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.

Diabetes Mellitus, Type 2 Clinical Trial

— DINAMO  

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01122979
• Other study ID #: LANTU_L_04737
• Status: Completed
• Phase: Phase 4
• First received: May 11, 2010
• Last updated: November 7, 2013
• Start date: July 2010
• Est. completion date: October 2013

Study information

• Verified date: November 2013
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Health Surveillance Agency
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 72
• Est. completion date: October 2013
• Est. primary completion date: October 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Renal Insufficiency

Intervention

Drug:
• INSULIN GLARGINE
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)
Pharmaceutical form: solution for injection Route of administration: subcutaneous Dose regimen: dose adjusted to the patient's glycemia
• INSULIN GLULISINE
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 insulin
Pharmaceutical form: solution for injection Route of administration: subcutaneous Dose regimen: dose adjusted to the patient's glycemia

Locations

Country	Name	City	State
Brazil	Investigational Site Number 076-007	Curitiba
Brazil	Investigational Site Number 076-001	Fortaleza
Brazil	Investigational Site Number 076-010	Fortaleza
Brazil	Investigational Site Number 076-003	Porto Alegre
Brazil	Investigational Site Number 076-002	São Paulo
Brazil	Investigational Site Number 076-004	São Paulo
Brazil	Investigational Site Number 076-005	São Paulo
Brazil	Investigational Site Number 076-009	São Paulo
Brazil	Investigational Site Number 076-013	São Paulo
Brazil	Investigational Site Number 076-006	Taguatinga

Sponsors (1)

Lead Sponsor	Collaborator
Sanofi

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of patients that reach the target of HbA1c =7% without confirmed nocturnal hypoglycaemia in each treatment group and the respective CI 90%.		From visit 1 (Day 1) to visit 13 (Day 169)	No
Secondary	Proportion of patients that reach the target of HbA1c =7% and proportion of patients reaching the target of Fasting Plasma Glucose (FPG =100mg/dL).		From baseline and Visit 13 (Day 169)	No
Secondary	Incidence of confirmed symptomatic and nocturnal hypoglycemias: plasma glucose measurement <= 70mg/dL.		From baseline and Visit 13 (Day 169)	No
Secondary	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		From baseline and Visit 13 (Day 169)	No
Secondary	Weight variation		From baseline to the end of treatment at visit 13 (day 169)	No
Secondary	Creatinine clearance variation		From baseline to the end of treatment at visit 13 (day 169)	No