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| ID | Type | Description | Link |
|---|---|---|---|
| H9X-JE-GBDY | Other Identifier | Eli Lilly and Company |
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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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). |
|
| 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). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LY2189265 | Drug |
|
| |
| Insulin glargine |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline, 26 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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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. | Aichi | 448-0852 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28606095 | Derived | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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). |
| FG001 | 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). |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
All randomized participants who received at least 1 dose of LY2189265 or insulin glargine.
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| ID | Title | Description |
|---|---|---|
| BG000 | 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). |
| Units | Counts |
|---|---|
| Participants |
|
| 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 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. | Participants who were randomized and received at least 1 dose of LY2189265 or insulin glargine with evaluable HbA1c data. Only pre-rescue measurements were used. | Posted | Least Squares Mean | Standard Error | percentage of HbA1c | Baseline, 26 weeks |
|
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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 | 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). |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Acute myocardial infarction | Cardiac disorders | MedDRA 16.1 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 16.1 | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Chief Medical Officer | Eli Lilly and Company | 800-545-5979 |
Not provided
| 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 |
| D000069036 | Insulin Glargine |
| D013453 | Sulfonylurea Compounds |
| D001645 | Biguanides |
| ID | Term |
|---|---|
| D049528 | Insulin, Long-Acting |
| D061385 | Insulins |
| D010187 | Pancreatic Hormones |
| D036361 | Peptide Hormones |
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| Drug |
|
| Sulfonylureas (SU) | Drug |
|
| Biguanide (BG) | Drug |
|
| 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. | 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. | 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. | 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. | Baseline through 26 Weeks |
| Japan |
| 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 | Japan |
| 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. | Ehime | 790-0024 | Japan |
| 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 | 819-0168 | Japan |
| 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. | Hokkaido | 0530018 | Japan |
| 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. | Kagoshima | 8910401 | Japan |
| 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. | Kanagawa | 247-0055 | Japan |
| 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. | Kumamoto | 860-0811 | Japan |
| 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 | 606-8397 | Japan |
| 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. | Nagano | 385-0022 | Japan |
| 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. | Nagasaki | 857-1195 | Japan |
| 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 | Japan |
| 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 | Japan |
| 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 | 103-0028 | Japan |
| 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 | Japan |
| Physician Decision |
|
| Lost to Follow-up |
|
| BG001 | 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). |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Number | participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | 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). |
|
|
|
| Secondary | 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. | Participants who were randomized and received at least 1 dose of LY2189265 or insulin glargine with evaluable HbA1c data. Only pre-rescue measurements were used. Missing endpoints were imputed with the last observation carried forward (LOCF), using only postbaseline data. | Posted | Number | percentage of participants | Up to 26 weeks |
