Impact of Treviamet® & Treviamet XR® on quality of life besides glycemic control in type 2 DM patients
Abstract Background Maintaining the quality of life is the main objective of managing type 2 diabetes (T2DM) (QoL). Since it is a key factor in patient motivation and adherence, treatment-related QoL has always been considered when choosing glucose-lowering medicines. The objective of the study was...
| Main Authors: | , , , , , , , , , , , |
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| Format: | Article |
| Language: | English |
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BMC
2023-11-01
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| Series: | BMC Endocrine Disorders |
| Subjects: | |
| Online Access: | https://doi.org/10.1186/s12902-023-01492-2 |
| _version_ | 1797630203763097600 |
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| author | Asima Khan Muhammad Adnan Kanpurwala Riasat Ali Khan Najum F. Mahmudi Verumal Lohano Shakeel Ahmed Majid Khan Fareed Uddin Syed Mohammad Ali Maliha Saghir Syed Hussain Baqar Abidi Jahanzeb Kamal |
| author_facet | Asima Khan Muhammad Adnan Kanpurwala Riasat Ali Khan Najum F. Mahmudi Verumal Lohano Shakeel Ahmed Majid Khan Fareed Uddin Syed Mohammad Ali Maliha Saghir Syed Hussain Baqar Abidi Jahanzeb Kamal |
| author_sort | Asima Khan |
| collection | DOAJ |
| description | Abstract Background Maintaining the quality of life is the main objective of managing type 2 diabetes (T2DM) (QoL). Since it is a key factor in patient motivation and adherence, treatment-related QoL has always been considered when choosing glucose-lowering medicines. The objective of the study was to evaluate the quality of life besides glycemic control among type 2 diabetes mellitus patients receiving Treviamet® & Treviamet XR® (Sitagliptin with Metformin) in routine care. Methods It was a prospective, open-label, non-randomized clinical trial including T2DM patients uncontrolled on Metformin therapy. All patients received Treviamet® & Treviamet XR® for six months. Sequential changes in QoL, fasting plasma glucose, HbA1c, body weight, and blood pressure were monitored from baseline to 3 consecutive follow-up visits. The frequency of adverse events (AEs) was also noted throughout the study. Results A total of 504 patients were screened; 188 completed all three follow-ups. The mean QoL score significantly declined from 57.09% at baseline to 33.64% at the 3rd follow-up visit (p < 0.01). Moreover, a significant decline in mean HbA1c and FPG levels was observed from baseline to 3rd follow-up visit (p < 0.01). Minor adverse events were observed, including abdominal discomfort, nausea, flatulence, and indigestion. Gender, HbA1c, diarrhea, and abdominal discomfort were significant predictors of a patient’s QoL, as revealed by the Linear Regression Model (R2 = 0.265, F(16, 99) = 2.231). Conclusion Treviamet® & Treviamet XR® significantly improved glycemic control (HbA1c levels) and QoL in T2DM patients without serious adverse events. Trial registration ClinicalTrials.gov identifier (NCT05167513), Date of registration: December 22, 2021. |
| first_indexed | 2024-03-11T11:04:52Z |
| format | Article |
| id | doaj.art-ecd5358ad7704a7ba8e0b154264efbe0 |
| institution | Directory Open Access Journal |
| issn | 1472-6823 |
| language | English |
| last_indexed | 2024-03-11T11:04:52Z |
| publishDate | 2023-11-01 |
| publisher | BMC |
| record_format | Article |
| series | BMC Endocrine Disorders |
