Diabetes Mellitus, Type 2Phase 2NCT01001104
A Study of LY2189265 in Japanese Patients With Type 2 Diabetes
A Phase 2 study testing LY2189265 in people with Diabetes Mellitus, Type 2, run by Eli Lilly and Company at 6 sites in Japan.
Trial summary
The main purpose of this study is to assess dose-response characteristics in Japanese patients with Type 2 Diabetes taking LY2189265 monotherapy. Read more about this study
- Who is it for?
- Ages 20 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
- 145 participants
- Where
- 6 sitesJapan
- Study dates
- Oct 2009to Dec 2010
- Phase
- Phase 2
- 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 20 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Japanese patients with type 2 diabetes with a body mass index (BMI)≥18.5 kilograms per square meter (kg/m^2) but <40.0 kg/m^2.
- Patients who are oral antidiabetic drug (OAD) naïve or are taking OAD monotherapy except for a dipeptidyl peptidase-4 inhibitor (DPP-IV) and are willing to discontinue their OAD.
- Patients who are OAD naïve with screening glycosylated hemoglobin (HbA1c) value of 7.0% to 9.5% and randomization HbA1c value of 7.0% to 9.5%, or who are taking OAD monotherapy with screening HbA1c value of 6.0% to 8.5% and randomization HbA1c value of 7.0% to 9.5%.
- Patients who have, in the opinion of the investigator, a stable weight during the 12 weeks prior to screening.
Who cannot join
- Patients who are currently taking prescription medications to promote weight loss
- Patients who are receiving chronic systemic glucocorticoid therapy, or have received such therapy within 4 weeks immediately prior to screening.
- Patients who have a known clinically significant gastrointestinal disorder, have undergone excision of all or any part of the gastrointestinal tract, have undergone gastric bypass surgery for treatment of obesity, or chronically take drugs that directly influence gastrointestinal motility.
- Patients who have poorly controlled hypertension, renal artery stenosis, or evidence of labile blood pressure including symptomatic postural hypotension.
- Patients who have obvious clinical signs or symptoms of pancreatitis, a history of chronic pancreatitis or acute pancreatitis. Patients who have amylase and/or lipase of 1.5 times or more the upper limit of the reference range.
- Have a family history, obvious clinical signs, or symptoms of medullary carcinoma of thyroid.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
Japan6 sites
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.
Chiba, 276-0049
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.
Kanagawa, 359-1161
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.
Kochi, 781-8555
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.
Kyoto, 604-8151
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.
Osaka, 530-0047
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.
Tokyo, 171-0021
About this study
Official title: Assessment of Dose-Dependent Effects of LY2189265 on Glycemic Control in Japanese Patients With Type 2 Diabetes
The main purpose of this study is to assess dose-response characteristics in Japanese patients with Type 2 Diabetes taking LY2189265 monotherapy.
- Conditions
- Diabetes Mellitus, Type 2
- Being tested
- LY2189265, Placebo
- Keywords
- Metabolic Diseases, Glucose Metabolism Disorders, Diabetes, GLP-1, Lilly
- Medical subject headings
- Diabetes Mellitus, Type 2, Metabolic Diseases, Glucose Metabolism Disorders, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LY2189265Drug
Administered by subcutaneous (SC) injection, once weekly (QW) for 12 weeks.
PlaceboDrug
Administered by SC injection, QW for 12 weeks.
| Study group | Role | What they receive |
|---|---|---|
| 0.75 mg LY2189265 | Experimental | Not described Receives: Drug: LY2189265 |
| 0.5 mg LY2189265 | Experimental | Not described Receives: Drug: LY2189265 |
| 0.25 mg LY2189265 | Experimental | Not described Receives: Drug: LY2189265 |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in Glycosylated Hemoglobin (HbA1c) at 12 Weeks
Change in HbA1c from baseline following 12 weeks of therapy (that is, HbA1c at week 12 minus HbA1c at baseline). Changes in HbA1c were analyzed by a mixed model repeated measures (MMRM) model that included dose, pre-study therapy, body mass index (BMI) group at baseline, baseline value, visit, and dose*visit, where the participant was treated as a random effect.
Measured: Baseline, 12 weeks
Secondary outcomes (9)
Percentage of Participants Achieving Glycosylated Hemoglobin (HbA1c)<7% up to 12 Weeks
Percentage of participants who achieved HbA1c<7% up to the 12-week endpoint.
Measured: up to 12 weeks
Percentage of Participants Achieving Glycosylated Hemoglobin (HbA1c)<6.5% up to 12 Weeks
Percentage of participants achieving HbA1c<6.5% up to the 12-week endpoint.
