Clinical trial NCT05167513: Monitoring Parameters Beyond Glycemic Control: Impact of Sitagliptin on Quality of Life in Type 2 Diabetes Patients
Official title: Monitoring Parameters Beyond Glycemic Control: Impact of Sitagliptin on Quality of Life in Type 2 Diabetes Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Quality of Life
Type 2 Diabetes
Metformin+Sitagliptin
Keywords: Quality of life
Type 2 Diabetes mellitus
Sitagliptin
Metformin
Lead sponsor: Getz Pharma
Sponsor class: INDUSTRY
First posted: 2021-12-22
Enrollment: 188
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Scarcity of local patients' quality of life data assessing diabetes treatment led us design a protocol to assess improvement in the quality of life of patients with Type II Diabetes mellitus. Quality of life measures are designed to enable patients' perspectives on the impact of health \& healthcare interventions on their lives to be assessed \& taken into account in clinical decision making \& research. Its an open label experimental study where participants are assessed for quality of life impact over 6 months duration on Metformin + Sitagliptin therapy. Their safety and efficacy profiles will also be monitored

Detailed description: Study Objective: To assess the changes in quality of life (QOL) in patients with type 2 diabetes mellitus receiving sitagliptin plus metformin therapy in routine care.

Study design: Open label, prospective, multicenter, experimental study.

Sample size: The sample size is 157. To overcome loss to follow-ups, total n=300 will be recruited where each site will enroll 30 patients.

Number of Site: There will be 10 sites.

Duration of study: 12 months (data lock point will be the completion of 6 months of follow-up from the time of last patient's enrollment date)

Study Treatment: Dose of Sitagliptin + Metformin (Treviamet® pharmaceutical brand used locally) :

For Sitagliptin + metformin: \[50mg+500mg, 50mg+850mg, 50mg+1000mg\] For Sitagliptin + metformin Extended Release (XR): \[50mg+500mg, 50mg+1000mg\].

Safety Assessment: Patient will be monitored for Hypoglycemia, Nausea, Vomiting, Diarrhea, Abdominal Discomfort, Flatulence, Asthenia, Indigestion Other adverse events and serious adverse events.

Follow up visits: After recruitment, patient is supposed to have three visits for follow-ups.

Visit 1: 4 to 6 weeks of initiation of therapy. Visit 02: At 12 weeks of initiation of therapy. Visit 03: At 24 weeks of initiation of therapy.

Study outcomes:

Primary (QoL outcomes): Diabetes Quality of Life assessment using DQOL-13 questionnaire.

Secondary (Safety and Efficacy outcomes): Frequency of adverse events and serious adverse events during the course of study follow-up. Change from baseline in HbA1c % and FBS (mg/dl) to the last-observation on treatment.

Ethical consideration: The ethical approval of study is taken from Pakistan Medical Association. The study will be conducted in compliance with the protocol, good clinical practices (GCP), the ethical principles that have their origin in the Declaration of Helsinki and the applicable regulatory requirements.

Eligibility criteria: Inclusion Criteria:

* Patient with Type 2 Diabetes mellitus between 18 to 65 years
* HbA1C 7% - 10%
* who can give informed consent.
* Patient uncontrolled on metformin and lifestyle modification from at least 3 months or who are metformin resistant

Exclusion Criteria:

* type 1 diabetes
* ≥1 episode of Diabetic Ketoacidosis and/or hyperosmolar hyperglycemic state,
* ≥1 episode of severe hypoglycaemia,
* Pregnant or lactating women,
* Pancreatitis,
* any serious complications or hypersensitivity

Primary outcomes:
measure: Diabetes Quality of Life assessment using DQOL-13 questionnaire
timeFrame: 6 months
Secondary outcomes:
measure: Frequency of adverse events and serious adverse events during the course of study follow-up
timeFrame: 6 months
measure: Change from baseline in HbA1c % and fasting blood sugar FBS (mg/dl) to the last-observation on treatment
timeFrame: 6 months
Other outcomes:
Locations:
city: Karachi
country: Pakistan
facility: Primary Care Diabetes Association
state: Sindh
Study officials:
affiliation: PCDA
name: Mansoor Khan
role: PRINCIPAL_INVESTIGATOR
affiliation: PCDA
name: Asima Khan
role: PRINCIPAL_INVESTIGATOR
References: