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.

Phase 4

Completed

• Conditions: Diabetes Mellitus, Type 2
• Interventions: Drug: INSULIN GLARGINE; Drug: NPH insulin (insulin isophane); Drug: INSULIN GLULISINE; Drug: Regular insulin

• Registration Number: NCT01122979
• Lead Sponsor: Sanofi

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2010-05-11
• Study First Submitted QC: 2010-05-12
• Study First Posted: 2010-05-13
• Study Start: 2010-07
• Primary Completion: 2013-10
• Study Completion: 2013-10
• Status Verified: 2013-11
• Last Update Submitted: 2013-11-07
• Last Update Posted: 2013-11-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 72

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
group 1: insulin glargine + insulin glulisine	INSULIN GLARGINE	insulin glargine once daily + glulisine at meal times
group 1: insulin glargine + insulin glulisine	INSULIN GLULISINE	insulin glargine once daily + glulisine at meal times
group 2 NPH insulin + regular insulin	NPH insulin (insulin isophane)	NPH insulin (isophane insulin) (2 or more divided doses) + regular insulin at meal times
group 2 NPH insulin + regular insulin	Regular insulin	NPH insulin (isophane insulin) (2 or more divided doses) + regular insulin at meal times

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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)
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)
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)

Trial Locations

Locations (10)

Investigational Site Number 076-013; 🇧🇷 São Paulo, Brazil

Investigational Site Number 076-007; 🇧🇷 Curitiba, Brazil

Investigational Site Number 076-005; 🇧🇷 São Paulo, Brazil

Investigational Site Number 076-004; 🇧🇷 São Paulo, 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 076-009; 🇧🇷 São Paulo, Brazil

Investigational Site Number 076-006; 🇧🇷 Taguatinga, Brazil

Investigational Site Number 076-001; 🇧🇷 Fortaleza, Brazil