A Phase 4 interventional study of Acarbose and Metformin in Type 2 Diabetes Mellitus, sponsored by Fifth Affiliated Hospital, Sun Yat-Sen University. Status unknown. Open to participants aged 20 Years to 75 Years. Per ClinicalTrials.gov, last updated 2015-11-18.
Sponsored by Fifth Affiliated Hospital, Sun Yat-Sen University · Phase 4, Interventional, and Treatment
To investigate the Safety and Efficacy of Acarbose+Saxagliptin Compared With Metformin+Saxagliptin in Patients With Type 2 Diabetes,100 patients with T2DM will be enrolled in this study.They will randomly be assigned to Acarbose+Saxagliptin or Metformin+Saxagliptin group.HbA1c，fasting and postprandial C-peptide will be observed before and after the interventions.
Participants coming on study will be assigned to two groups：Acarbose+Saxagliptin and Metformin+Saxagliptin. It may take 1 weeks to be stabilize to a standardized dose, and then the investigators will follow-up the patients for 3 months.During the period,patients will be asked to come back to the investigators center to receive the related examination every month. The investigators will detect HbA1c，fasting and postprandial C-peptide before and after the interventions.
10,925 studies on the registry are indexed under Diabetes Mellitus; 1,319 are open to participants now.
This study's planned enrollment of 100 is above the median of 80 across 8,367 interventional studies indexed under Diabetes Mellitus.
Browse Diabetes Mellitus studies →Fifth Affiliated Hospital, Sun Yat-Sen University is the lead sponsor of 57 studies on the registry; 20 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
metformin 0.5g tablet Saxagliptin 5mg tablet metformin 0.5g three times a day for three months Saxagliptin 5mg one time a day for three months
Drug: Metformin · Drug: Saxagliptin
acarbose 50mg tablet Saxagliptin 5mg tablet Saxagliptin 5mg one time a day for three months acarbose 100mg three times a day for three months
Drug: Acarbose · Drug: Saxagliptin
group1:metformin 1.5g + Saxagliptin 5mg group2:acarbose 300mg + Saxagliptin 5mg
Also known as: Glucobay
group1:metformin 1.5g + Saxagliptin 5mg group2:acarbose 300mg + Saxagliptin 5mg
Also known as: Glucophage
group1:metformin 1.5g + Saxagliptin 5mg group2:acarbose 300mg + Saxagliptin 5mg
Also known as: ONGLYZA
redunction of Hemoglobin A1c (HbA1c) Levels (%) in two groups respectively after three months intervention
HbA1c was measured by high performance liquid chromatography with an automated biochemistry analyzer (Roche, Switzerland).
Time frame: baseline(0 week), week twelve
Proportion of patients who achieve target of HbA1c<6.5% in two groups respectively at the end of study
Time frame: baseline(0 week), week twelve
Difference of Homeostasis model assessment of insulin resistance (HOMA-IR) and Homeostasis model assessment beta cell function index (HOMA-β) between two groups after three months intervention
HOMA-β= Fasting C-Peptide × 0.27/(Fasting Plasma Glucose-3.5 HOMA-IR = 1.5 + Fasting Plasma Glucose × Fasting CPeptide/ 2800.
Time frame: baseline(0 week), week twelve
No study locations are listed for this record.
This study is status unknown, as verified in Nov 2015. You cannot join it, but the record below documents what was studied.
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Fifth Affiliated Hospital, Sun Yat-Sen University