Crossover evaluation of anagliptin versus sitagliptin on blood glucose levels using continuous glucose monitoring system in insulin-treated type 2 diabetes.

Crossover evaluation of anagliptin versus sitagliptin on blood glucose levels using continuous glucose monitoring system in insulin-treated type 2 diabetes. - Cross-Assist

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000024511

Enrollment

Registered

2016-10-21

Start date

2016-07-01

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

Anagliptin preceding group: Anagliptin 200mg/day (Day4-8), Sitagliptin 50mg/day(Day9-13) Sitagliptin preceding group: Sitagliptin 50mg/day (Day4-8), Anagliptin 200mg/day (Day9-13)

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: The patients who meet all of the following items to the subject of this study . (1) Patients hospitalized being diagnosed type 2 diabetes mellitus (2) HbA1c of 7.0 % - 9.9% (3) Patients on use insulin preparations (4) 20 years of age or older (regardless of sex) (5) Patients who provided a written informed concent to participants of this study

Exclusion criteria

Exclusion criteria: Even if meet the inclusion criteria, patients in conflict with any of the following conditions is not the subject of this study. (1) patient with a history of hypersensitivity for Anagliptin and/or Sitagliptin (2) patients with severe ketosis, diabetic coma or pre-coma, or type 1 diabetes (3) patients with severe infection, before or after surgery, or severe external injury (4) women who are possibility of or during pregnancy, or lactating (5) patients who can not stop the DPP-4 inhibitors after hospitalization (6) patients who are taking insulin more than 40U of daily dose (7) patients who are taking or being required GLP-1 receptor agonists (8) patients who are inappropriate to participate in research determined by principal investigator or subinvestigator

Design outcomes

Primary

Measure	Time frame
Comparison of mean amplitude of glycemic excursions (MAGE) between Anagliptin and Sitagliptin.	—

Secondary

Measure	Time frame
1. Comparison of index of glycemic variability by CGM between Anagliptin and Sitagliptin. (1) Standard deviation (SD) (2) Mean 24h glucose level (3) Area under the curve (AUC) by blood glucose level >= 180mg/dL and time (4) Area over the curve curve (AOC) by blood glucose level < 70mg/dL and time (5) Maximal blood glucose level in 1 day (6) Maximal blood glucose level at after breakfast, lunch and dinner (7) Interquartile range (25%-75%) of blood glucose level 2. Comparison of blood glucose-related indicators by meal tolerance test between Anagliptin and Sitagliptin. (1) blood glucose level (fasting, 30 minutes, one hour, two hour, incremental AUC0-2h, AUC0-2h) (2) Glucagon level (fasting, 30 minutes, one hour, two hour, incremental AUC0-2h, AUC0-2h) (3) C-peptide (fasting, delta 0-30 minutes, incremental AUC0-1h, incremental AUC0-2h) 3. Comparison of CGM and blood glucose-related indicators by meal tolerance test between before and after administration of Anagliptin or Sitagliptin. 4. Comparison of side effects and laboratory values (including the SMBG) between administration groups and their changes between before and after administration.	—

Measure

Time frame

1. Comparison of index of glycemic variability by CGM between Anagliptin and Sitagliptin. (1) Standard deviation (SD) (2) Mean 24h glucose level (3) Area under the curve (AUC) by blood glucose level >= 180mg/dL and time (4) Area over the curve curve (AOC) by blood glucose level < 70mg/dL and time (5) Maximal blood glucose level in 1 day (6) Maximal blood glucose level at after breakfast, lunch and dinner (7) Interquartile range (25%-75%) of blood glucose level 2. Comparison of blood glucose-related indicators by meal tolerance test between Anagliptin and Sitagliptin. (1) blood glucose level (fasting, 30 minutes, one hour, two hour, incremental AUC0-2h, AUC0-2h) (2) Glucagon level (fasting, 30 minutes, one hour, two hour, incremental AUC0-2h, AUC0-2h) (3) C-peptide (fasting, delta 0-30 minutes, incremental AUC0-1h, incremental AUC0-2h) 3. Comparison of CGM and blood glucose-related indicators by meal tolerance test between before and after administration of Anagliptin or Sitagliptin. 4. Comparison of side effects and laboratory values (including the SMBG) between administration groups and their changes between before and after administration.

—

Countries

Japan

Contacts

Public ContactHiroji Kitazato

Omori Red Cross Hospital Department of Diabetes and Endocrinology

kitazato-tky@umin.net03-3775-3111

Outcome results

None listed

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