Type 2 Diabetes MellitusPhase 3NCT01584232
A Study of Dulaglutide in Japanese Participants With Type 2 Diabetes Mellitus
A Phase 3 study testing LY2189265, Insulin glargine and Sulfonylureas (SU) in people with Type 2 Diabetes Mellitus, run by Eli Lilly and Company at 15 sites in Japan.
Trial summary
The purpose of this trial is to examine the efficacy and safety of once-weekly LY2189265 (dulaglutide) in participants with type 2 diabetes mellitus taking an 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, Insulin glargine and Sulfonylureas (SU)
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 361 participants
- Where
- 15 sitesJapan
- Study dates
- Apr 2012to Jul 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 for at least 6 months before screening
- Participants who have been taking sulfonylurea (glibenclamide, gliclazide, or glimepiride) and/or biguanide (metformin or buformin). The dose of the drug(s) during the 8 weeks before screening must be stable
- Participants who have a qualifying glycosylated hemoglobin (HbA1c) value of 7.0% to 10.0% 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
- Participants who have received therapy with an alpha-glucosidase inhibitor (a-GI), thiazolidinedione (TZD), glinide, or dipeptidyl peptidase-IV (DPP-IV) inhibitor within 3 months before screening
- Participants who have been currently taking insulin or have had previous insulin treatment within 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
15 sites in 1 country.
15 sites in 1 country
Japan15 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, 448-0852
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, 286-0048
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Ehime, 790-0024
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Fukuoka, 819-0168
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Hokkaido, 0530018
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Kagoshima, 8910401
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Kanagawa, 247-0055
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Kumamoto, 860-0811
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Kyoto, 606-8397
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Nagano, 385-0022
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Nagasaki, 857-1195
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.
Ōita, 8700039
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, 598-0048
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Tokyo, 103-0028
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.
Yamaguchi, 754-0002
About this study
Official title: A Phase 3 Study of LY2189265 Compared to Insulin Glargine in Patients With Type 2 Diabetes Mellitus on a Sulfonylurea and/or Biguanide
The purpose of this trial is to examine the efficacy and safety of once-weekly LY2189265 (dulaglutide) in participants with type 2 diabetes mellitus taking an oral antihyperglycemic medication (OAM).
Read the detailed description
Rescue therapy (defined as alternative antihyperglycemic medication use or dose modification of oral antihyperglycemic medication [OAM]) may have been initiated during the planned treatment period if the participant discontinued study drug or met prespecified thresholds for severe, persistent hyperglycemia. Efficacy data, as well as data for hypoglycemic episodes from participants who permanently discontinued study treatment but switched to another diabetes medication and remained in the study, were censored from the point of initiating new treatment onwards.
- Conditions
- Type 2 Diabetes Mellitus
- Being tested
- LY2189265, Insulin glargine, Sulfonylureas (SU), Biguanide (BG)
- Keywords
- Glucagon-like peptide-1 (GLP-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
Insulin glargineDrug
Sulfonylureas (SU)Drug
Biguanide (BG)Drug
| Study group | Role | What they receive |
|---|---|---|
| LY2189265 + OAM | Experimental | LY2189265: 0.75 milligrams (mg), administered subcutaneously (SC), once weekly for 26 weeks
Participants were to continue on their stable, pre-study, physician-prescribed dose of oral antihyperglycemic medication (OAM) throughout the study. OAMs included sulfonylureas (SU; glibenclamide, gliclazide, or glimepiride) and/or biguanides (BG; metformin or buformin). Receives: Drug: LY2189265; Drug: Sulfonylureas (SU); Drug: Biguanide (BG) |
| Insulin glargine + OAM | Active comparator | Insulin glargine: dose based on targeting fasting blood glucose ≤110 milligrams per deciliter (mg/dL), administered subcutaneously (SC), once daily for 26 weeks
Participants were to continue on their stable, pre-study, physician-prescribed dose of oral antihyperglycemic medication (OAM) throughout the study. OAMs included sulfonylureas (SU; glibenclamide, gliclazide, or glimepiride) and/or biguanides (BG; metformin or buformin). Receives: Drug: Insulin glargine; Drug: Sulfonylureas (SU); Drug: Biguanide (BG) |
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 26 Weeks
Least squares (LS) means were calculated using a mixed-effects model for repeated measures (MMRM) analysis with treatment, visit, treatment-by-visit, oral antihyperglycemic medication regimen (sulfonylureas only, biguanides only, or both), and baseline body mass index (BMI) group (<25 or >=25 kilograms per meter squared [kg/m^2]) as fixed effects, baseline HbA1c as a covariate, and participant as a random effect.
