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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University Hospital, Toulouse
ClinicalTrials.gov Identifier:
NCT00942318
First received: July 16, 2009
Last updated: December 10, 2013
Last verified: December 2013
  Purpose

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%).


Condition Intervention Phase
Type 2 Diabetes Mellitus
Drug: Detemir insulin, Aspart insulin, Metformin
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Efficacy of Continuous Subcutaneous Insulin Infusion Versus Basal-bolus Multiple Daily Injections Regimen in Type 2 Diabetes: a One Year, Randomised, Parallel Study

Resource links provided by NLM:


Further study details as provided by University Hospital, Toulouse:

Primary Outcome Measures:
  • HbA1c [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Weight, waist perimeter, BP, triglycerides, total cholesterol, HDL and LDL cholesterol ; QOL, physical activity, treatment satisfaction and eating habits questionnaire. [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
  • self monitoring blood glucose measurements (frequency, mean and standard deviation, number of hypoglycaemic and hyperglycaemic events) [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]

Enrollment: 52
Study Start Date: March 2009
Study Completion Date: February 2013
Primary Completion Date: February 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00942318

Locations
France
University Hospital Toulouse
Toulouse, France, 31059
Sponsors and Collaborators
University Hospital, Toulouse
Investigators
Principal Investigator: Vincent Melki, MD University Hospital, Toulouse
  More Information

No publications provided

Responsible Party: University Hospital, Toulouse
ClinicalTrials.gov Identifier: NCT00942318     History of Changes
Other Study ID Numbers: 0816202, AOL 2008
Study First Received: July 16, 2009
Last Updated: December 10, 2013
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by University Hospital, Toulouse:
Type 2 Diabetes Mellitus
Continuous subcutaneous insulin infusion
Insulin external pump
Multiple daily injections
Basal-bolus regimen
Education

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Endocrine System Diseases
Glucose Metabolism Disorders
Metabolic Diseases
Insulin
Insulin, Globin Zinc
Metformin
Hypoglycemic Agents
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on November 25, 2014