Insulin Glargine Combination Therapies in Type II Diabetics

Phase 3

Completed

• Conditions: Diabetes Mellitus, Type 2
• Interventions: Drug: Insulin monotherapy with premixed insulin NPH 30/70; Drug: Insulin Glargine; Drug: Glimepiride; Drug: Metformin

• Registration Number: NCT00783744
• Lead Sponsor: Sanofi

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2001-12
• Primary Completion: 2003-08
• Study First Submitted: 2008-10-31
• Study First Submitted QC: 2008-10-31
• Study First Posted: 2008-11-02
• Status Verified: 2009-09
• Last Update Submitted: 2009-09-25
• Last Update Posted: 2009-09-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 375

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.

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2	Insulin monotherapy with premixed insulin NPH 30/70	Insulin monotherapy with premixed insulin NPH 30/70
1	Glimepiride	Insulin Glargine + Glimepiride + Metformin
1	Metformin	Insulin Glargine + Glimepiride + Metformin
1	Insulin Glargine	Insulin Glargine + Glimepiride + Metformin

Primary Outcome Measures

Name	Time	Method
Frequency of subjects with HbA1c ≤ 7.0 % and > 7.0 %	At endpoint

Secondary Outcome Measures

Name	Time	Method
Change of fasting blood glucose	baseline to endpoint
Change of fasting plasma glucose	baseline to endpoint and all visits
Frequency of subjects with hypoglycemic events (overall, severe, non-severe, nocturnal, asymptomatic, symptomatic)	Baseline to endpoint
Frequency of hypoglycemic events(overall, severe, non-severe, nocturnal, asymptomatic, symptomatic)	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)	At endpoint
Change of nocturnal & mean daytime blood glucose	baseline to endpoint

Trial Locations

Locations (3)

Sanofi-Aventis Administrative Office; 🇬🇧 Guildford, United Kingdom

Sanofi aventis administrative office; 🇦🇹 Vienna, Austria

Sanofi-aventis administrative office; 🇫🇷 Paris, France