A Study of Dulaglutide in Japanese Participants With Type 2 Diabetes

A Phase 4 study testing Dulaglutide in people with Type 2 Diabetes, run by Eli Lilly and Company at 25 sites in Japan.

Completed

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

Trial summary

The main purpose of this study is to evaluate the efficacy and safety of combination therapy with dulaglutide and insulin in Japanese participants with type 2 diabetes. Read more about this study

Who is it for?: Ages 20 years and older
Conditions the study is for: Type 2 Diabetes
What is being tested?: Dulaglutide
Type of treatment: Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 159 participants
Where: 25 sitesJapan
Study dates: Aug 2016to 18 Jun 2018
Phase: Phase 4
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
Participants who have been treated with insulin therapy (basal insulin, premixed insulin, or basal/mealtime insulin regimen) with or without 1 or 2 oral antidiabetics (OADs) at stable dose for at least 3 months before screening
Participants who have an HbA1c value ≥7.0% and ≤10.5% at screening if the participant is washing out OADs (dipeptidyl peptidase-4 [DPP-4] inhibitors, sulfonylurea [SU], or glinides) or ≥7.5% and ≤10.5% at screening if the participant is not washing out OADs
Participants who have stable weight (±5%) ≥3 months prior to 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 received therapy with a glucagon-like peptide-1 receptor agonist within 3 months prior to screening
Participants who have been previously treated with dulaglutide prior to screening
Participants who have been treated with 2 of the following at screening: DPP-4 inhibitor, SU, and glinide (ie, DPP-4 inhibitor and SU, or DPP-4 inhibitor and glinide)
Participants who have been treated with continuous subcutaneous insulin infusion (CSII) at screening
Participants who have clinically significant gastric emptying abnormality, hepatitis, pancreatitis, renal dysfunction, or thyroid abnormalities
Participants who have a history of clinically significant cardiovascular disease, transplanted organ, or active or untreated malignancy

Trial locations and contacts

25 sites in 1 country.

City, postcode or hospital

25 sites in 1 country

Japan25 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.
Adachi-ku, 123-0845
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Chiba, 2610004
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Chiyoda City, 102-0082
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Chūōku, 103-0027
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Chūōku, 103-0028
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Chuou-ku, 1030002
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Fuchū, 183-8524
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Ichikawa, 272-8516
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Isahaya, 8548501
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Kamakura, 247-0056
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Kashihara, 634-8522
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Kumamoto, 862-0965
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Kumamoto, 862-0976
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Maebashi, 3710821
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Mito, 310-0845
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Naka, 311-0113
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Nishinomiya, 662-0971
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Ōita, 870-0039
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Osaka, 530-0001
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Sasebo, 857-1195
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Shimotsuke, 329-0433
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Shizuoka, 424-0855
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
Tama, 206-0633
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.
Toda, 335-0023
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.
Yokohama, 241-0821

Other trials in Japan

About this study

Official title: A Phase 4 Study of Efficacy and Safety of Dulaglutide When Added to Insulin Treatment With or Without Oral Antidiabetic Medication in Patients With Type 2 Diabetes

The main purpose of this study is to evaluate the efficacy and safety of combination therapy with dulaglutide and insulin in Japanese participants with type 2 diabetes.

Conditions: Type 2 Diabetes
Being tested: Dulaglutide, 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.

DulaglutideDrug
Also called LY2189265
Administered subcutaneously (SC)
PlaceboDrug
Administered SC

Study groups in NCT02750410
Study group	Role	What they receive
Dulaglutide	Experimental	Dulaglutide 0.75 milligram (mg) administered once weekly for 16 weeks. After 16-weeks, dulaglutide administered once weekly for 36 weeks. Receives: Drug: Dulaglutide
Placebo	Placebo comparator	Placebo administered once weekly for 16 weeks. After 16-weeks, dulaglutide 0.75 mg administered once weekly for 36 weeks. Receives: Drug: Dulaglutide; Drug: Placebo

What is being measured

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

Change From Baseline in Hemoglobin A1c (HbA1c)
HbA1c is a form of hemoglobin that is measured primarily to identify the average plasma glucose concentration over prolonged periods of time. Least square (LS) mean in HbA1c was calculated using a restricted maximum likelihood (REML) based mixed-effects model for repeated measures (MMRM) and adjusted by, baseline HbA1c, treatment, visit, and treatment-by-visit insulin regimen (basal insulin, premixed insulin, or basal/mealtime insulin), where participant treated as a random effect.
Measured: Baseline, Week 16

Secondary outcomes (5)

