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Phase 1 N=38 Randomized Quadruple-blind Treatment

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

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

OutcomeResultp-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
View full record on ClinicalTrials.gov →

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.

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