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| Name | Class |
|---|---|
| Novo Nordisk A/S | INDUSTRY |
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Basal-bolus insulin therapy is recommended for patients with poorly controlled type 2 diabetes (T2D) and HbA1c >9%. However, basal-bolus insulin is labor intensive and associated with increased risk of hypoglycemia, glycemic variability, weight gain and poor compliance. Thus, there is a critical need for a simpler treatment regimen that could overcome these limitations. IDegLira, a fixed-ratio combination (FRC) therapy consisting of insulin degludec and liraglutide, is an attractive option for this population given its proven benefits on glycemic control, weight and compliance. This study aims to show that a simpler regimen using a novel FRC agent (IDegLira) can improve glycemic control, decrease hypoglycemia, reduce the burden of diabetes care, and improve satisfaction/adherence in patients with poorly controlled T2D with HbA1c between ≥ 9-12%. This open-label, treat-to- target, two-arm parallel, controlled trial will randomize participants with T2D and HbA1c ≥ 9%, treated with oral anti-diabetic agents and/or basal insulin therapy to lDegLira or basal-bolus insulin for 26 weeks.
Extensive literature has shown that persistent hyperglycemia is associated with short- and long-term complications. Sustained hyperglycemia, also known as glucotoxicity, leads to progressive loss of beta-cell function and is considered a key pathophysiological process in the development of type 2 diabetes (T2D). Patients with severe hyperglycemia may respond poorly to oral anti-diabetic agents (OAD) alone initially and frequently require insulin to achieve glycemic targets. Current guidelines recommend to initiate therapy with basal insulin and progressively step up to basal-bolus insulin in patients with high HbA1c >9%, particularly if symptomatic or with catabolic symptoms.
A basal-bolus insulin regimen increases the risk of hypoglycemia, weight gain and glycemic variability, which are limiting factors in achieving glycemic targets. A basal-bolus insulin regimen is also labor intensive and often requires multiple daily injections, further increasing the burden of diabetes care and decreasing patient adherence. In contrast, simplified treatment plans may improve adherence, leading to glycemic targets achievement. Thus, there is a critical need for simpler regimens that could overcome clinical inertia, improve patient adherence, and decrease glycemic variability in patients with poorly controlled type 2 diabetes. This prospective randomized control trial will compare IDegLira to basal-bolus insulin regimen in achieving glycemic control, while reducing hypoglycemia, glycemic variability, and weight gain in patients with uncontrolled T2D and HbA1c ≥9%.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| IDegLira | Experimental | Participants in this group will receive IDegLira (with metformin, unless contraindicated) for 26 weeks. |
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| Basal-Bolus Insulin | Active Comparator | Participants in this group will receive basal-bolus insulin (with metformin, unless contraindicated) for 26 weeks. The basal-bolus insulin regimen includes Insulin Degludec (U-100) and Insulin Aspart. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| IDegLira | Drug | Participants in this study arm will discontinue all other diabetes medications, except for metformin which will be continued at prescribed dose (unless contraindicated). IDegLira will be given once daily, at the same time of the day with or without food for 26 weeks. IDegLira will be titrated until the maximum dose is reached, up to the target fasting blood glucose of 70 to 100 milligrams per deciliter (mg/dL). |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Hemoglobin A1c (HbA1c) | HbA1c will be compared between study groups. HbA1c measures the average percentage of blood sugar over the past 2 to 3 months and HbA1c can reduce with management of diabetes through diet, exercise, and medication. HbA1c levels below 5.7% are considered normal. Persons with values between 5.7% and 6.4% are considered at high risk of developing diabetes while those with values of 6.5% and above are diagnosed with diabetes. Persons with diabetes aim to get their HbA1c in the range of 7.0 to 7.5% or lower, with below 7.0% being preferable. | Baseline, Week 26 |
| Measure | Description | Time Frame |
|---|---|---|
| Average Fasting Blood Glucose | Mean fasting blood glucose will be compared between study arms. Participants will perform an 8-point, self-monitored blood glucose (SMBG) check by testing their blood sugar at 8 different time points. The measurement taken before breakfast is used to assess fasting blood glucose. For people without diabetes, fasting blood glucose is typically between 70-100 mg/dL while fasting blood glucose for those with diabetes is in the range of 70-130 mg/dL. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Rodolfo Galindo, MD | Emory University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Grady Health System | Atlanta | Georgia | 30303 | United States | ||
