Efficacy and Safety of Henagliflozin Proline and Metformin Hydrochloride Extended-release Tablets (Ⅰ) Versus Metformin Tablets in Patients With New-onset Type 2 Diabetes: a Multicenter, Randomized Controlled Study

Sponsor
Zhejiang Provincial People's Hospital
Study ID
NCT06888050
Phase
PHASE4
Status
Recruiting
Apply to this trial

Conditions

  • New-onset Type 2 Diabetes

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • henagliflozin proline and metformin hydrochloride extended-release tablets (Ⅰ) — DRUG
    henagliflozin proline and metformin hydrochloride extended-release tablets (Ⅰ) (5mg/500mg, once a day, two tablets each time) plus lifestyle intervention
  • Metformin — DRUG
    Metformin (500mg, twice a day) plus lifestyle intervention

Study Details

This multicenter, randomized controlled trial aims to evaluate the efficacy and safety of Henagliflozin-Metformin Sustained-Release Tablets (I) versus Metformin Tablets in newly diagnosed type 2 diabetes mellitus (T2DM). A total of 268 participants will be randomized (1:1) into two groups: the experimental group receiving Henagliflozin-Metformin Sustained-Release Tablets (I) (5mg/500mg, once daily) with lifestyle intervention, and the control group receiving Metformin Tablets (500mg, twice daily) with lifestyle intervention. The primary outcome is the change in glycated hemoglobin (HbA1c) from baseline at 24 weeks. Secondary outcomes include changes in fasting/postprandial blood glucose, body weight, metabolic parameters, diabetes remission rate, and safety assessments. This trial will provide evidence for early combination therapy in newly diagnosed T2DM patients.

Key Dates

Start date
Apr 11, 2025
Status verified
Mar 2025
Primary completion
Jun 30, 2026
Completion
Dec 30, 2026

Study Design

Enrollment
268 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: henagliflozin proline and metformin hydrochloride extended-release tablets (Ⅰ)
    Start with henagliflozin proline and metformin hydrochloride extended-release tablets (Ⅰ) (5mg/500mg, once a day, two tablets at a time) + raw live-style intervention
  • Active Comparator: metformin
    Initiation of metformin (500 mg twice a day) + lifestyle intervention

Primary Outcome Measure

Glycosylated Hemoglobin, Type A1C（HbA1C） [ Time Frame: 24 weeks ]

Central Contacts