Measured: up to 12 weeks
Change From Baseline in Fasting Blood Glucose (FBG) Values to 12 Weeks
Change in FBG following 12 weeks of therapy (that is, FBG at week 12 minus FBG at baseline). The change in FBG was analyzed using a mixed model repeated measures (MMRM) model that included dose, pre-study therapy, body mass index (BMI) group at baseline, baseline value, visit, and dose*visit, where the participant was treated as a random effect.
Measured: Baseline, 12 weeks
Change From Baseline in the Mean Daily Blood Glucose (Based on Self-Monitoring Blood Glucose [SMBG]) at 12 Weeks
SMBG levels were measured at the following 7 timepoints during the day: fasting prebreakfast, 2 hours postbreakfast, prior to lunch, 2 hours postlunch, prior to dinner, 2 hours postdinner, and prior to bed. The change in mean daily blood glucose was analyzed by a mixed model repeated measures (MMRM) model that included dose, pre-study therapy, body mass index (BMI) group at baseline, baseline value, and dose*visit, where the participant was treated as a random effect.
Measured: Baseline, 12 weeks
Change From Baseline in Total Body Weight at 12 Weeks
Changes in body weight were analyzed by a mixed model repeated measures (MMRM) model that included dose, pre-study therapy, body mass index (BMI) group at baseline, baseline value, visit, and dose*visit, where the participant was treated as a random effect.
Measured: Baseline, 12 weeks
Change From Baseline in Insulin Sensitivity Using the Updated Homeostasis Model Assessment Insulin Sensitivity (HOMA2-S) at 12 Weeks
HOMA2-S is an estimated insulin sensitivity based on updated HOMA2 model. The HOMA2 model is a computer model that estimates insulin sensitivity (%S) as percentages of a normal reference population using simultaneously measured fasting plasma glucose and fasting insulin. Changes in HOMA2-S were analyzed by a mixed model repeated measures (MMRM) model that included dose, pre-study therapy, body mass index (BMI) group at baseline, baseline value, visit, and dose*visit, where the participant was treated as a random effect.
Measured: Baseline, 12 weeks
Change From Baseline in Beta-Cell Function Using the Updated Homeostasis Model Assessment Beta-Cell Function (HOMA2-B) at 12 Weeks
HOMA2-B is an estimated steady state beta cell function based on updated HOMA2 model. The HOMA2 model estimates steady state pancreatic beta cell function (%B) as a percentage of a normal reference population using simultaneously measured fasting plasma glucose and fasting insulin. Changes in HOMA2-B were analyzed by a mixed model repeated measures (MMRM) model that included dose, pre-study therapy, body mass index (BMI) group at baseline, baseline value, visit, and dose*visit, where the participant was treated as a random effect.
Measured: Baseline, 12 weeks
Steady-State Concentrations of LY2189265
Evaluable pharmacokinetics (PK) concentrations from all sampling time-points were combined and utilized in a population approach to determine the population mean estimate and standard deviation at 12 weeks. The model predicted LY2189265 steady state concentrations in each dose level were calculated as estimated area under the curve (AUC)/dosing period of 168 hours. The models and model parameters were described by nonlinear, mixed-effects regression modeling (NONMEM) using the program NONMEM 7®.
Measured: 12 weeks
Percentage of Participants With Self-Reported Hypoglycemic Episodes During the 12-week Treatment Period
Assessed the percentage of participants who reported a hypoglycemic episode during the 12-week treatment period. Hypoglycemia was defined as a measured plasma glucose level of ≤70 milligrams per deciliter (mg/dL) or ≤3.9 millimoles per liter (mmol/L).
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2009 (estimated)
- Study startOct 2009
- Primary completionDec 2010
- Study completionDec 2010
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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 145 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eli Lilly and Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9AM - 5PM Eastern time (UTC/GMT - 5 hours, EST), Study director, Eli Lilly and Company
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01001104
- Sponsor's protocol ID
- 12840
- Other IDs
- H9X-JE-GBCZ
- Status last verified
- Aug 2015
- First submitted
- 22 Oct 2009
- Last updated
- 28 Sep 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Dose-Dependent Effects of LY2189265 on Glycemic Control in Japanese Patients With Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT01001104
- Acronym / sponsor ID
- 12840
- Conditions
- Diabetes Mellitus, Type 2
- Keywords
- Metabolic Diseases, Glucose Metabolism Disorders, Diabetes, GLP-1, Lilly
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 145 participants (actual)
- Lead sponsor
- Eli Lilly and CompanyIndustry (pharma, biotech, devices)
- Study start
- Oct 2009
- Primary completion
- Dec 2010 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 23 Oct 2009 (estimated)
- Results
- Posted 28 Sep 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The main purpose of this study is to assess dose-response characteristics in Japanese patients with Type 2 Diabetes taking LY2189265 monotherapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 0.75 mg LY2189265 | Experimental | Drug: LY2189265 |
| 0.5 mg LY2189265 | Experimental | Drug: LY2189265 |
| 0.25 mg LY2189265 | Experimental | Drug: LY2189265 |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 20 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Japanese patients with type 2 diabetes with a body mass index (BMI)≥18.5 kilograms per square meter (kg/m^2) but <40.0 kg/m^2.