|
|
|
|
| Secondary | 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. | Participants who were randomized and received at least 1 dose of LY2189265 or insulin glargine with evaluable fasting blood glucose data. Only pre-rescue measurements were used. | Posted | Least Squares Mean | Standard Error | milligrams per deciliter (mg/dL) | Baseline, 26 weeks |
|
|
|
|
| Secondary | 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. | Participants who were randomized and received at least 1 dose of LY2189265 or insulin glargine with evaluable SMBG data. Only pre-rescue measurements were used. Missing endpoints were imputed with the last observation carried forward (LOCF), using only postbaseline data. | Posted | Least Squares Mean | Standard Error | milligrams per deciliter (mg/dL) | Baseline, Up to 26 weeks |
|
|
|
|
| Secondary | 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. | Participants who were randomized and received at least 1 dose of LY2189265 or insulin glargine with evaluable body weight data. Only pre-rescue measurements were used. | Posted | Least Squares Mean | Standard Error | kilograms (kg) | Baseline, 26 weeks |
|
|
|
|
| Secondary | 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. | Participants who were randomized and received at least 1 dose of LY2189265 or insulin glargine. Only pre-rescue data was used. | Posted | Number | percentage of participants | Baseline through 26 Weeks |
|
|
|
|
| 9 |
| 181 |
| 133 |
| 181 |
| EG001 | 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). | 3 | 180 | 111 | 180 |
| Cholelithiasis | Hepatobiliary disorders | MedDRA 16.1 | Systematic Assessment |
|
| Hyperplastic cholecystopathy | Hepatobiliary disorders | MedDRA 16.1 | Systematic Assessment |
|
| Anal abscess | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
|
| Fall | Injury, poisoning and procedural complications | MedDRA 16.1 | Systematic Assessment |
|
| Patella fracture | Injury, poisoning and procedural complications | MedDRA 16.1 | Systematic Assessment |
|
| Colon neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.1 | Systematic Assessment |
|
| Liver carcinoma ruptured | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.1 | Systematic Assessment |
|
| Cerebral infarction | Nervous system disorders | MedDRA 16.1 | Systematic Assessment |
|
| Spinal cord infarction | Nervous system disorders | MedDRA 16.1 | Systematic Assessment |
|
| Viith nerve paralysis | Nervous system disorders | MedDRA 16.1 | Systematic Assessment |
|
| Calculus ureteric | Renal and urinary disorders | MedDRA 16.1 | Systematic Assessment |
|
| Iron deficiency anaemia | Blood and lymphatic system disorders | MedDRA 16.1 | Systematic Assessment |
|
| Angina pectoris | Cardiac disorders | MedDRA 16.1 | Systematic Assessment |
|
| Bundle branch block right | Cardiac disorders | MedDRA 16.1 | Systematic Assessment |
|
| Palpitations | Cardiac disorders | MedDRA 16.1 | Systematic Assessment |
|
| Supraventricular tachycardia | Cardiac disorders | MedDRA 16.1 | Systematic Assessment |
|
| Vertigo | Ear and labyrinth disorders | MedDRA 16.1 | Systematic Assessment |
|
| Vertigo positional | Ear and labyrinth disorders | MedDRA 16.1 | Systematic Assessment |
|
| Age-related macular degeneration | Eye disorders | MedDRA 16.1 | Systematic Assessment |
|
| Asthenopia | Eye disorders | MedDRA 16.1 | Systematic Assessment |
|
| Cataract | Eye disorders | MedDRA 16.1 | Systematic Assessment |
|
| Conjunctival haemorrhage | Eye disorders | MedDRA 16.1 | Systematic Assessment |
|
| Conjunctivitis | Eye disorders | MedDRA 16.1 | Systematic Assessment |
|
| Conjunctivitis allergic | Eye disorders | MedDRA 16.1 | Systematic Assessment |
|
| Cystoid macular oedema | Eye disorders | MedDRA 16.1 | Systematic Assessment |
|
| Diabetic retinopathy | Eye disorders | MedDRA 16.1 | Systematic Assessment |
|
| Dry eye | Eye disorders | MedDRA 16.1 | Systematic Assessment |
|
| Eyelid ptosis | Eye disorders | MedDRA 16.1 | Systematic Assessment |
|
| Keratitis | Eye disorders | MedDRA 16.1 | Systematic Assessment |
|
| Macular degeneration | Eye disorders | MedDRA 16.1 | Systematic Assessment |
|
| Macular oedema | Eye disorders | MedDRA 16.1 | Systematic Assessment |
|
| Photopsia | Eye disorders | MedDRA 16.1 | Systematic Assessment |
|
| Retinal vein occlusion | Eye disorders | MedDRA 16.1 | Systematic Assessment |
|