Measured: Baseline, 26 weeks
Secondary outcomes (5)
Percentage of Participants Who Achieved Glycosylated Hemoglobin (HbA1c) <=6.5% or <7% at 26 Weeks
The percentage of participants achieving HbA1c level less than 7.0% and less than or equal to 6.5% was analyzed with a longitudinal logistic regression model with treatment, visit, treatment-by-visit, oral antihyperglycemic medication regimen (sulfonylureas only, biguanides only, or both), and baseline body mass index (BMI) group (<25 or >=25 kilograms per meter squared [kg/m^2]) as fixed effects, baseline HbA1c as a covariate, and participant as a random effect.
Measured: Up to 26 weeks
Change From Baseline in Fasting Blood Glucose (FBG) at 26 Weeks
Least squares (LS) means were calculated using a mixed-effects model for repeated measures (MMRM) analysis with treatment, visit, treatment-by-visit, oral antihyperglycemic medication regimen (sulfonylureas only, biguanides only, or both), and baseline body mass index (BMI) group (<25 or >=25 kilograms per meter squared [kg/m^2]) as fixed effects, baseline FBG as a covariate, and participant as a random effect.
Measured: Baseline, 26 weeks
Change From Baseline in 8-Point Self-Monitored Blood Glucose (SMBG) at 26 Weeks
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, at bedtime, and before breakfast the next morning (second pre-morning meal). Least squares (LS) means were calculated using analysis of covariance (ANCOVA) model with treatment, oral antihyperglycemic medication regimen (sulfonylureas only, biguanides only, or both), and baseline body mass index (BMI) group (<25 or >=25 kilograms per meter squared [kg/m^2]) as fixed effects and baseline SMBG as a covariate.
Measured: Baseline, Up to 26 weeks
Change From Baseline in Body Weight at 26 Weeks
Least squares (LS) means were calculated using a mixed-effects model for repeated measures (MMRM) analysis with treatment, visit, treatment-by-visit, oral antihyperglycemic medication regimen (sulfonylureas only, biguanides only, or both), and baseline body mass index (BMI) group (<25 or >=25 kilograms per meter squared [kg/m^2]) as fixed effects, baseline body weight as a covariate, and participant as a random effect.
Measured: Baseline, 26 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 one hypoglycemic episode over the 26-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 26 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2012 (estimated)
- Study startApr 2012
- Primary completionJul 2013
- Study completionJul 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.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 361 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 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST), Study director, Eli Lilly and Company
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01584232
- Sponsor's protocol ID
- 14359
- Other IDs
- H9X-JE-GBDY
- Status last verified
- Oct 2014
- First submitted
- 23 Apr 2012
- Last updated
- 20 Oct 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Suzuki S, Oura T, Takeuchi M, Boye KS. Evaluation of the impact of once weekly dulaglutide on patient-reported outcomes in Japanese patients with type 2 diabetes: comparisons with liraglutide, insulin glargine, and placebo in two randomized studies. Health Qual Life Outcomes. 2017 Jun 12;15(1):123. doi: 10.1186/s12955-017-0696-7.
PubMed 28606095
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 3 Study of LY2189265 Compared to Insulin Glargine in Patients With Type 2 Diabetes Mellitus on a Sulfonylurea and/or Biguanide
- ClinicalTrials.gov ID
- NCT01584232
- Acronym / sponsor ID
- 14359
- Conditions
- Type 2 Diabetes Mellitus
- Keywords
- Glucagon-like peptide-1 (GLP-1)
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 361 participants (actual)
- Lead sponsor
- Eli Lilly and CompanyIndustry (pharma, biotech, devices)
- Study start
- Apr 2012
- Primary completion
- Jul 2013 (actual)
- Study completion
- Jul 2013 (actual)
- First posted
- 24 Apr 2012 (estimated)
- Results
- Posted 20 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 purpose of this trial is to examine the efficacy and safety of once-weekly LY2189265 (dulaglutide) in participants with type 2 diabetes mellitus taking an oral antihyperglycemic medication (OAM).
