Insulin Glargine Combination Therapies in Type II Diabetics

Study Overview
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Brief Summary
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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.

Official Title
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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.

Conditions
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Diabetes Mellitus, Type 2

Intervention / Treatment
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* Drug: Insulin Glargine
* Drug: Glimepiride
* Drug: Metformin
* Drug: Insulin monotherapy with premixed insulin NPH 30/70


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 35 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Insulin Glargine + Glimepiride + Metformin | Drug: Insulin Glargine<br>* In the morning to target FBG ≤ 100 mg/dl<br>Drug: Glimepiride<br>* Glimepiride 3 or 4 mg<br>Drug: Metformin<br>* At least 850 mg od<br>|
| Active Comparator: 2<br>Insulin monotherapy with premixed insulin NPH 30/70 | Drug: Insulin monotherapy with premixed insulin NPH 30/70<br>* Given before breakfast and before dinner, target of pre-prandial BG ≤ 100 mg/dl<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Frequency of subjects with HbA1c ≤ 7.0 % and > 7.0 % |  | At endpoint | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of fasting blood glucose |  | baseline to endpoint | 
| Change of nocturnal & mean daytime 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 |