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| ID | Type | Description | Link |
|---|---|---|---|
| H9X-JE-GBGK | Other Identifier | Eli Lilly and Company |
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The purpose of this study is to evaluate the glucodynamic effects of dulaglutide in Japanese participants with type 2 diabetes mellitus.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dulaglutide, Placebo | Experimental | Dulaglutide 0.75 mg administered subcutaneously (SC) once weekly for 4 weeks in period 1 followed by placebo administered SC once weekly for 4 weeks in Period 2. There is a 4 to 6 week washout period between Period 1 and Period 2. |
|
| Placebo, Dulaglutide | Experimental | Placebo administered SC once weekly for 4 weeks in Period 1 followed by Dulaglutide 0.75 mg administered SC for 4 weeks in Period 2. There is a 4 to 6 week washout period between Period 1 and Period 2. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dulaglutide | Drug | Administered SC |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Glucose Area Under the Concentration Versus Time Curve From Time Zero to 4 Hours (AUC[0-4h]) | Least square (LS) means of glucose AUC 0-4h change from baseline was calculated using mixed-effects linear model. The model will include treatment, sequence, period, week, and treatment-by-week as fixed effects, baseline as a covariate, and participant as random effect. | Baseline, 4 Weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Fasting Blood Glucose | Change from baseline in fasting blood glucose obtained at pre-meal. | Baseline, 4 Weeks |
| Change From Baseline in Postprandial Blood Glucose | Change from baseline in postprandial blood glucose at 120 minutes at week 4. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| 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) | Eli Lilly and Company | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| 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. | Fukuoka | 812-0025 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30949907 | Derived | Inoue M, Shiramoto M, Oura T, Nasu R, Nakano M, Takeuchi M. Effect of Once-Weekly Dulaglutide on Glucose Levels in Japanese Patients with Type 2 Diabetes: Findings from a Phase 4, Randomized Controlled Trial. Diabetes Ther. 2019 Jun;10(3):1019-1027. doi: 10.1007/s13300-019-0605-7. Epub 2019 Apr 4. |
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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.
Data are available 6 months after the primary publication and approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting.
A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
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| ID | Title | Description |
|---|---|---|
| FG000 | Dulaglutide Then Placebo | Dulaglutide 0.75 milligrams (mg) administered subcutaneously (SC) once weekly for 4 weeks in Period 1 followed by placebo administered SC once weekly for 4 weeks in period 2. There is a 4 to 6 week washout period between Period 1 and Period 2. |
| FG001 | Placebo Then Dulaglutide | Placebo administered SC once weekly for 4 weeks in Period 1 followed byDulaglutide 0.75 mg administered SC once weekly for 4 weeks in Period 2. There is a 4 to 6 week washout period between Period 1 and Period 2. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Period 1 |
| ||||||||||||||||
| Period 2 |
|
All participants who received at least one dose of study drug.
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| ID | Title | Description |
|---|---|---|
| BG000 | Overall | Participants were randomized to one of two treatment sequences: Dulaglutide 0.75 mg administered subcutaneously (SC) in Period 1 and placebo administered SC in Period 2 or placebo administered SC in Period 1 and Dulaglutide 0.75 mg administered in Period 2. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change From Baseline in Glucose Area Under the Concentration Versus Time Curve From Time Zero to 4 Hours (AUC[0-4h]) | Least square (LS) means of glucose AUC 0-4h change from baseline was calculated using mixed-effects linear model. The model will include treatment, sequence, period, week, and treatment-by-week as fixed effects, baseline as a covariate, and participant as random effect. | All participants who receive at least one dose of study drug and have evaluable pharmacodynamic data. | Posted | Least Squares Mean | 95% Confidence Interval | milligram*hour per deciliter (mg*h/dL) | Baseline, 4 Weeks |
|
Baseline up to 14 weeks
All participants who received at least one dose of study drug.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Dulaglutide | Dulaglutide 0.75 mg administered SC once weekly for four weeks. | 0 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhoea | Gastrointestinal disorders | MedDRA 20.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Chief Medical Officer | Eli Lilly and Company | 800-545-5979 | Clinicaltrials.gov@lilly.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Sep 26, 2017 | Feb 22, 2019 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Oct 25, 2017 | Feb 22, 2019 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| C555680 | dulaglutide |
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| Placebo | Drug | Administered SC |
|
| Baseline, 4 Weeks |
| Change From Baseline in Insulin Area Under the Concentration Versus Time Curve From Time Zero to 4 Hours (AUC [0-4h]) | LS mean of the insulin change from baseline was analyzed using a mixed-effects linear model. The model includes treatment, sequence, period, week and treat-by-sequence as fixed effects, baseline as a covariate and participant as random effect. | Baseline, 4 Weeks |
| Change From Baseline in C-Peptide Area Under the Concentration Versus Time Curve From Time Zero to 4 Hours (AUC [0-4h]) | LS mean of C-peptide change from baseline was analyzed using a mixed-effects linear model. The model includes treatment, sequence, period, week and treat-by-sequence as fixed effects, baseline as a covariate and participant as random effect. | Baseline, 4 Weeks |
