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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 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 72

Last updated 2013-11-08

No results posted yet for this study

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

Interventions

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

NPH insulin (insulin isophane)

Pharmaceutical form: solution for injection 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

DRUG

Regular insulin

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

Sponsors & Collaborators

Principal Investigators

  • Clinical Sciences & Operations · Sanofi

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-07-31
Primary Completion
2013-10-31
Completion
2013-10-31

Countries

  • Brazil

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01122979 on ClinicalTrials.gov