Glimepiride, Empagliflozin, and Sitagliptin With Metformin for Type 2 Diabetes

NCT06759922 | Completed Phase 4

• 1 other identifier: BUHS-IRB # R-104/24
• Study Type: interventional
• Target: 172
• Locations: 1 country
• Sites: 1

Brief Summary

This clinical trial aims to evaluate and compare the clinical efficacy and safety of Glimepiride, Empagliflozin, and Sitagliptin with Metformin in newly diagnosed Type 2 Diabetes Mellitus patients. The study will involve 172 participants, aged 30-55, enrolled at the National Medical Centre, Karachi, Pakistan. The study involves four groups, subjects will receive following treatment: Group A will receive Tab Metforrmin 500mg + Tab Glimepiride 2mg (FDC) , Group B Tab Metforrmin 500mg + Tab Empagliflozin 12.5mg (FDC), Group C Tab Metforrmin 500mg + Tab Sitagliptin 50mg (FDC) and Group D Tab Metformin 500mg + Tab Empagliflozin 12.5mg (FDC) + Tab Sitagliptin 50mg per orally, once daily for 90 days. Safety and efficacy will be assessed through anthropometric measurements and lab investigations at baseline, 6 weeks, and 12 weeks, with weekly monitoring of blood sugar levels. The total duration of the study will be 6 months, with a 3-month individual treatment period.

Conditions

Type 2 Diabetes Mellitus

Keywords

Metformin; Glimepiride; Sitagliptin; Empagliflozin

Outcome Measures

Primary Outcomes (1)

• Primary Outcome

  Change in HbA1c levels in %

  3 months

Secondary Outcomes (1)

• Secondary Outcome

  3months

Study Arms (4)

Group A: Metformin + Glimepiride (Combination Therapy)

ACTIVE COMPARATOR

Dual therapy (Fixed Dose Combination): Tab Metformin 500mg + Tab Glimepiride 2mg Dosage: One tablet per day for 90 days.

Drug: Tab Metformin + Tab Glimepiride

Group B: Metformin + Empagliflozin (Combination Therapy)

ACTIVE COMPARATOR

Dual therapy (Fixed Dose Combination): Tab Metformin 500mg + Tab Empagliflozin 12.5mg Dosage: One tablet per day for 90 days.

Drug: Tab Metformin + Tab Empagliflozin

Group C: Metformin + Sitagliptin (Combination Therapy)

ACTIVE COMPARATOR

Dual therapy (Fixed Dose Combination): Tab Metformin 500mg + Tab Sitagliptin 50mg Dosage: One tablet per day for 90 days.

Drug: Tab Metformin +Tab Sitagliptin

Group D: Metformin + Empagliflozin + Sitagliptin (Combination Therapy)

ACTIVE COMPARATOR

Triple Therapy: Tab Metformin 500mg + Tab Empagliflozin 12.5mg (Fixed Dose Combination) + Tab Sitagliptin 50mg Dosage: One tablet of each per day for 90 days.

Drug: Tab Metformin + Tab Empagliflozin + Tab Sitagliptin

Interventions

Tab Metformin + Tab Empagliflozin DRUG

Tab Metformin 500mg+Tab Empagliflozin 12.5mg (FDC) once per orally for 90 days.

Also known as: Tab Jardy-Met (12.5/500mg)

Group B: Metformin + Empagliflozin (Combination Therapy)

Tab Metformin +Tab Sitagliptin DRUG

Tab Metformin 500mg+Tab Sitagliptin 50mg (FDC) once per orally for 90 days.

Also known as: Tab Sita-Met (50/500mg)

Group C: Metformin + Sitagliptin (Combination Therapy)

Tab Metformin + Tab Glimepiride DRUG

Tab Metformin 500mg+ Tab Glimepiride 2mg (FDC) once per orally for 90 days.

Also known as: Tab Orinase-Met (2/500mg)

Group A: Metformin + Glimepiride (Combination Therapy)

Tab Metformin + Tab Empagliflozin + Tab Sitagliptin DRUG

Tab Metformin 500mg+Tab Empagliflozin 12.5mg (FDC) + Tab Sitagliptin 50mg once per orally for 90 days.

