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A Study to Evaluate the Effect of LY2189265 on the Speed at Which Food and Drink Leaves the Stomach in Patients With Type 2 Diabetes Mellitus
A Study to Evaluate the Effect of LY2189265 on Gastric Emptying Using Scintigraphy in Patients With Type 2 Diabetes Mellitus
Lead sponsor
Asset
Dulaglutide
Subcutaneous · GLP-1 agonist
Listed sites
1
Recruiting sites
—
Enrollment
38
actual
Study population
Type 2 diabetes
Key I/E criterion
•BMI 18.5-40
Primary endpoint
•Time Required for 50% of Radioactivity To Be Emptied From the Stomach
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
1. Are males or females, diagnosed with Type 2 Diabetes Mellitus for greater than or equal to 3 months prior to screening.
2. Male patients agree to use a reliable method of birth control during the study and for 3 months following the last dose of study drug. Female patients must be of non-child-bearing potential due to surgical sterilization or menopause.
3. Have a body mass index (BMI) between 18.5 and 40.0 kilogram/square meter (kg/m²), inclusive.
4. Have Type 2 Diabetes Mellitus controlled with diet and exercise alone or are stable on a single oral antidiabetic medication (e.g. metformin) prior to screening, and have been taking a stable dose for >7 days prior to the first dosing occasion.
5. Have a fasting blood glucose value at screening >126 milligram/deciliter (mg/dL) (7.0 [millimoles/liter] mmol/L) for patients on a controlled diet, and >108 mg/dL (6.0 mmol/L) for patients on oral antidiabetic medication, with an upper limit of 180 mg/dL (approximately 9.9 mmol/L) in each case.
6. Have a hemoglobin A1c (HbA1c) (indicates what your average blood glucose level has been in the past 3 months) value at screening (or within 4 weeks prior to screening) of 6.5% to 9.5%. If HbA1c is between 6.1% and 6.5%, patients may participate in the study providing they are receiving permissible oral antidiabetic medication.
7. Have clinical laboratory test results within normal ranges as determined by the study doctor.
8. Can provide enough blood in order to undergo the blood sampling required for the study.
9. Are reliable and willing to make themselves available for the duration of the study and are willing to follow study procedures.
10. Have signed the consent form approved by Lilly and the Ethical Review Board (ERB) governing the site.
Exclusion criteria
11. Are currently enrolled in, or discontinued within the last 30 days from, a clinical trial involving an investigational drug or device, or are concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study.
12. Have previously been exposed to, or have known allergies to glucagon-like-peptide-1 (GLP-1)-related compounds including LY2189265.
13. Are persons who have previously completed or withdrawn from this study or any other study investigating LY2189265 or have received glucagon-like peptides or incretin mimetics in the past 3 months.
14. Have taken certain Type 2 Diabetes medications within 30 days prior to screening.
15. Have an abnormality in the electrocardiogram (ECG) performed at screening.
16. Have poorly controlled high blood pressure (systolic blood pressure >160 millimeters of mercury [mmHg] and/or diastolic blood pressure >100 mmHg).
17. Have a history or presence of respiratory, liver, kidney, hormonal, blood, or neurological disorders which may put the patient at risk when taking the study medication; or may interfere with the interpretation of data.
18. Have a history or presence of cardiovascular disorder within the last year, or signs of congestive heart failure, or are expected to require coronary artery bypass surgery or angioplasty.
19. Have a history or presence of pancreatitis or certain gastrointestinal disorders.
20. Have been exposed to radiation from clinical trials and from diagnostic X-ray or are exposed routinely via your job worker.
21. Have any non-removable metal objects such as metal plates, screws etc. in their chest or abdominal area.
22. Have had acute diarrhea or constipation within 14 days of study screening.
23. Show evidence of significant active neuropsychiatric disease.
24. Regularly use known drugs of abuse and/or show positive findings on urinary drug screening.
25. Intend to start new medication during the study, including over-the-counter and herbal medication.
26. Have donated blood of more than 500 milliliter (mL) within the last month prior to screening.
27. Have an average weekly alcohol intake that exceeds the study centre's guidelines and are unwilling to adhere to the alcohol restrictions in place throughout the study.
28. Smoke more than 10 cigarettes (or equivalent in nicotine) per day, and are unwilling to stop smoking on the day of medication administration or are unable to abide by clinical research unit (CRU) restrictions on other inpatient days.
