Study S000713

An Open-Label Study to Examine the Long-Term Effect on Glucose Control (HbA1c) and Safety of AC2993 Given Two Times a Day to Subjects With Type 2 Diabetes Treated With Metformin, a Sulfonylurea, or Metformin and Sulfonylurea Combination

ClinicalTrials.gov record

Registration

Registration: NCT00044668
Study type: INTERVENTIONAL
Allocation: NON_RANDOMIZED
Phase: PHASE3
Masking: NONE
Status: COMPLETED
Enrollment: 155
Start: 2002-08
Primary completion: 2005-09
Lead sponsor: AstraZeneca
Conditions: Diabetes Mellitus, Type 2
Interventions: DRUG:AC2993
Results posted: FALSE

Registered primary outcomes

Change in HbA1c (glycosylated hemoglobin) from Baseline to Week 24, Week 52, and to each intermediate visit [Baseline, and Weeks 1, 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52]
Change in concentrations of fasting plasma glucose and lipids from Baseline Visit 2 (Day 1) to Week 24, to Week 52, and to each intermediate visit [Baseline, and Weeks 1, 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52]

Linked records (2)

Automatic links, confirmed or rejected during screening. A record citing this registration may be a secondary analysis, a commentary or a review that mentions the trial.

Record	Title	Year	Design	Identifiers	Link basis
R0018514	Long-term effects of adding exenatide to a regimen of metformin and/or sulfonylurea in type 2 diabetes: an uncontrolled, open-label trial in Hungary. Iványi T, Clinical therapeutics	2012	Other trial	PMID 22608106 DOI	cites ClinicalTrials.gov:NCT00044668; registry reference DERIVED:22608106
R0026474	Clinical relevance of anti-exenatide antibodies: safety, efficacy and cross-reactivity with long-term treatment. Fineman MS, Diabetes, obesity & metabolism	2012	Other	PMID 22236356 DOI	cites ClinicalTrials.gov:NCT00044668; registry reference DERIVED:22236356