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

AstraZeneca17 sites in 2 countries455 target enrollmentNovember 2008

ConditionsType 2 Diabetes

InterventionsSaxagliptin, 5 mg + insulin Placebo + insulin

DrugsSaxagliptin, 5 mg + insulin Placebo + insulin

Overview

Phase: Phase 3
Intervention: Saxagliptin, 5 mg + insulin
Conditions: Type 2 Diabetes
Sponsor: AstraZeneca
Enrollment: 455
Locations: 17
Primary Endpoint: Adjusted Mean Change From Baseline in A1C Levels (Last Observation Carried Forward [LOCF])
Status: Completed
Last Updated: 10 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief 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.

Registry

clinicaltrials.gov

Start Date

November 2008

End Date

April 2010

Last Updated

10 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

AstraZeneca

Responsible Party

Sponsor

Eligibility Criteria

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
•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
•Unstable or rapidly progressing renal disease

Arms & Interventions

Saxagliptin, 5 mg + insulin

Saxagliptin, 5 mg, plus insulin, administered to participants with Type 2 diabetes inadequately controlled with insulin alone or with insulin plus metformin

Intervention: Saxagliptin, 5 mg + insulin

Placebo + insulin

Placebo administered to participants with Type 2 diabetes inadequately controlled with insulin alone or with insulin plus metformin

Intervention: Placebo + insulin

Outcomes

Primary Outcomes

Adjusted Mean Change From Baseline in A1C Levels (Last Observation Carried Forward [LOCF])

Time Frame: Baseline to Week 24

Change from baseline: post-pre. Adjusted for baseline (value and metformin use). ANCOVA model: difference between week t and baseline values=baseline values + treatment + metformin use

Secondary Outcomes

Change From Baseline in Mean Total Daily Dose of Insulin (MTDDI) (LOCF)(Baseline to Week 24)
Change From Baseline in Postprandial Glucose (PPG) Area Under the Curve (AUC) Response to an Meal Tolerance Test (MTT)(Baseline to Week 24)
Change From Baseline in 120-minute PPG Values During an MTT(Baseline to Week 24)
Change From Baseline in Fasting Plasma Glucose Values(Baseline to Week 24)
Percentage of Participants Achieving a Therapeutic Glycemic Response(Baseline to Week 24)