Diabetes Mellitus, Type 2Phase 4DINAMONCT01122979
Evaluation of the Safety and Efficacy of Insulin Glargine + Glulisine or Insulin Regular + NPH Insulin (Isophane Insulin) Use in Type 2 Diabetes Mellitus Patients With Moderate Renal Failure.
A Phase 4 study testing INSULIN GLARGINE, NPH insulin (insulin isophane) and INSULIN GLULISINE in people with Diabetes Mellitus, Type 2, run by Sanofi at 10 sites in Brazil.
Trial summary
Primary Objective: >To obtain an estimation for both treatment groups of the proportion of patients that reach the target of HbA1c <= 7% without confirmed nocturnal hypoglycaemia in each treatment group. 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, NPH insulin (insulin isophane) and INSULIN GLULISINE
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 10 sitesBrazil
- Study dates
- Jul 2010to Oct 2013
- 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
- Type 2 diabetes and renal failure in use of NPH regular insulin or fast-acting analog and HbA1c >= 8%.
- Albuminuria or microalbuminuria diabetic retinopathy.
- Creatinine clearance < 60 mL/min/1,73 m2 and >30 mL/min/1,73 m2
Who cannot join
- Hypersensibility to insulin glargine or any other component of the insulin formulation.
- Use of investigational medications during the last 12 months or use of any investigational insulin preparation during the last 4 months.
- History of diabetic ketoacidosis or positive GAD antibodies.
- Advanced retinopathy needing laser therapy.
- Diagnosed advanced neuropathy
- Severe hepatic disease or active hepatitis.
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- Cardiac failure class III or IV (NYHA).
- Patients on hemodialysis.
- Diagnosed cancer.
- Active infection.
- Current therapy with steroids.
- Patients with recognized or suspected endocrine disorders associated with increased insulin resistance, acromegaly, or hyperthyroidism.
- 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
10 sites in 1 country.
10 sites in 1 country
Brazil10 sites
Investigational Site Number 076-007
Curitiba, 80060-900
Investigational Site Number 076-010
Fortaleza, 60015-052
Investigational Site Number 076-001
Fortaleza, 60115-282
Investigational Site Number 076-003
Porto Alegre, 91350-250
Investigational Site Number 076-005
São Paulo, 01244-030
Investigational Site Number 076-013
São Paulo, 01308-050
Investigational Site Number 076-004
São Paulo, 01323-001
Investigational Site Number 076-002
São Paulo, 04024-002
Investigational Site Number 076-009
São Paulo, o4039-000
Investigational Site Number 076-006
Taguatinga, 72155000
About this study
Official title: National (Brazil), Phase IV, Multicentric, Open Label, Parallel, Comparative Study of the Use of Insulin Glargine + Glulisine or Insulin Regular + NPH Insulin (Isophane Insulin) in Type 2 Diabetes Mellitus Patients With Moderate Renal Failure.
Primary Objective:
>To obtain an estimation for both treatment groups of the proportion of patients that reach the target of HbA1c <= 7% without confirmed nocturnal hypoglycaemia in each treatment group.
Secondary Objectives:
- Glycemic control, measured by HbA1c and FPG (fasting plasma glucose) at baseline and after each period of treatment.
- Incidence of confirmed symptomatic and nocturnal hypoglycemia.
- Incidence of confirmed severe hypoglycemia (< 36mg/dL or need of help to recover). >Weight variation for each period of treatment.
- Creatinine clearance at baseline and after each period of treatment.
- Overall safety: Incidence of adverse events.
- Conditions
- Diabetes Mellitus, Type 2
- Being tested
- INSULIN GLARGINE, NPH insulin (insulin isophane), INSULIN GLULISINE, Regular insulin
- 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
Pharmaceutical form: 100 Units/mL solution for injection in a pre-filled SoloStar pen (3 mL) Route of administration: subcutaneous Dose regimen: dose adjusted to the patient's glycemia
NPH insulin (insulin isophane)Drug
Pharmaceutical form: solution for injection Route of administration: subcutaneous Dose regimen: dose adjusted to the patient's glycemia
INSULIN GLULISINEDrug
Pharmaceutical form: 100 Units/mL solution for injection in a pre-filled SoloStar pen (3 mL) Route of administration: subcutaneous Dose regimen: dose adjusted to the patient's glycemia
Regular insulinDrug
Pharmaceutical form: solution for injection Route of administration: subcutaneous Dose regimen: dose adjusted to the patient's glycemia
| Study group | Role | What they receive |
|---|---|---|
| group 1: insulin glargine + insulin glulisine | Experimental | insulin glargine once daily + glulisine at meal times Receives: Drug: INSULIN GLARGINE; Drug: INSULIN GLULISINE |
| group 2 NPH insulin + regular insulin | Active comparator | NPH insulin (isophane insulin) (2 or more divided doses) + regular insulin at meal times Receives: Drug: NPH insulin (insulin isophane); Drug: Regular insulin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients that reach the target of HbA1c ≤7% without confirmed nocturnal hypoglycaemia in each treatment group and the respective CI 90%.
Measured: From visit 1 (Day 1) to visit 13 (Day 169)
Secondary outcomes (5)
Proportion of patients that reach the target of HbA1c ≤7% and proportion of patients reaching the target of Fasting Plasma Glucose (FPG ≤100mg/dL).
Measured: From baseline and Visit 13 (Day 169)
Incidence of confirmed symptomatic and nocturnal hypoglycemias: plasma glucose measurement <= 70mg/dL.
