Not provided
Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| MACS-2015-101024 | Other Identifier | Takeda |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this study is to evaluate the effect of alogliptin benzoate (VIPIDIA®) on glycosylated hemoglobin (HbA1c) level dynamics in participants with diabetes mellitus type 2 (T2DM) at Month 6.
The drug being studied in this study is called alogliptin benzoate. Alogliptin benzoate is being researched to treat people who have T2DM. This study will look at the HbA1c level dynamics in participants with T2DM.
The study enrolled 1409 patients. Alogliptin benzoate will be prescribed by their physician in accordance with the Russian summary of product characteristics (SmPC).
This multi-center study will be conducted in the Russian Federation. The overall duration of study for observation will be approximately 6 months. Participants will make multiple visits to the clinic as assigned by each physician according to their routine practice, in every 3 months.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Alogliptin Benzoate | Participants with diabetes mellitus type 2 (T2DM) who received alogliptin benzoate tablets, orally, as prescribed by physician according to Russian summary of product characteristics (SmPC) were observed for approximately 6 months. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Alogliptin Benzoate | Drug | Alogliptin benzoate tablets |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Glycosylated Hemoglobin (HbA1c) Level at Month 6 | The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at Month 6 relative to baseline. Glycosylated hemoglobin (HbA1c) as a diagnostic criteria of diabetes mellitus is ≥6.5%. A negative change from Baseline indicates improvement. | Baseline and Month 6 |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in HbA1c Level at Month 6 in Subgroups of Participants With Different Clinical Characteristics | The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at Month 6 relative to baseline. Glycosylated hemoglobin (HbA1c) as a diagnostic criteria of diabetes mellitus is ≥6.5%. Subgroups included participants with different baseline clinical characteristics with predictors such as prior therapy of diabetes mellitus, sex, age group, cardiovascular risk group, therapy type (monotherapy or combined therapy), baseline body mass index (BMI) and initial glycemic control and T2DM duration. A negative change from Baseline indicates improvement. |
Not provided
Inclusion Criteria:
Male and female participants ≥ 18 years of age;
Has a diagnosis of type 2 diabetes mellitus (T2DM)
Participants with:
VIPIDIA® is prescribed according to the approved label for the Russian Federation.
The participant's physician decides to prescribe VIPIDIA®:
The participant (or, when applicable, the participant's legally acceptable representative) signs and dates a written, informed consent form prior to the start of data collection. Participant is capable of understanding the written informed consent, provides signed and written informed consent, and agrees to comply with protocol requirements. In case the participant is blind or unable to read, informed consent will also be witnessed.
Exclusion Criteria:
Not provided
Not provided
Not provided
Adult participants diagnosed with type 2 diabetes mellitus (T2DM) will be observed.
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Medical Director Clinical Science | Takeda | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| First City Clinical Hospital named after E.E. Vlosevich | Arkhangelsk | 163001 | Russia | |||
| City polyclinic #11 |
Takeda makes patient-level, de-identified data sets and associated documents available after applicable marketing approvals and commercial availability have been received, an opportunity for the primary publication of the research has been allowed, and other criteria have been met as set forth in Takeda's Data Sharing Policy (see www.TakedaClinicalTrials.com/Approach for details). To obtain access, researchers must submit a legitimate academic research proposal for adjudication by an independent review panel, who will review the scientific merit of the research and the requestor's qualifications and conflict of interest that can result in potential bias. Once approved, qualified researchers who sign a data sharing agreement are provided access to these data in a secure research environment.
Not provided
Not provided
Not provided
Not provided
Participants with a diagnosis of diabetes mellitus type 2 (T2DM) prescribed alogliptin benzoate in accordance with Russian SmPC were enrolled in this observational study.