| Emory Clinic |
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| ID | Title | Description |
|---|---|---|
| FG000 | IDegLira | Participants in this group will receive IDegLira (with metformin, unless contraindicated) for 26 weeks. IDegLira: Participants in this study arm will discontinue all other diabetes medications, except for metformin which will be continued at prescribed dose (unless contraindicated). IDegLira will be given once daily, at the same time of the day with or without food for 26 weeks. IDegLira will be titrated until the maximum dose is reached, up to the target fasting blood glucose of 70 to 100 milligrams per deciliter (mg/dL). |
| FG001 | Basal-Bolus Insulin | Participants in this group will receive basal-bolus insulin (with metformin, unless contraindicated) for 26 weeks. The basal-bolus insulin regimen includes Insulin Degludec (U-100) and Insulin Aspart. Insulin Degludec (U-100): Participants in the basal-bolus insulin study arm will discontinue all other diabetes medications, except for metformin which will be continued at the prescribed dose (unless contraindicated). Insulin Degludec (U-100) will be given once daily at the same time for 26 weeks. The dose will be titrated up to the fasting blood glucose target of 70 to 100 mg/dL, with no maximum dose. Insulin Aspart: Participants in the basal-bolus insulin study arm will discontinue all other diabetes medications, except for metformin which will be continued at the prescribed dose (unless contraindicated). Insulin aspart will be taken before meals with a titration schedule and dose adjustment protocol to target pre-meal blood glucose level of 70 to 100 mg/dL. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | IDegLira | Participants in this group will receive IDegLira (with metformin, unless contraindicated) for 26 weeks. IDegLira: Participants in this study arm will discontinue all other diabetes medications, except for metformin which will be continued at prescribed dose (unless contraindicated). IDegLira will be given once daily, at the same time of the day with or without food for 26 weeks. IDegLira will be titrated until the maximum dose is reached, up to the target fasting blood glucose of 70 to 100 milligrams per deciliter (mg/dL). |
| 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 in Hemoglobin A1c (HbA1c) | HbA1c will be compared between study groups. HbA1c measures the average percentage of blood sugar over the past 2 to 3 months and HbA1c can reduce with management of diabetes through diet, exercise, and medication. HbA1c levels below 5.7% are considered normal. Persons with values between 5.7% and 6.4% are considered at high risk of developing diabetes while those with values of 6.5% and above are diagnosed with diabetes. Persons with diabetes aim to get their HbA1c in the range of 7.0 to 7.5% or lower, with below 7.0% being preferable. | Number of patients analyzed include participants that completed the visit and had a valid HbA1c result. | Posted | Mean | Standard Deviation | percentage of HbA1c | Baseline, Week 26 |
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Duration of the study participation from enrollment up to 6 months
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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 | IDegLira | Participants in this group will receive IDegLira (with metformin, unless contraindicated) for 26 weeks. IDegLira: Participants in this study arm will discontinue all other diabetes medications, except for metformin which will be continued at prescribed dose (unless contraindicated). IDegLira will be given once daily, at the same time of the day with or without food for 26 weeks. IDegLira will be titrated until the maximum dose is reached, up to the target fasting blood glucose of 70 to 100 milligrams per deciliter (mg/dL). |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hospital Readmissions | General disorders | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea | Gastrointestinal disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Rodolfo Galindo | University of Miami Miller School of Medicine | 305-243-7707 | Rodolfo.galindo@miami.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 12, 2021 | Jul 5, 2023 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| C000613158 | IDegLira |
| C571886 | insulin degludec |
| D000069450 | Liraglutide |
| D061267 | Insulin Aspart |
| ID | Term |
|---|---|
| D052216 | Glucagon-Like Peptide 1 |
| D004763 | Glucagon-Like Peptides |
| D052336 | Proglucagon |
| D005768 | Gastrointestinal Hormones |
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Participants will be randomized in a 1 to 1 ratio to receive the study treatment or standard of care.
