Comparison of glycemic variations in Japanese patients with type 2 diabetes, between metformin high dose group and combination of metformin and sitagliptin or linagliptin group as assessed by continuous glucose monitoring (CGM)

Comparison of glycemic variations in Japanese patients with type 2 diabetes, between metformin high dose group and combination of metformin and sitagliptin or linagliptin group as assessed by continuous glucose monitoring (CGM) - Comparison of glycemic variations in T2D, between metformin highdose group and combination of metformin and sitagliptin or linagliptin group as assessed by CGM

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000019033

Enrollment

Registered

2015-09-17

Start date

2015-09-18

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 2 diabetes

Interventions

After more than 4 weeks of treatment at metformin (1500mg), it change to sitagliptin (50mg) or linagliptin (5mg) + metformin (750mg). After more than 4 weeks of treatment at sitagliptin (50mg) or lina

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1)Type 2 diabetes 2)Patients who are administrated dose of metformin (500-1,000 mg/day) for 2 weeks or more 3)HbA1c >= 7.0% and <10.0% 4) Patients who were on the diet therapy 5)Patients who give written informed consent to participate in this study on a voluntary basis after receiving and understanding a sufficient explanation of the study

Exclusion criteria

Exclusion criteria: 1)Patients with type 1 diabetes 2)Patients with insulin therapy 3)Patients who take oral hypoglycemic agent other than metformin 4)Patients with severe acidosis or diabetic coma 5)Patients with infections, before and after surgery,and severe trauma 6)Patiens with severe liver disease 7)Patients with severe renal disease with a serum creatinine (Cr) level (mg/dL) >1.5 8)Patients with shock, heart disease (heart failure, myocardial infarction, pulmonary embolism), severe lung failure 9)Patients with malnutrition, starvation, debilitating condition, pituitary dysfunction, adrenal insufficiency 10)Patients have history of lactic acidosis 11)Heavy drinkers 12)Patients with dehydration, gastrointestinal disorders (diarrhea, vomiting,etc) 13)Cancer patients 14)Patients for the biguanide drug with a history of allergy, or with a history of other drug allergy 15)Potential pregnant patients or patient with who are breast feeding

Design outcomes

Primary

Measure	Time frame
Glucose variability in CGM 1)Mean glucose levels 2)Standard deviations of glucose (SD) 3)MAGE 4)Time in hypoglycemia 5)Time in hyperglycemia 6)Area under the curve(AUC) 7)Magnitude of increase in glucose levels 8)The time to peak glucose levels from baseline after each meal	—

Secondary

Measure	Time frame
Pre-meal plasma glucose, 1 hour post prandial glucose, 2 hour post prandial glucose	—

Countries

Japan

Contacts

Public ContactHiroshi Takahashi

Jikei University School of Medicine Division of Diabetes, Metabolism and Endocrinology, Department of Internal Medicine

hiro3431_6117@yahoo.co.jp03-3433-1111

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026