Detailed description
Rescue therapy (defined as alternative antihyperglycemic medication use or dose modification of oral antihyperglycemic medication [OAM]) may have been initiated during the planned treatment period if the participant discontinued study drug or met prespecified thresholds for severe, persistent hyperglycemia. Efficacy data, as well as data for hypoglycemic episodes from participants who permanently discontinued study treatment but switched to another diabetes medication and remained in the study, were censored from the point of initiating new treatment onwards.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| LY2189265 + OAM | Experimental | Drug: LY2189265, Drug: Sulfonylureas (SU), Drug: Biguanide (BG)LY2189265: 0.75 milligrams (mg), administered subcutaneously (SC), once weekly for 26 weeks Participants were to continue on their stable, pre-study, physician-prescribed dose of oral antihyperglycemic medication (OAM) throughout the study. OAMs included sulfonylureas (SU; glibenclamide, gliclazide, or glimepiride) and/or biguanides (BG; metformin or buformin). |
| Insulin glargine + OAM | Active comparator | Drug: Insulin glargine, Drug: Sulfonylureas (SU), Drug: Biguanide (BG)Insulin glargine: dose based on targeting fasting blood glucose ≤110 milligrams per deciliter (mg/dL), administered subcutaneously (SC), once daily for 26 weeks Participants were to continue on their stable, pre-study, physician-prescribed dose of oral antihyperglycemic medication (OAM) throughout the study. OAMs included sulfonylureas (SU; glibenclamide, gliclazide, or glimepiride) and/or biguanides (BG; metformin or buformin). |
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 for at least 6 months before screening
- Participants who have been taking sulfonylurea (glibenclamide, gliclazide, or glimepiride) and/or biguanide (metformin or buformin). The dose of the drug(s) during the 8 weeks before screening must be stable
- Participants who have a qualifying glycosylated hemoglobin (HbA1c) value of 7.0% to 10.0% 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 (6 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
- Participants who have received therapy with an alpha-glucosidase inhibitor (a-GI), thiazolidinedione (TZD), glinide, or dipeptidyl peptidase-IV (DPP-IV) inhibitor within 3 months before screening
- Participants who have been currently taking insulin or have had previous insulin treatment within 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
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 + OAM |
| Insulin glargine | Drug | Insulin glargine + OAM |
| Sulfonylureas (SU) | Drug | Insulin glargine + OAM, LY2189265 + OAM |
| Biguanide (BG) | Drug | Insulin glargine + OAM, LY2189265 + OAM |
Primary outcome
Change From Baseline in Glycosylated Hemoglobin (HbA1c) at 26 Weeks
Time frame: Baseline, 26 weeks
Least squares (LS) means were calculated using a mixed-effects model for repeated measures (MMRM) analysis with treatment, visit, treatment-by-visit, oral antihyperglycemic medication regimen (sulfonylureas only, biguanides only, or both), and baseline body mass index (BMI) group (<25 or >=25 kilograms per meter squared [kg/m^2]) as fixed effects, baseline HbA1c as a covariate, and participant as a random effect.
5 secondary outcomes
Percentage of Participants Who Achieved Glycosylated Hemoglobin (HbA1c) <=6.5% or <7% at 26 Weeks
Time frame: Up to 26 weeks
Change From Baseline in Fasting Blood Glucose (FBG) at 26 Weeks
Time frame: Baseline, 26 weeks
Change From Baseline in 8-Point Self-Monitored Blood Glucose (SMBG) at 26 Weeks
Time frame: Baseline, Up to 26 weeks
Change From Baseline in Body Weight at 26 Weeks
Time frame: Baseline, 26 weeks
Percentage of Participants With Hypoglycemic Episodes
Time frame: Baseline through 26 Weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 28606095Suzuki S, Oura T, Takeuchi M, Boye KS. Evaluation of the impact of once weekly dulaglutide on patient-reported outcomes in Japanese patients with type 2 diabetes: comparisons with liraglutide, insulin glargine, and placebo in two randomized studies. Health Qual Life Outcomes. 2017 Jun 12;15(1):123. doi: 10.1186/s12955-017-0696-7.
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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
15 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, Insulin glargine and Sulfonylureas (SU) in people with Type 2 Diabetes Mellitus, run by Eli Lilly and Company at 15 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 20 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 15 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 20 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?
Change From Baseline in Glycosylated Hemoglobin (HbA1c) at 26 Weeks (time frame: Baseline, 26 weeks). 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 NCT01584232, which also lists 1 linked publication.
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 20 Oct 2014.