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| Insulin Degludec (U-100) | Drug | Participants in the basal-bolus insulin study arm will discontinue all other diabetes medications, except for metformin which will be continued at the prescribed dose (unless contraindicated). Insulin Degludec (U-100) will be given once daily at the same time for 26 weeks. The dose will be titrated up to the fasting blood glucose target of 70 to 100 mg/dL, with no maximum dose. |
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| Insulin Aspart | Drug | Participants in the basal-bolus insulin study arm will discontinue all other diabetes medications, except for metformin which will be continued at the prescribed dose (unless contraindicated). Insulin aspart will be taken before meals with a titration schedule and dose adjustment protocol to target pre-meal blood glucose level of 70 to 100 mg/dL. |
|
|
| Week1, Week 12, Week 26 |
| Average Daily Blood Glucose | Mean daily blood glucose will be compared between study arms. Participants will perform an 8-point, self-monitored blood glucose (SMBG) check by testing their blood sugar at 8 different time points. Blood glucose levels vary depending on when and what food has been consumed. A blood glucose level taken regardless of timing of meals of greater than 200 mg/dL often indicates diabetes. Blood glucose decreases with improved diabetes management. | Week1, Week 12, Week 26 |
| Participants With HbA1c <7.0% and no Hypoglycemia | Percent of study participants experiencing HbA1c <7.0% and no hypoglycemia will be compared between groups. Persons with diabetes aim to get their HbA1c in the range of 7.0 to 7.5% or lower, with below 7.0% being preferable. Hypoglycemia is defined as a blood glucose level of < 70 mg/dL. | Week 26 |
| Participants With HbA1c <7.0% and no Weight Gain and no Hypoglycemia | Percent of study participants reaching A1c < 7% without weight gain and no hypoglycemia will be compared between groups. Weight control is typically important in persons with type 2 diabetes and basal-bolus insulin is associated with weight gain. Persons with diabetes aim to get their HbA1c in the range of 7.0 to 7.5% or lower, with below 7.0% being preferable. Hypoglycemia is defined as a blood glucose level of < 70 mg/dL. | Week 26 |
| Participants With HbA1c <7.5% and no Weight Gain and no Hypoglycemia | Percent of study participants reaching A1c < 7.5% without weight gain and no hypoglycemia will be compared between groups. Weight control is typically important in persons with type 2 diabetes and basal-bolus insulin is associated with weight gain. Persons with diabetes aim to get their HbA1c in the range of 7.0 to 7.5% or lower, with below 7.0% being preferable. Hypoglycemia is defined as a blood glucose level of < 70 mg/dL. | Week 26 |
| Participants With HbA1c >10% Achieving HbA1c <7.5% | Percent of study participants with baseline HbA1c >10% reaching A1c < 7.5% will be compared between study groups. HbA1c measures the average percentage of blood sugar over the past 2 to 3 months and HbA1c can reduce with management of diabetes through diet, exercise, and medication. HbA1c levels below 5.7% are considered normal. Persons with values between 5.7% and 6.4% are considered at high risk of developing diabetes while those with values of 6.5% and above are diagnosed with diabetes. Persons with diabetes aim to get their HbA1c in the range of 7.0 to 7.5% or lower, with below 7.0% being preferable. | Baseline, Week 26 |
| Participants With HbA1c >10% Achieving HbA1c <8.0% | Percent of study participants with baseline HbA1c >10% reaching A1c < 8.0% will be compared between study groups. HbA1c measures the average percentage of blood sugar over the past 2 to 3 months and HbA1c can reduce with management of diabetes through diet, exercise, and medication. HbA1c levels below 5.7% are considered normal. Persons with values between 5.7% and 6.4% are considered at high risk of developing diabetes while those with values of 6.5% and above are diagnosed with diabetes. Persons with diabetes aim to get their HbA1c in the range of 7.0 to 7.5% or lower, with below 7.0% being preferable. | Baseline, Week 26 |
| Participants With HbA1c >11% Achieving HbA1c <7.5% | Percent of study participants with baseline HbA1c >11% reaching A1c < 7.5% will be compared between study groups. HbA1c measures the average percentage of blood sugar over the past 2 to 3 months and HbA1c can reduce with management of diabetes through diet, exercise, and medication. HbA1c levels below 5.7% are considered normal. Persons with values between 5.7% and 6.4% are considered at high risk of developing diabetes while those with values of 6.5% and above are diagnosed with diabetes. Persons with diabetes aim to get their HbA1c in the range of 7.0 to 7.5% or lower, with below 7.0% being preferable. | Baseline, Week 26 |
