A Study to Compare Insulin Pump With Conventional Treatment in Type 2 Diabetes

A Study to Compare the Efficacy and Safety of Insulin Pump Treatment in Patients With Uncontrolled Type 2 Diabetes Mellitus

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02198846

Enrollment

140

Registered

2014-07-24

Start date

2014-06-30

Completion date

2015-03-31

Last updated

2014-07-24

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

Conditions

Type 2 Diabetes Mellitus

Brief summary

Insulin deficiency resulted from progressive beta cell failure and insulin resistance in type 2 diabetes requires exogenous insulin therapy, escaping from oral antihyperglycemic agents. Previous data have been suggested that continuous subcutaneous insulin infusion (CSII) does not only have efficacy in glucose control but also restore beta cell failure. The investigators plan to compare the efficacy/safety and beta cell function between insulin pump treatment and the intensification of conventional treatment in patients with uncontrolled type 2 diabetes.

Interventions

DEVICEinsulin pump

stop any antihyperglycemic medication and convert to insulin pump

DRUGconventional treatment

intensification of conventional treatment by adding oral antihyperglycemic agents or subcutaneous insulin (once / twice/ multiple injection)

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 85 Years

Healthy volunteers

Inclusion criteria

* Type 2 diabetes * age: 18 \ 85 yrs * HbA1c: \> 7.5% * no change of anti-diabetic medication within 3 months

Exclusion criteria

* systemic corticosteroid administered within previous 6 months * pregnancy * severe liver or renal disease, heart failure * History of cancer within 5 years * Thyroid disease * Anti-obesity drugs or slimming products within previous 3 months

Design outcomes

Primary

Measure	Time frame
change of HbA1c	24 weeks

Secondary

Measure	Time frame	Description
changes of body weight	24 weeks	—
frequency of hypoglycemia	24 weeks	severe hypoglycemia : glucose \<40 mg/dl mild hypoglycemia : glucose 40 - 70 mg/dl
change of beta cell function	24 weeks	insulin secretion-sensitivity index-2 = insulinogenic index x Matsuda index
Percent of patients who reach target goal of HbA1c (<7.0%)	24 weeks	—

Countries

South Korea

Contacts

Primary ContactSoo Bong Choi, MD.PhD

mellitus@empal.com+82-10-4949-9504

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026