| spelling | doaj.art-ecd5358ad7704a7ba8e0b154264efbe02023-11-12T12:20:09ZengBMCBMC Endocrine Disorders1472-68232023-11-012311910.1186/s12902-023-01492-2Impact of Treviamet® & Treviamet XR® on quality of life besides glycemic control in type 2 DM patientsAsima Khan0Muhammad Adnan Kanpurwala1Riasat Ali Khan2Najum F. Mahmudi3Verumal Lohano4Shakeel Ahmed5Majid Khan6Fareed Uddin7Syed Mohammad Ali8Maliha Saghir9Syed Hussain Baqar Abidi10Jahanzeb Kamal11Public Health Department, Baqai Institute of Diabetology and Endocrinology Department of Physiology, Karachi Institute of Medical Sciences affiliated with NUMSDiabetes, Baqai Institute of Diabetology and EndocrinologyPrimary Care Diabetes AssociationPrimary Care Diabetes AssociationDiabetes & Endocrinology Department, College of Family MedicineMemon Medical ComplexMemon Medical ComplexLondon School of Hygiene and Tropical MedicineBahria UniversityInstitute of Business ManagementMedical Education, College of Physicians and Surgeons PakistanAbstract Background Maintaining the quality of life is the main objective of managing type 2 diabetes (T2DM) (QoL). Since it is a key factor in patient motivation and adherence, treatment-related QoL has always been considered when choosing glucose-lowering medicines. The objective of the study was to evaluate the quality of life besides glycemic control among type 2 diabetes mellitus patients receiving Treviamet® & Treviamet XR® (Sitagliptin with Metformin) in routine care. Methods It was a prospective, open-label, non-randomized clinical trial including T2DM patients uncontrolled on Metformin therapy. All patients received Treviamet® & Treviamet XR® for six months. Sequential changes in QoL, fasting plasma glucose, HbA1c, body weight, and blood pressure were monitored from baseline to 3 consecutive follow-up visits. The frequency of adverse events (AEs) was also noted throughout the study. Results A total of 504 patients were screened; 188 completed all three follow-ups. The mean QoL score significantly declined from 57.09% at baseline to 33.64% at the 3rd follow-up visit (p < 0.01). Moreover, a significant decline in mean HbA1c and FPG levels was observed from baseline to 3rd follow-up visit (p < 0.01). Minor adverse events were observed, including abdominal discomfort, nausea, flatulence, and indigestion. Gender, HbA1c, diarrhea, and abdominal discomfort were significant predictors of a patient’s QoL, as revealed by the Linear Regression Model (R2 = 0.265, F(16, 99) = 2.231). Conclusion Treviamet® & Treviamet XR® significantly improved glycemic control (HbA1c levels) and QoL in T2DM patients without serious adverse events. Trial registration ClinicalTrials.gov identifier (NCT05167513), Date of registration: December 22, 2021.https://doi.org/10.1186/s12902-023-01492-2Quality of lifeType 2 Diabetes MellitusSitagliptinMetformin |
| spellingShingle | Asima Khan Muhammad Adnan Kanpurwala Riasat Ali Khan Najum F. Mahmudi Verumal Lohano Shakeel Ahmed Majid Khan Fareed Uddin Syed Mohammad Ali Maliha Saghir Syed Hussain Baqar Abidi Jahanzeb Kamal Impact of Treviamet® & Treviamet XR® on quality of life besides glycemic control in type 2 DM patients BMC Endocrine Disorders Quality of life Type 2 Diabetes Mellitus Sitagliptin Metformin |
| title | Impact of Treviamet® & Treviamet XR® on quality of life besides glycemic control in type 2 DM patients |
| title_full | Impact of Treviamet® & Treviamet XR® on quality of life besides glycemic control in type 2 DM patients |
| title_fullStr | Impact of Treviamet® & Treviamet XR® on quality of life besides glycemic control in type 2 DM patients |
| title_full_unstemmed | Impact of Treviamet® & Treviamet XR® on quality of life besides glycemic control in type 2 DM patients |
| title_short | Impact of Treviamet® & Treviamet XR® on quality of life besides glycemic control in type 2 DM patients |
| title_sort | impact of treviamet r treviamet xr r on quality of life besides glycemic control in type 2 dm patients |
| topic | Quality of life Type 2 Diabetes Mellitus Sitagliptin Metformin |
| url | https://doi.org/10.1186/s12902-023-01492-2 |
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