Participants took part in the study in Russia from 20-Sep-2016 to 28-Apr-2018.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Alogliptin Benzoate | Participants with diabetes mellitus type 2 (T2DM) who received alogliptin benzoate tablets, orally, as prescribed by physician according to Russian summary of product characteristics (SmPC) were observed for approximately 6 months. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| SAP | No | Yes | No | Statistical Analysis Plan | Dec 17, 2018 | Apr 15, 2019 |
Not provided
Not provided
Not provided
Not provided
| Baseline and Month 6 |
| Percentage of Participants With a Decrease in HbA1c Level by <7.0% at Month 6 | The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at Month 6 relative to baseline. Percentage of participants with a decrease of <7.0% from baseline in HbA1c were reported. | Baseline and Month 6 |
| Change From Baseline in HbA1c Level Over Time | The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at Months 3 and 6 relative to baseline. Glycosylated hemoglobin (HbA1c) as a diagnostic criteria of diabetes mellitus is ≥6.5%. A negative change from Baseline indicates improvement. | Baseline, Months 3 and 6 |
| Percentage of Participants With Marked Hyperglycemia at Month 3 | Marked hyperglycemia is defined as fasting plasma glucose (FPG) higher than or equal to 11 mmol/L. | Month 3 |
| Change From Baseline in Fasting Plasma Glucose (FPG) Levels Over Time | The change in the value of fasting plasma glucose value collected at Months 3 and 6 relative to baseline. Target FPG depended on the defined individual targets of glycemic control by HbA1c level ≤6.5 to 8.0 mmol/l. A negative change from Baseline indicates improvement. | Baseline, Months 3 and 6 |
| Change From Baseline in Weight Over Time | Change in the participant's weight was collected at Months 3 and 6 relative to baseline. | Baseline, Months 3 and 6 |
| Change From Baseline in Postprandial Glycemia Over Time | The change between the baseline (pre-prandial (before meal)) and postprandial (after meal) glucose values were collected at Months 3 and 6 relative to baseline. | Baseline, Months 3 and 6 |
| Change From Baseline in Total Cholesterol, Triglycerides, Low Density Lipoproteins and High Density Lipoproteins Over Time | The change between the total cholesterol triglycerides, low density lipoproteins and high density lipoproteins values were collected at Months 3 and 6 relative to baseline. | Baseline, Months 3 and 6 |
| Percentage of Participants With a Decrease in HbA1c Level by ≥0.3% at Month 6 | The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at Month 6 relative to baseline. Percentage of participants with a decrease of ≥0.3% from baseline in HbA1c were reported. | Baseline and Month 6 |
| Percentage of Participants Who Used Healthcare Resources | Healthcare resources included rate of hospitalization, emergency, emergency room visits, physician office visits, and other type of usage. | Baseline up to Month 6 |
| Barnaul |
| 656019 |
| Russia |
| Belgorod Regional Clinical hospital named after Saint I Belgorod Regional Clinical Hospital of St. Joasaph | Belgorod | 308007 | Russia |
| LLC Medical center Lotos | Chelyabinsk | 454091 | Russia |
| Istochnik clinic | Chelyabinsk | 454100 | Russia |
| Regional clinical hospital #3 | Chelyabinsk | 454138 | Russia |
| Medical center Health Academy | Chita | 672038 | Russia |
| Chita State Medical Academy | Chita | 672090 | Russia |
| City polyclinic #11 | Kazan' | 420039 | Russia |
| Ciry polyclinic #10 | Kazan' | 420066 | Russia |
| Kemerovo Regional Clinical Hospital named after S.V. Belyaev | Kemerovo | 650066 | Russia |
| Medical Center Clinic of Hormonal Health | Khabarovsk | 680000 | Russia |
| Regional Clinical hospital named after S.I. Sergeev | Khabarovsk | 680009 | Russia |
| Road Clinical Hospital at Khabarovsk Station - 1 | Khabarovsk | 68022 | Russia |
| Northern Clinical Emergency Hospital | Kirov | 610011 | Russia |
| Kirov Clinical Hospital #7 named after V.I. Yurlova | Kirov | 610030 | Russia |
| Kostroma City hospital | Kostroma | 156005 | Russia |
| Kursk Regional Clinical Hospital | Kursk | 305007 | Russia |
| Lobnya Central City Hospital | Lobnya | 141730 | Russia |
| City polyclinic #166 | Moscow | 115551 | Russia |
| Endocrinology Research Center | Moscow | 117036 | Russia |
| City polyclinic #22 | Moscow | 117218 | Russia |
| City polyclinic #52 | Moscow | 117546 | Russia |
| The Scientific Center of Cardiovascular Surgery named after A.N. Bakulev | Moscow | 121552 | Russia |
| CJSC Medsi | Moscow | 123056 | Russia |
| Diagnostical Center #5 | Moscow | 127543 | Russia |
