Study S000790

Effect of Exenatide Plus Metformin vs. Premixed Human Insulin Aspart Plus Metformin on Glycemic Control and Hypoglycemia in Patients With Inadequate Control of Type 2 Diabetes on Oral Antidiabetic Treatment

Included trial: extracted data ClinicalTrials.gov record

Registration

Registration: NCT00434954
Study type: INTERVENTIONAL
Allocation: RANDOMIZED
Phase: PHASE3
Masking: NONE
Status: COMPLETED
Enrollment: 494
Start: 2007-02
Primary completion: 2009-06
Lead sponsor: AstraZeneca
Conditions: Type 2 Diabetes Mellitus
Interventions: DRUG:exenatide twice daily (BID); DRUG:premixed insulin aspart twice daily (BID)
Results posted: TRUE

Registered primary outcomes

Change in Glycosylated Hemoglobin (HbA1c) [Baseline and 26 weeks]
Incidence of Hypoglycemia (Percentage of Participants With at Least One Hypoglycemic Episode) [26 weeks]

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
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:NCT00434954; registry reference DERIVED:22913891
R0027127	Exenatide twice daily versus premixed insulin aspart 70/30 in metformin-treated patients with type 2 diabetes: a randomized 26-week study on glycemic control and hypoglycemia. Gallwitz B, Diabetes care	2011	Randomized trial	PMID 21285388 DOI	cites ClinicalTrials.gov:NCT00434954; registry reference DERIVED:21285388