Primary outcomeLeast squares mean· Baseline, 26 weeks
Change From Baseline in Glycosylated Hemoglobin (HbA1c) at 26 Weeks
| Group | Value (percentage of HbA1c) | Spread |
|---|---|---|
| LY2189265 + OAM | -1.44 | 0.05 |
| Insulin Glargine + OAM | -0.90 | 0.05 |
Trial · Interventional
CompletedPhase 3Results postedRegistry dataA Study of Dulaglutide in Japanese Participants With Type 2 Diabetes Mellitus
Overview
- Status
- Completed
- Phase
- Phase 3
- Enrollment
- 361 participants (actual)
- Sponsor
- Eli Lilly and Company · Industry
- Design
- Randomized · Open label (no masking)
- Countries
1 country
Japan
- Start
- Apr 2012
- Primary completion
- Jul 2013
- Completion
- Jul 2013
- First posted
- 24 Apr 2012 (estimated)
- Last update posted
- 20 Oct 2014 (estimated)
- Conditions
- Type 2 Diabetes Mellitus
Timeline
1 trial · 1 completed · 1 with posted results
- Completed
- Ongoing
- Not yet recruiting
- Stopped
- Estimated dates (est.)
- Results posted
201220132014
- Ph 3
A Study of Dulaglutide in Japanese Participants With Type 2 Diabetes Mellitus
NCT01584232Apr 2012 to Jul 2013
Registry summary
Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.
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).
Interventions
- LY2189265Drug
- Insulin glargineDrug
- Sulfonylureas (SU)Drug
- Biguanide (BG)Drug
Arms2
Experimental
LY2189265 + OAM
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).
Active comparator
Insulin glargine + OAM
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).
Primary outcomes1
Outcomes the sponsor listed as primary.
Change From Baseline in Glycosylated Hemoglobin (HbA1c) at 26 Weeks
Time frame · Baseline, 26 weeks
Registry description
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.
Secondary outcomes(5)
Percentage of Participants Who Achieved Glycosylated Hemoglobin (HbA1c) <=6.5% or <7% at 26 Weeks
Time frame · Up to 26 weeks
Registry description
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.
Change From Baseline in Fasting Blood Glucose (FBG) at 26 Weeks
Time frame · Baseline, 26 weeks
Registry description
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.
Change From Baseline in 8-Point Self-Monitored Blood Glucose (SMBG) at 26 Weeks
Time frame · Baseline, Up to 26 weeks
Registry description
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.
Change From Baseline in Body Weight at 26 Weeks
Time frame · Baseline, 26 weeks
Registry description
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.
Percentage of Participants With Hypoglycemic Episodes
Time frame · Baseline through 26 Weeks
Registry description
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.
Posted results
Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.
Primary outcome results
Secondary and other outcome results(5)
Secondary outcomeNumber· Up to 26 weeks
Percentage of Participants Who Achieved Glycosylated Hemoglobin (HbA1c) <=6.5% or <7% at 26 Weeks
| Group | Value (percentage of participants) |
|---|---|
| LY2189265 + OAM | 51.1 |
| Insulin Glargine + OAM | 24.0 |
Secondary outcomeLeast squares mean· Baseline, 26 weeks
Change From Baseline in Fasting Blood Glucose (FBG) at 26 Weeks
| Group | Value (milligrams per deciliter (mg/dL)) | Spread |
|---|---|---|
| LY2189265 + OAM | -34.3 | 1.9 |
| Insulin Glargine + OAM | -37.8 | 1.9 |
Secondary outcomeLeast squares mean· Baseline, Up to 26 weeks
Change From Baseline in 8-Point Self-Monitored Blood Glucose (SMBG) at 26 Weeks
| Group | Value (milligrams per deciliter (mg/dL)) | Spread |
|---|---|---|
| LY2189265 + OAM | -33.49 | 1.65 |
| Insulin Glargine + OAM | -38.66 | 1.64 |
Secondary outcomeLeast squares mean· Baseline, 26 weeks
Change From Baseline in Body Weight at 26 Weeks
| Group | Value (kilograms (kg)) | Spread |
|---|---|---|
| LY2189265 + OAM | -0.48 | 0.17 |
| Insulin Glargine + OAM | 0.94 | 0.17 |
Secondary outcomeNumber· Baseline through 26 Weeks
Percentage of Participants With Hypoglycemic Episodes
| Group | Value (percentage of participants) |
|---|---|
| LY2189265 + OAM | 26.0 |
| Insulin Glargine + OAM | 47.8 |
Adverse events, as posted
| Group | Deaths | Serious events | Other events |
|---|---|---|---|
| LY2189265 + OAMLY2189265: 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). | – | 9 / 181 | 133 / 181 |
| Insulin Glargine + OAMInsulin 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). | – | 3 / 180 | 111 / 180 |
Each cell reads participants affected / participants at risk, as the registry posted them.
Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works
Studies1
Studies that cite this trial.
Studies with results
1 study on this page
Indexing hint: Randomized controlled trial · 2017
4 results
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.
Suzuki et al. 2017Health and quality of life outcomescited by 11
PMID 28606095PMC5468988DOI 10.1186/s12955-017-0696-7PUB-28606095
CC BY4 results
Eligibility
Who could join, as posted.
- Sex
- All
- Age
- from 20 Years
- Healthy volunteers
- Not accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria:
* 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)
Exclusion Criteria:
* 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)
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