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Evaluate the Role of Adding Amaryl to Non-Insulin Dependent Diabetes Mellitus Patients Unresponsive to Maximum Dose Metformin & Thiazolidinedione | Clinical Trials | Clareo Health

COMPLETEDPHASE3

Evaluate the Role of Adding Amaryl to Non-Insulin Dependent Diabetes Mellitus Patients Unresponsive to Maximum Dose Metformin & Thiazolidinedione

A Double-Blind, Placebo-Controlled, Parallel Group Comparison Study to Evaluate the Role of the Addition of Amaryl to NIDDM Patients Not Responding to Maximum Dose Metformin and Thiazolidinedione Therapy

NCT00044447•Sanofi

View on ClinicalTrials.gov

Summary

The purpose of this study is to assess the efficacy and safety of Amaryl when added to Metformin and Thiazolidinedione (TZD) in non-insulin dependent diabetes mellitus (NIDDM) patients.

Eligibility

Age

18 - 80 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Patients must have given their signed informed consent.
•Males or females between 18 and 80 years old. Female patients must be surgically sterile, post-menopausal, or using an accepted method of birth control (i.e., oral contraceptives, intrauterine device, Norplant® system, Depo Provera®, or a spermicide and condom). Female patients of childbearing potential must have a negative serum pregnancy test and be advised not to become pregnant during the study.
•At least 1 year history of NIDDM and performing home blood glucose monitoring.
•Patients must have BMI of \> 26 to \< 42 kg/m2 at baseline (week 0).
•Patients must have HbA1C \> 7.5% but \< 9.5% at screen (week -4).
•Patients must have evidence of insulin secretory capacity (fasting C-peptide concentration \> or equal to 0.27 nmol/l during the stabilization period).
•Patients must have FPG \> 130 mg/dl but \< 235 mg/dl prior to (within 48-72 hours) randomization at Visit 1 Week 0.
•Patients must be receiving as their current diabetic therapy stable doses of metformin (at dose of 1.0-2.5gm/day), or metformin extended release at a maximum dose of 2 gm/day and a half maximum to a maximum dose of thiazolidinedione for at least 3 months.
•Patients must be able to understand and willing to adhere to and be compliant with the study protocol.

Exclusion Criteria

•Patients who require insulin therapy or are currently on other sulfonylureas.
•Patients with a history of hypersensitivity to sulfonylureas.
•Patients with past history of severe hypoglycemia reaction on their current antidiabetic therapy requiring medical attention.
•Patients with a history of acute metabolic complications such as hyperosmolar coma or ketonuria.
•Patients with clinically significant abnormal baseline laboratory values (hematology, blood chemistry or urinalysis) which define a disease or condition, which in the opinion of the investigator may either put the patient at risk because of participation in the study, or may influence the results of the study, or the patient's ability to participate and complete the study. Should there be a laboratory value which, upon initial screening, is substantially outside the normal range, the test should be repeated.
•Patients who had an increase in their thiazolidinedione medication within 2 months of entering the study (Visit 0).
•Patients who had an increase in the metformin medication within 1 month of entering the study (Visit 0).
•Patients whose body weight has changed more than 2% for patients \< 250 pounds or 3% for patients \>= 250 pounds, during the 4 week stabilization period when compared to the weight at the screening visit 0 (week - 4).
•Patients with acute infections.
•Patients who have received any drug (i.e. a chemotherapy agent) with a well-defined potential for toxicity to a major organ system during the three months prior to the study.
+6 more criteria

Locations (1)

Dallas Diabetes & Endocrine Center

Dallas, Texas, United States

Key Dates

Start Date

May 1, 2001

Completion Date

September 1, 2002

Last Updated

June 19, 2008

Enrollment

170

ACTUAL participants

Conditions

Diabetes Mellitus, Non-Insulin-Dependent

Interventions

Glimepiride

DRUG

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Diabetes Mellitus, Non-Insulin-DependentHypertriglyceridemia

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: June 19, 2008Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Evaluate the Role of Adding Amaryl to Non-Insulin Dependent Diabetes Mellitus Patients Unresponsive to Maximum Dose Metformin & Thiazolidinedione

Inclusion Criteria

Exclusion Criteria

Technology Intensified Diabetes Education Study in African Americans

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