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Safety and Efficacy of Saxagliptin Plus Insulin With or Without Metformin | Clinical Trials | Clareo Health

COMPLETEDPHASE3

Safety and Efficacy of Saxagliptin Plus Insulin With or Without Metformin

A Multicenter, Randomized, Double-Blind, Phase 3 Trial to Evaluate the Efficacy and Safety of Saxagliptin Added to Insulin Monotherapy or to Insulin in Combination With Metformin in Subjects With Type 2 Diabetes Who Have Inadequate Glycemic Control on Insulin Alone or on Insulin in Combination With Metformin

NCT00757588•AstraZeneca

View on ClinicalTrials.gov

Summary

The purpose of this study is to compare the effects of saxagliptin with those of placebo as add-on therapy to insulin and insulin with metformin in improving glycemic control at 24 and 52 weeks.

Eligibility

Age

18 - 78 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Type 2 diabetes mellitus
•Must have been taking a stable dose of basal or premixed insulin for 8 weeks or longer prior to screening
•If taking metformin, must have been taking the same daily dose for 8 weeks or longer prior to screening
•Insulin type should be intermediate- or long-acting (basal) or premixed (premixed formulation may include short- or rapid-acting insulin as 1 component).
•Inadequate glycemic control (A1C of 7.5% to 11.0%, inclusive)
•Body mass index of 45 kg/m² or lower
•Fasting C-peptide level of 0.8 ng/mL or higher

Exclusion Criteria

•Symptoms of poorly controlled diabetes, including but not limited to marked polyuria and polydipsia with greater than 10% weight loss during the last 3 months prior to screening or other signs and symptoms
•History of diabetic ketoacidosis or hyperosmolar nonketotic coma
•Women of childbearing potential unable or unwilling to use acceptable birth control
•Women who are pregnant or breastfeeding
•Active liver disease
•Anemia
•Chronic or repeated intermittent corticosteroid treatment (participants receiving stable doses of replacement corticosteroid (except dexamethasone) therapy may be enrolled)
•Use of short- or rapid-acting insulin
•Significant cardiovascular history defined as: myocardial infarction, coronary angioplasty or bypass graft, valvular disease or repair, unstable angina pectoris, transient ischemic attack, or cerebrovascular accident
•Congestive heart failure
+5 more criteria

Locations (80)

Clinical Research Advantage, Inc

Tempe, Arizona, United States

Valley Research

Fresno, California, United States

Torrance-Lomita Medical Center

Lomita, California, United States

Diabetes Medical Center Of California

Northridge, California, United States

Ritchken & First M.D.'S

San Diego, California, United States

Encompass Clinical Research

Spring Valley, California, United States

Central Florida Clinical Trials, Inc.

Altamonte Springs, Florida, United States

Family Care Associates Of Nw Florida

Chipley, Florida, United States

Panhandle Family Care Assoc. & Coastal Palms Res. Grp Inc.

Marianna, Florida, United States

Endocrine Research Solutions, Inc.

Roswell, Georgia, United States

Key Dates

Start Date

November 1, 2008

Primary Completion Date

April 1, 2010

Completion Date

April 1, 2010

Last Updated

June 1, 2015

Enrollment

455

ACTUAL participants

Conditions

Type 2 Diabetes

Interventions

Saxagliptin, 5 mg + insulin

DRUG

Placebo + insulin

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

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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 1, 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.

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Safety and Efficacy of Saxagliptin Plus Insulin With or Without Metformin

Inclusion Criteria

Exclusion Criteria

Feasibility of a Tailored Online Self-compassion Intervention

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