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| ID | Type | Description | Link |
|---|---|---|---|
| H9X-JE-GBGF | Other Identifier | Eli Lilly and Company |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dulaglutide | Experimental | Dulaglutide 0.75 milligram (mg) administered once weekly for 16 weeks. After 16-weeks, dulaglutide administered once weekly for 36 weeks. |
|
| Placebo | Placebo Comparator | Placebo administered once weekly for 16 weeks. After 16-weeks, dulaglutide 0.75 mg administered once weekly for 36 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dulaglutide | Drug | Administered subcutaneously (SC) |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline, Week 16 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Week 16 |
| Change From Baseline in Fasting Serum Glucose (FSG) |
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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. | Adachi-ku | 123-0845 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31994009 | Derived | 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. | |
| 31758520 | Derived | 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. |
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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.
After 16 weeks of the primary double-blind treatment period, participants taking placebo were switched to dulaglutide for an additional 36 weeks of open-label extension treatment. Efficacy was assessed for 16 weeks based on hypoglycemic agent evaluation.
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | Placebo administered subcutaneously (SC) once weekly for 16 weeks. After 16-weeks, Dulaglutide 0.75 milligram (mg) administered SC once weekly for 36 weeks. |
| FG001 | Dulaglutide | Dulaglutide administered SC once weekly for 16 weeks. After 16-weeks, Dulaglutide 0.75 mg administered SC once weekly for 36 weeks. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Double-Blind Treatment Period |
|
| ||||||||||||||||||||||||
| Open-Label Extension Period |
|
All randomized participants who received at least one dose of study drug.
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | Placebo administered SC once weekly for 16 weeks. After 16-weeks, Dulaglutide 0.75 mg administered SC once weekly for 36 weeks. |
| BG001 | Dulaglutide | Dulaglutide 0.75 mg administered SC once weekly for 16 weeks. After 16-weeks, Dulaglutide 0.75 mg administered SC once weekly for 36 weeks. |
| 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 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. | All randomized participants who received at least one dose of study drug and had evaluable baseline and post-baseline HbA1c. | Posted | Least Squares Mean | Standard Error | percentage of HbA1c | Baseline, Week 16 |
|
Up to 52 weeks
All randomized participants who received at least one dose of study drug in the double-blind treatment period and continued to open-label extension period.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo Double-Blind (DB) Treatment Period | Placebo administered SC once weekly for 16 weeks. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cataract | Eye disorders | MedDRA 21.0 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Palpitations | Cardiac disorders | MedDRA 21.0 | Systematic Assessment |
Not provided
| 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 | Jul 11, 2016 | Mar 1, 2019 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Sep 12, 2018 | Mar 1, 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 |
|
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.
| 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). | 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. | 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. | Baseline, Week 16 |
| 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 | 2610004 | 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. | Chiyoda City | 102-0082 | 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. | Chuou-ku | 1030002 | 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. | Chūōku | 103-0027 | 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 | Chūōku | 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. | Fuchū | 183-8524 | 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. | Ichikawa | 272-8516 | 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. | Isahaya | 8548501 | 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 | Kamakura | 247-0056 | 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 | Kashihara | 634-8522 | 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 | 862-0965 | 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 | 862-0976 | 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. | Maebashi | 3710821 | 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 | Mito | 310-0845 | 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 | Naka | 311-0113 | 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 | Nishinomiya | 662-0971 | 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 | 530-0001 | 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 | 870-0039 | 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 | Sasebo | 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 | Shimotsuke | 329-0433 | 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. | Shizuoka | 424-0855 | 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 | Tama | 206-0633 | 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. | Toda | 335-0023 | 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. | Yokohama | 241-0821 | Japan |
