Type 2 Diabetes MellitusPhase 3NCT01468181
A Study of LY2189265 in Japanese Participants With Type 2 Diabetes Mellitus
A Phase 3 study testing LY2189265, Sulfonylureas (SU) and Biguanides (BG) in people with Type 2 Diabetes Mellitus, run by Eli Lilly and Company at 14 sites in Japan.
Trial summary
This was a 52-week, multicenter, non-randomized, open-label, Phase 3 long-term safety study in participants with type 2 diabetes mellitus who have inadequate glycemic control with monotherapy of oral antihyperglycemic medication (OAM). Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Type 2 Diabetes Mellitus
- What is being tested?
- LY2189265, Sulfonylureas (SU) and Biguanides (BG)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 394 participants
- Where
- 14 sitesJapan
- Study dates
- Nov 2011to Dec 2013
- Phase
- Phase 3
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participants who have had a diagnosis of type 2 diabetes mellitus before screening
- Participants who have been taking SU (Glibenclamide, Gliclazide, Glimepiride), BG, TZD, a-GI or glinides monotherapy for at least 3 months before screening and have been on a stable dose for at least 8 weeks before screening
- Participants must have a qualifying HbA1c value of 7.0% to 11.0% at screening
- Participants who have a body mass index (BMI) of 18.5 to 35.0 kilograms per meter squared (kg/m^2)
Who cannot join
- Participants who have a diagnosis of type 1 diabetes
- Participants who have previously been treated with any other glucagon-like peptide-1 (GLP-1) analog within the 3 months before screening
- Participants who are currently taking insulin or have had previous insulin treatment within the 3 months before screening
- Participants who have obvious clinical signs or symptoms of pancreatitis, a history of chronic pancreatitis, or acute pancreatitis at screening, as determined by the investigator. Participants who have a serum amylase concentration ≥3 times the upper limit of the reference range and/or a serum lipase concentration ≥2 times the upper limit of the reference range, as determined by the central laboratory at screening
- Participants who have self or family history of medullary C-cell hyperplasia, focal hyperplasia, or medullary thyroid carcinoma (MTC)
Trial locations and contacts
14 sites in 1 country.
14 sites in 1 country
Japan14 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.
Aichi, 466-0815
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, 277-0825
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Hokkaido, 050-0073
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Hyōgo, 662-0971
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.
Ibaraki, 300-0053
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Kanagawa, 231-0023
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, 615-8125
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Nagano, 390-1401
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.
Okayama, 700-8558
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, 560-0082
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.
Saitama, 3438577
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, 1030002
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.
Toyama, 930-0859
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.
Wakayama, 644-0011
About this study
Official title: A 52-Week, Open-Label, Long-Term Safety Study of LY2189265 in Combination With Monotherapy of Oral Antihyperglycemic Medications in Patients With Type 2 Diabetes Mellitus
This was a 52-week, multicenter, non-randomized, open-label, Phase 3 long-term safety study in participants with type 2 diabetes mellitus who have inadequate glycemic control with monotherapy of oral antihyperglycemic medication (OAM).
- Conditions
- Type 2 Diabetes Mellitus
- Being tested
- LY2189265, Sulfonylureas (SU), Biguanides (BG), alpha-glucosidase inhibitor (a-GI), Thiazolidinedione (TZD)
- Keywords
- Type 2 diabetes mellitus, Oral antihyperglycemic medications, Long-Term Safety, GLP 1, Glucagon like peptide 1
- 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.
LY2189265Drug
Also called Dulaglutide
Sulfonylureas (SU)Drug
SU is a pre-study prescribed dose and is not being provided as part of the trial.
Biguanides (BG)Drug
Biguanides is a pre-study prescribed dose and is not being provided as part of the trial.
alpha-glucosidase inhibitor (a-GI)Drug
a-GI is a pre-study prescribed dose and is not being provided as part of the trial.
Thiazolidinedione (TZD)Drug
TZD is a pre-study prescribed dose and is not being provided as part of the trial.
