NCT00272077

Brief Summary

Primary objective: To evaluate in explorative manner the fasting blood glucose (FBG) coefficient of variability (CV)calculated on SMBG values (SMBG : Self-Monitoring of Blood Glucose). Secondary objectives: The secondary objectives are the assessment of: changes in glycaemic control (HbA1C), frequency of hypoglycaemias, changes in weight, final insulin dose, changes in lipid parameters, changes in urinary albumin-to-creatinine ratio, profile of patient which best fits each of the algorithms with the dependent variable of change in HbA1C and independent variables of age, gender, race, tobacco use, diabetes complications, initial HbA1C, initial weight, duration of diabetes mellitus, general education and diabetes education.

Trial Health

100
On Track

Trial Health Score

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

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

April 1, 2005

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

January 2, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 4, 2006

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2006

Completed
Last Updated

December 7, 2009

Status Verified

December 1, 2009

Enrollment Period

1.1 years

First QC Date

January 2, 2006

Last Update Submit

December 4, 2009

Conditions

Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (1)

  • SMBG values

    during the last 4 weeks before visit 3 (end of cycle 1) and visit 4

Secondary Outcomes (8)

  • glycaemic control (HbA1c, fasting blood glucose, insulin and C-peptide),

    During the study conduct

  • frequency of hypoglycaemias

    During the study conduct

  • body weight

    During the study conduct

  • final insulin dose

    During the study conduct

  • lipid profile (serum total cholesterol, LDL-cholesterol, HDL-cholesterol and triglycerides)

    During the study conduct

  • +3 more secondary outcomes

Interventions

Insuline glargineDRUG

Eligibility Criteria

Age45 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Diagnosis of type 2 diabetes mellitus for at least 5 years;
  • Treatment with oral antidiabetic drugs in fixed combination (Combo, i.e. glibenclamide 2.5 mg + metformin 400 mg, 2 or 3 tablets, at stable dose in the last 3 months);
  • HbA1c \>= 8% and \<= 11%;
  • Body mass index (BMI) \> 27 and \< 35 kg/m2;
  • Willingness and demonstrated ability to inject insulin;
  • Demonstrated ability and willingness to perform self-monitoring of blood glucose (SMBG);

You may not qualify if:

  • Patients diagnosed with type 1 insulin dependent diabetes;
  • Patients with latent autoimmune diabetes of adults (LADA), defined as fasting C-peptide levels \< 1 ng/ml;
  • Cardiac status NYHA III-IV;
  • Impaired renal function as shown by (but not limited to) serum creatinine \>= 1.5 mg/dl for males or \>= 1.4 mg/dl for females;
  • Planned pregnancy, pregnant or lactating females;
  • Failure to use adequate contraception (women of current reproductive potential only);
  • Any current malignancy, previous breast cancer, or malignant melanoma within the past 5 years;
  • Diagnosis of dementia
  • Hypersensitivity to insulin or any of their components or to metformin;
  • Current or previous insulin therapy other than during hospitalisations;
  • Inability or unwillingness to continue metformin at study dosages throughout the study;
  • Treatment with intermittent doses of systemic steroids or large doses of inhaled steroids for the past one year (fixed doses for the past 6 months is acceptable providing there is no plan to change the dosage regime);
  • Stroke, Myocardial Infarction (MI), Coronary Artery Bypass Graft (CABG), Percutaneous Transluminal Coronary Angioplasty (PTCA), or Angina Pectoris within the last 12 months;
  • History of drug or alcohol abuse;
  • Receipt of an experimental drug or use of an experimental device within the 30 days prior to study entry;

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • PAIZIS GEORGES, MD

    Sanofi

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

January 2, 2006

First Posted

January 4, 2006

Study Start

April 1, 2005

Primary Completion

May 1, 2006

Last Updated

December 7, 2009

Record last verified: 2009-12