| Abdominal discomfort | Gastrointestinal disorders | MedDRA 16.1 | Systematic Assessment |
|
| Abdominal distension | Gastrointestinal disorders | MedDRA 16.1 | Systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA 16.1 | Systematic Assessment |
|
| Abdominal pain lower | Gastrointestinal disorders | MedDRA 16.1 | Systematic Assessment |
|
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 16.1 | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA 16.1 | Systematic Assessment |
|
| Dental caries | Gastrointestinal disorders | MedDRA 16.1 | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 16.1 | Systematic Assessment |
|
| Dyspepsia | Gastrointestinal disorders | MedDRA 16.1 | Systematic Assessment |
|
| Enterocolitis | Gastrointestinal disorders | MedDRA 16.1 | Systematic Assessment |
|
| Epigastric discomfort | Gastrointestinal disorders | MedDRA 16.1 | Systematic Assessment |
|
| Gastritis | Gastrointestinal disorders | MedDRA 16.1 | Systematic Assessment |
|
| Gastritis atrophic | Gastrointestinal disorders | MedDRA 16.1 | Systematic Assessment |
|
| Gastrointestinal motility disorder | Gastrointestinal disorders | MedDRA 16.1 | Systematic Assessment |
|
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA 16.1 | Systematic Assessment |
|
| Haemorrhoids | Gastrointestinal disorders | MedDRA 16.1 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 16.1 | Systematic Assessment |
|
| Periodontal disease | Gastrointestinal disorders | MedDRA 16.1 | Systematic Assessment |
|
| Toothache | Gastrointestinal disorders | MedDRA 16.1 | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA 16.1 | Systematic Assessment |
|
| Chest pain | General disorders | MedDRA 16.1 | Systematic Assessment |
|
| Chills | General disorders | MedDRA 16.1 | Systematic Assessment |
|
| Fatigue | General disorders | MedDRA 16.1 | Systematic Assessment |
|
| Feeling abnormal | General disorders | MedDRA 16.1 | Systematic Assessment |
|
| Infusion site induration | General disorders | MedDRA 16.1 | Systematic Assessment |
|
| Injection site bruising | General disorders | MedDRA 16.1 | Systematic Assessment |
|
| Injection site dermatitis | General disorders | MedDRA 16.1 | Systematic Assessment |
|
| Injection site hypersensitivity | General disorders | MedDRA 16.1 | Systematic Assessment |
|
| Injection site pruritus | General disorders | MedDRA 16.1 | Systematic Assessment |
|
| Malaise | General disorders | MedDRA 16.1 | Systematic Assessment |
|
| Oedema | General disorders | MedDRA 16.1 | Systematic Assessment |
|
| Oedema due to renal disease | General disorders | MedDRA 16.1 | Systematic Assessment |
|
| Oedema peripheral | General disorders | MedDRA 16.1 | Systematic Assessment |
|
| Cholelithiasis | Hepatobiliary disorders | MedDRA 16.1 | Systematic Assessment |
|
| Gallbladder polyp | Hepatobiliary disorders | MedDRA 16.1 | Systematic Assessment |
|
| Hepatic calcification | Hepatobiliary disorders | MedDRA 16.1 | Systematic Assessment |
|
| Hepatic cyst | Hepatobiliary disorders | MedDRA 16.1 | Systematic Assessment |
|
| Hepatic steatosis | Hepatobiliary disorders | MedDRA 16.1 | Systematic Assessment |
|
| Seasonal allergy | Immune system disorders | MedDRA 16.1 | Systematic Assessment |
|
| Abscess oral | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
|
| Bacterial diarrhoea | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
|
| Bronchitis | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
|
| Bronchopulmonary aspergillosis | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
|
| Cystitis | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
|
| Enteritis infectious | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
|
| Enterocolitis bacterial | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
|
| Gastroenteritis | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
|
| Gastroenteritis bacterial | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
|
| Gastroenteritis viral | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
|
| Gingivitis | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
|
| Helicobacter infection | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
|
| Herpes zoster | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
|
| Hordeolum | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
|
| Impetigo | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
|
| Influenza | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
|
| Laryngitis | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
|
