Insulin Glargine Combination Therapies in Type II Diabetics

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

375 participants

Study Classification

INTERVENTIONAL

Study Start Date

2001-12-31

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.

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Detailed Description

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Conditions

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Diabetes Mellitus, Type 2

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

Insulin Glargine + Glimepiride + Metformin

Group Type EXPERIMENTAL

Insulin Glargine

Intervention Type DRUG

In the morning to target FBG ≤ 100 mg/dl

Glimepiride

Intervention Type DRUG

Glimepiride 3 or 4 mg

Metformin

Intervention Type DRUG

At least 850 mg od

2

Insulin monotherapy with premixed insulin NPH 30/70

Group Type ACTIVE_COMPARATOR

Insulin monotherapy with premixed insulin NPH 30/70

Intervention Type DRUG

Given before breakfast and before dinner, target of pre-prandial BG ≤ 100 mg/dl

Interventions

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Insulin Glargine

In the morning to target FBG ≤ 100 mg/dl

Intervention Type DRUG

Glimepiride

Glimepiride 3 or 4 mg

Intervention Type DRUG

Metformin

At least 850 mg od

Intervention Type DRUG

Insulin monotherapy with premixed insulin NPH 30/70

Given before breakfast and before dinner, target of pre-prandial BG ≤ 100 mg/dl

Intervention Type DRUG

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.

Minimum Eligible Age

35 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No