Efficacy of Continuous Subcutaneous Insulin Infusion Versus Basal-bolus Multiple Daily Injections Regimen in Type 2 Diabetes
NCT ID: NCT00942318
Last Updated: 2013-12-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
52 participants
INTERVENTIONAL
2009-03-31
2013-02-28
Brief Summary
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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
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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PPE
PPE : CSII +/- Metformin.
Detemir insulin, Aspart insulin, Metformin
Insulin doses adapted by patients according to self monitoring blood glucose results.
injections
INJ: basal/bolus MDI +/- Metformin
Detemir insulin, Aspart insulin, Metformin
Insulin doses adapted by patients according to self monitoring blood glucose results.
Interventions
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Detemir insulin, Aspart insulin, Metformin
Insulin doses adapted by patients according to self monitoring blood glucose results.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
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University Hospital, Toulouse
OTHER
Responsible Party
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Principal Investigators
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Vincent Melki, MD
Role: PRINCIPAL_INVESTIGATOR
University Hospital, Toulouse
Locations
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University Hospital Toulouse
Toulouse, , France
Countries
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Other Identifiers
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AOL 2008
Identifier Type: -
Identifier Source: secondary_id
0816202
Identifier Type: -
Identifier Source: org_study_id