Percentage of Participants With HbA1c <7.0% or ≤6.5%
Percentage of participants whose HbA1c was <7.0% or ≤6.5%. HbA1c <7.0% is presented.
Measured: Week 16
Change From Baseline in Fasting Serum Glucose (FSG)
The LS mean change from baseline in FSG was calculated using a REML based MMRM and adjusted by, baseline value, treatment, visit, treatment-by-visit, baseline HbA1c Group (<8.5%, >=8.5%) + insulin regimen (basal insulin, premixed insulin, or basal/mealtime insulin), where participant treated as a random effect.
Measured: Baseline, Week 16
Change From Baseline in Plasma Glucose From 7-Point Self-Monitored Blood Glucose Profiles (SMBG)
The self-monitored plasma glucose (SMBG) data were collected at the following 7 time points: prebreakfast blood glucose (BG), breakfast 2-hour postprandial blood glucose (PPBG), prelunch BG, lunch 2-hour PPBG, predinner BG, dinner 2-hour PPBG, and bedtime BG. LS mean was calculated with fixed effect test of analysis of covariance (ANCOVA) model and adjusted by, baseline value, treatment, baseline HbA1c Group (<8.5%, ≥8.5%), insulin regimen (basal insulin, premixed insulin, or basal/mealtime insulin).
Measured: Baseline, Week 16
Change From Baseline in Body Weight
LS mean change from baseline in body weight was calculated using a REML based MMRM and was adjusted by, baseline value, treatment, visit, treatment-by-visit, baseline HbA1c group (<8.5%, >=8.5%), insulin regimen (basal insulin, premixed insulin, or basal/mealtime insulin), where participant treated as a random effect.
Measured: Baseline, Week 16
Change From Baseline in Daily Total Insulin Dose
Mean change from baseline in total insulin dose was measured in each treatment groups.
Measured: Baseline, Week 16

Timeline

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

Aug 201618 Jun 2018

First posted25 Apr 2016 (estimated)
Study startAug 2016
Primary completion18 Jun 2018
Study completion18 Jun 2018

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 (2)Papers the sponsor has linked to this study.
Other trials for Type 2 DiabetesStudies 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 4
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 159 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02750410
Sponsor's protocol ID: 15803
Other IDs: H9X-JE-GBGF
Status last verified: Sep 2019
First submitted: 21 Apr 2016
Last updated: 24 Sep 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: Yes: Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.

Publications

Onishi Y, Ishii H, Oura T, Takeuchi M. Efficacy and Safety of Once-Weekly Dulaglutide in Type 2 Diabetes Patients Using Insulin: Exploratory Subgroup Analysis by Insulin Regimen. Diabetes Ther. 2020 Mar;11(3):735-745. doi: 10.1007/s13300-020-00765-6. Epub 2020 Jan 29.
PubMed 31994009
Ishii H, Onishi Y, Oura T, Takeuchi M. Once-Weekly Dulaglutide with Insulin Therapy for Type 2 Diabetes: Efficacy and Safety Results from a Phase 4, Randomized, Placebo-Controlled Study. Diabetes Ther. 2020 Jan;11(1):133-145. doi: 10.1007/s13300-019-00726-8. Epub 2019 Nov 22.
PubMed 31758520

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?

See locations

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All Type 2 Diabetes trials

Study at a glance

From the registry record, last updated by the sponsor on 24 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 4 Study of Efficacy and Safety of Dulaglutide When Added to Insulin Treatment With or Without Oral Antidiabetic Medication in Patients With Type 2 Diabetes
ClinicalTrials.gov ID: NCT02750410
Acronym / sponsor ID: 15803
Conditions: Type 2 Diabetes
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 159 participants (actual)
Lead sponsor: Eli Lilly and CompanyIndustry (pharma, biotech, devices)
Study start: Aug 2016
Primary completion: 18 Jun 2018 (actual)
Study completion: 18 Jun 2018 (actual)
First posted: 25 Apr 2016 (estimated)
Results: Posted 16 Sep 2019

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 evaluate the efficacy and safety of combination therapy with dulaglutide and insulin in Japanese participants with type 2 diabetes.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 2

Arm	Type	Receives
Dulaglutide	Experimental	Drug: DulaglutideDulaglutide 0.75 milligram (mg) administered once weekly for 16 weeks. After 16-weeks, dulaglutide administered once weekly for 36 weeks.
Placebo	Placebo comparator	Drug: Dulaglutide, Drug: PlaceboPlacebo administered once weekly for 16 weeks. After 16-weeks, dulaglutide 0.75 mg administered once weekly for 36 weeks.

