Phase 1
N=38
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
Diabetes Mellitus, Type 2
Bottom Line
View on ClinicalTrials.gov: NCT01215968 ↗Enrolled (actual)
38
Serious AEs
0.0%
Results posted
Oct 2014
Primary outcome: Primary: Time Required for 50% of Radioactivity To Be Emptied From the Stomach by Scintigraphy — 1.44; 1.72; 1.41; 3.77 hours
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 1
- Interventions
- LY2189265 (Biological); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Eli Lilly and Company
- Primary completion
- Jul 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Time Required for 50% of Radioactivity To Be Emptied From the Stomach by Scintigraphy |
1.44; 1.72; 1.41; 3.77; 1.60; 3.32 | — |
| SECONDARY Area Under the Curve (AUC) of Metformin |
13600; 13700; 14600; 15300; 14600; 15800 | — |
| SECONDARY Maximum Concentration (Cmax) of Metformin |
1610; 1690; 1690; 1500; 1770; 1680 | — |
| SECONDARY Time to Maximum Concentration (Tmax) of Metformin |
1.00; 2.02; 2.02; 2.05; 1.53; 2.02 | — |
| SECONDARY Number of Participants With Clinically Significant Effects |
0; 0; 0; 7; 11; 20 | — |
Summary
The primary purpose of this Study is to help answer the following research question(s).
* How does LY2189265 affect gastric emptying (the speed at which food and drink leaves the stomach) in patients with Type 2 diabetes?
* How does LY2189265 affect how the body handles metformin (a drug used to treat Type 2 diabetes)?
* Is LY2189265 safe and are any side effects associated with it?
The study will be participant-blind in Week 1, and participant- and investigator-blind from Week 2 through Week 5.
Each participant will receive placebo on Week 1 and once-weekly doses of LY2189265 or Placebo on Weeks 2 to 5. Participants taking metformin for the treatment of Type 2 Diabetes Mellitus (T2DM) will continue taking metformin as part of the study.
Eligibility Criteria
Inclusion Criteria
- Are males or females, diagnosed with Type 2 Diabetes Mellitus for greater than or equal to 3 months prior to screening.
- 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.
- Have a body mass index (BMI) between 18.5 and 40.0 kilogram/square meter (kg/m²), inclusive.
- 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.
- 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.
- 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.
- Have clinical laboratory test results within normal ranges as determined by the study doctor.
- Can provide enough blood in order to undergo the blood sampling required for the study.
- Are reliable and willing to make themselves available for the duration of the study and are willing to follow study procedures.
- Have signed the consent form approved by Lilly and the Ethical Review Board (ERB) governing the site.
Exclusion Criteria
- 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.
- Have previously been exposed to, or have known allergies to glucagon-like-peptide-1 (GLP-1)-related compounds including LY2189265.
- 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.
- Have taken certain Type 2 Diabetes medications within 30 days prior to screening.
- Have an abnormality in the electrocardiogram (ECG) performed at screening.
- Have poorly controlled high blood pressure (systolic blood pressure >160 millimeters of mercury [mmHg] and/or diastolic blood pressure >100 mmHg).
- 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.
- 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.
- Have a history or presence of pancreatitis or certain gastrointestinal disorders.
- Have been exposed to radiation from clinical trials and from diagnostic X-ray or are exposed routinely via your job worker.
- Have any non-removable metal objects such as metal plates, screws etc. in their chest or abdominal area.
- Have had acute diarrhea or constipation within 14 days of study screening.
- Show evidence of significant active neuropsychiatric disease.
- Regularly use known drugs of abuse and/or show positive findings on urinary drug screening.
- Intend to start new medication during the study, including over-the-counter and herbal medication.
- Have donated blood of more than 500 milliliter (mL) within the last month prior to screening.
- Have an average weekly alcohol intake that exceeds the study centre's guidelines an
Data sourced from ClinicalTrials.gov (NCT01215968). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.