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Not yet recruitingPhase 4

Real-World Evaluation of Omarigliptin for Type 2 Diabetes Meliitus in Bangladesh

Efficacy and Safety of Omarigliptin, A Weekly Dipeptidyl Peptidase-4 Inhibitor for Type 2 Diabetes Management: Real-World Evaluation in Bangladesh

Assets

Albiglutide / Dulaglutide / Exenatide / GLP-1 / incretin class catch-all / Liraglutide / Lixisenatide / Semaglutide

Listed sites

1

Recruiting sites

Enrollment

938

estimated

Study population

Type 2 diabetes

Key I/E criterion

HbA1c 7-10%

Primary endpoint

HbA1c, change

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT06449235
Org study IDBIRDEM
Secondary IDBADAS-ERC/EC/24/13BADAS

Timeline

Milestones

Study first posted2024-06-07actual
Last update posted2024-07-16actual
Study start2024-09estimated (month precision)
Primary completion2025-04estimated (month precision)
Study completion2025-06estimated (month precision)

Assets

Investigational agents

Study populations

Who this study enrolls

Type 2 diabetes

Eligibility

Who can enroll

Minimum age18 Years
SexAll
Healthy volunteersNot accepted

Inclusion criteria

Newly diagnosed T2DM (according to American Diabetic Association, ADA guideline) aged (≥ 18 years) treated with stable doses of antidiabetic medications (with or without omarigliptin) along with standard diet and exercise
HbA1C ranged ≥7.0% and ≤10.0%
Stables doses of drug at least 4 weeks

Exclusion criteria

Newly diagnosed T2DM who will be prescribed insulin for diabetes management
History of significant weight loss in past 6 months (more than or equal to 5 kg in 1 month)
Hypersensitivity to any antidiabetic drug
Type 1 diabetes, a history of ketoacidosis,
Active liver disease,
Significant cardiovascular disease,
A history of malignancy,
Hematological disorders
Omarigliptin at any time.
Any acute condition (acute coronary syndrome, acute stroke etc.)
Pregnancy and lactation
eGFR) <30 mL/min/1.73 m2
ALT (alanine aminotransferase)->2 times the upper limit of the normal
AST (aspartate aminotransferase)->2 times the upper limit of the normal
TSH-increased or decreased than the normal range
Hemoglobin <11 g/dL (male) or <10 g/dL (female),
Triglycerides >600 mg/dL, or
C-peptide <0.6 ng/mL

Endpoints (1)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Glycemic / diabetes

1 endpoint
Primary/protocol endpoint

Glycemic Control as Measured by HbA1c Levels

Time frame:Baseline assessment. Follow-up visits at 14 days, 3 months, and 6 months post-enrollment.

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2
Snapshot dateJuly 1, 2026
Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)
Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 1, 2026 snapshot.