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OpenTrials
Completed

NCT Number: NCT00653302

Phenotype Evaluation in Insulin Naive Patients Using Lantus (Insulin Glargine)

Primary objective:

* Efficacy assessment of the percentage of positive responders patients receiving Lantus plus glucophage association. Positive responders patients are defined by a final value of HbA1c<7% and/or a final decrease of HbA1c>15% compare to the basal value (HbA1c final - HbA1c basal).

Secondary objectives:

* Determination of the predictive criterion of HbA1c final, * Determination of the predictive criterion of weight variation, * Description of the glycemic and therapeutic criteria in the both groups of responders (positive and negative responders), * Assessment of the lipidic parameters according to the HbA1c and weight changes during the study (final value - basal value).

Safety:

* Adverse Event (AE)/Serious Adverse Event (SAE) assessments

Completed

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Key information

Conditions

Type 2 Diabetes Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

30 year–69 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Sanofi-aventis administrative office

Paris, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Known type 2 diabetes for at least 2 years
  • No history of Ketoacidosis
  • BMI> 25 & <35 kg/m2
  • Type 2 diabetes treated with oral bi or tritherapy for at least 6 months
  • With insulin release stimulator: sulfonamide or glinide at maximal posology (as defined in the SmPC),
  • and metformin at minimal posology 1700mg/day (1320 mg of metformin),
  • HbA1c >= 7.5 and <11% for 2 different dosages during the last year

Exclusion criteria

  • Type 1 diabetes
  • Glucophage intolerability
  • Pregnancy
  • Breast feeding
  • Partial pancreatectomy
  • Hypersensitivity to insulin glargine excipient
  • Renal failure with creatinin>135 µmol/L for male and >110 µmol/L for female patient
  • Hepatitis with transaminases >3ULN
  • Pre-proliferative or proliferative retinopathy
  • Acute cardiovascular accident within the last 6 months
  • Previous treatment with insulin within the last 6 months before randomization

Treatment and study plan

Lantus (insulin glargine) + Glucophage (Metformin)

Drug

Primary outcomes

  1. % of responders with HbA1c<7% and/or a final decrease of HbA1c>15% compare to the basal value (HbA1c final - HbA1c basal).

    Time frame: During the study conduct

Secondary outcomes

  1. Determination of the predictive criterion of HbA1c final

    Time frame: During the study conduct

  2. Determination of the predictive criterion of weight variation

    Time frame: During all the study conduct

  3. HbA1c and weight variations (final value - basal value)

    Time frame: during the study

  4. AE/SAE evaluation

    Time frame: from the informed consent signed up to the end of the study

Sponsors and collaborators

Lead sponsor

Sanofi

Industry

Registry information

Official study title

Assessment of the Phenotype of the Type 2 Diabetic Responders to the First Insulinisation Using Lantus (Insulin Glargine) Plus Glucophage (Metformin) Combination After Failure in OADs Treatment

Acronym: GALATEE

Important dates

Study start
2003
Primary completion
2004
Study completion
2005
First posted
Apr 4, 2008
Registry last updated
Dec 3, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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