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. (DINAMO)

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.

Study Overview

• Status: Completed
• Conditions: Diabetes Mellitus, Type 2
• Intervention / Treatment: Drug: INSULIN GLARGINE; Drug: INSULIN GLULISINE; Drug: NPH insulin (insulin isophane); Drug: Regular insulin

• Study Type: Interventional
• Enrollment (Actual): 72
• Phase: Phase 4

Contacts and Locations

Study Locations

• Brazil
  • Curitiba, Brazil, 80060-900
    • Investigational Site Number 076-007
  • Fortaleza, Brazil, 60015-052
    • Investigational Site Number 076-010
  • Fortaleza, Brazil, 60115-282
    • Investigational Site Number 076-001
  • Porto Alegre, Brazil, 91350-250
    • Investigational Site Number 076-003
  • São Paulo, Brazil, 01244-030
    • Investigational Site Number 076-005
  • São Paulo, Brazil, 01308-050
    • Investigational Site Number 076-013
  • São Paulo, Brazil, 01323-001
    • Investigational Site Number 076-004
  • São Paulo, Brazil, 04024-002
    • Investigational Site Number 076-002
  • São Paulo, Brazil, o4039-000
    • Investigational Site Number 076-009
  • Taguatinga, Brazil, 72155000
    • Investigational Site Number 076-006

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: group 1: insulin glargine + insulin glulisine; insulin glargine once daily + glulisine at meal times	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; Drug: 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
Active Comparator: group 2 NPH insulin + regular insulin; NPH insulin (isophane insulin) (2 or more divided doses) + regular insulin at meal times	Drug: NPH insulin (insulin isophane); Pharmaceutical form: solution for injection Route of administration: subcutaneous Dose regimen: dose adjusted to the patient's glycemia; Drug: Regular insulin; Pharmaceutical form: solution for injection Route of administration: subcutaneous Dose regimen: dose adjusted to the patient's glycemia

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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)

Secondary Outcome Measures

Outcome Measure	Time Frame
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)
Incidence of confirmed symptomatic and nocturnal hypoglycemias: plasma glucose measurement <= 70mg/dL.	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	From baseline and Visit 13 (Day 169)
Weight variation	From baseline to the end of treatment at visit 13 (day 169)
Creatinine clearance variation	From baseline to the end of treatment at visit 13 (day 169)

Collaborators and Investigators

• Sponsor: Sanofi

Study record dates

Study Major Dates

• Study Start: July 1, 2010
• Primary Completion (Actual): October 1, 2013
• Study Completion (Actual): October 1, 2013

Study Registration Dates

• First Submitted: May 11, 2010
• First Submitted That Met QC Criteria: May 12, 2010
• First Posted (Estimate): May 13, 2010

Study Record Updates

• Last Update Posted (Estimate): November 8, 2013
• Last Update Submitted That Met QC Criteria: November 7, 2013
• Last Verified: November 1, 2013

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Kidney Diseases; Urologic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2; Renal Insufficiency; Hypoglycemic Agents; Physiological Effects of Drugs; Insulin; Insulin, Globin Zinc; Insulin Glargine; Insulin glulisine; Insulin, Isophane; Isophane Insulin, Human; Isophane insulin, beef
• Other Study ID Numbers: LANTU_L_04737

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No