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A Study of Saxagliptin in Subjects With Type 2 Diabetes Who Have Inadequate Blood Sugar Control With Sulfonylureas

2014-08-27 03:45:16 | BioPortfolio

Summary

The purpose of this trial is to understand if adding saxagliptin to a sulfonylurea is safe and works better than increasing the amount of sulfonylurea a patient takes

Description

All subjects will participate in a lead-in period, and qualifying subjects will continue into a short-term randomized treatment period. Subjects who complete the short-term period will be eligible to enter the long term extension period. Also, subjects in the short-term period who have an elevated blood sugar that requires additional medication for blood sugar control (defined as rescue) will be eligible to enter the long-term treatment extension period where they will receive metformin.Rescue treatment with metformin is also available during the long-term extension period for subjects who meet glycemic criteria.

Study Design

Allocation: Randomized, Control: Dose Comparison, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Conditions

Diabetes

Intervention

Saxagliptin, Saxagliptin, Glyburide, Placebo, Glyburide, Metformin

Location

Reserach Solutions, Llc
Jonesboro
Arkansas
United States
72401

Status

Completed

Source

Bristol-Myers Squibb

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:45:16-0400

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PubMed Articles [4808 Associated PubMed Articles listed on BioPortfolio]

Saxagliptin add-on therapy in Chinese patients with type 2 diabetes inadequately controlled by insulin with or without metformin: results from the SUPER study, a randomized, double-blind, placebo-controlled trial.

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Efficacy and Safety of Saxagliptin in Combination with Metformin as Initial Therapy in Chinese Patients with Type 2 diabetes: Results from the START Study, a Multicenter, Randomized, Double-blind, Active-controlled, Phase 3 Trial.

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Medical and Biotech [MESH] Definitions

An antidiabetic sulfonylurea derivative with actions similar to those of chlorpropamide.

A biguanide hypoglycemic agent used in the treatment of non-insulin-dependent diabetes mellitus not responding to dietary modification. Metformin improves glycemic control by improving insulin sensitivity and decreasing intestinal absorption of glucose. (From Martindale, The Extra Pharmacopoeia, 30th ed, p289)

A pharmaceutical preparation of sitagliptin phosphate and metformin hydrochloride that is used in the treatment of TYPE 2 DIABETES.

An analog of GLUCAGON-LIKE PEPTIDE 1 and agonist of the GLUCAGON-LIKE PEPTIDE 1 RECEPTOR that is used as a HYPOGLYCEMIC AGENT and supplemental therapy in the treatment of DIABETES MELLITUS by patients who do not respond to METFORMIN.

Urination of a large volume of urine with an increase in urinary frequency, commonly seen in diabetes (DIABETES MELLITUS; DIABETES INSIPIDUS).

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