Insulin Glargine v Rosiglitazone as add-on Therapy in Patients Failing Sulfonylurea and Metformin Combination Therapy

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

PHASE4

Total Enrollment

220 participants

Study Classification

INTERVENTIONAL

Study Start Date

2001-01-31

Study Completion Date

2002-06-30

Brief Summary

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To compare the glycemic control, as measured by HbA1C, between insulin glargine and rosiglitazone add-on therapies in patients who fail oral combination of a sulfonylurea and metformin

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Detailed Description

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Conditions

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Type 2 Diabetes Mellitus

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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insulin glargine

Intervention Type DRUG

rosiglitazone

Intervention Type DRUG

metformin

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Diagnosis of type 2 diabetes mellitus for at least one year;
* Continuous treatment with at least half maximally labeled dose of a sulfonylurea and at least 1000 mg metformin daily for at least three months ;
* Glycated hemoglobin between 7.5 and 11 % units, inclusive;
* Willingness to accept, and ability to inject insulin glargine therapy

Exclusion Criteria

* Stroke, MI, coronary artery bypass graft, percutaneous transluminal coronary angioplasty or angina pectoris within the last 12 months;
* Congestive heart failure requiring pharmacological treatment;
* Serum creatinine \> 1.5 mg/dl for males, or \> 1.4 mg/dl for females;
* Acute or chronic metabolic acidosis, including diabetic ketoacidosis;
* Planned radiological examinations requiring administration of contrasting agents;
* Clinical evidence of active liver disease, or serum ALT 2.5 times the upper limit of the normal range;
* History of hypoglycemia unawareness;
* Pregnancy or lactation;
* Failure to use adequate contraception (women of current reproductive potential only);
* Known hypersensitivity to insulin glargine, rosiglitazone or any of the components of insulin glargine rosiglitazone;
* BMI \>25 kg/m2;
* Malignancy except basal cell carcinoma within the last five years;
* History of substance or alcohol abuse within last two years, or current addiction to substance or alcohol abuse;
* Any disease or condition that in the opinion of the investigator and/or sponsor may interfere with completion of the study;
* Incapability to comply with study procedures

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No