Study S002301

A Phase 3, Randomized, Triple-Blind, Parallel-Group, Long-Term, Placebo-Controlled, Multicenter Study to Examine the Effect on Glucose Control (HbA1c) of AC2993 Given Two Times a Day in Subjects With Type 2 Diabetes Mellitus Treated With Metformin Alone

ClinicalTrials.gov record

Registration

Registration: NCT00039013
Study type: INTERVENTIONAL
Allocation: RANDOMIZED
Phase: PHASE3
Masking: DOUBLE
Status: COMPLETED
Enrollment: 336
Start: 2002-03
Primary completion: 2003-06
Lead sponsor: AstraZeneca
Conditions: Diabetes Mellitus, Type 2
Interventions: DRUG:AC2993; DRUG:Placebo
Results posted: FALSE

Registered primary outcomes

Change in HbA1c (glycosylated hemoglobin) from baseline to study termination (Week 30) [Baseline (Day 1), Week 30]

Linked records (4)

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
R0018919	Exenatide twice daily: analysis of effectiveness and safety data stratified by age, sex, race, duration of diabetes, and body mass index. Pencek R, Postgraduate medicine	2012	Randomized trial	PMID 22913891 DOI	cites ClinicalTrials.gov:NCT00039013; registry reference DERIVED:22913891
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:NCT00039013; registry reference DERIVED:22236356
R0025778	Long-term effects of exenatide therapy over 82 weeks on glycaemic control and weight in over-weight metformin-treated patients with type 2 diabetes mellitus. Ratner RE, Diabetes, obesity & metabolism	2006	Randomized trial	PMID 16776749 DOI	registry reference RESULT:16776749
R0022664	Effects of exenatide (exendin-4) on glycemic control and weight over 30 weeks in metformin-treated patients with type 2 diabetes. DeFronzo RA, Diabetes care	2005	Randomized trial	PMID 15855572 DOI	registry reference RESULT:15855572