Efficacy of Continuous Subcutaneous Insulin Infusion Versus Basal-bolus Multiple Daily Injections Regimen in Type 2 Diabetes
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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 |
- HbA1c [ Time Frame: 12 months ] [ Designated as safety issue: No ]
- 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 ]
| Estimated Enrollment: | 52 |
| Study Start Date: | March 2009 |
| Estimated Study Completion Date: | February 2013 |
| Estimated 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 |
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 glucocorticoïds, octreotide, lanreotide or danazol
- Pregnancy wish or ongoing pregnancy
- Known Haemoglobinopathy.
- Creatinin clearance <30ml/min (MDRD formula).
- Organ transplant.
Contacts and Locations 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: | October 22, 2012 |
| 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 Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases Insulin aspart |
Insulin Metformin Hypoglycemic Agents Physiological Effects of Drugs Pharmacologic Actions |
ClinicalTrials.gov processed this record on June 18, 2013