Clinical trial NCT01122979: 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.
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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Diabetes Mellitus, Type 2
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2010-05-13
Enrollment: 72
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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.


Eligibility criteria: Inclusion criteria:

* 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

Exclusion criteria:

* 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.
* 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.

Primary outcomes:
measure: Proportion of patients that reach the target of HbA1c ≤7% without confirmed nocturnal hypoglycaemia in each treatment group and the respective CI 90%.
timeFrame: From visit 1 (Day 1) to visit 13 (Day 169)
Secondary outcomes:
measure: Proportion of patients that reach the target of HbA1c ≤7% and proportion of patients reaching the target of Fasting Plasma Glucose (FPG ≤100mg/dL).
timeFrame: From baseline and Visit 13 (Day 169)
measure: Incidence of confirmed symptomatic and nocturnal hypoglycemias: plasma glucose measurement <= 70mg/dL.
timeFrame: From baseline and Visit 13 (Day 169)
measure: 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
timeFrame: From baseline and Visit 13 (Day 169)
measure: Weight variation
timeFrame: From baseline to the end of treatment at visit 13 (day 169)
measure: Creatinine clearance variation
timeFrame: From baseline to the end of treatment at visit 13 (day 169)
Other outcomes:
Locations:
city: Curitiba
country: Brazil
facility: Investigational Site Number 076-007
city: Fortaleza
country: Brazil
facility: Investigational Site Number 076-010
city: Fortaleza
country: Brazil
facility: Investigational Site Number 076-001
city: Porto Alegre
country: Brazil
facility: Investigational Site Number 076-003
city: São Paulo
country: Brazil
facility: Investigational Site Number 076-005
city: São Paulo
country: Brazil
facility: Investigational Site Number 076-013
city: São Paulo
country: Brazil
facility: Investigational Site Number 076-004
city: São Paulo
country: Brazil
facility: Investigational Site Number 076-002
city: São Paulo
country: Brazil
facility: Investigational Site Number 076-009
city: Taguatinga
country: Brazil
facility: Investigational Site Number 076-006
Study officials:
affiliation: Sanofi
name: Clinical Sciences & Operations
role: STUDY_DIRECTOR
References: