Glycemic Control With Triple Pathway Approach Through Empagliflozin, Linagliptin and Metformin Combination

NCT06862739 | Recruiting Phase 4 DMC

• 1 other identifier: NQ/DY/GLX/CT-001
• Study Type: interventional
• Target: 800
• Locations: 1 country
• Sites: 2

Brief Summary

The efficacy and safety of a triple-pill combination therapy for advanced type 2 diabetes care. The study aims to assess the impact of 3 Oral Anti Diabetic (OAD) drugs on metabolic control, patient compliance, weight management, quality of life, diabetic treatment satisfaction and frequency of hypoglycemic events by combining them into a fixed-dose single pill.

Conditions

Diabetes Mellitus; Type 2 DM

Keywords

Combination; empagliflozin; metformin; linagliptin; compliance; Hypoglycemic events; weight management; quality of life; treatment satisfaction; glycemic control; Type 2 DM

Outcome Measures

Primary Outcomes (1)

• Changes in HbA1c levels

  Metabolic control

  03 months, 06 months

Secondary Outcomes (4)

• Change in scores of Quality of Life-Short Form "SF-36" questionnaire

  06 months

• Changes in Diabetic Treatment Satisfaction Questionnaire "DTSQ"

  06 months

• Hypoglycemic events

  06 months

• Changes in body weight

  03 and 06 months

Study Arms (1)

Glem-Lin MXR Single pill combination study

OTHER

Empagliflozin (25 mg) Linagliptin (5 mg) Metformin XR (1000 mg) once daily combination therapy

Combination Product: Empagliflozin+Linagliptin+Metformin

Interventions

Empagliflozin+Linagliptin+Metformin COMBINATION_PRODUCT

Scarcity of local population data on triple drug combination's impact on compliance, efficacy and safety in diabetic patients

Glem-Lin MXR Single pill combination study

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients of any gender
• Patients aged between 18-80 years
• Patients having HbA1c 8 % or above
• Patients diagnosed with type II diabetes (more than at least 06 months)
• Patients already on at least 02 or more anti-diabetic agents
• Patients not allergic to empagliflozin, linagliptin, or metformin

You may not qualify if:

• Patients with age less than 18
• Patients with Type-I diabetes
• Patients having diabetes for less than 06 months
• Patients on GLP-1 and GIP
• Patients who are pregnant or lactating females
• Patients with decompensated chronic liver disease (DCLD)
• Patients with eGFR less than 30 ml
• Patients with end-stage heart failure (NYHA Class 4)
• Patients who are allergic to empagliflozin, linagliptin, or metformin
• Patients who are not willing to consent
• Patients who are unable to give medical history

Sponsors & Collaborators

• Nabiqasim Industries (Pvt) Ltd: lead

Study Sites (2)

Faisalabad clinics

Faisalabad, Punjab Province, Pakistan

RECRUITING

Aap ka Clinic

Lahore, Punjab Province, Pakistan

RECRUITING

Related Links

• Screening for Diabetes in Adults
• IDF diabetes atlas 2021 Pakistan's ranking
• Health system performance for people with diabetes in LMICs

MeSH Terms

Conditions

Diabetes Mellitus; Patient Compliance

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Study Design

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

Model Details: 1

Study Record Dates

• First Submitted: February 19, 2025
• First Posted: March 6, 2025
• Study Start: October 30, 2025
• Primary Completion: April 30, 2026
• Study Completion (Estimated): June 30, 2026
• Last Updated: April 17, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

PA (2)