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Trial · Interventional

CompletedPhase 1Results postedRegistry data

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

NCTNCT01215968 (opens ClinicalTrials.gov in a new tab)Other id13598Other id2009-017305-11Other idH9X-EW-GBDMOther id2009

Overview

Status
Completed
Phase
Phase 1
Enrollment
38 participants (actual)
Sponsor
Eli Lilly and Company · Industry
Design
Randomized · Quadruple masking
Countries
1 country

United Kingdom

Start
Sept 2010
Primary completion
Jul 2011
Completion
Jul 2011
First posted
7 Oct 2010 (estimated)
Last update posted
7 Oct 2014 (estimated)
Conditions
Diabetes Mellitus, Type 2

Timeline

1 trial · 1 completed · 1 with posted results

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
201020112012
  1. Ph 1

    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

    NCT01215968

    Sept 2010 to Jul 2011

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

  • LY2189265Biological
  • PlaceboDrug

Arms2

  • Placebo comparator

    Placebo

    Each participant will receive placebo on Week 1. Participants randomized to placebo will receive once-weekly doses of placebo on Weeks 2 to 5. Placebo will be administered by single subcutaneous injection into the skin of the abdominal wall. Participants regularly taking metformin will continue their normal dosing regimen throughout the study.

  • Experimental

    LY2189265

    Participants randomized to LY2189265 will receive once-weekly doses of LY2189265 on Weeks 2 to 5. 1.5 milligram (mg) LY2189265 will be administered by single subcutaneous injection into the skin of the abdominal wall. Participants regularly taking metformin will continue their normal dosing regimen throughout the study.

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Time Required for 50% of Radioactivity To Be Emptied From the Stomach by Scintigraphy

    Time frame · Days 3, 10,17, 24 and 31

    Registry description

    After at least 8 hours fasting, participants received a radiolabeled breakfast containing technetium-99m-tin colloid (99mTc-tin colloid). After which serial anterior and posterior scintigraphy images were taken. Data presented are the time required for 50% of radioactivity to be emptied from stomach. The results presented are Geometric Least Squares (LS) Mean. LS Mean values were controlled for weeks.

Secondary outcomes(4)
  1. Area Under the Curve (AUC) of Metformin

    Time frame · Days 3, 17 and 31

    Registry description

    Metformin was used as a secondary marker in the study to correlate the effect of LY2189265 on gastric emptying to the pharmacokinetics (PK) (measured as AUC) of concomitant medications. Participants taking metformin for treatment of Type 2 Diabetes Mellitus (T2DM) underwent PK assessments for metformin in parallel to their scintigraphy assessments for gastric emptying. AUC of metformin was calculated during one dosing interval.

  2. Maximum Concentration (Cmax) of Metformin

    Time frame · Days 3, 17 and 31

    Registry description

    Metformin was used as a secondary marker in the study to correlate the effect of LY2189265 on gastric emptying to the pharmacokinetics (PK) (measured as Cmax) of concomitant medications. Participants taking metformin for treatment of Type 2 Diabetes Mellitus (T2DM) underwent PK assessments for metformin in parallel to their scintigraphy assessments for gastric emptying.

  3. Time to Maximum Concentration (Tmax) of Metformin

    Time frame · Days 3, 17 and 31

    Registry description

    Metformin was used as a secondary marker in the study to correlate the effect of LY2189265 on gastric emptying to the pharmacokinetics (PK) (measured as Tmax) of concomitant medications. Participants taking metformin for treatment of Type 2 Diabetes Mellitus (T2DM) underwent PK assessments for metformin in parallel to their scintigraphy assessments for gastric emptying.

  4. Number of Participants With Clinically Significant Effects

    Time frame · Baseline through 5 weeks

    Registry description

    Adverse events (AEs) were considered clinically significant effects. A summary of serious adverse events (SAEs) and other nonserious AEs are located in the Reported Adverse Event section.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeGeometric mean· Days 3, 10,17, 24 and 31

Time Required for 50% of Radioactivity To Be Emptied From the Stomach by Scintigraphy

GroupValue (hours)
Placebo1.44
LY21892651.72
Secondary and other outcome results(4)
Secondary outcomeGeometric mean· Days 3, 17 and 31

Area Under the Curve (AUC) of Metformin

GroupValue (nanograms*hour/milliliter (ng*h/mL))Spread
Placebo1360049
LY21892651370040
Secondary outcomeGeometric mean· Days 3, 17 and 31

Maximum Concentration (Cmax) of Metformin

GroupValue (nanograms/milliliter (ng/mL))Spread
Placebo161048
LY2189265169047
Secondary outcomeMedian· Days 3, 17 and 31

Time to Maximum Concentration (Tmax) of Metformin

GroupValue (hour)
Placebo1.00
LY21892652.02
Secondary outcomeNumber· Baseline through 5 weeks

Number of Participants With Clinically Significant Effects

GroupValue (participants)
Placebo0
Placebo (Week 1)0
LY21892650

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
GroupDeathsSerious eventsOther events
PlaceboParticipants received placebo on Week 1 and once-weekly doses of placebo on Weeks 2 to 5.–0 / 137 / 13
Placebo (Week 1)Participants received placebo on Week 1 and went on to receive once-weekly doses of 1.5 milligram (mg) LY2189265 on Weeks 2 to 5.–0 / 2511 / 25
LY2189265Participants received placebo on Week 1 and once-weekly doses of 1.5 mg LY2189265 on Weeks 2 to 5.–0 / 2420 / 24

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years up to 75 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
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.

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