Diabetes Mellitus, Type 2Phase 4DOMMENCT00488527
DOMME Dose Optimization Multicentric Mexican Evaluation
A Phase 4 study testing Insulin glargine in people with Diabetes Mellitus, Type 2, run by Sanofi at 1 site in Mexico.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes Mellitus, Type 2
- What is being tested?
- Insulin glargine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 371 participants
- Where
- 1 siteMexico
- Study dates
- Apr 2007to Dec 2008
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
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).
Read more
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
- Being tested
- Insulin glargine
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Insulin glargineDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Drug: Insulin glargine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the initial vs. final values of HbA1c
Measured: 9 months
Number of severe hypoglycemia
Measured: 9 months
Secondary outcomes (3)
- Change in the fasting glucose values with each visit
Measured: 9 months
- 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
Measured: 9 months
- Change in body weight initial visit vs. final visit
Measured: 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jun 2007 (estimated)
- Study startApr 2007
- Primary completionDec 2008
- Study completionDec 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
- More trials run by SanofiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 371 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sanofi
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Jesus Ruiz, MD, Study director, Sanofi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00488527
- Sponsor's protocol ID
- LANTU_L_01890
- Acronym
- DOMME
- Status last verified
- Sep 2010
- First submitted
- 19 Jun 2007
- Last updated
- 13 Sep 2010
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT00488527
- Acronym / sponsor ID
- DOMME / LANTU_L_01890
- Conditions
- Diabetes Mellitus, Type 2
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 371 participants (actual)
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Study start
- Apr 2007
- Primary completion
- Dec 2008 (actual)
- Study completion
- Dec 2008 (actual)
- First posted
- 20 Jun 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Insulin glargine |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (22 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Insulin glarginePatients 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. | Drug | 1 |
Primary outcome
Change in the initial vs. final values of HbA1c
Time frame: 9 months
Number of severe hypoglycemia
Time frame: 9 months
3 secondary outcomes
- Change in the fasting glucose values with each visit
Time frame: 9 months
- 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
- Change in body weight initial visit vs. final visit
Time frame: 9 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Sep 2010.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jesus Ruiz, MD study director
Sanofi
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Insulin glargine in people with Diabetes Mellitus, Type 2, run by Sanofi at 1 site in Mexico.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Sep 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in the initial vs. final values of HbA1c (time frame: 9 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Sep 2010.