| Participants With HbA1c >11% Achieving HbA1c <8.0% | Percent of study participants with baseline HbA1c >11% reaching A1c < 8.0% will be compared between study groups. HbA1c measures the average percentage of blood sugar over the past 2 to 3 months and HbA1c can reduce with management of diabetes through diet, exercise, and medication. HbA1c levels below 5.7% are considered normal. Persons with values between 5.7% and 6.4% are considered at high risk of developing diabetes while those with values of 6.5% and above are diagnosed with diabetes. Persons with diabetes aim to get their HbA1c in the range of 7.0 to 7.5% or lower, with below 7.0% being preferable. | Baseline, Week 26 |
| Participants With HbA1c <7.0% and no Weight Gain | Percent of study participants reaching A1c < 7% without weight gain will be compared between groups. | Week 26 |
| Participants With HbA1c <7.0% and no Hypoglycemia | Percent of study participants reaching A1c < 7% without hypoglycemia will be compared between groups. Hypoglycemia is defined as a blood glucose level of < 70 mg/dL. | Week 12 |
| Number of Participants With Documented Symptomatic Hypoglycemic Events | Documented symptomatic hypoglycemia is defined as an event with typical symptoms of hypoglycemia accompanied by SMBG <70 mg/dL or continuous glucose monitoring (CGM) < 54 mg/dL that occurs at any time of the day. Number of participants with documented hypoglycemic events will be compared between study groups. | Baseline through Week 26 |
| Asymptomatic Hypoglycemic Events | Asymptomatic hypoglycemia is defined as no typical symptoms reported by the study participant but detected by SMBG <70 mg/dL or continuous glucose monitoring (CGM) < 54 mg/dL. Incidence of asymptomatic hypoglycemic events will be compared between study groups. | Baseline through Week 26 |
| Number of Participants With Severe Hypoglycemic Events | Severe hypoglycemia is defined as severe cognitive impairment requiring assistance from another person. Number of participants with severe hypoglycemic events will be compared between study groups. | Baseline through Week 26 |
| Nocturnal Symptomatic Hypoglycemic Events | Nocturnal symptomatic hypoglycemia is defined as an event with typical symptoms of hypoglycemia accompanied by SMBG <70 mg/dL or continuous glucose monitoring (CGM) < 54 mg/dL that occurs between midnight and 5:59 am. Incidence of nocturnal symptomatic hypoglycemic events will be compared between study groups. | Baseline through Week 26 |
| Nocturnal Asymptomatic Hypoglycemic Events | Nocturnal asymptomatic hypoglycemia is defined as SMBG <70 mg/dL or continuous glucose monitoring (CGM) < 54 mg/dL between midnight and 5:59 am. Incidence of nocturnal asymptomatic hypoglycemic events will be compared between study groups. | Baseline through Week 26 |
| Percentage of Time With Interstitial Glucose <70 mg/dL | Percentage of time with a interstitial glucose level below 70 mg/dL as obtained by CGM will be compared between study groups. | Baseline through Week 26 |
| Percentage of Time With Interstitial Glucose <54 mg/dL | Percentage of time with a interstitial glucose level below <54 mg/dL as obtained by CGM will be compared between study groups. | Baseline through Week 26 |
| Percentage of Time With Interstitial Glucose Between 70 and 180 mg/dL | Percentage of time with interstitial glucose in the range of 70-180 mg/dL as measured by CGM will be compared between study groups. | Baseline through Week 26 |
| Glycemic Variability | Glycemic variability will be assessed with continuous glucose monitoring (CGM). It will be calculated using CGM and Standard Deviation. | Week1, Week 12, Week 26 |
| Diabetes Treatment Satisfaction Questionnaire - Status (DTSQs) Score | Treatment satisfaction will be assessed with the DTSQs. The DTSQs contains eight items scored on a seven-point scale where 0 = very dissatisfied and 6 = very satisfied. The satisfaction score is obtained by summing responses to yield a total score between 0 to 48. Higher scores indicate higher satisfaction with diabetes treatment. | Baseline, Week 12 |
| Diabetes Treatment Satisfaction Questionnaire - Change (DTSQc) Score | Satisfaction with the study treatment will be assessed with items 1, 4, 5, 6, 7, and 8 the DTSQc. Items are rated on a scale of -3 (much less satisfied compared to prior treatment) to 3 (much more satisfied compared to prior treatment). Total scores for these three items range from -18 to +18 with higher scores indicating greater satisfaction with the study treatment compared to their prior treatment. | Week 26 |
| Treatment-Related Impact Measures for Diabetes (TRIM-D) Survey Score | Satisfaction with the study treatment will be assessed with the TRIM-D survey. TRIM-D includes 28 items that are scored on a scale from 1 to 5. Total scores are transformed to a scale of 0 to 100 where higher scores indicate increased satisfaction. | Baseline, Week 12, Week 26 |
