New diabetes combo shows promise in chinese patients
NCT ID NCT02924064
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This phase 3 study tested whether adding teneligliptin to metformin helps Chinese adults with type 2 diabetes control their blood sugar better than metformin alone. 247 participants took either teneligliptin or a placebo for 24 weeks. The main goal was to see if HbA1c (a measure of average blood sugar) improved more with the combination.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
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247 people
The number who actually took part.
- Start date
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Sep 2016
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * A signed and dated informed consent form obtained from the subject, in accordance. * The subject is aged ≥18 years at signature of the informed consent form. * Hospitalization status: outpatient. * The subject has a documented diagnosis of type 2 diabetes mellitus for at least 3 months at the screening visit (Day -28). * The subject's type 2 diabetes mellitus is managed by metformin monotherapy ≥1000 mg/day plus diet and exercise therapy, and the dosage or dose regimen of metformin and diet and exercise regimen has not been changed for at least 8 consecutive weeks at the screening visit (Day -28). Subjects who cannot do exercise due to complication are not limited to this criteria. * The subject's HbA1c is ≥ 7.0% and \< 10.0% at the screening visit (Day -28) and on Day -14. Exclusion Criteria: * The subject has a history of type 1 diabetes mellitus or a secondary form of diabetes. * The subject has received insulin within 1 year prior to the screening visit (Day -28), with the exception of insulin therapy during hospitalization or insulin therapy for medical conditions not requiring hospitalization (\< 2 weeks' duration). * The subject has received an anti-diabetic drug within 8 weeks prior to the screening visit (Day -28).
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Investigational center
Beijing, China
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Other studies related to the condition(s) this trial covers.
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