Insulin Glargine Combination Therapies in Type II Diabetics

Sanofi375 enrolled

Overview

To compare efficacy of combination therapy of insulin glargine plus glimepiride and metformin versus 2 injections insulin monotherapy with premixed insulin NPH 30/70 bid in terms of change of HbA1c (baseline to endpoint) to show non-inferiority of insulin glargine plus glimepiride and metformin.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

375

Conditions

Diabetes Mellitus, Type 2

Interventions

Insulin GlargineDRUG

In the morning to target FBG ≤ 100 mg/dl

GlimepirideDRUG

Glimepiride 3 or 4 mg

MetforminDRUG

At least 850 mg od

Insulin monotherapy with premixed insulin NPH 30/70

Eligibility

Sex: ALLMin age: 35 YearsMax age: 75 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Diabetes mellitus patients type 2, poorly controlled with oral antidiabetic drug treatment(glimepiride 3 or 4 mg od or any sulfonylurea similar to glimepiride 3 or 4 mg in combination with metformin in a dose at least similar to 850 mg once daily) * HbA1c value ≥ 7.5 % to ≤ 10.5 % * FBG ≥ 120 mg/dl (6.6 mmol/l) * BMI ≤ 35 kg/m² The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Locations (10)

Sanofi aventis administrative office

Vienna, Austria

Sanofi-aventis administrative office

Helsinki, Finland

Sanofi-aventis administrative office

Paris, France

Sanofi-Aventis Administrative Office

Outcomes

Primary Outcomes

Frequency of subjects with HbA1c ≤ 7.0 % and > 7.0 %

Time frame: At endpoint

Secondary Outcomes

Change of fasting blood glucose

Time frame: baseline to endpoint

Change of nocturnal & mean daytime blood glucose

Time frame: baseline to endpoint

Change of fasting plasma glucose

Time frame: baseline to endpoint and all visits

Frequency of subjects with hypoglycemic events (overall, severe, non-severe, nocturnal, asymptomatic, symptomatic)

Time frame: Baseline to endpoint

Frequency of hypoglycemic events(overall, severe, non-severe, nocturnal, asymptomatic, symptomatic)

Time frame: Baseline to endpoint

Frequency of subjects with FBG ≤ 100 mg/dl (5.5 mmol/l), 100 mg/dl < FBG ≤ 120 mg/dl (5.5 mmol/l < FBG ≤ 6.6 mmol/l), 120 mg/dl < FBG ≤ 150 mg/dl (6.6 mmol/l < FBG ≤ 8.3 mmol/l) and > 150 mg/dl (> 8.3 mmol/l)

Time frame: At endpoint

Data from ClinicalTrials.gov

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