29. Are allergic to eggs or other components of the meals to be served.
30. Are patients who, in the opinion of the investigator, are in any way unsuitable to participate in the study.
Endpoints (10)
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
Safety / tolerability / PK
8 endpointsArea Under the Curve (AUC) of Metformin
Time frame:Days 3, 17 and 31
AUC₀–∞
concentration, descriptive
Posted result
| Group | Value (geometric_mean), nanograms*hour/milliliter (ng*h/mL) | 95% CI |
|---|---|---|
| PlaceboDay 3 | 13600 | 11228 – 16824 |
| Day 17 | 14600 | 12523 – 18766 |
| Day 31 (n=6, 11) | 14600 | 12941 – 19429 |
| LY2189265Day 3 | 13700 | — |
| Day 17 | 15300 | — |
| Day 31 (n=6, 11) | 15800 | — |
Maximum Concentration (Cmax) of Metformin
Time frame:Days 3, 17 and 31
Cmax
concentration, descriptive
Posted result
| Group | Value (geometric_mean), nanograms/milliliter (ng/mL) | 95% CI |
|---|---|---|
| PlaceboDay 3 | 1610 | — |
| Day 17 | 1690 | — |
| Day 31 (n=6, 11) | 1770 | — |
| LY2189265Day 3 | 1690 | — |
| Day 17 | 1500 | — |
| Day 31 (n=6, 11) | 1680 | — |
Time to Maximum Concentration (Tmax) of Metformin
Time frame:Days 3, 17 and 31
Tmax
descriptive
Posted result
| Group | Value (median), hour | 95% CI |
|---|---|---|
| PlaceboDay 3 | 1.00 | 1.00 – 2.03 |
| Day 17 | 2.02 | 1.02 – 8.00 |
| Day 31 (n=6, 11) | 1.53 | 0.98 – 4.00 |
| LY2189265Day 3 | 2.02 | 1.00 – 4.10 |
| Day 17 | 2.05 | 0.96 – 4.02 |
| Day 31 (n=6, 11) | 2.02 | 1.00 – 4.03 |
Number of Participants With Clinically Significant Effects
Time frame:Baseline through 5 weeks
Treatment-emergent AEs (any)
event count, event
Posted result
| Group | Value (number), participants | 95% CI |
|---|---|---|
| PlaceboSAEs | 0 | — |
| Other nonserious AEs | 7 | — |
| Placebo (Week 1)SAEs | 0 | — |
| Other nonserious AEs | 11 | — |
| LY2189265SAEs | 0 | — |
| Other nonserious AEs | 20 | — |
Area Under the Curve (AUC) of Metformin
Time frame:Days 3, 17 and 31
AUC₀–∞
concentration, descriptive
Maximum Concentration (Cmax) of Metformin
Time frame:Days 3, 17 and 31
Cmax
concentration, descriptive
Time to Maximum Concentration (Tmax) of Metformin
Time frame:Days 3, 17 and 31
Tmax
descriptive
Number of Participants With Clinically Significant Effects
Time frame:Baseline through 5 weeks
Treatment-emergent AEs (any)
event count, event
Other clinical outcomes
2 endpointsTime Required for 50% of Radioactivity To Be Emptied From the Stomach by Scintigraphy
Time frame:Days 3, 10,17, 24 and 31
descriptive
Posted result
| Group | Value (geometric_mean), hours | 95% CI |
|---|---|---|
| PlaceboDay 3 | 1.44 | 1.22 – 1.69 |
| Day 10 | 1.41 | 1.20 – 1.66 |
| Day 17 (n=9, 14) | 1.60 | 1.36 – 1.89 |
| Day 24 (n=9, 14) | 1.47 | 1.25 – 1.73 |
| Day 31 (n=10, 13) | 1.46 | 1.24 – 1.71 |
| LY2189265Day 3 | 1.72 | 1.43 – 2.06 |
| Day 10 | 3.77 | 3.15 – 4.51 |
| Day 17 (n=9, 14) | 3.32 | 2.76 – 4.00 |
| Day 24 (n=9, 14) | 3.28 | 2.72 – 3.94 |
| Day 31 (n=10, 13) | 3.15 | 2.61 – 3.81 |
Time Required for 50% of Radioactivity To Be Emptied From the Stomach by Scintigraphy
Time frame:Days 3, 10,17, 24 and 31
descriptive
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.