Measured: From baseline and Visit 13 (Day 169)
Incidence of confirmed severe hypoglycemia: plasma glucose level < 36 mg/dL (2 mmol/L) or with prompt recovery after oral carbohydrate, intravenous glucose, or glucagon administration
Measured: From baseline and Visit 13 (Day 169)
Weight variation
Measured: From baseline to the end of treatment at visit 13 (day 169)
Creatinine clearance variation
Measured: From baseline to the end of treatment at visit 13 (day 169)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2010 (estimated)
- Study startJul 2010
- Primary completionOct 2013
- Study completionOct 2013
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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sanofi
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Sciences & Operations, Study director, Sanofi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01122979
- Sponsor's protocol ID
- LANTU_L_04737
- Acronym
- DINAMO
- Status last verified
- Nov 2013
- First submitted
- 11 May 2010
- Last updated
- 8 Nov 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- National (Brazil), Phase IV, Multicentric, Open Label, Parallel, Comparative Study of the Use of Insulin Glargine + Glulisine or Insulin Regular + NPH Insulin (Isophane Insulin) in Type 2 Diabetes Mellitus Patients With Moderate Renal Failure.
- ClinicalTrials.gov ID
- NCT01122979
- Acronym / sponsor ID
- DINAMO / LANTU_L_04737
- Conditions
- Diabetes Mellitus, Type 2
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Study start
- Jul 2010
- Primary completion
- Oct 2013 (actual)
- Study completion
- Oct 2013 (actual)
- First posted
- 13 May 2010 (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.
Primary Objective:
>To obtain an estimation for both treatment groups of the proportion of patients that reach the target of HbA1c <= 7% without confirmed nocturnal hypoglycaemia in each treatment group.
Secondary Objectives:
- Glycemic control, measured by HbA1c and FPG (fasting plasma glucose) at baseline and after each period of treatment.
- Incidence of confirmed symptomatic and nocturnal hypoglycemia.
- Incidence of confirmed severe hypoglycemia (< 36mg/dL or need of help to recover). >Weight variation for each period of treatment.
- Creatinine clearance at baseline and after each period of treatment.
- Overall safety: Incidence of adverse events.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| group 1: insulin glargine + insulin glulisine | Experimental | Drug: INSULIN GLARGINE, Drug: INSULIN GLULISINEinsulin glargine once daily + glulisine at meal times |
| group 2 NPH insulin + regular insulin | Active comparator | Drug: NPH insulin (insulin isophane), Drug: Regular insulinNPH insulin (isophane insulin) (2 or more divided doses) + regular insulin at meal times |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Type 2 diabetes and renal failure in use of NPH regular insulin or fast-acting analog and HbA1c >= 8%.
- Albuminuria or microalbuminuria diabetic retinopathy.
- Creatinine clearance < 60 mL/min/1,73 m2 and >30 mL/min/1,73 m2
Key exclusion criteria (13 listed)
- Hypersensibility to insulin glargine or any other component of the insulin formulation.
- Use of investigational medications during the last 12 months or use of any investigational insulin preparation during the last 4 months.
- History of diabetic ketoacidosis or positive GAD antibodies.
- Advanced retinopathy needing laser therapy.
- Diagnosed advanced neuropathy
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 GLARGINEPharmaceutical form: 100 Units/mL solution for injection in a pre-filled SoloStar pen (3 mL) Route of administration: subcutaneous Dose regimen: dose adjusted to the patient's glycemia | Drug | group 1: insulin glargine + insulin glulisine |
| NPH insulin (insulin isophane)Pharmaceutical form: solution for injection Route of administration: subcutaneous Dose regimen: dose adjusted to the patient's glycemia | Drug | group 2 NPH insulin + regular insulin |
| INSULIN GLULISINEPharmaceutical form: 100 Units/mL solution for injection in a pre-filled SoloStar pen (3 mL) Route of administration: subcutaneous Dose regimen: dose adjusted to the patient's glycemia | Drug | group 1: insulin glargine + insulin glulisine |
| Regular insulinPharmaceutical form: solution for injection Route of administration: subcutaneous Dose regimen: dose adjusted to the patient's glycemia | Drug | group 2 NPH insulin + regular insulin |
Primary outcome
Proportion of patients that reach the target of HbA1c ≤7% without confirmed nocturnal hypoglycaemia in each treatment group and the respective CI 90%.
Time frame: From visit 1 (Day 1) to visit 13 (Day 169)
5 secondary outcomes
Proportion of patients that reach the target of HbA1c ≤7% and proportion of patients reaching the target of Fasting Plasma Glucose (FPG ≤100mg/dL).
Time frame: From baseline and Visit 13 (Day 169)
Incidence of confirmed symptomatic and nocturnal hypoglycemias: plasma glucose measurement <= 70mg/dL.
Time frame: From baseline and Visit 13 (Day 169)
Incidence of confirmed severe hypoglycemia: plasma glucose level < 36 mg/dL (2 mmol/L) or with prompt recovery after oral carbohydrate, intravenous glucose, or glucagon administration
Time frame: From baseline and Visit 13 (Day 169)
Weight variation
Time frame: From baseline to the end of treatment at visit 13 (day 169)
Creatinine clearance variation
Time frame: From baseline to the end of treatment at visit 13 (day 169)
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 8 Nov 2013.
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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.
Clinical Sciences & Operations study director
Sanofi
10 sites 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, NPH insulin (insulin isophane) and INSULIN GLULISINE in people with Diabetes Mellitus, Type 2, run by Sanofi at 10 sites in Brazil.
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 3 inclusion and 13 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 8 Nov 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in Brazil. 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?
Proportion of patients that reach the target of HbA1c ≤7% without confirmed nocturnal hypoglycaemia in each treatment group and the respective CI 90%. (time frame: From visit 1 (Day 1) to visit 13 (Day 169)). 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 8 Nov 2013.