Continuous Subcutaneous Insulin Infusion strAtegy Versus Multiple Daily Insulin Injections strAtegy

NCT01574508 | Unknown Phase 4

• 1 other identifier: CCEMD012
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

The current study will compare the different efficacy of two transient intensive insulin treatment strategies: Continuous subcutaneous insulin infusion (CSII) and multiple daily insulin injections (MDI) in patients who are not well controlled with oral hypoglycaemic agents.

Conditions

Type 2 Diabetes

Keywords

efficacy; safety; intensive insulin therapy

Outcome Measures

Primary Outcomes (2)

• Glycated hemoglobin levels

  The different influence of two intensive insulin treatment strategies: CSII and MDI on the change of glycated hemoglobin levels during two weeks intensive insulin treatment period and 1 year after the intensive treatment.

  During 2 weeks intensive insulin treatment period and 1 year after the intensive treatment.

• Glycated albumin levels

  The different influence of two intensive insulin treatment strategies: CSII and MDI on the change of glycated albumin levels during two weeks intensive insulin treatment period and 1 year after the intensive treatment.

  During 2 weeks intensive insulin treatment period and 1 year after the intensive treatment.

Secondary Outcomes (6)

• The glucose levels

  During 2 weeks intensive treatment and 1 year after treatment

• Episode of hypoglycemia

  During 2 weeks of intensive treatment and 1 year after treatment

• Body weight

  During 2 weeks intensive treatment and 1 year after treatment

• Biochemical parameters and inflammatory factors

  During 2 weeks intensive treatment and 1 year after treatment

• C peptide levels

  During 2 weeks intensive treatment and 1 year after treatment

Study Arms (2)

Continuous Subcutaneous Insulin Infusion

EXPERIMENTAL

CSII

Drug: Transient Continuous Subcutaneous Insulin Infusion

Multiple Daily Insulin Injections

ACTIVE COMPARATOR

MDI

Drug: Transient Multiple Daily Insulin Injections

Interventions

Transient Continuous Subcutaneous Insulin Infusion DRUG

Patients will be given Continuous Subcutaneous Insulin Infusion during two weeks confinement in the hospital. The initial dosage will be body weight (kg)\*0.5, and will be adjusted according to the 7 points glucose monitoring records in the hospital.

Also known as: CSII

Continuous Subcutaneous Insulin Infusion

Transient Multiple Daily Insulin Injections DRUG

Patients will be given Transient multiple daily insulin injections during two weeks confinement in the hospital. The initial dosage will be body weight (kg)\*0.5, and will be adjusted according to the 7 points glucose monitoring records in the hospital

Also known as: MDI

Multiple Daily Insulin Injections

Eligibility Criteria

• Age: 25 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Using at least two kinds of oral hypoglycaemic agents, one of which must be insulin secretagogues (at least half of the maximum permitted daily dose); or at least two kinds of oral hypoglycaemic agents, one of which must be insulin secretagogues (at least half of the maximum permitted daily dose), plus once daily basic insulin treatment (daily dosage \< 30IU);
• The anti-diabetic therapy is stable within 3 months before study screening;
• Age: 25-65years, both gender, BMI: 20-35kg/m2;
• Good compliance with the follow-up
• Signed informed consent
• HbA1c ≥ 8.0 % and ≤ 12%

You may not qualify if:

• Having the history of using insulin therapy twice daily or MDI or insulin pump (except the insulin therapy during gestational diabetes mellitus)
• For once daily insulin therapy: daily dose insulin therapy dosage \> 30IU
• Having the history of using GLP-1 for therapy within 3 months before screening
• Women in pregnancy or under breast feeding
• Having acute diabetic complications within 6 months before screening or having severe chronic diabetic complications at screening
• Allergic to study drugs
• Severe liver dysfunction, including serum alanine aminotransferase concentration more than 2.5 times above upper limit of normal range, abnormal renal function (GFR \< 60ml/min)
• Other severe conditions which will put the patients in high risk during the study
• Recently drug or alcohol abuse

Sponsors & Collaborators

• Shanghai Jiao Tong University School of Medicine: lead

Study Sites (1)

Ruijin hospital, Shanghai Jiao-Tong University School of Medicine

Shanghai, Shanghai Municipality, 200025, China

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: January 25, 2012
• First Posted: April 10, 2012
• Study Start: December 1, 2011
• Primary Completion: December 1, 2013
• Study Completion: December 1, 2014
• Last Updated: May 6, 2013

Record last verified: 2013-05

Locations

CN (1)