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Biguanide

Saxagliptin plus metformin IR for Type 2 Diabetes

Phase 3
Waitlist Available
Research Sponsored by AstraZeneca
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 1 to week 12; aes are included up to the last treatment day + 1 day or the last visit in the db period. saes are included up to the last of 1) the last treatment day + 30 days or 2) the last visit day + 30 days in the db period.
Awards & highlights
Approved for 20 Other Conditions
All Individual Drugs Already Approved
Pivotal Trial

Summary

The purpose of this study is to compare the reduction in hemoglobin A1C (A1C) for participants taking saxagliptin in combination with metformin immediate release (IR) versus metformin IR alone.

Eligible Conditions
  • Type 2 Diabetes

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 1 to week 12; aes are included up to the last treatment day + 1 day or the last visit in the double-blind (db) period. saes are included up to the last of 1) the last treatment day + 30 days or 2) the last visit day + 30 days in the db period.
This trial's timeline: 3 weeks for screening, Varies for treatment, and week 1 to week 12; aes are included up to the last treatment day + 1 day or the last visit in the double-blind (db) period. saes are included up to the last of 1) the last treatment day + 30 days or 2) the last visit day + 30 days in the db period. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Mean Hemoglobin A1C (A1c) and Change From Baseline to Week 12
Secondary study objectives
Mean Baseline and Change From Baseline in Fasting Plasma Glucose (FPG)
Percentage of Participants Achieving a Therapeutic Glycemic Response (A1C < 7.0%) at Week 12
Percentage of Participants Achieving a Therapeutic Glycemic Response (A1C <= 6.5%) at Week 12
Other study objectives
Baseline and Mean Change From Baseline in Participant Heart Rate (HR)
Baseline and Mean Change From Baseline in Participant Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
Participant Adverse Event (AE), Related AE, Serious Adverse Event (SAE), Related SAE, and Discontinued Due to AEs Summary
+5 more

Awards & Highlights

Approved for 20 Other Conditions
This treatment demonstrated efficacy for 20 other conditions.
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups
Active Control
Placebo Group
Group I: Saxagliptin plus metformin IRActive Control1 Intervention
Group II: Placebo plus metformin IRPlacebo Group1 Intervention

Find a Location

Who is running the clinical trial?

AstraZenecaLead Sponsor
4,378 Previous Clinical Trials
288,738,752 Total Patients Enrolled
Bristol-Myers SquibbStudy DirectorBristol-Myers Squibb
1,565 Previous Clinical Trials
3,383,829 Total Patients Enrolled
~10 spots leftby Oct 2025
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