| Federal State Autonomous Educational Institution of Higher Education I.M. Sechenov First Moscow State Medical University of the Ministry of Health of the Russian Federation | Moscow | 199435 | Russia |
| Clinical Diagnostical Center | Nizhny Novgorod | 603006 | Russia |
| City polyclinic #3 | Nizhny Novgorod | 603155 | Russia |
| Medical Center Healthy family LLC | Novosibirsk | 630099 | Russia |
| Republican Hospital named after V.A.Baranov | Petrozavodsk | 185000 | Russia |
| Rostov State Medical University | Rostov-on-Don | 344022 | Russia |
| City Clinical hospital #11 | Ryazan | 390037 | Russia |
| City policlinic #117 | Saint Petersburg | 125167 | Russia |
| City polyclinic #109 | Saint Petersburg | 192289 | Russia |
| Saint-Petersburg Territorial Diabetological Center | Saint Petersburg | 194354 | Russia |
| City policlinic #86 | Saint Petersburg | 195299 | Russia |
| Consultative and diagnostic polyclinic 1 of Primorsky district | Saint Petersburg | 197183 | Russia |
| Samara Regional Clinical Diagnostical polyclinic #14 | Samara | 443011 | Russia |
| LLC Center Diabet | Samara | 443041 | Russia |
| City policlinic #9 | Samara | 443110 | Russia |
| City polyclinic #22 | Saratov | 410005 | Russia |
| City policlinic #3 | Tomsk | 634009 | Russia |
| LLC Medical center Ideale | Tomsk | 634009 | Russia |
| City policlinic #3 | Tomsk | 634024 | Russia |
| Tomsk Regional Clinical Hospital | Tomsk | 634063 | Russia |
| City polyclinic #43 | Ufa | 450099 | Russia |
| Regional Clinical Hospital | Vladimir | 600023 | Russia |
| Regional Clinical Hospital #1 | Volgograd | 400081 | Russia |
| Volgograd State Medical University | Volgograd | 400131 | Russia |
| LLC Zdorovye, Diabetes Center | Vologda | 160019 | Russia |
| Voronezh Regional Clinical Diagnostical center | Voronezh | 394018 | Russia |
| Ural State Medical Academy | Yekaterinburg | 620043 | Russia |
| Received Therapy |
|
| Included in Efficacy and Safety Analysis |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
All participants with a diagnosis of diabetes mellitus type 2 (T2DM), newly diagnosed T2DM (drug naive) or inadequate glycemic control on previously prescribed any oral antidiabetic drug were enrolled in the study.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Alogliptin Benzoate | Participants with diabetes mellitus type 2 (T2DM) who received alogliptin benzoate tablets, orally, as prescribed by physician according to Russian summary of product characteristics (SmPC) were observed for approximately 6 months. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Race/Ethnicity, Customized | Count of Participants | Participants |
| ||||||||||||||||||
| Region of Enrollment | Count of Participants | Participants |
|
| 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) Level at Month 6 | The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at Month 6 relative to baseline. Glycosylated hemoglobin (HbA1c) as a diagnostic criteria of diabetes mellitus is ≥6.5%. A negative change from Baseline indicates improvement. | All participants with a diagnosis of diabetes mellitus type 2 (T2DM), newly diagnosed T2DM (drug naive) or inadequate glycemic control on previously prescribed any oral antidiabetic drug were enrolled in the study. Number analyzed is the number of participants with evaluable data at the given time-point. | Posted | Mean | Standard Deviation | percentage of glycosylated hemoglobin | Baseline and Month 6 |
|
|
| |||||||||||||||||||||||||||
| Secondary | Change From Baseline in HbA1c Level at Month 6 in Subgroups of Participants With Different Clinical Characteristics | The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at Month 6 relative to baseline. Glycosylated hemoglobin (HbA1c) as a diagnostic criteria of diabetes mellitus is ≥6.5%. Subgroups included participants with different baseline clinical characteristics with predictors such as prior therapy of diabetes mellitus, sex, age group, cardiovascular risk group, therapy type (monotherapy or combined therapy), baseline body mass index (BMI) and initial glycemic control and T2DM duration. A negative change from Baseline indicates improvement. | All participants with a diagnosis of T2DM, newly diagnosed T2DM (drug naive) or inadequate glycemic control on previously prescribed any oral antidiabetic drug were enrolled in the study. Number analyzed is the number of participants with evaluable data at the given time-point. | Posted | Mean | Standard Deviation | percentage of glycosylated hemoglobin | Baseline and Month 6 |
|