| Number of Emergency Room (ER) Visits | The number of emergency room visits occurring during the treatment period will be compared between study groups. | Baseline through Week 26 |
| Number of Hospital Readmissions | The number of hospital readmissions occurring during the treatment period will be compared between study groups. | Baseline through Week 26 |
| Total Daily Insulin Dose | The total insulin dose measured in units per day will be compared between study groups. | Baseline, Week 26 |
| Atlanta |
| Georgia |
| 30322 |
| United States |
| BG001 | Basal-Bolus Insulin | Participants in this group will receive basal-bolus insulin (with metformin, unless contraindicated) for 26 weeks. The basal-bolus insulin regimen includes Insulin Degludec (U-100) and Insulin Aspart. Insulin Degludec (U-100): Participants in the basal-bolus insulin study arm will discontinue all other diabetes medications, except for metformin which will be continued at the prescribed dose (unless contraindicated). Insulin Degludec (U-100) will be given once daily at the same time for 26 weeks. The dose will be titrated up to the fasting blood glucose target of 70 to 100 mg/dL, with no maximum dose. Insulin Aspart: Participants in the basal-bolus insulin study arm will discontinue all other diabetes medications, except for metformin which will be continued at the prescribed dose (unless contraindicated). Insulin aspart will be taken before meals with a titration schedule and dose adjustment protocol to target pre-meal blood glucose level of 70 to 100 mg/dL. |
| BG002 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| OG001 | Basal-Bolus Insulin | Participants in this group will receive basal-bolus insulin (with metformin, unless contraindicated) for 26 weeks. The basal-bolus insulin regimen includes Insulin Degludec (U-100) and Insulin Aspart. Insulin Degludec (U-100): Participants in the basal-bolus insulin study arm will discontinue all other diabetes medications, except for metformin which will be continued at the prescribed dose (unless contraindicated). Insulin Degludec (U-100) will be given once daily at the same time for 26 weeks. The dose will be titrated up to the fasting blood glucose target of 70 to 100 mg/dL, with no maximum dose. Insulin Aspart: Participants in the basal-bolus insulin study arm will discontinue all other diabetes medications, except for metformin which will be continued at the prescribed dose (unless contraindicated). Insulin aspart will be taken before meals with a titration schedule and dose adjustment protocol to target pre-meal blood glucose level of 70 to 100 mg/dL. |
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| Secondary | Average Fasting Blood Glucose | Mean fasting blood glucose will be compared between study arms. Participants will perform an 8-point, self-monitored blood glucose (SMBG) check by testing their blood sugar at 8 different time points. The measurement taken before breakfast is used to assess fasting blood glucose. For people without diabetes, fasting blood glucose is typically between 70-100 mg/dL while fasting blood glucose for those with diabetes is in the range of 70-130 mg/dL. | Number of participants analyzed include total patients that completed each study visit and provided data for each study visit. | Posted | Mean | Standard Deviation | mg/dL | Week1, Week 12, Week 26 |
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| Secondary | Average Daily Blood Glucose | Mean daily blood glucose will be compared between study arms. Participants will perform an 8-point, self-monitored blood glucose (SMBG) check by testing their blood sugar at 8 different time points. Blood glucose levels vary depending on when and what food has been consumed. A blood glucose level taken regardless of timing of meals of greater than 200 mg/dL often indicates diabetes. Blood glucose decreases with improved diabetes management. | Number of participants analyzed include total patients that completed each study visit and provided data for each study visit. | Posted | Mean | Standard Deviation | mg/dL | Week1, Week 12, Week 26 |
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| Secondary | Participants With HbA1c <7.0% and no Hypoglycemia | Percent of study participants experiencing HbA1c <7.0% and no hypoglycemia will be compared between groups. Persons with diabetes aim to get their HbA1c in the range of 7.0 to 7.5% or lower, with below 7.0% being preferable. Hypoglycemia is defined as a blood glucose level of < 70 mg/dL. | Posted | Count of Participants | Participants | Week 26 |