Also known as: Tab Jardy-Met (12.5/500mg) + Tab Sita 50mg

Group D: Metformin + Empagliflozin + Sitagliptin (Combination Therapy)

Eligibility Criteria

• Age: 30 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Males and females
• Age 30-55yrs
• HbA1c = ≥ 8.5 \<10 mmol/mol (ADA. 2018)
• BMI \>18.5- \<29.9 (WHO Asian Criteria)
• Treatment naïve patients
• With / without dyslipidemia.

You may not qualify if:

• HbA1c \>10 mmol/mol
• BMI \> 30
• Pregnancy or lactation
• Systemic diseases such as: hypertension, thyroid, liver, renal diseases etc.
• Known allergy or intolerance to Metformin, Glimepiride, Sitagliptin or Empagliflozin.

Sponsors & Collaborators

• Bahria University: lead

Study Sites (1)

National Medical Center

Karachi, Sindh, 75500, Pakistan

Location

Related Publications (14)

• Ahmed M, Saeed A, Khan MZ, Javaid SZ, Aslam F, Dar SI. A Comparison of the Effects of Empagliflozin and Sitagliptin, When Combined With Metformin, on Lipid Levels in Patients with Type 2 Diabetes: A Clinical Investigation. Cureus. 2023 Sep 5;15(9):e44709. doi: 10.7759/cureus.44709. eCollection 2023 Sep.

  PMID: 37809225 BACKGROUND

• Davies MJ, Aroda VR, Collins BS, Gabbay RA, Green J, Maruthur NM, Rosas SE, Del Prato S, Mathieu C, Mingrone G, Rossing P, Tankova T, Tsapas A, Buse JB. Management of hyperglycaemia in type 2 diabetes, 2022. A consensus report by the American Diabetes Association (ADA) and the European Association for the Study of Diabetes (EASD). Diabetologia. 2022 Dec;65(12):1925-1966. doi: 10.1007/s00125-022-05787-2. Epub 2022 Sep 24.

  PMID: 36151309 BACKGROUND

• Dominguez Rieg JA, Rieg T. What does sodium-glucose co-transporter 1 inhibition add: Prospects for dual inhibition. Diabetes Obes Metab. 2019 Apr;21 Suppl 2(Suppl 2):43-52. doi: 10.1111/dom.13630.

  PMID: 31081587 BACKGROUND

• ElSayed NA, Aleppo G, Aroda VR, Bannuru RR, Brown FM, Bruemmer D, Collins BS, Hilliard ME, Isaacs D, Johnson EL, Kahan S, Khunti K, Leon J, Lyons SK, Perry ML, Prahalad P, Pratley RE, Seley JJ, Stanton RC, Gabbay RA, on behalf of the American Diabetes Association. 9. Pharmacologic Approaches to Glycemic Treatment: Standards of Care in Diabetes-2023. Diabetes Care. 2023 Jan 1;46(Suppl 1):S140-S157. doi: 10.2337/dc23-S009.

  PMID: 36507650 BACKGROUND

• Huang J, Liu X, Wei Y, Li X, Gao S, Dong L, Rao X, Zhong J. Emerging Role of Dipeptidyl Peptidase-4 in Autoimmune Disease. Front Immunol. 2022 Mar 4;13:830863. doi: 10.3389/fimmu.2022.830863. eCollection 2022.

  PMID: 35309368 BACKGROUND

• Hur KY, Moon MK, Park JS, Kim SK, Lee SH, Yun JS, Baek JH, Noh J, Lee BW, Oh TJ, Chon S, Yang YS, Son JW, Choi JH, Song KH, Kim NH, Kim SY, Kim JW, Rhee SY, Lee YB, Jin SM, Kim JH, Kim CH, Kim DJ, Chun S, Rhee EJ, Kim HM, Kim HJ, Jee D, Kim JH, Choi WS, Lee EY, Yoon KH, Ko SH; Committee of Clinical Practice Guidelines, Korean Diabetes Association. 2021 Clinical Practice Guidelines for Diabetes Mellitus of the Korean Diabetes Association. Diabetes Metab J. 2021 Jul;45(4):461-481. doi: 10.4093/dmj.2021.0156. Epub 2021 Jul 30.