| Lymphadenitis bacterial | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
|
| Mastitis | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
|
| Oral herpes | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
|
| Periodontitis | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
|
| Pharyngitis | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
|
| Pyelonephritis acute | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
|
| Sinusitis | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
|
| Subcutaneous abscess | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
|
| Tinea infection | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
|
| Tinea pedis | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
|
| Tonsillitis | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
|
| Upper respiratory tract infection bacterial | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
|
| Arthropod sting | Injury, poisoning and procedural complications | MedDRA 16.1 | Systematic Assessment |
|
| Contusion | Injury, poisoning and procedural complications | MedDRA 16.1 | Systematic Assessment |
|
| Foot fracture | Injury, poisoning and procedural complications | MedDRA 16.1 | Systematic Assessment |
|
| Joint injury | Injury, poisoning and procedural complications | MedDRA 16.1 | Systematic Assessment |
|
| Ligament sprain | Injury, poisoning and procedural complications | MedDRA 16.1 | Systematic Assessment |
|
| Thermal burn | Injury, poisoning and procedural complications | MedDRA 16.1 | Systematic Assessment |
|
| Amylase increased | Investigations | MedDRA 16.1 | Systematic Assessment |
|
| Blood creatine phosphokinase increased | Investigations | MedDRA 16.1 | Systematic Assessment |
|
| Blood pressure increased | Investigations | MedDRA 16.1 | Systematic Assessment |
|
| Blood urea increased | Investigations | MedDRA 16.1 | Systematic Assessment |
|
| Blood urine present | Investigations | MedDRA 16.1 | Systematic Assessment |
|
| Heart rate increased | Investigations | MedDRA 16.1 | Systematic Assessment |
|
| Lipase increased | Investigations | MedDRA 16.1 | Systematic Assessment |
|
| Occult blood | Investigations | MedDRA 16.1 | Systematic Assessment |
|
| Weight decreased | Investigations | MedDRA 16.1 | Systematic Assessment |
|
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 16.1 | Systematic Assessment |
|
| Dyslipidaemia | Metabolism and nutrition disorders | MedDRA 16.1 | Systematic Assessment |
|
| Hyperuricaemia | Metabolism and nutrition disorders | MedDRA 16.1 | Systematic Assessment |
|
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA 16.1 | Systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 16.1 | Systematic Assessment |
|
| Arthritis | Musculoskeletal and connective tissue disorders | MedDRA 16.1 | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 16.1 | Systematic Assessment |
|
| Bursitis | Musculoskeletal and connective tissue disorders | MedDRA 16.1 | Systematic Assessment |
|
| Intervertebral disc protrusion | Musculoskeletal and connective tissue disorders | MedDRA 16.1 | Systematic Assessment |
|
| Limb discomfort | Musculoskeletal and connective tissue disorders | MedDRA 16.1 | Systematic Assessment |
|
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA 16.1 | Systematic Assessment |
|
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA 16.1 | Systematic Assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 16.1 | Systematic Assessment |
|
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA 16.1 | Systematic Assessment |
|
| Sensation of heaviness | Musculoskeletal and connective tissue disorders | MedDRA 16.1 | Systematic Assessment |
|
| Spinal column stenosis | Musculoskeletal and connective tissue disorders | MedDRA 16.1 | Systematic Assessment |
|
| Spinal ligament ossification | Musculoskeletal and connective tissue disorders | MedDRA 16.1 | Systematic Assessment |
|
| Tenosynovitis | Musculoskeletal and connective tissue disorders | MedDRA 16.1 | Systematic Assessment |
|
| Carotid arteriosclerosis | Nervous system disorders | MedDRA 16.1 | Systematic Assessment |
|
| Cerebellar infarction | Nervous system disorders | MedDRA 16.1 | Systematic Assessment |
|
| Cervicobrachial syndrome | Nervous system disorders | MedDRA 16.1 | Systematic Assessment |
|
| Diabetic neuropathy | Nervous system disorders | MedDRA 16.1 | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA 16.1 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 16.1 | Systematic Assessment |
|
| Hypoaesthesia | Nervous system disorders | MedDRA 16.1 | Systematic Assessment |
