NCT04706637

A Clinical Trial to Evaluate the Bone Metabolism and the Blood Sugar of Evogliptin and Dapagliflozin

A Multicenter Randomized Exploratory Clinical Trial to Evaluate the Effect of Bone Metabolism and the Efficacy of Evogliptin and Dapagliflozin for Blood Sugar in the Menopause Female Patients With Osteopenia and Type 2 Diabetes

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 120 (estimated)
• Sponsor: Kyung Hee University Hospital at Gangdong · Academic / Other
• Sex: Female
• Age: 40 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

This multi-center, randomized and exploratory clinical trial is designed to evaluate the effect of bone metabolism and blood sugar of evogliptin and dapagliflozin in the menopause female patients with osteopenia and type 2 diabetes. The trial will evaluate bone metabolism (bone markers and bone density) and blood sugar (AGE and glucose variability) after 12 weeks and 48 weeks. This clinical trial conducts in two arms, and each arm recruits 60 subjects.

Detailed description

This clinical trial is to evaluate the effect of bone metabolism and blood sugar of evogliptin and dapagliflozin in the menopause female patients with osteopenia and type 2 diabetes. Bone metabolism (bone markers and bone density) and blood sugar (AGE and glucose variability) after 12 weeks and 48 weeks will be evaluated. This clinical trial conducts in two arms, and each arm recruits 60 subjects. If a subject voluntarily agrees to participate and meets the inclusion and exclusion criteria for the clinical trial, the subject will be randomly assigned to one of the two arms. The total period after the subject enrollment is 48 weeks, and a total of six visits are made with screening, baseline, 12 weeks, 24 weeks, 36 weeks, and 48 weeks. Efficacy evaluation will be carried out changes on blood sugar, bone markers and density and after 12 and 48 weeks. The results of this study are intended to be a reference to future clinical trials.

Conditions

• Bone Diseases, Metabolic
• Diabetes Mellitus, Type 2

Interventions

Type	Name	Description
DRUG	Evogliptin	evogliptin 5mg + metformin, oral administration once a day for 48 weeks
DRUG	Dapagliflozin	dapagliflozin 10mg + metformin, oral administration once a day for 48 weeks

Timeline

• Start date: 2021-02-01
• Primary completion: 2022-01-31
• Completion: 2023-01-31
• First posted: 2021-01-13
• Last updated: 2021-01-13

Locations

7 sites across 1 country: South Korea