| ||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With a Decrease in HbA1c Level by <7.0% at Month 6 | The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at Month 6 relative to baseline. Percentage of participants with a decrease of <7.0% from baseline in HbA1c were reported. | All participants with a diagnosis of T2DM, newly diagnosed T2DM (drug naive) or inadequate glycemic control on previously prescribed any oral antidiabetic drug were enrolled in the study. | Posted | Number | 95% Confidence Interval | percentage of participants | Baseline and Month 6 |
|
| ||||||||||||||||||||||||||||
| Secondary | Change From Baseline in HbA1c Level Over Time | The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at Months 3 and 6 relative to baseline. Glycosylated hemoglobin (HbA1c) as a diagnostic criteria of diabetes mellitus is ≥6.5%. A negative change from Baseline indicates improvement. | All participants with a diagnosis of T2DM, newly diagnosed T2DM (drug naive) or inadequate glycemic control on previously prescribed any oral antidiabetic drug were enrolled in the study. Number analyzed is the number of participants with evaluable data at the given time-point. | Posted | Mean | Standard Deviation | percentage of glycosylated hemoglobin | Baseline, Months 3 and 6 |
|
| ||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Marked Hyperglycemia at Month 3 | Marked hyperglycemia is defined as fasting plasma glucose (FPG) higher than or equal to 11 mmol/L. | All participants with a diagnosis of T2DM, newly diagnosed T2DM (drug naive) or inadequate glycemic control on previously prescribed any oral antidiabetic drug were enrolled in the study. | Posted | Number | 95% Confidence Interval | percentage of participants | Month 3 |
|
| ||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Fasting Plasma Glucose (FPG) Levels Over Time | The change in the value of fasting plasma glucose value collected at Months 3 and 6 relative to baseline. Target FPG depended on the defined individual targets of glycemic control by HbA1c level ≤6.5 to 8.0 mmol/l. A negative change from Baseline indicates improvement. | All participants with a diagnosis of T2DM, newly diagnosed T2DM (drug naive) or inadequate glycemic control on previously prescribed any oral antidiabetic drug were enrolled in the study. Number analyzed is the number of participants with evaluable data at the given time-point. | Posted | Mean | Standard Deviation | mmol/l | Baseline, Months 3 and 6 |
|
| ||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Weight Over Time | Change in the participant's weight was collected at Months 3 and 6 relative to baseline. | All participants with a diagnosis of T2DM, newly diagnosed T2DM (drug naive) or inadequate glycemic control on previously prescribed any oral antidiabetic drug were enrolled in the study. Number analyzed is the number of participants with evaluable data at the given time-point. | Posted | Mean | Standard Deviation | kg | Baseline, Months 3 and 6 |
|
| ||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Postprandial Glycemia Over Time | The change between the baseline (pre-prandial (before meal)) and postprandial (after meal) glucose values were collected at Months 3 and 6 relative to baseline. | All participants with a diagnosis of T2DM, newly diagnosed T2DM (drug naive) or inadequate glycemic control on previously prescribed any oral antidiabetic drug were enrolled in the study. Number analyzed is the number of participants with evaluable data at the given time-point. | Posted | Mean | Standard Deviation | mmol/l | Baseline, Months 3 and 6 |
|
| ||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Total Cholesterol, Triglycerides, Low Density Lipoproteins and High Density Lipoproteins Over Time | The change between the total cholesterol triglycerides, low density lipoproteins and high density lipoproteins values were collected at Months 3 and 6 relative to baseline. | All participants with a diagnosis of T2DM, newly diagnosed T2DM (drug naive) or inadequate glycemic control on previously prescribed any oral antidiabetic drug were enrolled in the study. Number analyzed is the number of participants with evaluable data at the given time-point. | Posted | Mean | Standard Deviation | mmol/l | Baseline, Months 3 and 6 |
|
| ||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With a Decrease in HbA1c Level by ≥0.3% at Month 6 | The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at Month 6 relative to baseline. Percentage of participants with a decrease of ≥0.3% from baseline in HbA1c were reported. | All participants with a diagnosis of T2DM, newly diagnosed T2DM (drug naive) or inadequate glycemic control on previously prescribed any oral antidiabetic drug were enrolled in the study. | Posted | Number | 95% Confidence Interval | percentage of participants | Baseline and Month 6 |