- Patients who are oral antidiabetic drug (OAD) naïve or are taking OAD monotherapy except for a dipeptidyl peptidase-4 inhibitor (DPP-IV) and are willing to discontinue their OAD.
- Patients who are OAD naïve with screening glycosylated hemoglobin (HbA1c) value of 7.0% to 9.5% and randomization HbA1c value of 7.0% to 9.5%, or who are taking OAD monotherapy with screening HbA1c value of 6.0% to 8.5% and randomization HbA1c value of 7.0% to 9.5%.
- Patients who have, in the opinion of the investigator, a stable weight during the 12 weeks prior to screening.
Key exclusion criteria (6 listed)
- Patients who are currently taking prescription medications to promote weight loss
- Patients who are receiving chronic systemic glucocorticoid therapy, or have received such therapy within 4 weeks immediately prior to screening.
- Patients who have a known clinically significant gastrointestinal disorder, have undergone excision of all or any part of the gastrointestinal tract, have undergone gastric bypass surgery for treatment of obesity, or chronically take drugs that directly influence gastrointestinal motility.
- Patients who have poorly controlled hypertension, renal artery stenosis, or evidence of labile blood pressure including symptomatic postural hypotension.
- Patients who have obvious clinical signs or symptoms of pancreatitis, a history of chronic pancreatitis or acute pancreatitis. Patients who have amylase and/or lipase of 1.5 times or more the upper limit of the reference range.
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 |
|---|---|---|
| LY2189265Administered by subcutaneous (SC) injection, once weekly (QW) for 12 weeks. | Drug | 0.25 mg LY2189265, 0.5 mg LY2189265, 0.75 mg LY2189265 |
| PlaceboAdministered by SC injection, QW for 12 weeks. | Drug | Placebo |
Primary outcome
Change From Baseline in Glycosylated Hemoglobin (HbA1c) at 12 Weeks
Time frame: Baseline, 12 weeks
Change in HbA1c from baseline following 12 weeks of therapy (that is, HbA1c at week 12 minus HbA1c at baseline). Changes in HbA1c were analyzed by a mixed model repeated measures (MMRM) model that included dose, pre-study therapy, body mass index (BMI) group at baseline, baseline value, visit, and dose*visit, where the participant was treated as a random effect.
9 secondary outcomes
Percentage of Participants Achieving Glycosylated Hemoglobin (HbA1c)<7% up to 12 Weeks
Time frame: up to 12 weeks
Percentage of Participants Achieving Glycosylated Hemoglobin (HbA1c)<6.5% up to 12 Weeks
Time frame: up to 12 weeks
Change From Baseline in Fasting Blood Glucose (FBG) Values to 12 Weeks
Time frame: Baseline, 12 weeks
Change From Baseline in the Mean Daily Blood Glucose (Based on Self-Monitoring Blood Glucose [SMBG]) at 12 Weeks
Time frame: Baseline, 12 weeks
Change From Baseline in Total Body Weight at 12 Weeks
Time frame: Baseline, 12 weeks
Change From Baseline in Insulin Sensitivity Using the Updated Homeostasis Model Assessment Insulin Sensitivity (HOMA2-S) at 12 Weeks
Time frame: Baseline, 12 weeks
Change From Baseline in Beta-Cell Function Using the Updated Homeostasis Model Assessment Beta-Cell Function (HOMA2-B) at 12 Weeks
Time frame: Baseline, 12 weeks
Steady-State Concentrations of LY2189265
Time frame: 12 weeks
Percentage of Participants With Self-Reported Hypoglycemic Episodes During the 12-week Treatment Period
Time frame: 12 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2015.
- 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 9AM - 5PM Eastern time (UTC/GMT - 5 hours, EST) study director
Eli Lilly and Company
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing LY2189265 in people with Diabetes Mellitus, Type 2, run by Eli Lilly and Company at 6 sites in Japan.
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 4 inclusion and 6 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 28 Sep 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Japan. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 28 Sep 2015). 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?
Change From Baseline in Glycosylated Hemoglobin (HbA1c) at 12 Weeks (time frame: Baseline, 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 28 Sep 2015.