An observational study in Diabetes Mellitus, Type 2, sponsored by AstraZeneca. Completed at 1 site in South Korea. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-08-08.
Sponsored by AstraZeneca · Observational
The purpose of this post-marketing surveillance is to investigate and confirm the type and incidence of newly identified adverse events and any other factors affecting safety and efficacy of Kombiglyze Extended release (XR) so that the regulatory authority can manage the marketing approval properly
9,590 studies on the registry are indexed under Diabetes Mellitus, Type 2; 1,332 are open to participants now.
This study's enrollment of 755 is above the median of 300 across 1,622 observational studies indexed under Diabetes Mellitus, Type 2.
Browse Diabetes Mellitus, Type 2 studies →AstraZeneca is the lead sponsor of 3,492 studies on the registry; 265 are open to participants now.
Of its 368 completed or terminated interventional studies of FDA-regulated products, 176 (48%) have results posted.
Counted across the registry records on this site, refreshed daily.
Patients with diagnosis of type 2 diabetes mellitus initiating Kombiglyze XR treatment within the approved indications will be enrolled
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com.
Inclusion Criteria:
Exclusion Criteria:
Patients with diagnosis of type 2 diabetes mellitus initiating Kombiglyze XR treatment within the approved indications will be enrolled
Occurrence of known and unexpected adverse events, especially serious adverse events
Time frame: 30 days after last dose of study drug (Approximately up to 4.5 years)
Incidence of adverse events under the routine drug use
Time frame: 30 days after last dose of study drug (Approximately up to 4.5 years)
Effectiveness of Kombiglyze XR as assessed by change from baseline in Hemoglobin A1c (HbA1c), Fasting plasma glucose (FPG), and 2-hour post-prandial glucose (2-hr PPG)
Time frame: Baseline and Week 12
Effectiveness of Kombiglyze XR as assessed by change from baseline in Hemoglobin A1c (HbA1c), Fasting plasma glucose (FPG), and 2-hour post-prandial glucose (2-hr PPG)
Time frame: Baseline and Week 24 (for patients that have a post Week 12 follow-up visit)
Safety information related to factors (eg, gender, demographics etc) that may affect the safety of the drug based on incidence rates of AEs
Adverse events (AEs)
Time frame: Approximately up to 4.5 years
Safety information related to factors (eg, gender, demographics etc) that may affect the effectiveness of the drug based on incidence rates of AEs
Time frame: Approximately up to 4.5 years
Safety information related to overdose, drug-to-drug interaction and laboratory abnormalities based on incidence rates of AEs
Time frame: Approximately up to 4.5 years
Ran from Nov 2012 to primary completion in Sep 2016, 45 months.
Of 164 industry-sponsored observational studies under Diabetes Mellitus, Type 2, half reached primary completion within 25 months of starting (the median), counting those still running; a quarter within 16 and three quarters within 44. This study's 45 months is above that.
Counting every sponsor, half of 562 studies reached it within 31 months; a quarter within 17 and three quarters within 60.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Aug 2017. You cannot join it, but the record below documents what was studied.
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