  PMID: 34352984 BACKGROUND

• Janani L, Bamehr H, Tanha K, Mirzabeigi P, Montazeri H, Tarighi P. Effects of Sitagliptin as Monotherapy and Add-On to Metformin on Weight Loss among Overweight and Obese Patients with Type 2 Diabetes: A Systematic Review and Meta-Analysis. Drug Res (Stuttg). 2021 Nov;71(9):477-488. doi: 10.1055/a-1555-2797. Epub 2021 Aug 13.

  PMID: 34388848 BACKGROUND

• Kim HJ, Noh JH, Moon MK, Choi SH, Ko SH, Rhee EJ, Hur KY, Jeong IK. A Multicenter, Randomized, Open-Label Study to Compare the Effects of Gemigliptin Add-on or Escalation of Metformin Dose on Glycemic Control and Safety in Patients with Inadequately Controlled Type 2 Diabetes Mellitus Treated with Metformin and SGLT-2 Inhibitors (SO GOOD Study). J Diabetes Res. 2024 Jan 5;2024:8915591. doi: 10.1155/2024/8915591. eCollection 2024.

  PMID: 38223523 BACKGROUND

• Lovic D, Piperidou A, Zografou I, Grassos H, Pittaras A, Manolis A. The Growing Epidemic of Diabetes Mellitus. Curr Vasc Pharmacol. 2020;18(2):104-109. doi: 10.2174/1570161117666190405165911.

  PMID: 30961501 BACKGROUND

• Magkos F, Hjorth MF, Astrup A. Diet and exercise in the prevention and treatment of type 2 diabetes mellitus. Nat Rev Endocrinol. 2020 Oct;16(10):545-555. doi: 10.1038/s41574-020-0381-5. Epub 2020 Jul 20.

  PMID: 32690918 BACKGROUND

• Packer M, Anker SD, Butler J, Filippatos G, Ferreira JP, Pocock SJ, Sattar N, Brueckmann M, Jamal W, Cotton D, Iwata T, Zannad F; EMPEROR-Reduced Trial Committees and Investigators. Empagliflozin in Patients With Heart Failure, Reduced Ejection Fraction, and Volume Overload: EMPEROR-Reduced Trial. J Am Coll Cardiol. 2021 Mar 23;77(11):1381-1392. doi: 10.1016/j.jacc.2021.01.033.

  PMID: 33736819 BACKGROUND

• Shin H, Schneeweiss S, Glynn RJ, Patorno E. Trends in First-Line Glucose-Lowering Drug Use in Adults With Type 2 Diabetes in Light of Emerging Evidence for SGLT-2i and GLP-1RA. Diabetes Care. 2021 Aug;44(8):1774-1782. doi: 10.2337/dc20-2926. Epub 2021 Jun 18.

  PMID: 34385345 BACKGROUND

• Tomic D, Shaw JE, Magliano DJ. The burden and risks of emerging complications of diabetes mellitus. Nat Rev Endocrinol. 2022 Sep;18(9):525-539. doi: 10.1038/s41574-022-00690-7. Epub 2022 Jun 6.

  PMID: 35668219 BACKGROUND

• Uusitupa M, Schwab U. Evolving Nutritional Therapy for Diabetes Mellitus. Nutrients. 2020 Feb 6;12(2):423. doi: 10.3390/nu12020423.

  PMID: 32041141 BACKGROUND

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Metformin

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Biguanides; Guanidines; Amidines; Organic Chemicals

Study Officials

• Saima Chandio, MBBS

  Bahria University Islamabad

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MPhil Trainee in Pharmacology Department

Study Record Dates

• First Submitted: December 9, 2024
• First Posted: January 6, 2025
• Study Start: January 1, 2025
• Primary Completion: March 30, 2025
• Study Completion: June 30, 2025
• Last Updated: April 14, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: The IPD data will become accessible one year after publication and will remain available indefinitely.
• Access Criteria: All the data will be accessible to everyone.

Locations

PA (1)