GlinidesDrug
Glinides is a pre-study prescribed dose and is not being provided as part of the trial.
| Study group | Role | What they receive |
|---|---|---|
| LY2189265 + Sulfonylureas (SU) | Experimental | LY2189265: 0.75 milligrams (mg) administered subcutaneously (SC), once weekly for 52 weeks
Participants were to continue on their stable, pre-study, physician-prescribed dose of SU monotherapy throughout the study. Receives: Drug: LY2189265; Drug: Sulfonylureas (SU) |
| LY2189265 + Biguanides (BG) | Experimental | LY2189265: 0.75 mg administered SC, once weekly for 52 weeks
Participants were to continue on their stable, pre-study, physician-prescribed dose of BG monotherapy throughout the study. Receives: Drug: LY2189265; Drug: Biguanides (BG) |
| LY2189265 + alpha-glucosidase inhibitor (a-GI) | Experimental | LY2189265: 0.75 mg administered SC, once weekly for 52 weeks
Participants were to continue on their stable, pre-study, physician-prescribed dose of a-GI monotherapy throughout the study. Receives: Drug: LY2189265; Drug: alpha-glucosidase inhibitor (a-GI) |
| LY2189265 + Thiazolidinedione (TZD) | Experimental | LY2189265: 0.75 mg administered SC, once weekly for 52 weeks
Participants were to continue on their stable, pre-study, physician-prescribed dose of TZD monotherapy throughout the study. Receives: Drug: LY2189265; Drug: Thiazolidinedione (TZD) |
| LY2189265 + Glinides | Experimental | LY2189265: 0.75 mg administered SC, once weekly for 52 weeks
Participants were to continue on their stable, pre-study, physician-prescribed dose of glinides monotherapy throughout the study. Receives: Drug: LY2189265; Drug: Glinides |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs)
A TEAE was defined as an event that first occurs or worsens (increases in severity) after baseline, regardless of causality or severity. The percentage of participants with TEAEs was calculated by dividing the number of participants with at least 1 TEAE over the 52-week treatment period by the total number of participants analyzed, multiplied by 100%. A summary of serious and other non-serious adverse events, regardless of causality, is located in the Reported Adverse Events module.
Measured: Baseline through 52 Weeks
Percentage of Participants With Hypoglycemic Episodes
The percentage of participants with hypoglycemic episodes was calculated by dividing the number of participants with at least 1 hypoglycemic episode over the 52-week treatment period by the total number of participants analyzed, multiplied by 100%. All classifications of hypoglycemia (documented symptomatic, asymptomatic, severe, nocturnal, non-nocturnal, probable symptomatic, relative, and unspecified) were included, except for episodes of relative hypoglycemia that were not severe. A summary of serious and other non-serious adverse events, regardless of causality, is located in the Reported Adverse Events module.
Measured: Baseline through 52 Weeks
Secondary outcomes (6)
Change From Baseline in Glycosylated Hemoglobin (HbA1c)
Measured: Baseline, up to 26 Weeks and up to 52 Weeks
Percentage of Participants Who Achieve HbA1c ≤6.5% or <7%
Measured: 26 weeks and 52 weeks
Change From Baseline in Fasting Blood Glucose (FBG)
Measured: Baseline, up to 26 weeks and up to 52 weeks
Change From Baseline in 7-Point Self-Monitored Blood Glucose (SMBG)
Participants were to test and record SMBG concentrations in their study diaries before each meal (breakfast, lunch, and dinner), approximately 2 hours after the start of each meal. For the mean of all 7-point blood glucose values, the daily mean was calculated as the average of 7 blood glucose values collected on a particular day. The mean of all 7-point blood glucose values at each visit was calculated as the average of 2 daily means. The change from baseline was calculated as the mean of all 7-point blood glucose values at endpoint minus the mean of all 7-point blood glucose values at baseline.
