DOMME Dose Optimization Multicentric Mexican Evaluation (DOMME)
Primary Purpose
Diabetes Mellitus, Type 2
Status
Completed
Phase
Phase 4
Locations
Mexico
Study Type
Interventional
Intervention
Insulin glargine
Sponsored by
About this trial
This is an interventional treatment trial for Diabetes Mellitus, Type 2
Eligibility Criteria
Inclusion Criteria:
- Patients with type 2 diabetes mellitus receiving antidiabetic treatment (1 or 2 oral agents) during more than 6 months, who need a prolonged action basal insulin to control hyperglycemia
- Glycosylated hemoglobin > 8,0% and < 10 %
- Body mass index (BMI) < 40 kg/m2
- Voluntary acceptation of the treatment and capability to self inject the insulin glargine
- Capability and desire to carry out self-determination of glycemia levels using glucometers
Exclusion Criteria:
- Renal function disorder, revealed by a serum creatinine > 177 µmol/l (> 2,0 mg/dl) in Visit 1 or currently undergoing kidney dialysis
- Acute metabolic acidosis (> 1 episode during the last year) or chronic, including diabetic ketoacidosis
- Clinical evidence of an active liver disease or serum ALT/AST >2.5 times the upper normality limit
- A history of unnoticed hypoglycemia
- Surgical treatment for diabetic retinopathy, (laser photocoagulation or a vitrectomy), during the three months prior to joining the trial, or patient that has needed treatment within three months of entering the trial
- Pregnancy or breast feeding
- Not using an adequate birth control method, (only for potentially fertile females) : for example, the use of systemic hormones, (pills or birth control implants), intrauterine devices or a barrier method, (diaphragm with intra-vaginal spermicides, male or female preservative)
- Known hypersensitivity to insulin glargine or any of its excipients
- Malignant process, except for basal carcinoma cells during the last five years
- More than two weeks of continuous treatment with systemic glucocorticoids in the last 6 months
- Concomitant treatment with non-cardio selective beta blockers
- Known supra-renal failure
- Known hemoglobinopathy or anemia, uncontrolled or unstable
- A psychiatric disturbance which prevents the patient from understanding the nature, objective and possible consequences of the trial
- A history of drug or alcohol abuse in the last two years or any current addiction
- Current use of insulin glargine
- Any clinically relevant, cardiovascular, hepatic, neurological, endocrinal or systemic major disease, or any other type, which may hinder the development of the protocol or the interpretation of the results of the trial
- Known existence of GAD (glutamic acid decarboxylase) antibodies
- Type 1 diabetes mellitus, according to its definition by the WHO
- The use of a drug being researched other than insulin during six months prior to joining the trial or the use of an insulin under study during four weeks before entering the trial
- A history of severe hypoglycemia with repeated blackouts, (more than 1), during the last year
The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Sites / Locations
- Sanofi-Aventis
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
1
Arm Description
Outcomes
Primary Outcome Measures
Change in the initial vs. final values of HbA1c
Number of severe hypoglycemia
Secondary Outcome Measures
- Change in the fasting glucose values with each visit
- Incidences of symptomatic and asymptomatic nocturnal hypoglycemia - Evaluations of safety with regards to the use of insulin glargine, recording the adverse events, excluding hypoglycemia - Abnormal laboratory results
- Change in body weight initial visit vs. final visit
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00488527
Brief Title
DOMME Dose Optimization Multicentric Mexican Evaluation
Acronym
DOMME
Official Title
Multicentric, Open Label Clinical Trial. Use of Optimal Method to Initiate and Maintain Lantus Therapy (Insulin Glargine) in Combination With Hypoglycemic Agents, Assessing the Resulting Metabolic Control and the Safety in T2 Diabetes Mellitus Patients.
Study Type
Interventional
2. Study Status
Record Verification Date
September 2010
Overall Recruitment Status
Completed
Study Start Date
April 2007 (undefined)
Primary Completion Date
December 2008 (Actual)
Study Completion Date
December 2008 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Sanofi
4. Oversight
5. Study Description
Brief 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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type 2
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
371 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Insulin glargine
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in the initial vs. final values of HbA1c
Time Frame
9 months
Title
Number of severe hypoglycemia
Time Frame
9 months
Secondary Outcome Measure Information:
Title
- Change in the fasting glucose values with each visit
Time Frame
9 months
Title
- Incidences of symptomatic and asymptomatic nocturnal hypoglycemia - Evaluations of safety with regards to the use of insulin glargine, recording the adverse events, excluding hypoglycemia - Abnormal laboratory results
Time Frame
9 months
Title
- Change in body weight initial visit vs. final visit
Time Frame
9 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients with type 2 diabetes mellitus receiving antidiabetic treatment (1 or 2 oral agents) during more than 6 months, who need a prolonged action basal insulin to control hyperglycemia
Glycosylated hemoglobin > 8,0% and < 10 %
Body mass index (BMI) < 40 kg/m2
Voluntary acceptation of the treatment and capability to self inject the insulin glargine
Capability and desire to carry out self-determination of glycemia levels using glucometers
Exclusion Criteria:
Renal function disorder, revealed by a serum creatinine > 177 µmol/l (> 2,0 mg/dl) in Visit 1 or currently undergoing kidney dialysis
Acute metabolic acidosis (> 1 episode during the last year) or chronic, including diabetic ketoacidosis
Clinical evidence of an active liver disease or serum ALT/AST >2.5 times the upper normality limit
A history of unnoticed hypoglycemia
Surgical treatment for diabetic retinopathy, (laser photocoagulation or a vitrectomy), during the three months prior to joining the trial, or patient that has needed treatment within three months of entering the trial
Pregnancy or breast feeding
Not using an adequate birth control method, (only for potentially fertile females) : for example, the use of systemic hormones, (pills or birth control implants), intrauterine devices or a barrier method, (diaphragm with intra-vaginal spermicides, male or female preservative)
Known hypersensitivity to insulin glargine or any of its excipients
Malignant process, except for basal carcinoma cells during the last five years
More than two weeks of continuous treatment with systemic glucocorticoids in the last 6 months
Concomitant treatment with non-cardio selective beta blockers
Known supra-renal failure
Known hemoglobinopathy or anemia, uncontrolled or unstable
A psychiatric disturbance which prevents the patient from understanding the nature, objective and possible consequences of the trial
A history of drug or alcohol abuse in the last two years or any current addiction
Current use of insulin glargine
Any clinically relevant, cardiovascular, hepatic, neurological, endocrinal or systemic major disease, or any other type, which may hinder the development of the protocol or the interpretation of the results of the trial
Known existence of GAD (glutamic acid decarboxylase) antibodies
Type 1 diabetes mellitus, according to its definition by the WHO
The use of a drug being researched other than insulin during six months prior to joining the trial or the use of an insulin under study during four weeks before entering the trial
A history of severe hypoglycemia with repeated blackouts, (more than 1), during the last year
The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jesus Ruiz, MD
Organizational Affiliation
Sanofi
Official's Role
Study Director
Facility Information:
Facility Name
Sanofi-Aventis
City
Mexico
Country
Mexico
12. IPD Sharing Statement
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DOMME Dose Optimization Multicentric Mexican Evaluation
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