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DOMME Dose Optimization Multicentric Mexican Evaluation

NCT00488527 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 371

Last updated 2010-09-13

No results posted yet for this study

Summary

To evaluate the efficiency of Lantus plus combined oral hypoglycaemic agents in terms of respondents percentage. The respondent is defined as the person achieving a value in the final determination of HbA1c \< 7% as its absolute value and/or a decreasing in the final value of HbA1c of more than 12% compared with the initial value (final HbA1c vs. initial HbA1c).

Describe the glycemia levels and body weight change in the two response groups, (respondents and non-respondents).

Describe the adverse events Evaluate the safety of using the medication according to the incidence and relevance of the hypoglycemia events, (symptomatic, diurnal, nocturnal, severe).

Estimate the intra-patient variability of the fasting glycemia

Conditions

  • Diabetes Mellitus, Type 2

Interventions

DRUG

Insulin glargine

Patients will begin with a fixed, subcutaneous dose of insulin glargine, (10 U), in its commercial presentation, which will be adjusted week by week, according to the values of the glycemia when fasting (FBG), adding 2, 4, 6 or 8 units of insulin glargine over the following twelve weeks, during which the therapeutic objective should be attained, namely the glucose goal during fasting of 100 mg/dl (\<6.0 mmol/L), and the active treatment is to be continued for three more months.

Sponsors & Collaborators

Principal Investigators

  • Jesus Ruiz, MD · Sanofi

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-04-30
Primary Completion
2008-12-31
Completion
2008-12-31

Countries

  • Mexico

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00488527 on ClinicalTrials.gov