Phase 3 Completed N=744 Randomized Double-blind Treatment

Safety and Efficacy of Co-Administration of Sitagliptin and Metformin in China (MK-0431-121)

Type 2 Diabetes Mellitus

Source: ClinicalTrials.gov NCT01076088 ↗

Enrolled (actual)

744

Serious AEs

0.8%

Results posted

Feb 2014

Primary outcomePrimary: Change From Baseline in Hemoglobin A1C (A1C) at Week 24 — -1.67; -1.83; -1.29; -1.56 Percent of glycosylated hemoglobin — p=0.087

Summary

This study will assess the efficacy and safety of initial treatment with sitagliptin and metformin in patients with type 2 diabetes mellitus in China. The primary hypothesis is that after 24 weeks, initial co-administration treatment with sitagliptin and metformin provided greater reduction in hemoglobin A1C (A1C) compared to initial treatment with sitagliptin alone and with metformin alone.

Outcome Measures

Outcome	Result	p-value
PRIMARY Change From Baseline in Hemoglobin A1C (A1C) at Week 24	-1.67; -1.83; -1.29; -1.56; -0.99; -0.59	0.087
SECONDARY Change From Baseline in 2-hour Post Meal Glucose (2-h PMG) at Week 24	-97.05; -109.46; -65.67; -90.93; -48.11; -21.88	0.017 sig
SECONDARY Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24	-39.38; -47.74; -33.66; -39.63; -21.86; -11.93	0.069

Eligibility Criteria

Inclusion Criteria

has type 2 diabetes mellitus
is male, a female who cannot have children, or a female who agrees to use birth control during the study
is not on an antihyperglycemic agent (AHA) (hemoglobin A1c [A1C] 7.5-11.0%) or on oral single AHA (A1C 7.0-10.5%) or low-dose AHA combination therapy (A1C 7.0-10.0%)

Exclusion Criteria

Patient has type 1 diabetes mellitus or ketoacidosis
Patient is taking a dipeptidyl peptidase-4 (DPP-4) inhibitor (such as sitagliptin)
Patient is on a weight loss program not in the maintenance phase or on a weight loss medication
Patient has a history of liver disease, heart failure, heart disease, stroke, high blood pressure, blood disorders, or cancer
Patient is HIV positive
Patient is pregnant

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01076088). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.