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

Sanofi

Status and phase: Completed; Phase 4

Conditions: Type 2 Diabetes

Treatments: Drug: Lantus (insulin glargine) + Glucophage (Metformin)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00653302

HOE901_4043

Details and patient eligibility

About

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

Enrollment: 280 patients

Sex: All

Ages: 30 to 69 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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280 participants in 1 patient group

1

Experimental group

Description:

Lantus once a day plus Glucophage 1000mg, twice a day per os

Treatment:

Drug: Lantus (insulin glargine) + Glucophage (Metformin)