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

NCT05167513 | Completed Phase 4 DMC

• 1 other identifier: GTZ-DM-002-20
• Study Type: interventional
• Target: 188
• Locations: 1 country
• Sites: 1

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

Conditions

Quality of Life; Type 2 Diabetes; Metformin+Sitagliptin

Keywords

Quality of life; Type 2 Diabetes mellitus; Sitagliptin; Metformin

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• 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

Study Arms (1)

Uncontrolled Diabetes with Metformin or Metformin resistant

EXPERIMENTAL

Drug: Metformin / Sitagliptin Oral Tablet

Interventions

Metformin / Sitagliptin Oral Tablet DRUG

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.

Uncontrolled Diabetes with Metformin or Metformin resistant

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Getz Pharma: lead

Study Sites (1)

Primary Care Diabetes Association

Karachi, Sindh, 75330, Pakistan

Location

Related Publications (1)

• Khan A, Kanpurwala MA, Khan RA, Mahmudi NF, Lohano V, Ahmed S, Khan M, Uddin F, Ali SM, Saghir M, Baqar Abidi SH, Kamal J. Impact of Treviamet(R) & Treviamet XR(R) on quality of life besides glycemic control in type 2 DM patients. BMC Endocr Disord. 2023 Nov 8;23(1):244. doi: 10.1186/s12902-023-01492-2.

  PMID: 37940936 DERIVED

Related Links

• Related Info
• Related Info

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Sitagliptin Phosphate, Metformin Hydrochloride Drug Combination

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Metformin; Biguanides; Guanidines; Amidines; Organic Chemicals; Sitagliptin Phosphate; Triazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pyrazines; Drug Combinations; Pharmaceutical Preparations

Study Officials

• Mansoor Khan

  PCDA

  PRINCIPAL INVESTIGATOR

• Asima Khan

  PCDA

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 29, 2021
• First Posted: December 22, 2021
• Study Start: January 1, 2021
• Primary Completion: April 28, 2022
• Study Completion: April 28, 2022
• Last Updated: May 4, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)