Who may qualify

Ages: 20 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

Participants who have had a diagnosis of type 2 diabetes mellitus
Participants who have been treated with insulin therapy (basal insulin, premixed insulin, or basal/mealtime insulin regimen) with or without 1 or 2 oral antidiabetics (OADs) at stable dose for at least 3 months before screening
Participants who have an HbA1c value ≥7.0% and ≤10.5% at screening if the participant is washing out OADs (dipeptidyl peptidase-4 [DPP-4] inhibitors, sulfonylurea [SU], or glinides) or ≥7.5% and ≤10.5% at screening if the participant is not washing out OADs
Participants who have stable weight (±5%) ≥3 months prior to 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 (7 listed)

Participants who have a diagnosis of type 1 diabetes
Participants who have previously received therapy with a glucagon-like peptide-1 receptor agonist within 3 months prior to screening
Participants who have been previously treated with dulaglutide prior to screening
Participants who have been treated with 2 of the following at screening: DPP-4 inhibitor, SU, and glinide (ie, DPP-4 inhibitor and SU, or DPP-4 inhibitor and glinide)
Participants who have been treated with continuous subcutaneous insulin infusion (CSII) 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
DulaglutideAlso: LY2189265Administered subcutaneously (SC)	Drug	Dulaglutide, Placebo
PlaceboAdministered SC	Drug	Placebo

Primary outcome

Change From Baseline in Hemoglobin A1c (HbA1c)
Time frame: Baseline, Week 16
HbA1c is a form of hemoglobin that is measured primarily to identify the average plasma glucose concentration over prolonged periods of time. Least square (LS) mean in HbA1c was calculated using a restricted maximum likelihood (REML) based mixed-effects model for repeated measures (MMRM) and adjusted by, baseline HbA1c, treatment, visit, and treatment-by-visit insulin regimen (basal insulin, premixed insulin, or basal/mealtime insulin), where participant treated as a random effect.

5 secondary outcomes

Percentage of Participants With HbA1c <7.0% or ≤6.5%
Time frame: Week 16
Change From Baseline in Fasting Serum Glucose (FSG)
Time frame: Baseline, Week 16
Change From Baseline in Plasma Glucose From 7-Point Self-Monitored Blood Glucose Profiles (SMBG)
Time frame: Baseline, Week 16
Change From Baseline in Body Weight
Time frame: Baseline, Week 16
Change From Baseline in Daily Total Insulin Dose
Time frame: Baseline, Week 16

Results and safety

Results posted to the registry on 16 Sep 2019, 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	39	37
Dulaglutide	120	117

Primary outcome: Change From Baseline in Hemoglobin A1c (HbA1c)

Time frame: Baseline, Week 16. Least squares mean (Standard Error). Unit: percentage of HbA1c

Measure	Placebo n = 39	Dulaglutide n = 120
Value	0.06 (0.099)	-1.45 (0.057)

Placebo: LS mean percent difference: -1.50 (95% CI -1.73 to -1.28), p <0.001, Mixed Models Analysis

Population analysed: All randomized participants who received at least one dose of study drug and had evaluable baseline and post-baseline HbA1c.

5 secondary outcomes are reported in the full results.

Adverse events

Time frame: Up to 52 weeks. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Placebo Double-Blind (DB) Treatment Period	0 of 39 (0%)	18 of 39 (46.2%)	0 of 39
Dulaglutide 0.75 mg DB Treatment Period	3 of 120 (2.5%)	47 of 120 (39.2%)	0 of 120
Placebo DB Treatment, Dulaglutide 0.75 mg Extension Period	1 of 39 (2.6%)	28 of 39 (71.8%)	0 of 39
Dulaglutide 0.75 mg DB Treatment/Extension Period	6 of 120 (5%)	59 of 120 (49.2%)	0 of 120

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 31994009Onishi Y, Ishii H, Oura T, Takeuchi M. Efficacy and Safety of Once-Weekly Dulaglutide in Type 2 Diabetes Patients Using Insulin: Exploratory Subgroup Analysis by Insulin Regimen. Diabetes Ther. 2020 Mar;11(3):735-745. doi: 10.1007/s13300-020-00765-6. Epub 2020 Jan 29.
Derived from this study: PubMed 31758520Ishii H, Onishi Y, Oura T, Takeuchi M. Once-Weekly Dulaglutide with Insulin Therapy for Type 2 Diabetes: Efficacy and Safety Results from a Phase 4, Randomized, Placebo-Controlled Study. Diabetes Ther. 2020 Jan;11(1):133-145. doi: 10.1007/s13300-019-00726-8. Epub 2019 Nov 22.
Individual participant dataSharing planned: Yes. Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.

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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

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

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Dulaglutide in people with Type 2 Diabetes, run by Eli Lilly and Company at 25 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 5 inclusion and 7 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 24 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 25 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

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 Sep 2019). 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 Hemoglobin A1c (HbA1c) (time frame: Baseline, Week 16). 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 NCT02750410, which also lists 2 linked publications.

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 24 Sep 2019.