Clinical trial NCT06959030: the Safety and Efficacy of Henggliflozin in Chinese Patients With Type 2 Diabetes
Official title: An Observational Study on the Safety and Efficacy of Henggliflozin in Chinese Patients With Type 2 Diabetes
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Type 2 Diabetes Mellitus (T2DM)
Lead sponsor: Second Affiliated Hospital of Guangxi Medical University
Sponsor class: OTHER
First posted: 2025-05-06
Enrollment: 10000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Chinese Patients with Type 2 Diabetes

Brief summary: An Observational Study on the Safety and Efficacy of Henggliflozin in Chinese Patients with Type 2 Diabetes Primary Research Objective

• To evaluate the safety of Henggliflozin in Chinese patients with type 2 diabetes mellitus (T2DM) in real world.

Exploratory Research Objectives

* 1. Improvement in metabolic parameters: To assess changes in metabolic indicators, including glycated hemoglobin (HbA1c), fasting plasma glucose (FPG), 2-hour postprandial plasma glucose (PPG), blood pressure, and body weight, in T2DM patients treated with Henggliflozin.
* 2. Incidence of specific adverse events: To investigate the occurrence of key adverse events, with a focus on hypovolemia, amputation or amputation risk, fractures, urinary tract infections, genital infections, renal impairment, diabetic ketoacidosis, hepatic dysfunction, and severe hypoglycemia.
* 3. Impact on muscle health: To evaluate changes in muscle health indicators, such as skeletal muscle mass index, lean body mass, and grip strength, in T2DM patients receiving Henggliflozin therapy.


Eligibility criteria: Inclusion Criteria:

1. 18 years old≤ age ≤ 80 years old;
2. Diagnosed with type 2 diabetes mellitus according to WHO diagnostic criteria, currently receiving or eligible for add-on therapy with Henggliflozin;
3. Voluntarily participate in this study and sign the informed consent form. If the subject does not have the ability to read the informed consent form (e.g., illiterate subjects), a witness is required to witness the informed process and sign the informed consent form.

Exclusion Criteria:

1. Participation in or current enrollment in clinical trials investigating other glucose-lowering medications within 1 month prior to the initiation of this study.
2. Current or history of recurrent urinary tract infections (UTIs) and/or genital infections.
3. Patients judged by the investigator to be unsuitable to participate in this clinical trial, with considerations such as current blood volume status, estimated glomerular filtration rate (eGFR), and other clinical parameters.

Primary outcomes:
measure: incidence of adverse events and serious adverse events during 24 weeks of treatment
timeFrame: 24 weeks
Secondary outcomes:
measure: changes of HbA1c (mmol/L) in T2DM patients during treatment with henggliflozin
timeFrame: 24 weeks
measure: changes of fasting plasma glucose (FPG) in T2DM patients during treatment with henggliflozin
timeFrame: 24 weeks
measure: changes of 2-hour postprandial plasma glucose (PPG) in T2DM patients during treatment with henggliflozin
timeFrame: 24 weeks
measure: changes of blood pressure in T2DM patients during treatment with henggliflozin
timeFrame: 24 weeks
measure: changes of weight in T2DM patients during treatment with henggliflozin
timeFrame: 24 weeks
measure: incidence of specific adverse events during 24 weeks of treatment
timeFrame: 24 weeks
measure: changes of limb skeletal muscle mass index in T2DM patients during treatment with henggliflozin
timeFrame: 24 weeks
measure: changes of lean body mass in T2DM patients during treatment with henggliflozin lean body mass
timeFrame: 24 weeks
measure: changes of grip strength in T2DM patients during treatment with henggliflozin
timeFrame: 24 weeks
Other outcomes:
Locations:
city: Nanning
country: China
facility: the Second Affiliated Hospital of Guangxi Medical University
state: Guangxi
Study officials:
References: