Status:
UNKNOWN
A Study for Sufficient Acarbose Decreased Glucose Excursion in Type 2 Diabetic Patients
Lead Sponsor:
Qilu Hospital of Shandong University
Collaborating Sponsors:
Bayer
Conditions:
Type 2 Diabetes Mellitus
Poor Glycemic Control
Eligibility:
All Genders
18+ years
Brief Summary
This is a multicentre observational study to investigate the improvement in glucose fluctuation of sufficient acarbose therapy on type 2 diabetes patient with high blood glucose fluctuation
Detailed Description
Acarbose competitively inhibits the a-glycosidase on the surface of epithelial cells from the duodenum and small intestine, delays the metabolism and assimilation of carbohydrates, and thus effectivel...
Eligibility Criteria
Inclusion
- All enrolled patients sign the informed consent. sign the informed consent form.
- Clinical diagnosis of T2DM(1999 WHO).
- No acarbose in nearly 3 months.
- 7% \< HbA1c ≤10% .
- PPGE \>2.2mmol/L and LAGE \>4.4mmol/L.
- MAGE \> 3.9 mmol/L.
- The previous therapy remain the same.
- Contraception is needed for women of child-bearing age until 28 days after the end.
Exclusion
- Women of childbearing potential unable or unwilling to use acceptable birth control, or women who are pregnant or breastfeeding.
- Replacement or chronic systemic corticosteroid therapy. Cytochrome P450 3A4 enzyme inducer or inhibitor therapy.Antiviral therapy for immunodeficiency disease.
- History of gastrointestinal disease or surgery including Roemheld Syndrome, severe hernia, intestinal obstruction, intestinal ulcer, gastroenterostomy, enterectomy, bariatric surgery or lap-band procedure.
- Known immunocompromised status, including but not limited to, individuals who had undergone organ transplantation or acquired immunodeficiency syndrome (AIDS).
- History of hemoglobinopathy .
- Any subject who was currently abusing alcohol or other drugs or had done so within the last 12 months.
- There are contraindications listed in the acarbose instructions.
- History of acute or chronic pancreatitis, or current acute or chronic pancreatitis.
- Type 1 diabetees mellitus.
- History of diabetic ketoacidosis or hyperosmolar nonketosis coma in recent 1 month.
- Patients with clinically apparent hepatobiliary disease, including but not limited to chronic active hepatitis and/or severe hepatic insufficiency. Alanine Aminotransferase(ALT) or Aspartate Aminotransferase(AST) \> 3x upper limit of normal (ULN), or serum total bilirubin (TB) \>34.2 μmol/L (\>2 mg/dL).
- Patients with following renal disease history or renal disease related features:
- History of unstable or rapidly progressing renal disease;
- Patients with moderate /severe renal impairment or end-stage renal disease (eGFR\< 60 mL/min/1.73 m2);
- Urinary albumin: creatinine ratio \>1800 mg/g;
- Serum creatinine (Cr) ≥133 μmol/L (≥1.50 mg/dL) for male subjects; Serum Cr≥124 μmol/L (≥1.40 mg/dL) for female subjects;
- Conditions of congenital renal glycosuria.
- Any of the following cardiovascular diseases within 6 months of the enrollment visit:
- Myocardial infarction;
- Cardiac surgery or revascularization (coronary artery bypass graft/percutaneous transluminal coronary angioplasty);
- Unstable angina;
- Congestive heart failure New York Heart Association Class III or IV;
- Transient ischemic attack or significant cerebrovascular disease.
- Any subject , in the judgment of the investigator, was at risk that might affect the interpretation of efficacy or safety data or the conduct ion of the study，including laboratory and physical examination or ECG.
Key Trial Info
Start Date :
January 1 2019
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 30 2022
Estimated Enrollment :
900 Patients enrolled
Trial Details
Trial ID
NCT03805191
Start Date
January 1 2019
End Date
December 30 2022
Last Update
April 12 2019
Active Locations (1)
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1
Qilu Hospital of Shandong University
Jinan, China