| Change From Baseline in Glucagon Area Under the Concentration Versus Time Curve From Time Zero to 4 Hours (AUC [0-4h]) | LS mean of glucagon change from baseline was analyzed using a mixed-effects linear model. The model includes treatment, sequence, period, week and treat-by-sequence as fixed effects, baseline as a covariate and participant as random effect. | Baseline, 4 Weeks |
| Change From Baseline in Triglyceride Area Under the Concentration Versus Time Curve From Time Zero to 4 Hours (AUC [0-4h]) | LS mean of triglyceride change from baseline was analyzed using a mixed-effects linear model. The model includes treatment, sequence, period, week and treat-by-sequence as fixed effects, baseline as a covariate and participant as random effect. | Baseline, 4 Weeks |
| Number of Participants Who Develop Hypoglycemic Events | Number of participants who develop hypoglycemic events. | Baseline through 4 weeks |
| Japan |
| NOT COMPLETED |
|
| years |
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| Sex: Female, Male | Count of Participants | Participants | No |
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| Race/Ethnicity, Customized | Count of Participants | Participants | No |
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| Region of Enrollment | Count of Participants | Participants | No |
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| Duration of Diabetes | Mean | Standard Deviation | years |
|
| Screening HbA1c | Mean | Standard Deviation | percentage of HbA1c |
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| Fasting Blood Glucose | Mean | Standard Deviation | milligram per deciliter (mg/dL) |
|
Placebo administered SC once weekly for four weeks. |
|
|
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| Secondary | Change From Baseline in Fasting Blood Glucose | Change from baseline in fasting blood glucose obtained at pre-meal. | All participants who received at least one dose of study drug and evaluable had fasting blood glucose data. | Posted | Mean | Standard Deviation | milligrams per deciliter (mg/dL) | Baseline, 4 Weeks |
|
|
|
| Secondary | Change From Baseline in Postprandial Blood Glucose | Change from baseline in postprandial blood glucose at 120 minutes at week 4. | All participants who received at least one dose of study drug and had evaluable postprandial blood glucose data. | Posted | Mean | Standard Error | mg/dL | Baseline, 4 Weeks |
|
|
|
| Secondary | Change From Baseline in Insulin Area Under the Concentration Versus Time Curve From Time Zero to 4 Hours (AUC [0-4h]) | LS mean of the insulin change from baseline was analyzed using a mixed-effects linear model. The model includes treatment, sequence, period, week and treat-by-sequence as fixed effects, baseline as a covariate and participant as random effect. | All participants who received at least one dose of study drug and had evaluable insulin data. | Posted | Least Squares Mean | 95% Confidence Interval | insulin units*h/mL (µU*h/mL) | Baseline, 4 Weeks |
|
|
|
|
| Secondary | Change From Baseline in C-Peptide Area Under the Concentration Versus Time Curve From Time Zero to 4 Hours (AUC [0-4h]) | LS mean of C-peptide change from baseline was analyzed using a mixed-effects linear model. The model includes treatment, sequence, period, week and treat-by-sequence as fixed effects, baseline as a covariate and participant as random effect. | All participants who received at least one dose of study drug and had evaluable c-peptide data. | Posted | Least Squares Mean | 95% Confidence Interval | nanogram*h/milliliter (ng*h/mL) | Baseline, 4 Weeks |
|
|
|
|
| Secondary | Change From Baseline in Glucagon Area Under the Concentration Versus Time Curve From Time Zero to 4 Hours (AUC [0-4h]) | LS mean of glucagon change from baseline was analyzed using a mixed-effects linear model. The model includes treatment, sequence, period, week and treat-by-sequence as fixed effects, baseline as a covariate and participant as random effect. | All participants who received at least one dose of study drug and had evaluable glucagon data. | Posted | Least Squares Mean | 95% Confidence Interval | picomole*h/Liter (pmol*h/L) | Baseline, 4 Weeks |
|
|
|
|
| Secondary | Change From Baseline in Triglyceride Area Under the Concentration Versus Time Curve From Time Zero to 4 Hours (AUC [0-4h]) | LS mean of triglyceride change from baseline was analyzed using a mixed-effects linear model. The model includes treatment, sequence, period, week and treat-by-sequence as fixed effects, baseline as a covariate and participant as random effect. | All participants who received at least one dose of study drug and had evaluable triglyceride data. | Posted | Least Squares Mean | 95% Confidence Interval | mg*h/dL | Baseline, 4 Weeks |
|
|
|
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| Secondary | Number of Participants Who Develop Hypoglycemic Events | Number of participants who develop hypoglycemic events. | All participants who received at least one dose of study drug. | Posted | Count of Participants | Participants | No | Baseline through 4 weeks |
|
|
|
| 12 |
| 0 |
| 12 |
| 5 |
| 12 |
| EG001 | Placebo | Placebo administered SC once weekly for four weeks. | 0 | 12 | 0 | 12 | 4 | 12 |
| Nausea | Gastrointestinal disorders | MedDRA 20.0 | Systematic Assessment |
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| Periodontal disease | Gastrointestinal disorders | MedDRA 20.0 | Systematic Assessment |
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| Influenza | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
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| Pericoronitis | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
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| Periodontitis | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
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| Pharyngitis | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
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| Viral upper respiratory tract infection | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
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| Decreased appetite | Metabolism and nutrition disorders | MedDRA 20.0 | Systematic Assessment |
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| D004700 | Endocrine System Diseases |