Study of BMS-477118 as Monotherapy With Titration in Subjects With Type 2 Diabetes Who Are Not Controlled With Diet and Exercise

Conditions

• Diabetes

Eligibility Criteria

Sex

ALL

Age

18 Years - 77 Years

Healthy Volunteers

Not accepted

Interventions

• Saxagliptin — DRUG
  Coated tablets, Oral, 2.5 mg, QAM, Daily (6 months ST, 12 months LT)
• Saxagliptin — DRUG
  Coated tablets, Oral, 2.5 mg titrated to 5mg, QAM, Daily (6 months ST, 12 months LT)
• Saxagliptin — DRUG
  Coated tablets, Oral, 5mg, QAM, Daily, (6 months ST, 12 months LT)
• Saxagliptin — DRUG
  Coated tablets, Oral, 5mg QPM, Daily (6 months ST, 12 months LT)
• Placebo — DRUG
  Coated tablets, Oral, 0mg, Daily (6 months ST, 12 months LT)
• metformin — DRUG
  Tablets, Oral, 500-2000 mg, as needed (12 months LT)

Study Details

The purpose of this trial is to understand if saxagliptin is more effective than placebo as a treatment for type 2 diabetic subjects who are not controlled with diet and exercise

Key Dates

First listed

Apr 20, 2006

Start date

Jun 30, 2006

Status verified

Mar 2015

Primary completion

Nov 30, 2007

Completion

Nov 30, 2008

Study Design

Enrollment

365 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Saxagliptin 2.5 mg QAM (A)
  PLUS open-label metformin (as needed as rescue medication)
• Experimental: Saxagliptin 2.5 mg titrated to 5 mg QAM (B)
  PLUS open-label metformin (as needed as rescue medication)
• Experimental: Saxagliptin 5 mg QAM (C)
  PLUS open-label metformin (as needed as rescue medication)
• Experimental: Saxagliptin 5 mg QPM (D)
  PLUS open-label metformin (as needed as rescue medication)
• Placebo Comparator: Placebo (E)
  PLUS open-label metformin (as needed as rescue medication)

Primary Outcome Measure

Change From Baseline in Hemoglobin A1 (A1C) at Week 24 [ Time Frame: Baseline, Week 24 ]

Locations (51)

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