Diabetes Mellitus, Type 2Phase 1NCT01215968

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 Phase 1 study testing LY2189265 in people with Diabetes Mellitus, Type 2, run by Eli Lilly and Company at 1 site in United Kingdom.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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… Read more about this study

Who is it for?: Ages 18 to 75 years
Conditions the study is for: Diabetes Mellitus, Type 2
What is being tested?: LY2189265
Type of treatment: Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 38 participants
Where: 1 siteUnited Kingdom
Study dates: Sep 2010to Jul 2011
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 75 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

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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.

Who cannot join

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).

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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 and are unwilling to adhere to the alcohol restrictions in place throughout the study.
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.
Are allergic to eggs or other components of the meals to be served.
Are patients who, in the opinion of the investigator, are in any way unsuitable to participate in the study.

Trial locations and contacts

1 site in 1 country.

United Kingdom1 site

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Glasgow

Other trials in United Kingdom

About this study

Official title: A Study to Evaluate the Effect of LY2189265 on Gastric Emptying Using Scintigraphy in Patients With Type 2 Diabetes Mellitus

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.

Conditions: Diabetes Mellitus, Type 2
Being tested: LY2189265, Placebo
Medical subject headings: Diabetes Mellitus, Type 2

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

LY2189265Biological
1.5 mg administered subcutaneously
PlaceboDrug
Administered subcutaneously

Study groups in NCT01215968
Study group	Role	What they receive
Placebo	Placebo comparator	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. Receives: Drug: Placebo
LY2189265	Experimental	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. Receives: Biological: LY2189265; Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Time Required for 50% of Radioactivity To Be Emptied From the Stomach by Scintigraphy
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.
Measured: Days 3, 10,17, 24 and 31

Secondary outcomes (4)

Area Under the Curve (AUC) of Metformin
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.
Measured: Days 3, 17 and 31
Maximum Concentration (Cmax) of Metformin
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.
Measured: Days 3, 17 and 31
Time to Maximum Concentration (Tmax) of Metformin
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.
Measured: Days 3, 17 and 31
Number of Participants With Clinically Significant Effects
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.
Measured: Baseline through 5 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Sep 2010Jul 2011

First posted7 Oct 2010 (estimated)
Study startSep 2010
Primary completionJul 2011
Study completionJul 2011

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
More trials run by Eli Lilly and CompanyThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Single group
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 38 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01215968
Sponsor's protocol ID: 13598
Other IDs: 2009-017305-11, H9X-EW-GBDM, 2009
Status last verified: Oct 2014
First submitted: 5 Oct 2010
Last updated: 7 Oct 2014
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 7 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Study to Evaluate the Effect of LY2189265 on Gastric Emptying Using Scintigraphy in Patients With Type 2 Diabetes Mellitus
ClinicalTrials.gov ID: NCT01215968
Acronym / sponsor ID: 13598
Conditions: Diabetes Mellitus, Type 2
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 38 participants (actual)
Lead sponsor: Eli Lilly and CompanyIndustry (pharma, biotech, devices)
Study start: Sep 2010
Primary completion: Jul 2011 (actual)
Study completion: Jul 2011 (actual)
First posted: 7 Oct 2010 (estimated)
Results: Posted 7 Oct 2014

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Single group
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Placebo	Placebo comparator	Drug: PlaceboEach 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.
LY2189265	Experimental	Biological: LY2189265, Drug: PlaceboParticipants 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.

Who may qualify

Ages: 18 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (10 listed)

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.

Key exclusion criteria (20 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
LY21892651.5 mg administered subcutaneously	Biological	LY2189265
PlaceboAdministered subcutaneously	Drug	LY2189265, Placebo

Primary outcome

Time Required for 50% of Radioactivity To Be Emptied From the Stomach by Scintigraphy
Time frame: Days 3, 10,17, 24 and 31
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.

4 secondary outcomes

Area Under the Curve (AUC) of Metformin
Time frame: Days 3, 17 and 31
Maximum Concentration (Cmax) of Metformin
Time frame: Days 3, 17 and 31
Time to Maximum Concentration (Tmax) of Metformin
Time frame: Days 3, 17 and 31
Number of Participants With Clinically Significant Effects
Time frame: Baseline through 5 weeks

Results and safety

Results posted to the registry on 7 Oct 2014, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Placebo	13	11
LY2189265	25	18

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

Time frame: Days 3, 10,17, 24 and 31. Geometric mean (90% Confidence Interval). Unit: hours

Measure	Placebo n = 10	LY2189265 n = 15
Day 3	1.44 (1.22 to 1.69)	1.72 (1.43 to 2.06)
Day 10	1.41 (1.20 to 1.66)	3.77 (3.15 to 4.51)
Day 17 (n=9, 14)	1.60 (1.36 to 1.89)	3.32 (2.76 to 4.00)
Day 24 (n=9, 14)	1.47 (1.25 to 1.73)	3.28 (2.72 to 3.94)
Day 31 (n=10, 13)	1.46 (1.24 to 1.71)	3.15 (2.61 to 3.81)

LY2189265: Ratio of Geometric LS Mean: 2.19 (90% CI 1.83 to 2.62), Mixed Linear effects model analyses
LY2189265: Ratio of Geometric LS Mean: 1.94 (90% CI 1.61 to 2.33), Mixed Linear effects model analyses
LY2189265: Ratio of Geometric LS Mean: 1.91 (90% CI 1.59 to 2.29), Mixed Linear effects model analyses

Population analysed: All randomized participants who received study drug, a radiolabeled breakfast, and had scintigraphy images taken. Those who violated protocol were excluded.

4 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Placebo	0 of 13 (0%)	7 of 13 (53.8%)	Not reported
Placebo (Week 1)	0 of 25 (0%)	11 of 25 (44%)	Not reported
LY2189265	0 of 24 (0%)	20 of 24 (83.3%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 7 Oct 2014.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) study director

Eli Lilly and Company

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing LY2189265 in people with Diabetes Mellitus, Type 2, run by Eli Lilly and Company at 1 site in United Kingdom.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 7 Oct 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 7 Oct 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Time Required for 50% of Radioactivity To Be Emptied From the Stomach by Scintigraphy (time frame: Days 3, 10,17, 24 and 31). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01215968.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Oct 2014.