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| Secondary | Participants With HbA1c <7.0% and no Weight Gain and no Hypoglycemia | Percent of study participants reaching A1c < 7% without weight gain and no hypoglycemia will be compared between groups. Weight control is typically important in persons with type 2 diabetes and basal-bolus insulin is associated with weight gain. Persons with diabetes aim to get their HbA1c in the range of 7.0 to 7.5% or lower, with below 7.0% being preferable. Hypoglycemia is defined as a blood glucose level of < 70 mg/dL. | Posted | Count of Participants | Participants | Week 26 |
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| Secondary | Participants With HbA1c <7.5% and no Weight Gain and no Hypoglycemia | Percent of study participants reaching A1c < 7.5% without weight gain and no hypoglycemia will be compared between groups. Weight control is typically important in persons with type 2 diabetes and basal-bolus insulin is associated with weight gain. Persons with diabetes aim to get their HbA1c in the range of 7.0 to 7.5% or lower, with below 7.0% being preferable. Hypoglycemia is defined as a blood glucose level of < 70 mg/dL. | This outcome include participants with a baseline HbA1c <7.5%. | Posted | Number | percentage of participants | Week 26 |
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| Secondary | Participants With HbA1c >10% Achieving HbA1c <7.5% | Percent of study participants with baseline HbA1c >10% reaching A1c < 7.5% will be compared between study groups. HbA1c measures the average percentage of blood sugar over the past 2 to 3 months and HbA1c can reduce with management of diabetes through diet, exercise, and medication. HbA1c levels below 5.7% are considered normal. Persons with values between 5.7% and 6.4% are considered at high risk of developing diabetes while those with values of 6.5% and above are diagnosed with diabetes. Persons with diabetes aim to get their HbA1c in the range of 7.0 to 7.5% or lower, with below 7.0% being preferable. | This outcome includes participants with a baseline HbA1c >10%. | Posted | Number | percentage of participants | Baseline, Week 26 |
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| Secondary | Participants With HbA1c >10% Achieving HbA1c <8.0% | Percent of study participants with baseline HbA1c >10% reaching A1c < 8.0% will be compared between study groups. HbA1c measures the average percentage of blood sugar over the past 2 to 3 months and HbA1c can reduce with management of diabetes through diet, exercise, and medication. HbA1c levels below 5.7% are considered normal. Persons with values between 5.7% and 6.4% are considered at high risk of developing diabetes while those with values of 6.5% and above are diagnosed with diabetes. Persons with diabetes aim to get their HbA1c in the range of 7.0 to 7.5% or lower, with below 7.0% being preferable. | This outcome includes study participants with baseline HbA1c >10%. | Posted | Number | percentage of participants | Baseline, Week 26 |
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| Secondary | Participants With HbA1c >11% Achieving HbA1c <7.5% | Percent of study participants with baseline HbA1c >11% reaching A1c < 7.5% will be compared between study groups. HbA1c measures the average percentage of blood sugar over the past 2 to 3 months and HbA1c can reduce with management of diabetes through diet, exercise, and medication. HbA1c levels below 5.7% are considered normal. Persons with values between 5.7% and 6.4% are considered at high risk of developing diabetes while those with values of 6.5% and above are diagnosed with diabetes. Persons with diabetes aim to get their HbA1c in the range of 7.0 to 7.5% or lower, with below 7.0% being preferable. | This outcome includes study participants with baseline HbA1c >11%. | Posted | Number | percentage of participants | Baseline, Week 26 |
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| Secondary | Participants With HbA1c >11% Achieving HbA1c <8.0% | Percent of study participants with baseline HbA1c >11% reaching A1c < 8.0% will be compared between study groups. HbA1c measures the average percentage of blood sugar over the past 2 to 3 months and HbA1c can reduce with management of diabetes through diet, exercise, and medication. HbA1c levels below 5.7% are considered normal. Persons with values between 5.7% and 6.4% are considered at high risk of developing diabetes while those with values of 6.5% and above are diagnosed with diabetes. Persons with diabetes aim to get their HbA1c in the range of 7.0 to 7.5% or lower, with below 7.0% being preferable. | This outcome includes study participants with baseline HbA1c >11%. | Posted | Number | percentage of participants | Baseline, Week 26 |
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| Secondary | Participants With HbA1c <7.0% and no Weight Gain | Percent of study participants reaching A1c < 7% without weight gain will be compared between groups. | Posted | Count of Participants | Participants | Week 26 |
