The effect of SGLT-2 inhibitor, empagliflozin, a new diabetes medication, over sitagliptin on nerve and muscle health in patients with type 2 diabetes

Effects of sodium glucose co-transporter-2 (SGLT2) inhibitor, empagliflozin, compared to dipeptidyl peptidase-4 inhibitor, sitagliptin on functions of the autonomic nervous system, peripheral nerves and muscles of the patients with type 2 diabetes attending National Hospital Galle and laboratory evaluation of the quality control parameters of commercially available SGLT2 inhibitor tablets in Galle, Sri Lanka.

Status

Recruiting

Phases

Phase 4

Study type

Interventional

Source

SLCTR

Registry ID

SLCTR/2025/013

Enrollment

Unknown

Registered

2025-04-04

Start date

2025-05-01

Completion date

Unknown

Last updated

2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 2 Diabetes

Interventions

Study Setting: National Hospital, Galle, Sri Lanka Participants meeting the inclusion /exclusion criterial will be randomly allocated to two arms. Sealed opaque envelopes will be used for allocation c

Eligibility

Inclusion criteria

Inclusion criteria: 1. Patients with type 2 diabetes who are on all 3 medications (biguanides, sulfonylureas and DPP- 4 inhibitors) 2. Males and females 3. Age between 26- 69 years 4. HbA1c 20 ml/min per 1.73 m2

Exclusion criteria

Exclusion criteria: 1. Contraindications to empagliflozin (pregnancy, critical illness) 2. Patients who are on insulin 3. Patients with type 1 diabetes 4. Patients with other neurological or neuropathic disorders other than diabetic neuropathy. 5. Patients with a history of complications due to previous SGLT -2 inhibitor treatment.

Design outcomes

Primary

Measure	Time frame
Heart rate variability and Valsalva maneuver – Time and frequency domain of heart rate variability will be measured (LF and HF power ms2 and LF/HF ratio % and sympathetic/parasympathetic dominance). The ADInstrument machine and software will be used to measure heart rate variability. Valsalva maneuver will be assessed using FUUDA DENSHI- ECG/PHONO system FD-31P machine. The heart rate (baseline, during Valsalva and post procedure) will be measured. [Baseline, at the end of 1 month, at the end of 3 months and at the end of 6 months. ] Hand grip strength test measured using a LAFAYETTE Hand Dynamometer, previously calibrated, with a resolution of 2 kg, following the procedures adopted by the American Society of Hand Therapists. The grip strength average (in newton) will be measured. [Baseline, at the end of 1 month, at the end of 3 months and at the end of 6 months.] Nerve conduction study of posterior tibial and sural nerve of lower limb assessed using NIHON KOHDEN Neuropack machine. The velocity and amplitude of both motor and sensory nerves will be measured. p value 10% in FVC, FEV1 and PEFR after treatment will be considered as significant. [Baseline, at the end of 1 month, at the end of 3 months and at the end of 6 months.]	—

Measure

Time frame

Heart rate variability and Valsalva maneuver – Time and frequency domain of heart rate variability will be measured (LF and HF power ms2 and LF/HF ratio % and sympathetic/parasympathetic dominance). The ADInstrument machine and software will be used to measure heart rate variability. Valsalva maneuver will be assessed using FUUDA DENSHI- ECG/PHONO system FD-31P machine. The heart rate (baseline, during Valsalva and post procedure) will be measured. [Baseline, at the end of 1 month, at the end of 3 months and at the end of 6 months. ] Hand grip strength test measured using a LAFAYETTE Hand Dynamometer, previously calibrated, with a resolution of 2 kg, following the procedures adopted by the American Society of Hand Therapists. The grip strength average (in newton) will be measured. [Baseline, at the end of 1 month, at the end of 3 months and at the end of 6 months.] Nerve conduction study of posterior tibial and sural nerve of lower limb assessed using NIHON KOHDEN Neuropack machine. The velocity and amplitude of both motor and sensory nerves will be measured. p value 10% in FVC, FEV1 and PEFR after treatment will be considered as significant. [Baseline, at the end of 1 month, at the end of 3 months and at the end of 6 months.]

—

Secondary

Measure	Time frame
None []	—

Countries

Sri Lanka

Contacts

Public ContactDr. M.A.L.D. Malwatta

Lecturer (probationary)

dhananjanee@med.ruh.ac.lk091 2234801

Outcome results

None listed

Source: SLCTR (via WHO ICTRP) · Data processed: Aug 10, 2026