NCT04075110

Investigation the Safety and Efficacy of The Antileukotriene Agents, Montelukast, as Adjuvant Therapy in Obese Patients With Type 2 Diabetes Mellitus

Investigation the Safety and Efficacy of The Antileukotriene Agents, Montelukast, as Adjuvant Therapy in Obese Patients With Type 2 Diabetes Mellitus: A Randomized, Controlled Trial

• Status: Completed
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 100 (actual)
• Sponsor: Sadat City University · Academic / Other
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

Summary

The aim of the current study is to evaluate the safety and efficacy of Montelukast in treatment of obese patients with type 2 diabetes (T2DM).

Conditions

• Obesity; Endocrine; Diabetes Type 2

Interventions

Type	Name	Description
DRUG	Montelukast 10mg	Montelukast is an orally dosed drug (available as a chewable tablet) which is FDA-approved for the treatment of chronic asthma and prophylaxis and the prevention of exercise-induced bronchoconstriction. It is also approved for the relief of symptoms of both seasonal and perennial allergic rhinitis.
DRUG	Placebo	Placebo tablet once daily

Timeline

• Start date: 2019-07-01
• Primary completion: 2022-06-01
• Completion: 2023-04-10
• First posted: 2019-08-30
• Last updated: 2023-04-11

Locations

1 site across 1 country: Egypt

Regulatory

• FDA-regulated drug study