| NOT COMPLETED |
|
|
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants | No |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants | No |
|
| Race (NIH/OMB) | Count of Participants | Participants | No |
|
| Region of Enrollment | Count of Participants | Participants | No |
|
| Percentage of Hemoglobin A1c (HbA1c) at Baseline | Mean | Standard Deviation | Percentage of HbA1c |
|
| Percentage of Participants with Insulin regimen | Number | percentage of insulin regimen |
|
| OG001 |
| Dulaglutide |
Dulaglutide 0.75 mg administered SC once weekly for 16 weeks. |
|
|
|
| Secondary | 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. | All randomized participants who received at least one dose of study drug had evaluable post-baseline HbA1c data. HbA1c ≤6.5% had no results since model did not converge. | Posted | Number | percentage of participants | Week 16 |
|
|
|
|
| Secondary | 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. | All randomized participants who received at least one dose of study drug and had evaluable post baseline data. | Posted | Least Squares Mean | Standard Error | milligram/deciliter (mg/dL) | Baseline, Week 16 |
|
|
|
|
| Secondary | 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). | All randomized participants who received at least one dose of study drug and had evaluable post baseline data. | Posted | Least Squares Mean | Standard Error | mg/dL | Baseline, Week 16 |
|
|
|
|
| Secondary | 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. | All randomized participants who received at least one dose of study drug and had evaluable post baseline data. | Posted | Least Squares Mean | Standard Error | kilogram (kg) | Baseline, Week 16 |
|
|
|
|
| Secondary | Change From Baseline in Daily Total Insulin Dose | Mean change from baseline in total insulin dose was measured in each treatment groups. | All randomized participants who received at least one dose of study drug. | Posted | Mean | Standard Deviation | International Units (IU)/Day | Baseline, Week 16 |
|
|
|
| 0 |
| 39 |
| 0 |
| 39 |
| 18 |
| 39 |
| EG001 | Dulaglutide 0.75 mg DB Treatment Period | Dulaglutide 0.75 mg administered SC once weekly for 16 weeks. | 0 | 120 | 3 | 120 | 47 | 120 |
| EG002 | Placebo DB Treatment, Dulaglutide 0.75 mg Extension Period | Placebo administered SC once weekly for 16 weeks then Dulaglutide 0.75 mg administered SC once weekly for 36 weeks. | 0 | 39 | 1 | 39 | 28 | 39 |
| EG003 | Dulaglutide 0.75 mg DB Treatment/Extension Period | Dulaglutide 0.75 mg administered SC once weekly for 52 weeks. | 0 | 120 | 6 | 120 | 59 | 120 |
| Large intestine polyp | Gastrointestinal disorders | MedDRA 21.0 | Systematic Assessment |
|
| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA 21.0 | Systematic Assessment |
|
| Myositis | Musculoskeletal and connective tissue disorders | MedDRA 21.0 | Systematic Assessment |
|
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA 21.0 | Systematic Assessment |
|
| Lung adenocarcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 21.0 | Systematic Assessment |
|
| Depression | Psychiatric disorders | MedDRA 21.0 | Systematic Assessment |
|
| Suicide attempt | Psychiatric disorders | MedDRA 21.0 | Systematic Assessment |
|
| Abdominal discomfort | Gastrointestinal disorders | MedDRA 21.0 | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA 21.0 | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 21.0 | Systematic Assessment |
|
| Dyspepsia | Gastrointestinal disorders | MedDRA 21.0 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 21.0 | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA 21.0 | Systematic Assessment |
|
| Influenza | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
|
| Pharyngitis | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
|
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 21.0 | Systematic Assessment |
|
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA 21.0 | Systematic Assessment |
|
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA 21.0 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 21.0 | Systematic Assessment |
|
Not provided
| D004700 | Endocrine System Diseases |
| Breakfast 2-hour PPBG |
|
|
| Prelunch BG |
|
|
| Lunch 2-hour PPBG |
|
|
| Predinner BG |
|
|
| Dinner 2-hour PPBG |
|
|
| Bedtime BG |
|
|
| <0.001 |
| LS mean difference |
| -45.38 |
| 2-Sided |
| 95 |
| -61.77 |
| -29.00 |
| Superiority |
| Prelunch BG | t-test, 2 sided | <0.001 | LS mean difference | -36.82 | 2-Sided | 95 | -49.20 | -24.45 | Superiority |
| Lunch 2-hour PPBG | t-test, 2 sided | <0.001 | LS mean difference | -50.16 | 2-Sided | 95 | -67.85 | -32.46 | Superiority |
| Predinner BG | t-test, 2 sided | <0.001 | LS mean difference | -31.27 | 2-Sided | 95 | -44.05 | -18.48 | Superiority |
| Dinner 2-hour PPBG | t-test, 2 sided | <0.001 | LS mean difference | -34.97 | 2-Sided | 95 | -52.55 | -17.38 | Superiority |
| Bedtime BG | t-test, 2 sided | <0.001 | LS mean difference | -41.45 | 2-Sided | 95 | -58.81 | -24.09 | Superiority |