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

Type 2 Diabetes Mellitus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02198846
• Other study ID #: KU_PUMP1
• Status: Recruiting
• Phase: N/A
• First received: July 22, 2014
• Last updated: July 23, 2014
• Start date: June 2014
• Est. completion date: March 2015

Study information

• Verified date: July 2014
• Source: Konkuk University Medical Center
• Contact: Soo Bong Choi, MD.PhD
• Phone: +82-10-4949-9504
• Email: mellitus[@]empal.com
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 140
• Est. completion date: March 2015
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type 2 Diabetes Mellitus

Intervention

Device:
• insulin pump
stop any antihyperglycemic medication and convert to insulin pump

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

Locations

Country	Name	City	State
Korea, Republic of	Konkuk University Chungju Hospital	Chungju

Sponsors (1)

Lead Sponsor	Collaborator
Konkuk University Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	change of HbA1c		24 weeks	No
Secondary	changes of body weight		24 weeks	No
Secondary	frequency of hypoglycemia	severe hypoglycemia : glucose <40 mg/dl mild hypoglycemia : glucose 40 - 70 mg/dl	24 weeks	Yes
Secondary	change of beta cell function	insulin secretion-sensitivity index-2; = insulinogenic index x Matsuda index	24 weeks	No
Secondary	Percent of patients who reach target goal of HbA1c (<7.0%)		24 weeks	No