UnknownPhase NA

A Cohort Study of Incretin-based Therapy Combined With Insulin in Type 2 Diabetic Patients for 5 Years

Effect of Incretin-based Therapy Combined With Insulin on HbA1c, Hypoglycemia and Chronic Diabetic Complications in Type 2 Diabetic Patients

Lead sponsor

Nagaoka Red Cross Hospital

Asset

GLP-1 / incretin class catch-all

Listed sites

Recruiting sites

Estimated enrollment

500

Study population

Chronic kidney disease, Obesity / overweight, Type 2 diabetes

Eligibility highlights

Primary endpoint

•Death

Registered trial locations

Locations reported to ClinicalTrials.gov for this trial snapshot. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT01681550

Org study ID8-Kamoi

Timeline

Milestones

Study first posted2012-09-10estimated

Last update posted2012-09-11estimated

Study start2012-10 (month precision)

Primary completion2018-10estimated (month precision)

Study completion2018-10estimated (month precision)

Assets

Investigational agents

GLP-1 / incretin class catch-all

Who this study enrolls

Chronic kidney diseaseObesity / overweightType 2 diabetes

Who can enroll

Minimum age20 Years

Maximum age95 Years

SexAll

Healthy volunteersNot accepted

Inclusion criteria

After a detailed baseline examination, 500 Japanese subjects with type 2 diabetes were followed up for all-cause mortality and morbidity. All participants visited our clinic regularly. All patients were fully informed about the purposes and procedures for the study and provided oral consent at enrolment.

Exclusion criteria

Patients participating in other clinical study. Other than the above, patients judged inappropriate as the subjects of this study by the investigator.

Endpoints (9)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Glycemic / diabetes

Safety / tolerability / PK

Weight & body composition

Renal / kidney

Cardiometabolic biomarkers

Other clinical outcomes

Other (unclassified)

Weight & body composition

1 endpoint

Secondary/protocol endpoint

BMI

Time frame:Average time requires 5 years

descriptive

Glycemic / diabetes

2 endpoints

Secondary/protocol endpoint

HbA1c

Time frame:Average time requires 5 years

descriptive

Secondary/protocol endpoint

Insulin dose

Time frame:Average time requires 5 years

descriptive

Renal / kidney

1 endpoint

Secondary/protocol endpoint

Microvascular complications including renal anemia

Time frame:Average time requires 5 years

descriptive

Cardiometabolic biomarkers

1 endpoint

Secondary/protocol endpoint

Blood pressure

Time frame:Average time requires 5 years

descriptive

Safety / tolerability / PK

2 endpoints

Secondary/protocol endpoint

Hypoglycemia

Time frame:Average time requires 5 yearsinsulin.

descriptive

Secondary/protocol endpoint

Hypoglycemia

Time frame:Average time requires 5 years

descriptive

Other clinical outcomes

1 endpoint

Primary/protocol endpoint

Death

Time frame:Duration varied between individual patients and was as the period of time after treatment with incretin-based therapy combined with insulin.

descriptive

Other (unclassified)

1 endpoint

Secondary/protocol endpoint/low confidence

Macrovasular complications

Time frame:Average time requires 5 years

descriptive

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 6, 2026

Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)

Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 6, 2026 snapshot.