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| Secondary | Participants With HbA1c <7.0% and no Hypoglycemia | Percent of study participants reaching A1c < 7% without hypoglycemia will be compared between groups. Hypoglycemia is defined as a blood glucose level of < 70 mg/dL. | Posted | Count of Participants | Participants | Week 12 |
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| Secondary | Number of Participants With Documented Symptomatic Hypoglycemic Events | Documented symptomatic hypoglycemia is defined as an event with typical symptoms of hypoglycemia accompanied by SMBG <70 mg/dL or continuous glucose monitoring (CGM) < 54 mg/dL that occurs at any time of the day. Number of participants with documented hypoglycemic events will be compared between study groups. | CGM hypoglycemia BG < 54 mg/dL was reported only in participants who did not have any issues with the CGM device. | Posted | Number | participants | Baseline through Week 26 |
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| Secondary | Asymptomatic Hypoglycemic Events | Asymptomatic hypoglycemia is defined as no typical symptoms reported by the study participant but detected by SMBG <70 mg/dL or continuous glucose monitoring (CGM) < 54 mg/dL. Incidence of asymptomatic hypoglycemic events will be compared between study groups. | Data for this outcome was not collected. Participants did not record details about symptoms when providing the blood glucose records. | Posted | Baseline through Week 26 |
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| Secondary | Number of Participants With Severe Hypoglycemic Events | Severe hypoglycemia is defined as severe cognitive impairment requiring assistance from another person. Number of participants with severe hypoglycemic events will be compared between study groups. | Participants who reported any BG<54 mg/dL during study participation up to 6 months | Posted | Number | participants | Baseline through Week 26 |
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| Secondary | Nocturnal Symptomatic Hypoglycemic Events | Nocturnal symptomatic hypoglycemia is defined as an event with typical symptoms of hypoglycemia accompanied by SMBG <70 mg/dL or continuous glucose monitoring (CGM) < 54 mg/dL that occurs between midnight and 5:59 am. Incidence of nocturnal symptomatic hypoglycemic events will be compared between study groups. | Posted | Mean | Standard Deviation | Number of events | Baseline through Week 26 |
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| Secondary | Nocturnal Asymptomatic Hypoglycemic Events | Nocturnal asymptomatic hypoglycemia is defined as SMBG <70 mg/dL or continuous glucose monitoring (CGM) < 54 mg/dL between midnight and 5:59 am. Incidence of nocturnal asymptomatic hypoglycemic events will be compared between study groups. | Posted | Mean | Standard Deviation | Number of events | Baseline through Week 26 |
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| Secondary | Percentage of Time With Interstitial Glucose <70 mg/dL | Percentage of time with a interstitial glucose level below 70 mg/dL as obtained by CGM will be compared between study groups. | Number of participants analyzed include total patients that completed the study visit and provided CGM data. | Posted | Mean | Standard Deviation | % of time | Baseline through Week 26 |
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| Secondary | Percentage of Time With Interstitial Glucose <54 mg/dL | Percentage of time with a interstitial glucose level below <54 mg/dL as obtained by CGM will be compared between study groups. | Number of participants analyzed include total patients that completed the study visit and provided CGM data. | Posted | Mean | Standard Deviation | % of time | Baseline through Week 26 |
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| Secondary | Percentage of Time With Interstitial Glucose Between 70 and 180 mg/dL | Percentage of time with interstitial glucose in the range of 70-180 mg/dL as measured by CGM will be compared between study groups. | Number of participants analyzed include total patients that completed the study visit and provided CGM data. | Posted | Mean | Standard Deviation | % of time | Baseline through Week 26 |
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| Secondary | Glycemic Variability | Glycemic variability will be assessed with continuous glucose monitoring (CGM). It will be calculated using CGM and Standard Deviation. | This analyses included participants that had valid CGM data at each study visit. | Posted | Mean | Standard Deviation | mg/dl | Week1, Week 12, Week 26 |
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| Secondary | Diabetes Treatment Satisfaction Questionnaire - Status (DTSQs) Score | Treatment satisfaction will be assessed with the DTSQs. The DTSQs contains eight items scored on a seven-point scale where 0 = very dissatisfied and 6 = very satisfied. The satisfaction score is obtained by summing responses to yield a total score between 0 to 48. Higher scores indicate higher satisfaction with diabetes treatment. | Posted | Mean | Standard Deviation | score on a scale | Baseline, Week 12 |