Measured: Baseline, up to 26 weeks and up to 52 weeks
Change From Baseline in Body Weight
Measured: Baseline, up to 26 weeks and up to 52 weeks
Change From Baseline in Updated Homeostasis Model Assessment (HOMA2)
The HOMA2 is a computer model that uses fasting plasma insulin and glucose concentrations to estimate steady state pancreatic beta cell function (%B) and to estimate insulin sensitivity (%S) as a percentage of a normal reference population (normal young adults). The normal reference population was set at 100%. The change from baseline for fasting insulin concentrations are presented as insulin secretion (HOMA2-%B) and insulin sensitivity (HOMA2-%S).
Measured: Baseline, up to 26 weeks and up to 52 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2011 (estimated)
- Study startNov 2011
- Primary completionDec 2013
- Study completionDec 2013
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 Type 2 Diabetes MellitusStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 394 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
- NCT01468181
- Sponsor's protocol ID
- 13991
- Other IDs
- H9X-JE-GBDQ
- Status last verified
- Jan 2015
- First submitted
- 7 Nov 2011
- Last updated
- 29 Jan 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 29 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A 52-Week, Open-Label, Long-Term Safety Study of LY2189265 in Combination With Monotherapy of Oral Antihyperglycemic Medications in Patients With Type 2 Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT01468181
- Acronym / sponsor ID
- 13991
- Conditions
- Type 2 Diabetes Mellitus
- Keywords
- Type 2 diabetes mellitus, Oral antihyperglycemic medications, Long-Term Safety, GLP 1, Glucagon like peptide 1
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 394 participants (actual)
- Lead sponsor
- Eli Lilly and CompanyIndustry (pharma, biotech, devices)
- Study start
- Nov 2011
- Primary completion
- Dec 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 9 Nov 2011 (estimated)
- Results
- Posted 16 Dec 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This was a 52-week, multicenter, non-randomized, open-label, Phase 3 long-term safety study in participants with type 2 diabetes mellitus who have inadequate glycemic control with monotherapy of oral antihyperglycemic medication (OAM).
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| LY2189265 + Sulfonylureas (SU) | Experimental | Drug: LY2189265, Drug: Sulfonylureas (SU)LY2189265: 0.75 milligrams (mg) administered subcutaneously (SC), once weekly for 52 weeks Participants were to continue on their stable, pre-study, physician-prescribed dose of SU monotherapy throughout the study. |
| LY2189265 + Biguanides (BG) | Experimental | Drug: LY2189265, Drug: Biguanides (BG)LY2189265: 0.75 mg administered SC, once weekly for 52 weeks Participants were to continue on their stable, pre-study, physician-prescribed dose of BG monotherapy throughout the study. |
| LY2189265 + alpha-glucosidase inhibitor (a-GI) | Experimental | Drug: LY2189265, Drug: alpha-glucosidase inhibitor (a-GI)LY2189265: 0.75 mg administered SC, once weekly for 52 weeks Participants were to continue on their stable, pre-study, physician-prescribed dose of a-GI monotherapy throughout the study. |
| LY2189265 + Thiazolidinedione (TZD) | Experimental | Drug: LY2189265, Drug: Thiazolidinedione (TZD)LY2189265: 0.75 mg administered SC, once weekly for 52 weeks Participants were to continue on their stable, pre-study, physician-prescribed dose of TZD monotherapy throughout the study. |
| LY2189265 + Glinides | Experimental | Drug: LY2189265, Drug: GlinidesLY2189265: 0.75 mg administered SC, once weekly for 52 weeks Participants were to continue on their stable, pre-study, physician-prescribed dose of glinides monotherapy throughout the study. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Participants who have had a diagnosis of type 2 diabetes mellitus before screening
- Participants who have been taking SU (Glibenclamide, Gliclazide, Glimepiride), BG, TZD, a-GI or glinides monotherapy for at least 3 months before screening and have been on a stable dose for at least 8 weeks before screening
- Participants must have a qualifying HbA1c value of 7.0% to 11.0% at screening
- Participants who have a body mass index (BMI) of 18.5 to 35.0 kilograms per meter squared (kg/m^2)
Key exclusion criteria (5 listed)
- Participants who have a diagnosis of type 1 diabetes
- Participants who have previously been treated with any other glucagon-like peptide-1 (GLP-1) analog within the 3 months before screening
