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.

NCT01122979 | Completed Phase 4

• 1 other identifier: LANTU_L_04737
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 10

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.

Conditions

Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (1)

• 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 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).

  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)

Study Arms (2)

group 1: insulin glargine + insulin glulisine

EXPERIMENTAL

insulin glargine once daily + glulisine at meal times

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

Drug: NPH insulin (insulin isophane); Drug: Regular insulin

Interventions

INSULIN GLARGINE DRUG

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

group 1: insulin glargine + insulin glulisine

NPH insulin (insulin isophane) DRUG

Pharmaceutical form: solution for injection Route of administration: subcutaneous Dose regimen: dose adjusted to the patient's glycemia

group 2 NPH insulin + regular insulin

INSULIN GLULISINE DRUG

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

group 1: insulin glargine + insulin glulisine

Regular insulin DRUG

Pharmaceutical form: solution for injection Route of administration: subcutaneous Dose regimen: dose adjusted to the patient's glycemia

group 2 NPH insulin + regular insulin

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sanofi: lead

Study Sites (10)

Investigational Site Number 076-007

Curitiba, 80060-900, Brazil

Location

Investigational Site Number 076-010

Fortaleza, 60015-052, Brazil

Location

Investigational Site Number 076-001

Fortaleza, 60115-282, Brazil

Location

Investigational Site Number 076-003

Porto Alegre, 91350-250, Brazil

Location

Investigational Site Number 076-005

São Paulo, 01244-030, Brazil

Location

Investigational Site Number 076-013

São Paulo, 01308-050, Brazil

Location

Investigational Site Number 076-004

São Paulo, 01323-001, Brazil

Location

Investigational Site Number 076-002

São Paulo, 04024-002, Brazil

Location

Investigational Site Number 076-009

São Paulo, o4039-000, Brazil

Location

Investigational Site Number 076-006

Taguatinga, 72155000, Brazil

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Insulin Glargine; Insulin, Isophane; insulin glulisine; Insulin

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Insulin, Long-Acting; Insulins; Pancreatic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins; Proinsulin

Study Officials

• Clinical Sciences & Operations

  Sanofi

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 11, 2010
• First Posted: May 13, 2010
• Study Start: July 1, 2010
• Primary Completion: October 1, 2013
• Study Completion: October 1, 2013
• Last Updated: November 8, 2013

Record last verified: 2013-11

Locations

BR (10)