Efficacy of Continuous Subcutaneous Insulin Infusion Versus Basal-bolus Multiple Daily Injections Regimen in Type 2 Diabetes
Overview[ - collapse ][ - ]
| 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%). |
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| Condition | Type 2 Diabetes Mellitus |
| Intervention | Drug: Detemir insulin, Aspart insulin, Metformin |
| Phase | Phase 4 |
| Sponsor | University Hospital, Toulouse |
| Responsible Party | University Hospital, Toulouse |
| ClinicalTrials.gov Identifier | NCT00942318 |
| First Received | July 16, 2009 |
| Last Updated | December 10, 2013 |
| Last verified | December 2013 |
Tracking Information[ + expand ][ + ]
| First Received Date | July 16, 2009 |
|---|---|
| Last Updated Date | December 10, 2013 |
| Start Date | March 2009 |
| Estimated Primary Completion Date | February 2013 |
| Current Primary Outcome Measures | HbA1c [Time Frame: 12 months] [Designated as safety issue: No] |
| Current Secondary Outcome Measures |
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Descriptive Information[ + expand ][ + ]
| Brief Title | Efficacy of Continuous Subcutaneous Insulin Infusion Versus Basal-bolus Multiple Daily Injections Regimen in Type 2 Diabetes |
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| 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 |
| Brief Summary | 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%). |
| 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 |
| Study Phase | Phase 4 |
| Study Design | Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment |
| Condition | Type 2 Diabetes Mellitus |
| Intervention | Drug: Detemir insulin, Aspart insulin, Metformin Insulin doses adapted by patients according to self monitoring blood glucose results. |
| Study Arm (s) |
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Recruitment Information[ + expand ][ + ]
| Recruitment Status | Completed |
|---|---|
| Estimated Enrollment | 52 |
| Estimated Completion Date | February 2013 |
| Estimated Primary Completion Date | February 2013 |
| Eligibility 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. |
| Gender | Both |
| Ages | 18 Years |
| Accepts Healthy Volunteers | No |
| Contacts | Not Provided |
| Location Countries | France |
Administrative Information[ + expand ][ + ]
| NCT Number | NCT00942318 |
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| Other Study ID Numbers | 0816202 |
| Has Data Monitoring Committee | No |
| Information Provided By | University Hospital, Toulouse |
| Study Sponsor | University Hospital, Toulouse |
| Collaborators | Not Provided |
| Investigators | Principal Investigator: Vincent Melki, MD University Hospital, Toulouse |
| Verification Date | December 2013 |
Locations[ + expand ][ + ]
| University Hospital Toulouse | Toulouse, France, 31059 |
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