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Saxagliptin Treatment in Subjects With Type 2 Diabetes Who Are Not Controlled With Diet and Exercise

AstraZeneca logo

AstraZeneca

Status and phase

Completed
Phase 3

Conditions

Diabetes Mellitus, Type 2

Treatments

Drug: Placebo matching Metformin
Drug: Placebo matching Saxagliptin
Drug: Saxagliptin
Drug: Metformin

Study type

Interventional

Funder types

Industry

Identifiers

NCT00121641
CV181-011

Details and patient eligibility

About

The purpose of this clinical research study is to learn whether saxagliptin (BMS-477118) is more effective than placebo as a treatment for type 2 diabetic subjects who are not sufficiently controlled with diet and exercise

Full 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 will be eligible to enter the long-term treatment extension period where they will receive metformin added onto their blinded study medication. Subjects with screening hemoglobin A1c (A1C) > 10.0% and ≤ 12.0%, who otherwise meet all inclusion/exclusion criteria, were eligible to enroll directly into Open-Label Treatment Cohort (Direct Enrollees) and receive open-label saxagliptin 10 mg. Those who completed the short-term period were eligible to enter into the long-term treatment extension period.Saxagliptin dose titration was not permitted.

Enrollment

1,035 patients

Sex

All

Ages

18 to 77 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Type 2 diabetes mellitus
  • Drug naive
  • Hemoglobin (Hb) A1c >= 7.0% and <= 10.0% (>10% and <= 12% for open label arm)
  • Fasting C-peptide >= 1 ng/mL
  • Body mass index <= 40 kg/m2

Exclusion criteria

  • Symptomatic poorly controlled diabetes
  • Recent cardiac or cerebrovascular event
  • Serum creatinine >= 1.5 mg/dL for males and >= 1.4 mg/dL for Women of Child Bearing Potential

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

1,035 participants in 5 patient groups, including a placebo group

Saxagliptin 2.5 mg (A)
Experimental group
Description:
Metformin 500-2000 mg (as needed for rescue)
Treatment:
Drug: Placebo matching Metformin
Drug: Metformin
Drug: Metformin
Drug: Saxagliptin
Drug: Saxagliptin
Drug: Saxagliptin
Drug: Saxagliptin
Saxagliptin 5 mg (B)
Experimental group
Description:
Metformin 500-2000 mg (as needed for rescue)
Treatment:
Drug: Placebo matching Metformin
Drug: Metformin
Drug: Metformin
Drug: Saxagliptin
Drug: Saxagliptin
Drug: Saxagliptin
Drug: Saxagliptin
Saxagliptin 10 mg (C)
Experimental group
Description:
Metformin 500-2000 mg (as needed for rescue)
Treatment:
Drug: Placebo matching Metformin
Drug: Metformin
Drug: Metformin
Drug: Saxagliptin
Drug: Saxagliptin
Drug: Saxagliptin
Drug: Saxagliptin
Placebo (D)
Placebo Comparator group
Description:
Metformin 500-2000 mg (as needed for rescue)
Treatment:
Drug: Metformin
Drug: Placebo matching Saxagliptin
Drug: Metformin
Open-Label Treatment Cohort (Direct Enrollees) (E)
Experimental group
Description:
Saxagliptin 10 mg Metformin 500-2000 mg (as needed for rescue)
Treatment:
Drug: Metformin
Drug: Metformin
Drug: Saxagliptin
Drug: Saxagliptin
Drug: Saxagliptin
Drug: Saxagliptin

Trial contacts and locations

135

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Data sourced from clinicaltrials.gov

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