Efficacy of Continuous Subcutaneous Insulin Infusion Versus Basal-bolus Multiple Daily Injections Regimen in Type 2 Diabetes

Efficacy of Continuous Subcutaneous Insulin Infusion Versus Basal-bolus Multiple Daily Injections Regimen in Type 2 Diabetes: a One Year, Randomised, Parallel Study

A lot of insulin-treated type 2 diabetic patients do not reach adequate glycemic control despite intensive basal-bolus insulin regimen. In such cases, continuous subcutaneous insulin infusion (CSII), using an external pump, could be a solution to improve diabetes control.

The aim of this study is to compare, over a one-year period, the efficacy of CSII (with aspart insulin) and basal-bolus multiple daily injections (MDI) treatment (with detemir x 2/d and aspart before meals) in type 2 diabetic patients, already treated by basal-bolus regimen for at least 6 months, who didn't reach adequate target for glycemic at baseline (HbA1c>7 -10%).

Study Overview

• Status: Completed
• Conditions: Type 2 Diabetes Mellitus
• Intervention / Treatment: Drug: Detemir insulin, Aspart insulin, Metformin

Detailed Description

Visit 1: patient information and eligibility criteria assessment Visit 2: Inform consent signature and randomisation (group CSII or MDI). Patients randomised in the CSII group are instructed to use pump between V2 and V3.

Visit 3: 5-day's hospitalisation. Start of CSII or MDI treatments. Stop of all oral diabetic medications except for metformin, which is followed up until the end of the study. Teaching program on diabetes management (diet, physical activity and self-adjustment of insulin doses). HbA1c, clinical and biological parameters. Questionnaires.

Follow-up visits 4-7 (1, 3, 6, 9 months): HbA1c. Treatment adjustment. Adverse events collection.

Final visit (12 months): HbA1c, clinical and biological parameters. Questionnaires. Adverse events collection.

• Study Type: Interventional
• Enrollment (Actual): 52
• Phase: Phase 4

Contacts and Locations

Study Locations

• France
  • Toulouse, France, 31059
    • University Hospital toulouse

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Type 2 diabetes mellitus
• Age > 18 years
• Patients treated for at least 6 months by Multiple daily insulin injections associating long acting insulin (at least 1 long acting insulin analog injection -Glargine or Detemir- or at least 2 NPH insulin injections) plus mealtimes rapid acting insulin injections (Human or analogs) +/- oral hypoglycemic agents.
• 7,5% ≤ HbA1c ≤ 10%
• Patients able to perform self-monitoring blood glucose (SMBG) measurement and insulin injections.
• SMBG > 3/day

Exclusion Criteria:

• Diabetic retinopathy contraindicating glycemic control intensification
• Situation or pathology not allowing therapeutic education program (blindness, deafness, low language fluency…)
• Situation or pathology not allowing insulin therapy self-management and / or portable insulin pump use (rheumatologic pathology, low visual acuity, …)
• Recent (<3 month) serious pathology
• Planned treatment or therapy able to induce long-term glycemic control worsening
• Long lasting (> 2 month) planned treatment with glucocorticoids, octreotide, lanreotide or danazol
• Pregnancy wish or ongoing pregnancy
• Known Haemoglobinopathy.
• Creatinin clearance <30ml/min (MDRD formula).
• Organ transplant.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: PPE; PPE : CSII +/- Metformin.	Drug: Detemir insulin, Aspart insulin, Metformin; Insulin doses adapted by patients according to self monitoring blood glucose results.
Active Comparator: injections; INJ: basal/bolus MDI +/- Metformin	Drug: Detemir insulin, Aspart insulin, Metformin; Insulin doses adapted by patients according to self monitoring blood glucose results.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
HbA1c	12 months

Secondary Outcome Measures

Outcome Measure	Time Frame
Weight, waist perimeter, BP, triglycerides, total cholesterol, HDL and LDL cholesterol ; QOL, physical activity, treatment satisfaction and eating habits questionnaire.	12 months
self monitoring blood glucose measurements (frequency, mean and standard deviation, number of hypoglycaemic and hyperglycaemic events)	12 months

Collaborators and Investigators

• Sponsor: University Hospital, Toulouse
• Investigators: Principal Investigator: Vincent Melki, MD, University Hospital, Toulouse

Study record dates

Study Major Dates

• Study Start: March 1, 2009
• Primary Completion (Actual): February 1, 2013
• Study Completion (Actual): February 1, 2013

Study Registration Dates

• First Submitted: July 16, 2009
• First Submitted That Met QC Criteria: July 17, 2009
• First Posted (Estimate): July 20, 2009

Study Record Updates

• Last Update Posted (Estimate): December 11, 2013
• Last Update Submitted That Met QC Criteria: December 10, 2013
• Last Verified: December 1, 2013

More Information

Terms related to this study

• Keywords: Education; Type 2 Diabetes Mellitus; Continuous subcutaneous insulin infusion; Multiple daily injections; Insulin external pump; Basal-bolus regimen
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2; Hypoglycemic Agents; Physiological Effects of Drugs; Insulin; Insulin Aspart; Metformin
• Other Study ID Numbers: 0816202; AOL 2008