Trial intelligence / Profile preview

AC2993 (Exenatide) Dose-Response in Type 2 Diabetes

NCT00044694Phase 2

Key facts

Status
Completed
Start
Aug 2002
Primary completion
May 2003
Countries
1
Modality
Peptides
Conditions
type 2 diabetes mellitus (T2DM)
01

Overview

Phase 2, randomised, triple-blind trial of exenatide in type 2 diabetes mellitus (T2DM) (8 arms), sponsored by AstraZeneca. Primary endpoint: Change in HbA1c (glycosylated hemoglobin) at Day 28. Started Aug 2002; status: completed.

02

Design

8 arms
Study design
RandomizedTriple-blind
  • Placebo 0.01 mL

    Placebo 0.01 mL subcutaneously injected twice daily

  • Placebo 0.02 mL

    Placebo 0.02 mL subcutaneously injected twice daily

  • Placebo 0.03 mL

    Placebo 0.03 mL subcutaneously injected twice daily

  • Placebo 0.04 mL

    Placebo 0.04 mL subcutaneously injected twice daily

  • AC2993 2.5 mcg

    AC2993 2.5 mcg (0.01 mL) subcutaneously injected twice daily

  • AC2993 5.0 mcg

    AC2993 5.0 mcg (0.02 mL) subcutaneously injected twice daily

2 more in the full profile.

03

Endpoints

Primary

  • Change in HbA1c (glycosylated hemoglobin)

Secondary

  • Change in HbA1c

  • Change in fasting plasma glucose

  • Change in serum fructosamine

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