|
| Vith nerve paralysis | Nervous system disorders | MedDRA 16.1 | Systematic Assessment |
|
| Alcohol problem | Psychiatric disorders | MedDRA 16.1 | Systematic Assessment |
|
| Insomnia | Psychiatric disorders | MedDRA 16.1 | Systematic Assessment |
|
| Mental disorder | Psychiatric disorders | MedDRA 16.1 | Systematic Assessment |
|
| Calculus ureteric | Renal and urinary disorders | MedDRA 16.1 | Systematic Assessment |
|
| Calculus urinary | Renal and urinary disorders | MedDRA 16.1 | Systematic Assessment |
|
| Diabetic nephropathy | Renal and urinary disorders | MedDRA 16.1 | Systematic Assessment |
|
| Dysuria | Renal and urinary disorders | MedDRA 16.1 | Systematic Assessment |
|
| Renal cyst | Renal and urinary disorders | MedDRA 16.1 | Systematic Assessment |
|
| Benign prostatic hyperplasia | Reproductive system and breast disorders | MedDRA 16.1 | Systematic Assessment |
|
| Endometriosis | Reproductive system and breast disorders | MedDRA 16.1 | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 16.1 | Systematic Assessment |
|
| Hiccups | Respiratory, thoracic and mediastinal disorders | MedDRA 16.1 | Systematic Assessment |
|
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 16.1 | Systematic Assessment |
|
| Rhinitis allergic | Respiratory, thoracic and mediastinal disorders | MedDRA 16.1 | Systematic Assessment |
|
| Sleep apnoea syndrome | Respiratory, thoracic and mediastinal disorders | MedDRA 16.1 | Systematic Assessment |
|
| Upper respiratory tract inflammation | Respiratory, thoracic and mediastinal disorders | MedDRA 16.1 | Systematic Assessment |
|
| Acne | Skin and subcutaneous tissue disorders | MedDRA 16.1 | Systematic Assessment |
|
| Asteatosis | Skin and subcutaneous tissue disorders | MedDRA 16.1 | Systematic Assessment |
|
| Dermatitis | Skin and subcutaneous tissue disorders | MedDRA 16.1 | Systematic Assessment |
|
| Dermatitis contact | Skin and subcutaneous tissue disorders | MedDRA 16.1 | Systematic Assessment |
|
| Eczema | Skin and subcutaneous tissue disorders | MedDRA 16.1 | Systematic Assessment |
|
| Eczema asteatotic | Skin and subcutaneous tissue disorders | MedDRA 16.1 | Systematic Assessment |
|
| Prurigo | Skin and subcutaneous tissue disorders | MedDRA 16.1 | Systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 16.1 | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA 16.1 | Systematic Assessment |
|
| Urticaria chronic | Skin and subcutaneous tissue disorders | MedDRA 16.1 | Systematic Assessment |
|
| Percutaneous coronary intervention | Surgical and medical procedures | MedDRA 16.1 | Systematic Assessment |
|
| Tooth extraction | Surgical and medical procedures | MedDRA 16.1 | Systematic Assessment |
|
| Hot flush | Vascular disorders | MedDRA 16.1 | Systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA 16.1 | Systematic Assessment |
|
Not provided
| D004700 | Endocrine System Diseases |
| D006728 |
| Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D014508 | Urea |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |
| D006146 | Guanidines |
| D000578 | Amidines |
Treatment comparison for HbA1c <7%. |
| No |
| Superiority or Other |
| Pre-midday meal (n=178, 179) |
|
| 2 hours post-midday meal (n=178, 179) |
|
| Pre-evening meal (n=178, 179) |
|
| 2 hours post-evening meal (n=177, 178) |
|
| Bedtime (n=177, 172) |
|
| Second pre-morning meal (n=178, 179) |
|
| 0.003 |
Treatment comparison for 2 hours post-morning meal. |
| LS Mean Difference |
| -13.40 |
| 2-Sided |
| 95 |
| -22.28 |
| -4.52 |
| No |
| Superiority or Other |
| ANCOVA | 0.025 | Treatment comparison for pre-midday meal. | LS Mean Difference | -8.22 | 2-Sided | 95 | -15.37 | -1.06 | No | Superiority or Other |
| ANCOVA | <0.001 | Treatment comparison for 2 hours post-midday meal. | LS Mean Difference | -23.22 | 2-Sided | 95 | -31.92 | -14.51 | No | Superiority or Other |
| ANCOVA | <0.001 | Treatment comparison for pre-evening meal. | LS Mean Difference | -13.63 | 2-Sided | 95 | -21.03 | -6.24 | No | Superiority or Other |
| ANCOVA | <0.001 | Treatment comparison for 2 hours post-evening meal. | LS Mean Difference | -31.13 | 2-Sided | 95 | -39.26 | -23.00 | No | Superiority or Other |
| ANCOVA | <0.001 | Treatment comparison for bedtime. | LS Mean Difference | -23.73 | 2-Sided | 95 | -31.68 | -15.79 | No | Superiority or Other |
| ANCOVA | 0.005 | Treatment comparison for second pre-morning meal. | LS Mean Difference | 6.21 | 2-Sided | 95 | 1.92 | 10.50 | No | Superiority or Other |