Type 2 diabetes
Conditions
Interventions
Patients with lifestyle therapy or metformin monotherapy up to 1250 mg per day, and then are randomly assigned to add anagliptin 200 mg per day.
Patients with lifestyle therapy or metformin monotherap
Sponsors
St. Marianna University School of Medicine
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) age between 20 and 75 years at the time on giving consent, female or male, 2) inadequate glycemic control (HbA1c from 6.5% to 9.0% on giving consent, and variation of HbA1c by <0.5% within 3 months before recruitment), 3) body mass index less than 35 kg/m2, 4) duration of diabetes more than 1 years, and 5) current treatment for type 2 diabetes with lifestyle therapy or metformin monotherapy up to 1250 mg per day, 6)Patients who are capable of making a decision by themselves, and can provide written consent.
Exclusion criteria
Exclusion criteria: 1) type 1 diabetes, 2) glucagonoma, 3) hospital admission to improve glycemic control within the past 1 year on giving consent, 4) a history of coronary artery disease, coronary revascularization, stroke, or transient ischemic attacks within the past 1 year on giving consent, 5) a history of severe infectious disease within the past 1 year on giving consent, 6) malignancy, 7) severe renal dysfunction (estimated glomerular filtration rate < 45 mL/min/1.73 m2) or nephrotic syndrome, 8) severe liver dysfunction (AST, ALT greater than 3 times upper standard values), 9) being treated with steroids, immune-suppressive agents and/or azole antifungal medication, beta blocker, 10) women who were pregnant, possibly pregnant, planned to become pregnant, or were breast-feeding, 11) a history of gastric and duodenal operation, and 12) other patients who were considered to be ineligible for the study by the attending doctor, 13) the use of any investigational drug within 12 weeks on giving consent, 14) Insulin-dependent type 2 diabetes, 15) allergy for anagliptin and metformin, 16) Patients with any changes in their oral diabetes medicine for type 2 diabetes within 12 weeks prior to giving consent.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The change of the plasma glucagon AUC from baseline in the liquid test meal performed after 4 weeks. | — |
Secondary
| Measure | Time frame |
|---|---|
| The change of the plasma insulin and plasma glucose AUC from baseline in the liquid test meal performed after 4 weeks, and the change of Tlag and T1/2 from baseline in the liquid test meal performed after 4 weeks. And the change of HbA1c, glycoalbumin and fasting plasma glucose in the liquid test meal performed after 4 weeks. | — |
Countries
Japan
Contacts
Public ContactTomoko Nakagawa
St. Marianna University School of Medicine Division of Metabolism and Endocrinology, Department of Internal Medicine
Outcome results
None listed