Study of Multiple Doses of Saxagliptin (BMS-477118)

AstraZeneca

Status and phase

Completed

Phase 2

Conditions

Type 2 Diabetes Mellitus

Treatments

Drug: Saxagliptin

Drug: Placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT00950599

CV181-008

Details and patient eligibility

About

To evaluate the positive efficacy trend among doses of saxagliptin (BMS-477118) in subjects with Type 2 diabetes mellitus by assessing the change from baseline in HbA1c following 12 weeks of double-blind treatment.

Enrollment

423 patients

Sex

All

Ages

21 to 70 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Type 2 diabetes who are drug-naive
Screening HbA1c ≥ 6.8% and ≤ 9.7%
Screening fasting or random C-peptide > 0.5 ng/mL
< 35 years old must be negative for anti-GAD antibodies
Body Mass Index < 35 kg/m2

Exclusion criteria

Symptoms of poorly controlled diabetes
History of diabetic ketoacidosis, hyperosmolar nonketotic coma, or insulin therapy within one year of screening
Receipt of oral antihyperglycemic medications for more than six months in total since diagnosis
Significant cardiovascular history

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

423 participants in 7 patient groups, including a placebo group

Saxagliptin (2.5 mg)

Experimental group

Treatment:

Drug: Saxagliptin

Saxagliptin (5 mg)

Experimental group

Treatment:

Drug: Saxagliptin

Saxagliptin (10 mg)

Experimental group

Treatment:

Drug: Saxagliptin

Saxagliptin (20 mg)

Experimental group

Treatment:

Drug: Saxagliptin

Saxagliptin (40 mg)

Experimental group

Treatment:

Drug: Saxagliptin

Saxagliptin (100 mg)

Experimental group

Treatment:

Drug: Saxagliptin

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo

Trial contacts and locations

0

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