Trial · Interventional
CompletedPhase 3Registry dataUnited States
1 trial · 1 completed
Evaluation of the Effect on Glucose Control of AC2993 in Patients With Type 2 Diabetes Mellitus
NCT00035984May 2002 to Aug 2003
Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.
This is a multicenter, randomized, blinded, placebo-controlled study to assess the effects on glucose control of AC2993 as compared to placebo in patients with type 2 diabetes. Patients will be randomized into one of two AC2993 treatment arms or to placebo treatment and will continue with their required existing diabetes medications (metformin and a sulfonylurea) throughout the study.
Experimental
AC2993 5 mcg (0.02 mL)
Placebo, then AC2993 5 mcg, then AC2993 5 mcg
Experimental
AC2993 10mcg (0.04 mL)
Placebo, then AC2993 5 mcg, then AC2993 10 mcg
Placebo comparator
Placebo 0.02 mL
Placebo 0.02 mL, then Placebo 0.02 mL, then Placebo 0.02 mL
Placebo comparator
Placebo 0.04 mL
Placebo 0.02 mL, then Placebo 0.02 mL, then Placebo 0.04 mL
Outcomes the sponsor listed as primary.
Change in HbA1c from Baseline to Week 30
Time frame · Baseline (Day 1) to Week 30
Change in HbA1c from Baseline (Day 1) to study termination (Week 30)
Change in HbA1c from baseline (Day 1) to each of the intermediate visits
Time frame · Baseline (Day 1), Week 2, Week 4, Week 6, Week 12, Week 18, Week 24
Change in HbA1c from baseline, measured from Visit 3 (Day 1) to each of the intermediate visits (Baseline (Day 1), Week 2, Week 4, Week 6, Week 12, Week 18, and Week 24)
The number of subjects achieving HbA1c target values of < 7% and < 8% by Week 30
Time frame · Baseline (Day 1) and Week 30
The number of subjects achieving HbA1c target values of \< 7% and \< 8% by study termination (Week 30)
The number of subjects achieving HbA1c reductions of > 0.5% and > 1.0% by Week 30
Time frame · Baseline (Day 1), and Week 30
The number of subjects achieving HbA1c reductions of \> 0.5% and \> 1.0% by study termination (Week 30)
The time to achieve specific HbA1c target values of < 7% and < 8%
Time frame · Baseline (Day 1), Week 2, Week 4, Week 6, Week 12, Week 18, Week 24, Week 30
The time it takes subjects to achieve HbA1c target values of \< 7% and \< 8%
The time to achieve HbA1c reductions of 0.5% or more and >1.0% or more
Time frame · Baseline (Day 1), Week 2, Week 4, Week 6, Week 12, Week 18, Week 24, Week 30
The time it takes subjects to achieve HbA1c reductions of 0.5% or more and \>1.0% or more
Change in body weight from Baseline to each intermediate visit and Week 30
Time frame · Baseline (Day 1), Week 2, Week 4, Week, 6, Week 12, Week 18, Week 24, Week 30
Change in body weight (kg) from Baseline to each intermediate visit and Week 30
Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.
No results are posted for this trial.
Completed trials do not always post results.
Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works
Studies that cite this trial.
3 studies on this page
PubMed tag: none · 2012
Fineman et al. 2012Diabetes, obesity & metabolismcited by 117
PMID 22236356DOI 10.1111/j.1463-1326.2012.01561.xPUB-22236356
PubMed tag: none · 2012
Pencek et al. 2012Postgraduate medicinecited by 45
PMID 22913891DOI 10.3810/pgm.2012.07.2567PUB-22913891
Indexing hint: Randomized controlled trial · 2005
Kendall et al. 2005Diabetes carecited by 835
PMID 15855571DOI 10.2337/diacare.28.5.1083PUB-15855571
Who could join, as posted.
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