Adding SGLt2 Inhibitors to Patients With Type 2 Diabetes

NCT06268977 | Completed Phase 4

• 1 other identifier: SGLt2i in type 2 diabetes
• Study Type: interventional
• Target: 482
• Locations: 1 country
• Sites: 1

Brief Summary

To detect the efficacy of SGLT2i in improving the metabolic parameters in patients with type 2 diabetes. \- To detect the side-effects of SGLT2i

Conditions

Type 2 Diabetes

Keywords

type 2 diabetes

Outcome Measures

Primary Outcomes (2)

• Effect of adding SGLTi on HbA1c

  Compare the effect on HbA1c between study arms

  Six months

• comparing CAP change between study arms

  compare steatosis by FibroScan between study arms

  Six months

Secondary Outcomes (3)

• Effect of adding SGLTi on WC

  Six months

• comparing adverse-events between study arms

  six months

• compare other metabolic parameters between study arms

  six months

Study Arms (2)

Experimental Arm: add-on SGLT2i, beside usual treatment

EXPERIMENTAL

participants will receive addon SGLT2i, beside continuing their standard of care treatment

Drug: SGLT2 inhibitor

Control group: Standard of Care, no add-on treatment

NO INTERVENTION

Interventions

SGLT2 inhibitor DRUG

a class of prescription medicines that are FDA-approved for use with diet and exercise to lower blood sugar in adults with type 2 diabetes.

Also known as: gliflozins or flozins

Experimental Arm: add-on SGLT2i, beside usual treatment

Eligibility Criteria

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

You may qualify if:

• Adults (≥18 years)
• both genders ( male and female)
• type 2 diabetic patients

You may not qualify if:

• history of severe hypoglycemia
• patients with history of weight loss
• Patients with history of recurrent UTI
• patients already receiving SGLT2i as part of their treatment
• very high blood glucose (A1c more than 11%) or presenting at the clinic with BG above 300 mg/dL.
• clinical evidence of dehydration.
• Frailty.

Sponsors & Collaborators

• Assiut University: lead

Study Sites (1)

Assiut University Hospital

Asyut, Egypt

Location

Related Publications (3)

• Sun H, Saeedi P, Karuranga S, Pinkepank M, Ogurtsova K, Duncan BB, Stein C, Basit A, Chan JCN, Mbanya JC, Pavkov ME, Ramachandaran A, Wild SH, James S, Herman WH, Zhang P, Bommer C, Kuo S, Boyko EJ, Magliano DJ. IDF Diabetes Atlas: Global, regional and country-level diabetes prevalence estimates for 2021 and projections for 2045. Diabetes Res Clin Pract. 2022 Jan;183:109119. doi: 10.1016/j.diabres.2021.109119. Epub 2021 Dec 6.

  PMID: 34879977 BACKGROUND

• Levine MJ. Empagliflozin for Type 2 Diabetes Mellitus: An Overview of Phase 3 Clinical Trials. Curr Diabetes Rev. 2017;13(4):405-423. doi: 10.2174/1573399812666160613113556.

  PMID: 27296042 BACKGROUND

• Vukadinovic D, Abdin A, Anker SD, Rosano GMC, Mahfoud F, Packer M, Butler J, Bohm M. Side effects and treatment initiation barriers of sodium-glucose cotransporter 2 inhibitors in heart failure: a systematic review and meta-analysis. Eur J Heart Fail. 2022 Sep;24(9):1625-1632. doi: 10.1002/ejhf.2584. Epub 2022 Jul 8.

  PMID: 35730422 BACKGROUND

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Sodium-Glucose Transporter 2 Inhibitors

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses; Hypoglycemic Agents; Physiological Effects of Drugs

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident doctor

Model Details: non-randomized (quasi-random, sequential) with two steps: First, Clinical Screening foe eligibility. Second, Sequential Allocation (based on the order of cleared medical enrollment: Odd-numbered cleared participants (e.g., 1, 3, 5...) will be allocated to the Experimental Arm and Even-numbered cleared participants (e.g., 2, 4, 6...) will be allocated to the Control Arm.

Study Record Dates

• First Submitted: January 17, 2024
• First Posted: February 21, 2024
• Study Start: April 1, 2025
• Primary Completion: January 1, 2026
• Study Completion: January 30, 2026
• Last Updated: September 10, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)