Study on the effects of sitagliptin on glycemic control in newly treated or uncontrolled patients with type 2 diabetes mellitus

Study on the effects of sitagliptin on glycemic control in newly treated or uncontrolled patients with type 2 diabetes mellitus - Study on the effects of sitagliptin on glycemic control in newly treated or uncontrolled patients with type 2 diabetes mellitus (JAMP study)

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000019154

Enrollment

1400

Registered

2015-10-01

Start date

2011-01-01

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

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Patients who fulfill the following criteria are to be included: - Despite receiving either dietary or exercise therapy or a combination of those and treatment with antidiabetic drugs*1, having uncontrolled type 2 diabetes mellitus*2 *1 sulphnoylurea agent glimepiride 0.5 mg - 2 mg, thiazolidine agents, biguanides, and alpha-glucosidase inhibitors * HbA1c (JDS value) >or= 6.5% or fasting blood glucose >or= 130 mg/dL; based on 'Treatment Guide for Diabetes 2010' by the Japan Diabetes Society. - Outpatients - Patients who have given consent for their data to be used.

Exclusion criteria

Exclusion criteria: Patients who met any of the following criteria are to be excluded: 1) Patients with a history of severe ketosis, diabetic coma or pre-coma within the past 6 months 2) Patients who are about to have or who have undergone an operation or who have severe infections or serious injury 3) Pregnant, possibly pregnant, or lactating women 4) Patients with moderate kidney dysfunction (serum creatinine >or= 1.5 mg/dL for men, >or= 1.3 mg/dL for women ) 5) Patients who are being treated with insulin 6) Patients who are being treated with rapid acting insulin secretagogues 7) Patients with a history of hypersensitivity to ingredients of the study drug 8) Patients who are considered not eligible for the study by the attending doctor due to medical reasons

Design outcomes

Primary

Measure	Time frame
Change in HbA1c after 3 months of treatment from baseline	—

Secondary

Measure	Time frame
1) The following parameters at baseline, and 1, 3, and 12 months after treatment - Percentage of patients with normal HbA1c level - Percentage of patients with normal fasting blood glucose level 2) Change in the following parameters after 1,3,and 12 months of treatment from baseline - HbA1c (except the value after 3 months) - Fasting blood glucose - HOMA-beta - lipids (LDL-C, TG, and HDL-C) 3) Safety throughout the study period - Incidence of adverse reactions / incidence of hypoglycemia 4) Exploratory analysis Subanalyses stratifying patients by factors including response to sitagliptin, complications, concomitant drugs, and a history of diabetes.	—

Measure

Time frame

1) The following parameters at baseline, and 1, 3, and 12 months after treatment - Percentage of patients with normal HbA1c level - Percentage of patients with normal fasting blood glucose level 2) Change in the following parameters after 1,3,and 12 months of treatment from baseline - HbA1c (except the value after 3 months) - Fasting blood glucose - HOMA-beta - lipids (LDL-C, TG, and HDL-C) 3) Safety throughout the study period - Incidence of adverse reactions / incidence of hypoglycemia 4) Exploratory analysis Subanalyses stratifying patients by factors including response to sitagliptin, complications, concomitant drugs, and a history of diabetes.

—

Countries

Japan

Contacts

Public ContactHiroshi Sakura

Tokyo Women's Medical University Medical Center East

hsakura.dmc@twmu.ac.jp03-3810-1111

Outcome results