|
| ||||||||||||||||||||||||||||
| Secondary | Percentage of Participants Who Used Healthcare Resources | Healthcare resources included rate of hospitalization, emergency, emergency room visits, physician office visits, and other type of usage. | All participants with a diagnosis of T2DM, newly diagnosed T2DM (drug naive) or inadequate glycemic control on previously prescribed any oral antidiabetic drug were enrolled in the study. | Posted | Number | 95% Confidence Interval | percentage of participants | Baseline up to Month 6 |
|
|
From first dose of study drug administration up to Month 6
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
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 | Alogliptin Benzoate | Participants with diabetes mellitus type 2 (T2DM) who received alogliptin benzoate tablets, orally, as prescribed by physician according to Russian summary of product characteristics (SmPC) were observed for approximately 6 months. | 0 | 1,399 | 5 | 1,399 | 69 | 1,399 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Vertebrobasilar insufficiency | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| Endometrial adenocarcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
| |
| Vulval cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
| |
| Femoral neck fracture | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| Schizophrenia | Psychiatric disorders | MedDRA | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Blood cholesterol increased | Investigations | MedDRA | Systematic Assessment |
| |
| HbA1C increased | Investigations | MedDRA | Systematic Assessment |
| |
| Blood triglycerides increased | Investigations | MedDRA | Systematic Assessment |
| |
| Blood glucose increased | Investigations | MedDRA | Systematic Assessment |
| |
| Low density lipoprotein increased | Investigations | MedDRA | Systematic Assessment |
| |
| High density lipoprotein decrease | Investigations | MedDRA | Systematic Assessment |
| |
| Blood creatine increased | Investigations | MedDRA | Systematic Assessment |
| |
| Glomerular filtration rate decreased | Investigations | MedDRA | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Pyelonephritis chronic | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Respiratory tract infection | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Viral infection | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Viral tracheitis | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Cystitis | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Respiratory tract infection viral | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Tracheitis | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Tracheobronchitis | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
| |
| Dyslipidaemia | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
| |
| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
| |
| Hypercholesterolaemia | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
| |
| Hypertriglyceridaemia | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
| |
| Increased appetite | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
| |
| Drug ineffective | General disorders | MedDRA | Systematic Assessment |
| |
| Autonomic neuropathy | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| Goitre | Endocrine disorders | MedDRA | Systematic Assessment |
| |
| Diarrhea | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Hypothyroidism | Endocrine disorders | MedDRA | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
| |
| Diabetic retinopathy | Eye disorders | MedDRA | Systematic Assessment |
| |
| Disease risk factor | Social circumstances | MedDRA | Systematic Assessment |
| |
| Vestibular disorder | Ear and labyrinth disorders | MedDRA | Systematic Assessment |
|
The first study related publication will be a multi-center publication submitted within 24 months after conclusion or termination of a study at all sites. After such multi site publication, all proposed site publications and presentations will be submitted to sponsor for review 60 days in advance of publication. Site will remove Sponsor confidential information unrelated to study results. Sponsor can delay a proposed publication for another 60 days to preserve intellectual property.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Director | Takeda | +1-877-825-3327 | trialdisclosures@takeda.com |
| SAP_000.pdf |
| Prot | Yes | No | No | Study Protocol | Dec 19, 2018 | Apr 15, 2019 | Prot_001.pdf |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
Not provided
Not provided
| African American or African |
|
|
| Participants |
|
|
|
|
|
|
|
|
|
|
|