NCT00942318

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%).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
52

participants targeted

Target at P25-P50 for phase_4 type-2-diabetes-mellitus

Timeline
Completed

Started Mar 2009

Longer than P75 for phase_4 type-2-diabetes-mellitus

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2009

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

July 16, 2009

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 20, 2009

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2013

Completed
Last Updated

December 11, 2013

Status Verified

December 1, 2013

Enrollment Period

3.9 years

First QC Date

July 16, 2009

Last Update Submit

December 10, 2013

Conditions

Type 2 Diabetes Mellitus

Keywords

Type 2 Diabetes MellitusContinuous subcutaneous insulin infusionInsulin external pumpMultiple daily injectionsBasal-bolus regimenEducation

Outcome Measures

Primary Outcomes (1)

  • HbA1c

    12 months

Secondary Outcomes (2)

  • 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

Study Arms (2)

PPE

EXPERIMENTAL

PPE : CSII +/- Metformin.

Drug: Detemir insulin, Aspart insulin, Metformin

injections

ACTIVE COMPARATOR

INJ: basal/bolus MDI +/- Metformin

Drug: Detemir insulin, Aspart insulin, Metformin

Interventions

Detemir insulin, Aspart insulin, MetforminDRUG

Insulin doses adapted by patients according to self monitoring blood glucose results.

PPEinjections

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.
  • ,5% ≤ HbA1c ≤ 10%
  • Patients able to perform self-monitoring blood glucose (SMBG) measurement and insulin injections.
  • SMBG \> 3/day

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Toulouse

Toulouse, 31059, France

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Insulin DetemirInsulin AspartMetformin

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Insulin, Long-ActingInsulinsPancreatic HormonesPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsPeptidesAmino Acids, Peptides, and ProteinsInsulin, Short-ActingBiguanidesGuanidinesAmidinesOrganic Chemicals

Study Officials

  • Vincent Melki, MD

    University Hospital, Toulouse

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 16, 2009

First Posted

July 20, 2009

Study Start

March 1, 2009

Primary Completion

February 1, 2013

Study Completion

February 1, 2013

Last Updated

December 11, 2013

Record last verified: 2013-12

Locations

FR(1)