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| Secondary | Diabetes Treatment Satisfaction Questionnaire - Change (DTSQc) Score | Satisfaction with the study treatment will be assessed with items 1, 4, 5, 6, 7, and 8 the DTSQc. Items are rated on a scale of -3 (much less satisfied compared to prior treatment) to 3 (much more satisfied compared to prior treatment). Total scores for these three items range from -18 to +18 with higher scores indicating greater satisfaction with the study treatment compared to their prior treatment. | Posted | Mean | Standard Deviation | score on a scale | Week 26 |
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| Secondary | Treatment-Related Impact Measures for Diabetes (TRIM-D) Survey Score | Satisfaction with the study treatment will be assessed with the TRIM-D survey. TRIM-D includes 28 items that are scored on a scale from 1 to 5. Total scores are transformed to a scale of 0 to 100 where higher scores indicate increased satisfaction. | Posted | Mean | Standard Deviation | score on a scale | Baseline, Week 12, Week 26 |
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| Secondary | Number of Emergency Room (ER) Visits | The number of emergency room visits occurring during the treatment period will be compared between study groups. | All participants that were randomized and received at least one dose of study medication and completed at least one follow-up. | Posted | Number | Number of ER visits | Baseline through Week 26 |
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| Secondary | Number of Hospital Readmissions | The number of hospital readmissions occurring during the treatment period will be compared between study groups. | All participants who were randomized and received at least one dose of study medication and completed at least one follow-up. | Posted | Number | Number of Hospital readmissions | Baseline through Week 26 |
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| Secondary | Total Daily Insulin Dose | The total insulin dose measured in units per day will be compared between study groups. | All participants who were randomized and received at least one dose of study medication and completed at least one follow-up. | Posted | Mean | Standard Deviation | units per day | Baseline, Week 26 |
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| 0 |
| 72 |
| 14 |
| 72 |
| 30 |
| 72 |
| EG001 | Basal-Bolus Insulin | Participants in this group will receive basal-bolus insulin (with metformin, unless contraindicated) for 26 weeks. The basal-bolus insulin regimen includes Insulin Degludec (U-100) and Insulin Aspart. Insulin Degludec (U-100): Participants in the basal-bolus insulin study arm will discontinue all other diabetes medications, except for metformin which will be continued at the prescribed dose (unless contraindicated). Insulin Degludec (U-100) will be given once daily at the same time for 26 weeks. The dose will be titrated up to the fasting blood glucose target of 70 to 100 mg/dL, with no maximum dose. Insulin Aspart: Participants in the basal-bolus insulin study arm will discontinue all other diabetes medications, except for metformin which will be continued at the prescribed dose (unless contraindicated). Insulin aspart will be taken before meals with a titration schedule and dose adjustment protocol to target pre-meal blood glucose level of 70 to 100 mg/dL. | 0 | 73 | 12 | 73 | 13 | 73 |
| Emergency Room Visits | General disorders | Non-systematic Assessment |
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| Vomiting | Gastrointestinal disorders | Non-systematic Assessment |
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| Abdominal Pain | Gastrointestinal disorders | Non-systematic Assessment |
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| Diarrhea | Gastrointestinal disorders | Non-systematic Assessment |
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Not provided
Not provided
| D006728 |
| Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D061266 | Insulin, Short-Acting |
| D061385 | Insulins |
| D010187 | Pancreatic Hormones |
| D036361 | Peptide Hormones |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| Week 12 |
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| Week 26 |
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| Week 12 |
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| Week 26 |
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| Hypoglycemia < 54 mg/dL by CGM |
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| CGM Week 12 |
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| CGM Week 26 |
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| 6 months follow up |
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