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OMNEON-026

A PHASE III, MULTICENTER, DOUBLE-BLIND, RANDOMIZED STUDY TO EVALUATE THE SAFETY AND EFFICACY OF THE ADDITION OF SITAGLIPTIN IN SUBJECTS WITH TYPE 2 DIABETES MELLITUS WITH INADEQUATE GLYCEMIC CONTROL ON METFORMIN

Status
Unknown
Phases
Unknown
Study type
Interventional
Source
REPEC
Registry ID
PER-048-13
Enrollment
48
Registered
2013-11-12
Start date
2013-12-01
Completion date
Unknown
Last updated
2023-09-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

At Visit 2/Week -2, subjects with T2DM &#8805
18 years old, on a stable dose (for at least 12 weeks before Visit 1/Screening) of metformin &#8805
1500 mg/day, with inadequate glycemic control (hemoglobin A1c [A1C] &#8805
6.5% [48mmol/mol] to &#8804
9.0% [75 mmol/mol]) and who meet all other enrollment criteria, will enter the 2-week, single-blind, placebo run-in period. At Visit 3/Day 1, subjects who meet all enrollment criteria will enter th

Sponsors

Merck Sharp & Dohme Corp., una subsidiaria de Mer·ck & Co. Inc.,
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Have T2DM and be ≥18 years of age on the day of signing the informed consent form. Be currently taking a stable dose of metformin (≥1500 mg/day) for ≥12 weeks and have an A1C ≥6.5% (48 mmol/mol) and ≤9.0% (75 mmol/mol). Meet one of the following criteria: a. Subject is a male. b. Subject is a female not of reproductive potential or Subject is a female of reproductive potential and agrees to remain abstinent from heterosexual activity OR agrees to use (or have their partner use) acceptable contraception to prevent pregnancy within the projected duration of the trial and for 21 days after the last dose of blinded study medication. Understand the trial procedures, alternative treatments available, and risks involved with the trial, and voluntarily agrees to participate by giving written informed consent. The subject may also provide consent for Future Biomedical Research. However, the subject may participate in the main trial without participating in Future Biomedical Research. At Visit 3/Randomization/Day 1 Must be 100% compliant with MK-3102 placebo treatment and 85% compliant with sitagliptin placebo treatment during the single-blind run-in period (as determined by site-performed capsule/tablet count).

Exclusion criteria

Exclusion criteria: -

Countries

Argentina, Canada, Croatia, Georgia, Hungary, Israel, Malasya, Peru, Philippines, Poland, Romania, South Africa, United States

Contacts

Public ContactYngrid Saldariaga

PAREXEL INTERNATIONAL (PERU) S.A.

yngrid.saldarriaga@parexel.com712-8447

Outcome results

None listed

Source: REPEC (via WHO ICTRP)