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CompletedPhase 1Results posted

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

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

NCT IDNCT01215968
Org study ID13598
Secondary ID2009-017305-11
Secondary IDH9X-EW-GBDMEli Lilly and Company

Timeline

Milestones

Study first posted2010-10-07estimated
Last update posted2014-10-07estimated
Results first posted2014-10-07estimated
Study start2010-09 (month precision)
Primary completion2011-07actual (month precision)
Study completion2011-07actual (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

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
Other clinical outcomes
2

Safety / tolerability / PK

8 endpoints
Secondary/registry result

Area Under the Curve (AUC) of Metformin

Time frame:Days 3, 17 and 31

AUC₀–∞

concentration, descriptive

Posted result

GroupValue (geometric_mean), nanograms*hour/milliliter (ng*h/mL)95% CI
PlaceboDay 31360011228 – 16824
Day 171460012523 – 18766
Day 31 (n=6, 11)1460012941 – 19429
LY2189265Day 313700
Day 1715300
Day 31 (n=6, 11)15800
Secondary/registry result

Maximum Concentration (Cmax) of Metformin

Time frame:Days 3, 17 and 31

Cmax

concentration, descriptive

Posted result

GroupValue (geometric_mean), nanograms/milliliter (ng/mL)95% CI
PlaceboDay 31610
Day 171690
Day 31 (n=6, 11)1770
LY2189265Day 31690
Day 171500
Day 31 (n=6, 11)1680
Secondary/registry result

Time to Maximum Concentration (Tmax) of Metformin

Time frame:Days 3, 17 and 31

Tmax

descriptive

Posted result

GroupValue (median), hour95% CI
PlaceboDay 31.001.00 – 2.03
Day 172.021.02 – 8.00
Day 31 (n=6, 11)1.530.98 – 4.00
LY2189265Day 32.021.00 – 4.10
Day 172.050.96 – 4.02
Day 31 (n=6, 11)2.021.00 – 4.03
Secondary/registry result

Number of Participants With Clinically Significant Effects

Time frame:Baseline through 5 weeks

Treatment-emergent AEs (any)

event count, event

Posted result

GroupValue (number), participants95% CI
PlaceboSAEs0
Other nonserious AEs7
Placebo (Week 1)SAEs0
Other nonserious AEs11
LY2189265SAEs0
Other nonserious AEs20
Secondary/protocol endpoint

Area Under the Curve (AUC) of Metformin

Time frame:Days 3, 17 and 31

AUC₀–∞

concentration, descriptive

Secondary/protocol endpoint

Maximum Concentration (Cmax) of Metformin

Time frame:Days 3, 17 and 31

Cmax

concentration, descriptive

Secondary/protocol endpoint

Time to Maximum Concentration (Tmax) of Metformin

Time frame:Days 3, 17 and 31

Tmax

descriptive

Secondary/protocol endpoint

Number of Participants With Clinically Significant Effects

Time frame:Baseline through 5 weeks

Treatment-emergent AEs (any)

event count, event

Other clinical outcomes

2 endpoints
Primary/registry result

Time 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

GroupValue (geometric_mean), hours95% CI
PlaceboDay 31.441.22 – 1.69
Day 101.411.20 – 1.66
Day 17 (n=9, 14)1.601.36 – 1.89
Day 24 (n=9, 14)1.471.25 – 1.73
Day 31 (n=10, 13)1.461.24 – 1.71
LY2189265Day 31.721.43 – 2.06
Day 103.773.15 – 4.51
Day 17 (n=9, 14)3.322.76 – 4.00
Day 24 (n=9, 14)3.282.72 – 3.94
Day 31 (n=10, 13)3.152.61 – 3.81
Ratio of Geometric LS Mean2.1990% CI1.832.62Mixed Linear effects model analyses
Ratio of Geometric LS Mean1.9490% CI1.612.33Mixed Linear effects model analyses
Ratio of Geometric LS Mean1.9190% CI1.592.29Mixed Linear effects model analyses
Ratio of Geometric LS Mean1.8490% CI1.522.22Mixed Linear effects model analyses
Primary/protocol endpoint

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 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.