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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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11 February 2013 |
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Main ID: |
NCT00044694 |
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Date of registration:
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03/09/2002 |
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Primary sponsor: |
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Public title:
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Evaluation of the Effect on Glucose Control and the Safety and Tolerability of AC2993 in Patients With Type 2 Diabetes Mellitus
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Scientific title:
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A Phase 2, Randomized, Triple-Blind, Placebo-Controlled, Short-Term, Dose-Response Study to Examine the Effect on Glucose Control and Safety and Tolerability of AC2993 Given Two Times a Day in Subjects With Type 2 Diabetes Mellitus |
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Date of first enrolment:
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August 2002 |
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Target sample size:
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156 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00044694 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
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Countries of recruitment
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United States
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Subjects with type 2 diabetes
- Treated with diet and exercise alone or with metformin for at least 3 months prior to
screening
- BMI 27-45 kg/m^2
- HbA1c between 7.0 % and 8.0 %
Exclusion Criteria:
- Treated with other oral anti-diabetic agents other than metformin within 3 months of
screening
- Patients previously treated with AC2993
- Patients presently treated with insulin
Age minimum:
18 Years
Age maximum:
65 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Diabetes Mellitus, Non-Insulin-Dependent
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Intervention(s)
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Drug: AC2993 10.0 mcg
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Drug: AC2993 2.5 mcg
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Drug: AC2993 5.0 mcg
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Drug: AC2993 7.5 mcg
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Drug: Placebo 0.01 mL
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Drug: Placebo 0.02 mL
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Drug: Placebo 0.03 mL
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Drug: Placebo 0.04 mL
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Primary Outcome(s)
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Change in HbA1c (glycosylated hemoglobin) from Baseline to Day 28
[Time Frame: Baseline (Day 1) to Day 28]
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Secondary Outcome(s)
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Change in fasting plasma glucose from Baseline to Day 14 and to Day 28
[Time Frame: Baseline, Day 14, Day28]
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Change in HbA1c from Baseline to Day 14
[Time Frame: Baseline, Day 14]
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Change in serum fructosamine from Baseline (Day 1) to Day 14 and to Day 28
[Time Frame: Baseline, Day 14, Day 28]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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