milligrams (mg) LY2189265Documented Symptomatic Hypoglycemic Rate | 0.61 | — |
| Asymptomatic Hypoglycemic Rate | 0.02 | — |
| Severe Hypoglycemic Rate | 0 | — |
| Nocturnal Hypoglycemic Rate | 0.21 | — |
| PlaceboDocumented Symptomatic Hypoglycemic Rate | -0.09 | — |
| Asymptomatic Hypoglycemic Rate | 0.01 | — |
| Severe Hypoglycemic Rate | 0 | — |
| Nocturnal Hypoglycemic Rate | -0.08 | — |
Treatment Emergent Adverse Events
Time frame:Baseline through 12 weeks
Treatment-emergent AEs (any)
event count, event
Posted result
| Group | Value (number), participants | 95% CI |
|---|---|---|
| 0.1 Milligrams (mg) LY2189265 | 21 | — |
| 0.5 Milligrams (mg) LY2189265 | 17 | — |
| 1.0 Milligrams (mg) LY2189265 | 20 | — |
| 1.5 Milligrams (mg) LY2189265 | 18 | — |
| 3.0 Milligrams (mg) LY2189265 | 1 | — |
| Placebo | 18 | — |
Antibody Production and Effects to LY2189265
Time frame:Baseline, 4 weeks, 12 weeks, 16 weeks
Immunogenicity (ADA)
threshold achievement, event
Posted result
| Group | Value (number), participants | 95% CI |
|---|---|---|
| 0.1 Milligrams (mg) LY2189265Week 4 | 0 | — |
| Week 12 | 0 | — |
| Week 16 | 0 | — |
| 0.5 Milligrams (mg) LY2189265Week 4 | 0 | — |
| Week 12 | 0 | — |
| Week 16 | 0 | — |
| 1.0 Milligrams (mg) LY2189265Week 4 | 1 | — |
| Week 12 | 0 | — |
| Week 16 | 0 | — |
| 1.5 Milligrams (mg) LY2189265Week 4 | 0 | — |
| Week 12 | 0 | — |
| Week 16 | 0 | — |
| PlaceboWeek 4 | 0 | — |
| Week 12 | 0 | — |
| Week 16 | 0 | — |
Collection and Evaluation of Plasma Levels (Pharmacokinetics [PK]) of LY2189265
Time frame:4 weeks, 8 weeks, 12 weeks
AUC₀–∞
concentration, descriptive
Posted result
| Group | Value (mean), nanograms*hour/milliliter (ng*h/mL) | 95% CI |
|---|---|---|
| 0.1 Milligrams (mg) LY2189265 | 2294 | — |
| 0.5 Milligrams (mg) LY2189265 | 6650 | — |
| 1.0 Milligrams (mg) LY2189265 | 11671 | — |
| 1.5 Milligrams (mg) LY2189265 | 16649 | — |
| 3.0 Milligrams (mg) LY2189265 | 31538 | — |
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
Number of Participants With Self-reported Hypoglycemic Events
Time frame:Baseline through 12 weeks
Documented hypoglycemia
event count, event
Rate of Self-reported Hypoglycemic Events
Time frame:Baseline through 12 weeks
Documented hypoglycemia
event count, event
Treatment Emergent Adverse Events
Time frame:Baseline through 12 weeks
Treatment-emergent AEs (any)
event count, event
Antibody Production and Effects to LY2189265
Time frame:Baseline, 4 weeks, 12 weeks, 16 weeks
Immunogenicity (ADA)
threshold achievement, event
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.
Registry references + supporting bibliography
- Diabetic medicine : a journal of the British Diabetic Association2012 Oct (month)PMID22804250doi:10.1111/j.1464-5491.2012.03745.xvia CT.gov background
Provenance
Sources
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.