Type 2 Diabetes Clinical Trial
Official title:
Effect of Acarbose and Fixed Mixture of Pioglitazone and Metformin in Patients With Type 2 Diabetes Receiving Anti-diabetic Monotherapy
Monotherapy with DPP-IV inhibitors, SGLT-2 inhibitors or insulin secretagogues frequently failed to maintain blood glucose in patients with type 2 diabtes. It was critical to determine which was more suitable of acarbose versus metformin plus pioglitazone.
Status | Recruiting |
Enrollment | 50 |
Est. completion date | May 31, 2023 |
Est. primary completion date | May 31, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 60 Years |
Eligibility | Inclusion Criteria: - Willing to participate in this present study; - Patients with type 2 diabetes receiving stable monotherapy of DPP-IV inhibitors, SGLT-2 inhibitors or insulin secretagogues for more than 3 months; - Screening glycated hemoglobin (HbA1c) between 7.0% and 10.0%; - Regular diet and exercise; - Body mass index (BMI) = 18.5 kg/m2 Exclusion Criteria: - Intolerance of metformin, pioglitazone and acarbose; - Severe liver disease or elevated transaminases (2.5-fold the upper limit); - Renal dysfunction or elevated creatinine (1.3-fold the upper limit); - Systemic steroids therapy or other medication influencing cholesterol metabolism in the past 3 months; - Infection or stress state in the past 4 weeks; - Pregnancy or lactation; - Patients otherwise adjudged by the investigator to be inappropriate for inclusion into the study. |
Country | Name | City | State |
---|---|---|---|
China | Nanjing First Hospital, Nanjing Medical Univesity | Nanjing |
Lead Sponsor | Collaborator |
---|---|
Nanjing First Hospital, Nanjing Medical University |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Blood glucose fluctuation | change from baseline blood glucsoe fluctuation at end of study | week 24 |
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