- Participants who are currently taking insulin or have had previous insulin treatment within the 3 months before screening
- Participants who have obvious clinical signs or symptoms of pancreatitis, a history of chronic pancreatitis, or acute pancreatitis at screening, as determined by the investigator. Participants who have a serum amylase concentration ≥3 times the upper limit of the reference range and/or a serum lipase concentration ≥2 times the upper limit of the reference range, as determined by the central laboratory at screening
- Participants who have self or family history of medullary C-cell hyperplasia, focal hyperplasia, or medullary thyroid carcinoma (MTC)
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 |
|---|---|---|
| LY2189265Also: Dulaglutide | Drug | LY2189265 + Biguanides (BG), LY2189265 + Glinides, LY2189265 + Sulfonylureas (SU), LY2189265 + Thiazolidinedione (TZD), LY2189265 + alpha-glucosidase inhibitor (a-GI) |
| Sulfonylureas (SU)SU is a pre-study prescribed dose and is not being provided as part of the trial. | Drug | LY2189265 + Sulfonylureas (SU) |
| Biguanides (BG)Biguanides is a pre-study prescribed dose and is not being provided as part of the trial. | Drug | LY2189265 + Biguanides (BG) |
| alpha-glucosidase inhibitor (a-GI)a-GI is a pre-study prescribed dose and is not being provided as part of the trial. | Drug | LY2189265 + alpha-glucosidase inhibitor (a-GI) |
| Thiazolidinedione (TZD)TZD is a pre-study prescribed dose and is not being provided as part of the trial. | Drug | LY2189265 + Thiazolidinedione (TZD) |
| GlinidesGlinides is a pre-study prescribed dose and is not being provided as part of the trial. | Drug | LY2189265 + Glinides |
Primary outcome
Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs)
Time frame: Baseline through 52 Weeks
A TEAE was defined as an event that first occurs or worsens (increases in severity) after baseline, regardless of causality or severity. The percentage of participants with TEAEs was calculated by dividing the number of participants with at least 1 TEAE over the 52-week treatment period by the total number of participants analyzed, multiplied by 100%. A summary of serious and other non-serious adverse events, regardless of causality, is located in the Reported Adverse Events module.
Percentage of Participants With Hypoglycemic Episodes
Time frame: Baseline through 52 Weeks
The percentage of participants with hypoglycemic episodes was calculated by dividing the number of participants with at least 1 hypoglycemic episode over the 52-week treatment period by the total number of participants analyzed, multiplied by 100%. All classifications of hypoglycemia (documented symptomatic, asymptomatic, severe, nocturnal, non-nocturnal, probable symptomatic, relative, and unspecified) were included, except for episodes of relative hypoglycemia that were not severe. A summary of serious and other non-serious adverse events, regardless of causality, is located in the Reported Adverse Events module.
6 secondary outcomes
Change From Baseline in Glycosylated Hemoglobin (HbA1c)
Time frame: Baseline, up to 26 Weeks and up to 52 Weeks
Percentage of Participants Who Achieve HbA1c ≤6.5% or <7%
Time frame: 26 weeks and 52 weeks
Change From Baseline in Fasting Blood Glucose (FBG)
Time frame: Baseline, up to 26 weeks and up to 52 weeks
Change From Baseline in 7-Point Self-Monitored Blood Glucose (SMBG)
Time frame: Baseline, up to 26 weeks and up to 52 weeks
Change From Baseline in Body Weight
Time frame: Baseline, up to 26 weeks and up to 52 weeks
Change From Baseline in Updated Homeostasis Model Assessment (HOMA2)
Time frame: Baseline, up to 26 weeks and up to 52 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 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
14 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing LY2189265, Sulfonylureas (SU) and Biguanides (BG) in people with Type 2 Diabetes Mellitus, run by Eli Lilly and Company at 14 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 5 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 29 Jan 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 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. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 16 Dec 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?
Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs) (time frame: Baseline through 52 Weeks). The study lists 2 primary outcomes in all. 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 29 Jan 2015.