The study of ANagliptin effects on Glucagon LEvels of type 2 DM patients using insulin / ANGLE study

The study of ANagliptin effects on Glucagon LEvels of type 2 DM patients using insulin / ANGLE study - ANGLE study

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000023414

Enrollment

Registered

2017-08-01

Start date

2017-09-01

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 mellitus

Interventions

4-weeks treatment by anagliptin 200mg

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Outpatients with type 2 diabetes mellitus 2. 20 years of age or over 3. HbA1c with 7.0% to 10.9% 4. No change of anti-diabetes drugs within 8 weeks before acquirung consent 5. Patients treated with up to 3 drugs of biguanide, thiazolidine, glinide, sulfonylurea, SGLT2 inhibitor, alpha-glucosidase inhibitor in addition to insulin

Exclusion criteria

Exclusion criteria: 1. Type 1 diabetes 2. patients with change of insulin of 4 unit and more within observation period 3. patients with change of kinds of insulin within observation period 4. patients previously treated with anagliptin 5. BMI of 30 and more 6. severe liver disease (AST or ALT 100IU/ L and more) 7. severe kidney disease or serum creatinine of 1.5mg/dl and more 8. severe heart failure or patients with attacks of myocardial infarction and angina 9. patients with stroke within 24 weeks before acquirung consent 10.patients with malignancy 11.severe diabetic complications (neuropathy, retinopathy, nephropathy) 12.severe ketosis including diabetic coma 13.anemia (Hb < 9.5g/dl) 14.enteropathy with abnormal digestion and absorption 15.patients with past history of gastrointestinal resection

Design outcomes

Primary

Measure	Time frame
Comparison of results by measurement methods (ELISA and LC-MS/MS) for delta AUC0-180min (plasma glucagon) before and after anagliptin administration	—

Secondary

Measure	Time frame
1.Comparison of results by measurement methods (ELISA and LC-MS/MS) for delta plasma glucagon (from 0min to each measurement point) before and after anagliptin administration 2.Comparison of results by measurement methods (ELISA and CC-MS/MS) for delta AUC0-120min (plasma glucagon) before and after anagliptin administration 3.Evaluation of correlations between the results by two methods (ELISA and LC-MS/MS) at each measurement point before and after anagliptin administration 4.Comparisons of changes of the following parameters from baseline to 4 weeks (active GIP, active GLP-1, total GLP-1, C-peptide and plasma glucose) 5.Comparisons of the levels of active GIP, active GLP-1, and total GLP-1 at baseline and 4 weeks	—

Measure

Time frame

1.Comparison of results by measurement methods (ELISA and LC-MS/MS) for delta plasma glucagon (from 0min to each measurement point) before and after anagliptin administration 2.Comparison of results by measurement methods (ELISA and CC-MS/MS) for delta AUC0-120min (plasma glucagon) before and after anagliptin administration 3.Evaluation of correlations between the results by two methods (ELISA and LC-MS/MS) at each measurement point before and after anagliptin administration 4.Comparisons of changes of the following parameters from baseline to 4 weeks (active GIP, active GLP-1, total GLP-1, C-peptide and plasma glucose) 5.Comparisons of the levels of active GIP, active GLP-1, and total GLP-1 at baseline and 4 weeks

—

Countries

Japan

Contacts

Public ContactAkio Kanazawa

Juntendo University Department of Metabolism & Endocrinology

akana@juntendo.ac.jp03-3813-3111

Outcome results

None listed

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