Loading clinical trials...

Study To Evaluate 24 Hour Blood Sugar Control (24-hour Mean Weighted Glucose) In Subjects That Are Taking Saxagliptin 5 mg Added Onto Metformin XR 1500 XR mg Compared To Subjects Taking Metformin XR 1500 mg Up-titrated To Metformin XR 2000 mg | Clinical Trials | Clareo Health

COMPLETEDPHASE3

Study To Evaluate 24 Hour Blood Sugar Control (24-hour Mean Weighted Glucose) In Subjects That Are Taking Saxagliptin 5 mg Added Onto Metformin XR 1500 XR mg Compared To Subjects Taking Metformin XR 1500 mg Up-titrated To Metformin XR 2000 mg

A 4-Week, Multicenter, Randomized, Double-Blind, Phase 3b Trial to Evaluate the Efficacy of Saxagliptin in Combination With Metformin XR 1500 mg Versus Up-titrated Metformin XR to 2000 mg in Subjects With Type 2 Diabetes Who Have Inadequate Glycemic Control With Diet and Exercise and a Stable Dose of Metformin XR 1500 mg

NCT00918138•AstraZeneca

View on ClinicalTrials.gov

Summary

The purpose of this study was to compare effect of Saxagliptin as add-on to Metformin on 24-hour mean weighted glucose (MWG) to the effect of uptitrating Metformin in subjects with T2DM inadequately controlled on metformin alone.

Eligibility

Age

18 - 78 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Type 2 diabetes
•18-78 years of age
•Taking stable dose of metformin immediate release (IR) or XR ≥850 mg and ≤1500 mg as monotherapy for at least 8 weeks prior to screening
•Glycosylated hemoglobin A1C (A1C) 7.5-11.5% at screening
•Fasting C-peptide: ≥1.0 ng/mL
•FPG≥126 mg/dl obtained at the Day -7 visit
•Body mass index (BMI): ≤ 40kg/m²
•A1C ≥ 7.0% and ≤ 11.0% obtained at the Day -7 visit for randomization

Exclusion Criteria

•Women of childbearing potential unable or unwilling to use acceptable birth control
•Women who are pregnant or breastfeeding
•Significant cardiovascular history
•Active liver disease
•Renal impairment

Locations (21)

Dedicated Phase I, Inc.

Phoenix, Arizona, United States

Pacific Sleep Medicine Services (Avastra Clinical Trials)

Redlands, California, United States

Orange County Research Center

Tustin, California, United States

Clinical Research Of South Florida

Coral Gables, Florida, United States

Palm Springs Research Institute

Hialeah, Florida, United States

Healthcare Clinical Data, Inc.

North Miami, Florida, United States

River Birch Research Alliance, Llc

Blue Ridge, Georgia, United States

Jasper Clinic, Inc.

Kalamazoo, Michigan, United States

Clinilabs, Inc.

New York, New York, United States

Medpace Clinical Pharmacology Unit

Cincinnati, Ohio, United States

Key Dates

Start Date

August 1, 2009

Primary Completion Date

May 1, 2010

Completion Date

May 1, 2010

Last Updated

May 21, 2015

Enrollment

219

ACTUAL participants

Conditions

Type 2 Diabetes

Interventions

Saxagliptin

DRUG

Metformin XR

DRUG

Placebo matching Metformin XR

DRUG

Metformin XR

DRUG

Placebo matching Saxagliptin

DRUG

Feasibility of a Tailored Online Self-compassion Intervention

NCT07051005

Type 1 Diabetes MellitusType 2 Diabetes Mellitus (T2DM)

View study

RECRUITINGPHASE2

Trial Against INtractable Type 2 Diabetes (CAPTAIN-T2D)

NCT07296484

Type 2 DiabetesCortisol Excess

View study

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: May 21, 2015Data 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.

View ClinicalTrials.gov Terms and Conditions

Study To Evaluate 24 Hour Blood Sugar Control (24-hour Mean Weighted Glucose) In Subjects That Are Taking Saxagliptin 5 mg Added Onto Metformin XR 1500 XR mg Compared To Subjects Taking Metformin XR 1500 mg Up-titrated To Metformin XR 2000 mg

Inclusion Criteria

Exclusion Criteria

Feasibility of a Tailored Online Self-compassion Intervention

Trial Against INtractable Type 2 Diabetes (CAPTAIN-T2D)

iGlarLixi CGM Study in Chinese T2D Individuals After OADs

High Intensity Interval Training and Insulin Sensitivity in Type 2 Diabetes

Closed-loop in Adults With Type 2 Diabetes

SGLT2i, Pioglitazone, and Ketone Production in T2D