Blood Glucose Fluctuation, Type 2 Diabetes
Conditions
Brief summary
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.
Interventions
DRUGMetformin plus pioglitazone
After the screening period, eligible subjects were admitted to two tablets of fixed mixture of metformin plus pioglitazone (15mg pioglitazone plus 500mg metformin) for 12 weeks. Then the subjects were titrated onto the alternative treatment of 50mg acarbose three times daily for 12 weeks. During this timeframe, all patients were instructed to monitor their blood glucose fluctuations with a FreeStyle Libre Pro Sensor (FGM system) before and after the study and the time point of drug replacement.
DRUGAcarbose
After the screening period, eligible subjects were admitted to 50mg acarbose three times daily for 12 weeks. Then the subjects were titrated onto the alternative treatment of two tablets of fixed mixture of metformin plus pioglitazone (15mg pioglitazone plus 500mg metformin) for 12 weeks. During this timeframe, all patients were instructed to monitor their blood glucose fluctuations with a FreeStyle Libre Pro Sensor (FGM system) before and after the study and the time point of drug replacement.
Sponsors
Nanjing First Hospital, Nanjing Medical University
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Blood glucose fluctuation | week 24 | change from baseline blood glucsoe fluctuation at end of study |
Countries
China
Contacts
Primary ContactJianhua Ma, professor
Outcome results
None listed