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Lantus Versus NPH: Comparison in Insulin Naive People Not Adequately Controlled With at Least One Oral Anti Diabetics (OAD) Treatment

NCT00949442 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 708

Last updated 2012-08-21

No results posted yet for this study

Summary

Primary Objective:

To demonstrate the superiority of insulin glargine over insulin NPH (Neutral Protamin Hagedornon) the change in HbA1c from baseline to the end of the treatment period.

Secondary Objective:

To compare between treatment groups:

* Plasma glucose (fasting, nocturnal) over time,
* Changes from baseline in HbA1c over time,
* Percentage of patients who reach the target of HbA1c \<7 and \<6.5,
* Use of prandial insulin as rescue medication at month 6,
* Incidence and rate of hypoglycemia (symptomatic diurnal and nocturnal, asymptomatic and severe),
* Daily dose of insulin,
* Change in body weight from baseline,
* Evolution of 8-point plasma-glucose (PG) profiles,
* Overall safety,
* Patient reported outcomes (treatment satisfaction).

Conditions

  • Diabetes Mellitus, Type 2

Interventions

DRUG

Insulin Glargine (HOE901) [Lantus]

100 Units/ml solution for injection in a pre-filled pen SoloStar® (3 ml)

DRUG

Glimepiride

tablets of 1 and 2 mg

DRUG

human insulin [NPH]

100 IU/ml suspension for injection in a prefilled pen OptiSet® (3 ml)

Sponsors & Collaborators

Principal Investigators

  • Valerie Pilorget, MD · Sanofi

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
30 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-07-31
Primary Completion
2012-07-31
Completion
2012-07-31

Countries

  • Brazil
  • Czechia
  • Egypt
  • France
  • Italy
  • Kuwait
  • Mexico
  • Netherlands
  • Poland
  • Romania
  • Russia
  • Slovakia
  • South Korea
  • Sweden
  • Switzerland
  • Thailand
  • United Arab Emirates

Study Locations

More Related Trials

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 NCT00949442 on ClinicalTrials.gov