Clinical trial NCT00783744: Insulin Glargine Combination Therapies in Type II Diabetics
Official title: 28-week, Open, Randomized, Multinational, Multicenter Clinical Trial to Compare Efficacy and Safety of Combination Therapy of Glimepiride Plus Metformin Plus HOE901 Insulin Analogue Versus a Two-injection Conventional Therapy With Premixed Insulin NPH 30/70 Bid in Type 2 Diabetes Mellitus Patients Poorly Controlled With Oral Antidiabetic Drug Treatment.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Diabetes Mellitus, Type 2
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2008-11-02
Enrollment: 375
Sex: ALL
Minimum age (years): 35
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Frequency of subjects with HbA1c ≤ 7.0 % and > 7.0 %
timeFrame: At endpoint
Secondary outcomes:
measure: Change of fasting blood glucose
timeFrame: baseline to endpoint
measure: Change of nocturnal & mean daytime blood glucose
timeFrame: baseline to endpoint
measure: Change of fasting plasma glucose
timeFrame: baseline to endpoint and all visits
measure: Frequency of subjects with hypoglycemic events (overall, severe, non-severe, nocturnal, asymptomatic, symptomatic)
timeFrame: Baseline to endpoint
measure: Frequency of hypoglycemic events(overall, severe, non-severe, nocturnal, asymptomatic, symptomatic)
timeFrame: Baseline to endpoint
measure: 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)
timeFrame: At endpoint
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Sanofi aventis administrative office
city: Helsinki
country: Finland
facility: Sanofi-aventis administrative office
city: Paris
country: France
facility: Sanofi-aventis administrative office
city: Berlin
country: Germany
facility: Sanofi-Aventis Administrative Office
city: Milan
country: Italy
facility: Sanofi-Aventis Administrative Office
city: Gouda
country: Netherlands
facility: Sanofi-Aventis Administrative Office
city: Barcelona
country: Spain
facility: Sanofi-Aventis Administrative Office
city: Bromma
country: Sweden
facility: Sanofi-Aventis Administrative Office
city: Geneva
country: Switzerland
facility: Sanofi-Aventis Administrative Office
city: Guildford
country: United Kingdom
facility: Sanofi-Aventis Administrative Office
Study officials:
affiliation: Sanofi
name: Christine Kliebe-Frisch, MD
role: STUDY_DIRECTOR
References: