Monitoring Parameters Beyond Glycemic Control: Impact of Sitagliptin on Quality of Life in Type 2 Diabetes Patients (DQOL)

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

Study Overview

• Status: Completed
• Conditions: Quality of Life; Type 2 Diabetes; Metformin+Sitagliptin
• Intervention / Treatment: Drug: Metformin / Sitagliptin Oral Tablet

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.

• Study Type: Interventional
• Enrollment (Actual): 188
• Phase: Phase 4

Contacts and Locations

Study Locations

• Pakistan
  • Sindh
    • Karachi, Sindh, Pakistan, 75330
      • Primary Care Diabetes Association

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Uncontrolled Diabetes with Metformin or Metformin resistant

Drug: Metformin / Sitagliptin Oral Tablet; Metformin and sitagliptin are oral diabetes medicines that help control blood sugar levels. Metformin works by decreasing glucose (sugar) production in the liver and decreasing absorption of glucose by the intestines. Sitagliptin works by regulating the levels of insulin your body produces after eating. Metformin and sitagliptin is a combination medicine that is used together with diet and exercise to improve blood sugar control in adults with type 2 diabetes mellitus. metformin and sitagliptin is not for treating type 1 diabetes.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Diabetes Quality of Life assessment using DQOL-13 questionnaire	Satisfaction (6 questions) Impact (4 questions) Worry (3 questions) Scoring from 1 to 5 for worst to best quality at each question (low score means poor quality) Assessment at enrollment and follow ups (at 1st, 3rd and 6th months)	6 months

Secondary Outcome Measures

Outcome Measure	Time Frame
Frequency of adverse events and serious adverse events during the course of study follow-up	6 months
Change from baseline in HbA1c % and fasting blood sugar FBS (mg/dl) to the last-observation on treatment	6 months

Collaborators and Investigators

• Sponsor: Getz Pharma
• Investigators: Principal Investigator: Mansoor Khan, PCDA; Principal Investigator: Asima Khan, PCDA

Publications and helpful links

Helpful Links

• Related Info
• Related Info

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2021
• Primary Completion (Actual): April 28, 2022
• Study Completion (Actual): April 28, 2022

Study Registration Dates

• First Submitted: November 29, 2021
• First Submitted That Met QC Criteria: December 9, 2021
• First Posted (Actual): December 22, 2021

Study Record Updates

• Last Update Posted (Actual): May 4, 2022
• Last Update Submitted That Met QC Criteria: April 28, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Keywords: Quality of life; Metformin; Type 2 Diabetes mellitus; Sitagliptin
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2; Hypoglycemic Agents; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Protease Inhibitors; Incretins; Dipeptidyl-Peptidase IV Inhibitors; Metformin; Sitagliptin Phosphate
• Other Study ID Numbers: GTZ-DM-002-20

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: Diabetes Quality of Life (DQOL) scores, HbA1c, Fasting Blood Sugars (FBS) (masking patients' identity)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No