Trial record 1 of 1 for:
NCT02756832
An Observational Study of Alogliptin Benzoate in Participants With Diabetes Mellitus Type 2
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| ClinicalTrials.gov Identifier: NCT02756832 |
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Recruitment Status :
Completed
First Posted : April 29, 2016
Results First Posted : July 10, 2019
Last Update Posted : July 10, 2019
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Sponsor:
Takeda
Information provided by (Responsible Party):
Takeda
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Brief Summary:
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.
| Condition or disease | Intervention/treatment |
|---|---|
| Diabetes Mellitus | Drug: Alogliptin Benzoate |
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.
| Study Type : | Observational |
| Actual Enrollment : | 1409 participants |
| Observational Model: | Cohort |
| Time Perspective: | Prospective |
| Official Title: | Local, Multicentre, Observational, Non-Interventional Prospective Study of Alogliptin Benzoate in Patients With Diabetes Mellitus Type 2 |
| Actual Study Start Date : | September 20, 2016 |
| Actual Primary Completion Date : | April 28, 2018 |
| Actual Study Completion Date : | April 28, 2018 |
Resource links provided by the National Library of Medicine
MedlinePlus Genetics related topics:
Type 2 diabetes
| Group/Cohort | Intervention/treatment |
|---|---|
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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.
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Drug: Alogliptin Benzoate
Alogliptin benzoate tablets
Other Name: VIPIDIA® |
Primary Outcome Measures :
- Change From Baseline in Glycosylated Hemoglobin (HbA1c) Level at Month 6 [ Time Frame: Baseline and 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.
Secondary Outcome Measures :
- Change From Baseline in HbA1c Level at Month 6 in Subgroups of Participants With Different Clinical Characteristics [ Time Frame: Baseline and 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%. 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.
- Percentage of Participants With a Decrease in HbA1c Level by <7.0% at Month 6 [ Time Frame: Baseline and 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.
- Change From Baseline in HbA1c Level Over Time [ Time Frame: Baseline, Months 3 and 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 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.
- Percentage of Participants With Marked Hyperglycemia at Month 3 [ Time Frame: Month 3 ]Marked hyperglycemia is defined as fasting plasma glucose (FPG) higher than or equal to 11 mmol/L.
- Change From Baseline in Fasting Plasma Glucose (FPG) Levels Over Time [ Time Frame: Baseline, Months 3 and 6 ]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.
- Change From Baseline in Weight Over Time [ Time Frame: Baseline, Months 3 and 6 ]Change in the participant's weight was collected at Months 3 and 6 relative to baseline.
- Change From Baseline in Postprandial Glycemia Over Time [ Time Frame: Baseline, Months 3 and 6 ]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.
- Change From Baseline in Total Cholesterol, Triglycerides, Low Density Lipoproteins and High Density Lipoproteins Over Time [ Time Frame: Baseline, Months 3 and 6 ]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.
- Percentage of Participants With a Decrease in HbA1c Level by ≥0.3% at Month 6 [ Time Frame: Baseline and 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.
- Percentage of Participants Who Used Healthcare Resources [ Time Frame: Baseline up to Month 6 ]Healthcare resources included rate of hospitalization, emergency, emergency room visits, physician office visits, and other type of usage.
Information from the National Library of Medicine
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Study Population
Adult participants diagnosed with type 2 diabetes mellitus (T2DM) will be observed.
Criteria
Inclusion Criteria:
- Male and female participants ≥ 18 years of age;
- Has a diagnosis of type 2 diabetes mellitus (T2DM)
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Participants with:
- newly diagnosed diabetes mellitus (DM) type 2 (drug naïve) or
- inadequate glycemic control on previously prescribed any oral antidiabetic drug.
- VIPIDIA® is prescribed according to the approved label for the Russian Federation.
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The participant's physician decides to prescribe VIPIDIA®:
- as monotherapy or
- as a part of combination therapy.
- 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:
- Contraindications of respective approved Russian summary of product characteristics (SmPC);
- In the opinion of the physician, the participant has any reasons of medical and non-medical character, which in the opinion of the physician can prevent participant participation in the study;
- Had used Dipeptidyl peptidase-4 inhibitors (DPP-IV inhibitors) or Glucagon like peptide-1 agonists (aGLP-1) within the 3 months prior to the start of VIPIDIA® treatment.
- Is an immediate family member, study site employee, or is in a dependent relationship with a study site employee who is involved in conduct of this study (eg, spouse, parent, child, sibling) or may consent under duress.
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02756832
Locations
Show 53 study locations
Sponsors and Collaborators
Takeda
Investigators
| Study Director: | Medical Director Clinical Science | Takeda |
Study Documents (Full-Text)
Documents provided by Takeda:
Documents provided by Takeda:
Statistical Analysis Plan [PDF] December 17, 2018
Study Protocol [PDF] December 19, 2018
| Responsible Party: | Takeda |
| ClinicalTrials.gov Identifier: | NCT02756832 |
| Other Study ID Numbers: |
Alogliptin-4018 MACS-2015-101024 ( Other Identifier: Takeda ) |
| First Posted: | April 29, 2016 Key Record Dates |
| Results First Posted: | July 10, 2019 |
| Last Update Posted: | July 10, 2019 |
| Last Verified: | July 2019 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | Yes |
| Plan Description: | 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. |
| Studies a U.S. FDA-regulated Drug Product: | Yes |
| Studies a U.S. FDA-regulated Device Product: | No |
Keywords provided by Takeda:
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Drug Therapy |
Additional relevant MeSH terms:
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Diabetes Mellitus Diabetes Mellitus, Type 2 Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases Alogliptin Hypoglycemic Agents Physiological Effects of Drugs |
Incretins Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Dipeptidyl-Peptidase IV Inhibitors Protease Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |